Regeneron Says Antibody Therapy Prevents COVID-19 Infections

Regeneron Pharmaceuticals is planning to ask the Food and Drug Administration (FDA) to allow its antibody cocktail to be used as a preventive treatment for COVID-19, the company said Monday.

New results from a clinical trial conducted with the National Institute of Allergy and Infectious Diseases found the drug reduced the risk of symptomatic infection by 81 percent in people who were not infected at the start of the trial, Regeneron said.

The company has already received emergency use authorization from the FDA to use its antibody drugs to treat adults with mild to moderate COVID-19 and pediatric patients at least 12 years old who have tested positive for the virus and are at high risk of severe disease but are not yet hospitalized.

The trial enrolled 1,505 people who were not infected with the virus but lived in the same household as someone who recently tested positive. The patients were randomized to receive either one dose of the antibody therapy or a placebo administered as injections.

After 29 days, 11 people out of the 753 who received a single 1,200 mg dose of the treatment developed symptomatic COVID-19; 59 people who received a placebo out of 752 participants developed symptomatic COVID-19.

The drug provided 72 percent protection against symptomatic infections in the first week and 93 percent protection in subsequent weeks, Regeneron said. The data has not yet been peer reviewed or published.

Regeneron also said the trial found individuals treated with the therapy who experienced a symptomatic infection resolved their symptoms in one week, compared to three weeks with placebo. Infected individuals also cleared the virus faster with the therapy, the company said.

Adverse events occurred in 20 percent of patients who received the antibody drug and 29 percent of those who received a placebo, Regeneron said, but nobody withdrew from the trial because of them.

None of the participants who received the therapy were hospitalized or went to the ER because of COVID-19 over the course of 29 days; four in the placebo group did so. There were four deaths in the trial — two in the therapy group and two in the placebo group — but none were reported due to COVID-19 or the drug.

“With more than 60,000 Americans continuing to be diagnosed with COVID-19 every day, the REGEN-COV antibody cocktail may help provide immediate protection to unvaccinated people who are exposed to the virus, and we are also working to understand its potential to provide ongoing protection for immunocompromised patients who may not respond well to vaccines,” George Yancopoulos, president and chief scientific officer at Regeneron, said in a statement.

The trial tested the antibody treatment for use as a “passive vaccine,” which involves directly injecting antibodies into the body. Traditional vaccines rely on a person’s immune system to activate and develop its own antibodies.

That means the treatment may provide immediate benefits, in contrast to active vaccines, which take weeks to provide protection. In addition, using injections rather than an infusion could make administering it more convenient than the currently authorized use for antibody drugs.

While much of the attention has been focused on vaccines, experts say therapeutic treatments are just as important to ending the pandemic, which has killed more than 562,000 Americans.

Source: Regeneron says antibody therapy prevents COVID-19 infections | TheHill

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The Strange Story Of Remdesivir, A Covid Drug That Doesn’t Work

Remdesivir in a syringe.

While clinical trials suggest remdesivir isn’t very effective in treating Covid-19, recent studies have shown that it does block Coronavirus activity. That apparent contradiction makes the antiviral drug even more controversial.

Remdesivir is an experimental drug developed by biotech company Gilead Sciences (under the brand name Veklury) in collaboration with the US Centers for Disease Control and Army Medical Research Institute of Infectious Diseases.

It’s one of many drug candidates that were originally designed in response to the threat from emerging diseases caused by RNA viruses — germs like the one behind the 2002 SARS outbreak — that have potential to cause global pandemics.

Such ‘broad-spectrum’ drugs target features shared by a wide range of disease-causing germs. In remdesivir’s case, that’s the virus’ genetic material, RNA. The drug proved ineffective against the Ebola virus, however, yet was still subsequently repurposed for SARS-CoV-2 coronavirus.

Remdesivir is not effective for Covid

News media prematurely reported that patients were responding to treatment. But the published data lated showed that “remdesivir was not associated with statistically significant clinical benefits [and] the numerical reduction in time to clinical improvement in those treated earlier requires confirmation in larger studies.”

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As our special series On the Front Lines continues, NBC’s Joe Fryer profiles one of the country’s first COVID-19 patients, Raymond Sismaet, who spent nearly a month in a hospital before recovering. His story spotlights the antiviral drug remdesivir as a possible coronavirus treatment. » Subscribe to TODAY: http://on.today.com/SubscribeToTODAY » Watch the latest from TODAY: http://bit.ly/LatestTODAY About: TODAY brings you the latest headlines and expert tips on money, health and parenting. We wake up every morning to give you and your family all you need to start your day.
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The controversy surrounding remdesivir therefore revolves around whether the drug is actually an effective treatment. Early studies produced conflicting evidence on remdesivir’s effectiveness. Some found that Covid patients who received the drug recovered faster and fewer people died, but other studies showed that it didn’t reduce the length of hospitalization or death rate.

What’s weird about remdesivir is that it hasn’t been held to the same standards as other drug candidates. Covid-19 vaccines have been developed 10 times faster than traditional drugs, but they’ve passed the phase-3 clinical trials that test whether a potential medicine is both safe and effective in thousands of people.

Normally, a drug is only approved for use by a regulatory body like the US Food and Drug Administration if it meets the two criteria for safety and efficacy. Nonetheless, in October 2020, remdesivir was granted approval by FDA based on promising data from relatively small trials with about 1000 participants.

A large-scale analysis by the World Health Organization’s Solidarity trial consortium has cleared-up the confusion. Based on interim results from studying more than 5000 participants, the international study concluded that remdesivir “had little or no effect on hospitalized patients with Covid-19, as indicated by overall mortality, initiation of ventilation, and duration of hospital stay.”

As a consequence of being mostly ineffective, WHO recommends against the use of remdesivir in Covid-19 patients.

Remdesivir is an expensive drug

The drug is administered over 5 or 10 days. A five-day course of treatment costs around $2600 per person. So for a hospital with hundreds of Covid patients, that would amount to millions of dollars for one antiviral.

That price could be cost-effective if remdesivir saved lives and its use was limited to moderate or severe disease, but it’s also being made available for milder cases and WHO found that it isn’t a lifesaving drug.

What next for remdesivir? Following WHO’s finding, an article in the British Medical Journal highlighted another antiviral as a cautionary tale: oseltamivir or ‘Tamiflu’ — a drug that aims to block the influenza virus.

During the early 2000s, governments started stockpiling Tamiflu, paying billions to its manufacturer, pharmaceutical firm Roche. Then in 2013, independent researchers gained access to Roche’s unpublished data, revealing that the drug caused many side effects and only shortened the duration of flu symptoms by a few hours.

Tamiflu only cost $75 per treatment and yet was still a massive waste of money. The BMJ article implies that the story of remdesivir is another scandal waiting to happen.

Given that remdesivir is expensive and doesn’t seem to save lives, does it have any value? Maybe — but not as a medicine itself. Recent research suggests scientists should at least keep studying how it works in order to develop better drugs.

Remdesivir does block Coronavirus

Remdesivir doesn’t prevent people from being infected by the SARS-CoV-2 virus.

Whereas a vaccine is designed prompt your immune system to recognize the spike protein that allows Coronavirus to invade cells — and protect people from infection — antivirals such as remdesivir aim to disrupt the virus’ ability to replicate, to slow its spread and give your body extra time to develop immunity.

Coronaviruses use RNA for their genetic material — not the DNA used by cells — which means that they need a special molecular machine to copy their genes when producing new virus particles. That machine, ‘RNA polymerase’, is what’s targeted by remdesivir.

Two studies have now revealed how remdesivir blocks SARS-CoV-2 at the molecular level.

First, chemical engineers at the University of Chicago found that remdesivir is better at reducing virus replication than two similar antivirals, ribavirin and favilavir. Their computer models suggest that remdesivir beats the other drugs because it’s the best at binding and destabilizing the RNA polymerase.

In the second new study, researchers at the University of Texas at Austin used ‘cryogenic-electron microscopy’ (cryo-EM) to take snapshots of the structure of the molecules involved in replication as they would interact in a Covid patient.

After adding remdesivir to RNA polymerase, cryo-EM images showed that the drug acts like a blockage in a photocopier, getting stuck in the RNA polymerase. When four molecules of remdesivir get between the gears of the polymerase machine, its copies of RNA ‘paper’ can no longer pass through, stalling the virus-copying process.

That leads us to why it’s worth studying remdesivir. As structural biologist David Taylor explains, “We were able to identify the point where that paper jam happens […] If we want to make the blockage even worse, we could do so.”

One of remdesivir’s flaws is its (possibly toxic) high dosage over a short timeframe, which contributes to adverse side effects. By tweaking the drug molecule’s structure, scientists may be able to make it block the RNA polymerase machine with fewer molecules, which would then allow the drug to be delivered in a smaller dose.

In fact, Gilead Sciences has already isolated a compound similar to remdesivir, GS-441524, which costs less and is easier to manufacture. It’s also simpler to administer: while remdesivir must be injected, GS-441524 could be ingested in pill form. More of the molecule reaches the lungs — the main site of infection — too, which led researchers to state that “GS-441524 is superior to remdesivir for Covid-19 treatment.”

As SARS-CoV-2’s genetic material mutates to create new strains of the virus — and variants of Covid-19 — we may need antivirals to buy us time if those new strains end-up evading our current vaccines.

So despite being expensive and ineffective at treating Covid, remdesivir’s true value could be to help researchers create more effective medicines.

Follow me on Twitter or LinkedIn. Check out my website or some of my other work here.

I’m a science communicator specialising in public engagement and outreach through entertainment, focusing on popular culture. I have a PhD in evolutionary biology and spent several years at BBC Science Focus magazine, running the features section and writing about everything from gay genes and internet memes to the science of death and origin of life. I’ve also contributed to Scientific American and Men’s Health. My latest book is ’50 Biology Ideas You Really Need to Know’

Source: The Strange Story Of Remdesivir, A Covid Drug That Doesn’t Work

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India Bans Exports of Antiviral Drug Remdesivir as COVID-19 Cases Surge
science.thewire.in – Today
Seven Indian companies have licensed the drug from Gilead Sciences, with an installed capacity of about 3.9 million units per month.
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India bans exports of Remdesivir drug as new COVID-19 cases hit another record | Health
India on Sunday banned the export of anti-viral drug Remdesivir and its active pharmaceutical ingredients as demand rocketed due to a record surge in COVID-1 […] In addition to the Remdesivir ban “till the situation improves”, the health ministry said in a statement that manufacturers ha […] media posts on Sunday showed large queues of people in the western state of Gujarat waiting to buy Remdesivir injections for COVID-19 patients. “Every day the central government is providing 50,000 Remdesivir injections but all of them are getting consumed,” Rajesh Tope, health minister of India’ […]
0
Amidst sharp rise in COVID-19 cases, India bans export of Remdesivir; its active pharmaceutical ingredients
asianews.press – Today
[…] As a result, it has led to a sudden spike in demand for Injection Remdesivir used in the treatment of COVID patients and the potential for a further increase in this demand i […] The Government of India has prohibited the exports of Injection Remdesivir and Remdesivir Active Pharmaceutical Ingredients (API) “till the situation improves in the country […] India govt has taken the following steps to ensure easy access of hospital and patients to Remdesivir: All domestic manufactures of Remdesivir have been advised to display on their website, details of their stockists/distributors t […]
1
No export of Remdesivir till COVID situation improves in India: Govt
New Delhi: In view of increased demand for Remdesivir due to a surge in COVID-19 cases, the Centre on Sunday said the export of the antiviral injectio […] which is used in treatment of coronavirus, to hospitals and patients, all domestic manufacturers of Remdesivir have been advised to display on their website details of their stockists and distributors, th […] This has led to a sudden spike in demand for Remdesivir injection used in treatment of COVID patients,” the ministry said […] “In light of the above, Government of India has prohibited the exports of remdesivir injection and remdesivir Active Pharmaceutical Ingredients (API) till the situation improves,” it said […]
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India halts export of key Covid drug Remdesivir as cases rise across country
theprint.in – Today
Text Size: A- A+ New Delhi: The Centre on Sunday prohibited exports of injection Remdesivir and Remdesivir Active Pharmaceutical Ingredients (API) till the Covid-19 situation in the country improves. Remdesivir is considered a key anti-viral drug in the fight against Covid-19 […] addition, the government has taken three steps to ensure easy access of hospitals and patients to Remdesivir. All domestic manufactures of Remdesivir have been advised to display on their website, details of their stockists/distributors t […]
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Enterprise Information | Inventory and Share Market Information – Information by Automobilnews.eu
automobilnews.eu – Today
“Export of injection Remdesivir and Remdesivir Energetic Pharmaceutical Components (API) prohibited until the COVID-19 state of affairs within the […]
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As coronavirus cases spike, Indore’s health infrastructure gets stretched | Business Standard News
[…] uploading videos and messages on social media about shortage of beds and key medicines like Remdesivir […] He said Remdesivir consignments were coming in at present and their distribution was taking place as per guidelines […] “Doctors have been told to give Remdesivir injections only to those who absolutely need it,” Satya said […]
2
India bans exports of anti-viral drug Remdesivir as COVID-19 cases surge
India on Sunday banned the export of anti-viral drug Remdesivir and its active pharmaceutical ingredients as demand rocketed due to a record surge in COVID-1 […] sixth record rise in seven days, harried relatives of patients made a kilometre-long queue to buy Remdesivir outside a big hospital in the western state of Gujarat, witnesses said […] In addition to the Remdesivir ban “till the situation improves,” the health ministry said that manufacturers had been asked t […] The World Health Organization in November issued a conditional recommendation against the use of Remdesivir in hospitalized patients, saying there was no evidence that the drug improved survival and othe […]
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Covid-19: India bans export of Remdesivir injection, API
India today prohibited the export of Remdesivir injection, which is used to treat Covid patients, and also Remdesivir Active Pharmaceutical Ingredients (API), amidst a surge in coronavirus cases in the country […] “This has led to a sudden spike in the demand for injection Remdesivir used in treatment of Covid patients […] Seven Indian companies are producing the Remdesivir injection under voluntary licensing agreement with M/S Gilead Sciences of the USA […]
3
Maharashtra likely to announce 15-day lockdown after weekend curbs, marginal drop in Covid-19 cases after night curfew
[…] Other suggestions by Fadnavis like the early report of tests, availability of Remdesivir and oxygen for treatment will also be considered […]
1
“For God’s Sake, Get Vaccine, Drugs”: Top Mumbai Doctor’s Desperate Appeal
[…] The hospital was not only short of vaccines but also life-saving drugs like Remdesivir, said Dr Jalil Parkar, a pulmonary consultant with the hospital […] There is a shortage of Remdesivir, there is shortage of Tosilizubam […] “My earnest request for god’s sake please see to it that Remdesivir, Tosilizubam, vaccination — they are available […]
0
COVID-19: Centre bans exports of anti-viral drug Remdesivir till situation in India improves
COVID-19: Centre bans exports of anti-viral drug Remdesivir till situation in India improves India’s sudden spike in COVID-19 cases has led to an increase i […] Zee Media Updated: Apr 11, 2021, 06:29 PM IST The Centre on Sunday prohibited exports of injection Remdesivir and Remdesivir Active Pharmaceutical Ingredients (API) till the Covid-19 situation in the country improves […] data on deaths In light of the above, Government of India has prohibited the exports of Injection Remdesivir and Remdesivir Active Pharmaceutical Ingredients (API) till the situation improves,” the statement said […]
1
8k Remdesivir vials have arrived: Madhya Pradesh official as cases surge
[…] (Representational image: IE) Amid a surge in coronavirus cases and a clamour for Remdesivir, a drug considered useful in the treatment of the infection, a senior Madhya Pradesh official o […]
1
India bans Remdesivir exports till COVID surge abates
Seven Indian companies producing Remdesivir injections under voluntary licensing agreement with US-based Gilead Sciences have an installed capacity of about 38.80 lakh units per month
2
Government Halts Export Of Remdesivir Till COVID-19 Situation Improves
[…] The Government of India said: “Export of injection Remdesivir and Remdesivir Active Pharmaceutical Ingredients (API) prohibited till the COVID-19 situation in the countr […] of Pharmaceuticals has been in contact with the domestic manufacturers to ramp up the production of Remdesivir in India. Notably, there are seven Indian companies that are currently producing injection Remdesivir under voluntary licensing agreement with M/s Gilead Sciences, USA […]
6
Export of anti-viral drug remdesivir prohibited in view of increased demand due to surge in COVID-19 cases: Centre. | Newsalert
Export of anti-viral drug remdesivir prohibited in view of increased demand due to surge in COVID-19 cases: Centre. PTI | New Delhi | Updated: 11-04-2021 18:11 IST | Created: 11-04-2021 18:11 IST Export of anti-viral drug remdesivir prohibited in view of increased demand due to surge in COVID-19 cases: Centre. (This story has not been edited by Devdiscourse staff and is auto-generated from a syndicated feed.) POST / READ COMMENTS Country India Share
0
Clinical Research Forum Presents Moderna and Pfizer with Award for Extraordinary Impact on Health | NEWS-Line for Healthcare Professionals
[…] Hospital; Margaret Lippincott, MD, Instructor in Medicine, Massachusetts General Hospital · Remdesivir in COVID 19 – John Beigel, MD, Associate Director for Clinical Research, National Institute o […]
1
Centre bans export of Remdesivir amid crunch, eases access of Covid patients to anti-viral drug – Coronavirus Outbreak News
[…] being used in the treatment of Covid-19 patients, the Centre has prohibited the export of Injection Remdesivir and Remdesivir Active Pharmaceutical Ingredients (API) […] In a press note on Sunday, the Centre prohibited exports of Injection Remdesivir and Remdesivir Active Pharmaceutical Ingredients (API). A number of companies in India produce Injection Remdesivir under a voluntary licensing agreement with US pharma giant Gilead Sciences […]
3
For God’s Sake, Get Vaccine, Drugs: Top Mumbai Doctor’s Desperate Appeal
[…] The hospital was not only short of vaccines but also life-saving drugs like Remdesivir, said Dr Jalil Parkar, a pulmonary consultant with the hospital […] There is a shortage of Remdesivir, there is shortage of Tosilizubam […] “My earnest request for god’s sake please see to it that Remdesivir, Tosilizubam, vaccination — they are available […]
16
Government bans export of Remdesivir till Covid-19 situation improves
economictimes.indiatimes.com – Today
[…] In an order, the government said it has banned export of Remdesivir injection and Remdesivir active pharmaceutical ingredients (API) till the pandemic situation in the country stabilises […] the government has also taken a few steps to ensure easy access of hospital and patients to Remdesivir. These steps are: – All domestic manufactures of Remdesivir have been advised to display on their website, details of their stockists/distributors t […]
6
COVID-19: India bans export of Remdesivir drug, injection as coronavirus cases surge | India News
zeenews.india.com – Today
CORONAVIRUS COVID-19: India bans export of Remdesivir drug, injection as coronavirus cases surge The Centre banned the export of Remdesivir and its active pharmaceutical ingredients as the demand for anti-viral drug Remdesivir has surged […] As India experiences a second wave of novel coronavirus infections, the demand for anti-viral drug Remdesivir has surged too. The Centre on Sunday (April 11, 2021) banned the export of Remdesivir and its active pharmaceutical ingredients […]
16
India bans export of Remdesivir, its ingredients till COVID situation improves | Coronavirus News | Inshorts
inshorts.com – Today
india has banned the export of injection remdesivir and its active pharmaceutical ingredients api till the coronavirus situation in the country improves the centre said on sunday theres potential for further increase in demand for remdesivir in the coming days the government said adding that the …
0
Centre Bans Export of Remdesivir and Its Active Ingredients till Covid Crisis Eases in India
The Centre on Sunday prohibited the export of Remdesivir injection and its active pharmaceutical ingredients (API) till the pandemic situation arising ou […] The decision has been taken to ensure easy access of Remdesivir to infected patients and hospitals providing treating against the virus […] Several hospitals have complained of shortage of Remdesivir, considered a key anti-viral drug in the fight against COVID-19, especially in adult patients wit […] other steps to bring the situation under control, including advising all domestic manufactures of Remdesivir to display on their website, details of their stockists and distributors to facilitate access t […]
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India bans export of Remdesivir injection amid surge in Covid cases | India News – Times of India
NEW DELHI: India on Sunday banned the export of Remdesivir injection till the Covid-19 situation improves in the country […] The government in a statement said that all domestic manufactures of Remdesivir have been advised to display on their website, details of their stockists/distributors t […] of Pharmaceuticals has been in contact with the domestic manufacturers to ramp up the production of Remdesivir […] The alarming spike in Covid cases in the country has led to a sudden increase in demand for the Remdesivir injection used in treating Covid patients […]
0
India bans exports of anti-viral drug Remdesivir as COVID-19 cases surge
NEW DELHI: India said on Sunday it had banned the export of anti-viral drug Remdesivir and its active pharmaceutical ingredients after a record spike in COVID-19 cases sent deman […] “In light of the above, Government of India has prohibited the exports of Injection Remdesivir and Remdesivir Active Pharmaceutical Ingredients (API) till the situation improves,” the health ministry said in a […]
0
India bans exports of anti-viral drug Remdesivir as COVID-19 cases surge | Reuters
[…] 1 MIN READ NEW DELHI (Reuters) – India said on Sunday it had banned the export of anti-viral drug Remdesivir and its active pharmaceutical ingredients after a record spike in COVID-19 cases sent deman […] “In light of the above, Government of India has prohibited the exports of Injection Remdesivir and Remdesivir Active Pharmaceutical Ingredients (API) till the situation improves,” the health ministry said in a […]
2
India bans export of Remdesivir injection amid surge in Covid cases | India News – Times of India
timesofindia.indiatimes.com – Today
India News: NEW DELHI: India on Sunday banned the export of Remdesivir injection till the Covid-19 situation improves in the country.
19
No lockdown in Madhya Pradesh, only ‘corona curfew’, says CM | Business Standard News
[…] We have received 4,000 injections of Remdesivir (the key anti-viral drug) and would be getting 5,000 more today […]
N/A
Coronavirus: Centre bans export of antiviral drug Remdesivir amid surge in cases
scroll.in – Today
The Centre on Sunday banned the export of antiviral drug Remdesivir indefinitely, in view of the rising coronavirus cases in the country, ANI reported […] The government said the ban, which covers Remdesivir injections and Remdesivir active pharmaceutical ingredients, will be lifted only after there is an improvement in th […] Remdesivir is considered a key drug in combating Covid-19, especially in adult patients with sever […]
1
Gilead Sciences : India bans exports of anti-viral drug Remdesivir as COVID-19 cases surge | MarketScreener
“In light of the above, Government of India has prohibited the exports of Injection Remdesivir and Remdesivir Active Pharmaceutical Ingredients (API) till the situation improves,” the health ministry said in a statement. Seven Indian companies have licensed the drug from Gilead Sciences, with an installed capacity of about 3.9 million units per month. (Reporting by Krishna N. Das and Devjyot Ghoshal; Editing by Susan Fenton)
0
Centre Prohibits Export of Remdesivir till COVID-19 Situation in Country Improves
Centre Prohibits Export of Remdesivir till COVID-19 Situation in Country Improves…
1
India bans exports of anti-viral drug Remdesivir as COVID-19 cases surge
mumbaimirror.indiatimes.com – Today
India bans exports of anti-viral drug Remdesivir as COVID-19 cases surge Reuters / Updated: Apr 11, 2021, 17:50 IST Representational Image […] Photo: BCCL New Delhi: India said on Sunday it had banned the export of anti-viral drug Remdesivir and its active pharmaceutical ingredients after a record spike in COVID-19 cases sent deman […] “In light of the above, Government of India has prohibited the exports of Injection Remdesivir and Remdesivir Active Pharmaceutical Ingredients (API) till the situation improves,” the health ministry said in a […]
7
Centre prohibits export of Remdesivir & its API till COVID-19 situation improves in India
With several states complaining of shortage of Remdesivir injections – which is used in COVID-19 treatment, the Centre on Sunday, has banned the export of Remdesivir and Remdesivir Active Pharmaceutical Ingredients (API) till the COVID-19 situation in the country improves […] READ | Remdesivir shortage in Nagpur; Union Minister Nitin Gadkari dials Sun Pharma chief Govt bans export of Remdesivir Additionally, Centre has taken the following steps to streamline Remdesivir supply: All domestic manufactures of Remdesivir have been advised to display on their website […]
15
Govt suspends export of Remdesivir till coronavirus situation improves | Business Standard News
The union government on Sunday suspended the export of Remdesivir injections and Remdesivir Active Pharmaceutical Ingredients (API) till the coronavirus situation improves in the country […] “The current situation has led to a sudden spike in demand for Remdesivir injection used in treatment of Covid patients […] In addition, the government has taken the steps to ensure easy access of hospital and patients to Remdesivir All domestic manufactures of Remdesivir have been advised to display on their website, details of their stock lists or distributors t […]
2
India bans export of Remdesivir drug, injection till Covid situation improves
“Export of injection Remdesivir and Remdesivir Active Pharmaceutical Ingredients (API) prohibited till the COVID-19 situation in the countr […] This has led to a sudden spike in demand for Injection Remdesivir used in treatment of COVID patients. There is a potential of a further increase in demand for Remdesivir injection in the coming days,” the Centre said in a statement […] of Pharmaceuticals has been in contact with domestic manufacturers to ramp up the production of Remdesivir, it further stated. In its fresh order, it said that all domestic manufactures of Remdesivir advised to display on their website, details of their stockists/distributors to facilitate acces […]
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No lockdown in MP, only ‘corona curfew’: Chouhan | Health
[…] We have received 4,000 injections of Remdesivir (the key anti-viral drug) and would be getting 5,000 more today […]
0
India Bans Export Of Anti-Viral Drug Remdesivir Amid Surge In Covid Cases
[…] In an order, the government said it has banned export of Remdesivir injection and Remdesivir active pharmaceutical ingredients (API) till the pandemic situation in the country stabilises […] To ensure more people can get Remdesivir, the government said manufactures of Remdesivir have been asked to show on their website the details of their stockists and distributors […] of Pharmaceuticals has been in contact with the domestic manufacturers to ramp up the production of Remdesivir,” the government said. The National Clinical Management Protocol for COVID-19 lists Remdesivir as an investigational therapy, where informed and shared decision making is essential […]
14
Remdesivir injections and Favipiravir tablets vanish from UP’s Prayagraj medicine shops | Allahabad News
dlsnewsindia.com – Today
PRAYAGRAJ: The Remdesivir injection and Favipiravir tablets seem to have vanished from the city-based medicine market wit […] at Leader road dealing wholesale medicine market claimed that there was an acute shortage of Remdesivir injection and Favipiravir tablets […] UP Chemist & Druggist Federation admitted to TOI that there has been an acute shortage of Remdesivir injection and Favipiravir tablets in markets and we have been demanding from concerne […] “ I have made calls to my relatives to arrange Remdesivir injection after seeing its acute crisis in city” said Ashutosh who arrived Leader road medicin […]
0
NEWS HIGHLIGHTS FROM WESTERN REGION AT 5 pm. | Law-Order
[…] BOM2 MH-REMDESIVIR-CONTROL ROOMS Maha to set up control rooms for smooth supply of Remdesivir Mumbai: The Maharashtra government has decided to set up district-level control rooms to ensur […] government has decided to set up district-level control rooms to ensure smooth supply of Remdesivir injections and prevent hoarding and black-marketing of the drug, officials said on Sunday […]
0
Coronavirus update: Latest Covid-19 vaccine and world news
[…] India has banned the export of anti-viral drug remdesivir and its active pharmaceutical ingredients following a rise in coronavirus cases, a statement fro […] The ban would apply to Injection Remdesivir and Remdesivir Active Pharmaceutical Ingredients (API) until the Covid-19 situation in the country improves, th […] ministry said, adding that this rise has led to a sudden spike in demand for the anti-viral drug remdesivir and its active pharmaceutical ingredients used in the treatment of coronavirus patients […]
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[…] Carnival-loving, eloquent Soeder wants to be Germany’s first Bavarian chancellor 2h ago India bans Remdesivir exports as coronavirus rages on; rallies continue 2h ago Pacific island devotees of Prince Phili […]
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AAP slams BJP’s ‘free Remdesivir distribution’ in Surat; Guj CM says ‘not from govt stock’
Last Updated: 11th April, 2021 16:37 IST AAP Slams BJP’s ‘free Remdesivir Distribution’ In Surat; Guj CM Says ‘not From Govt Stock’ Slamming BJP’s Gujarat unit over Remdesivir injection hoarding, AAP said that the BJP had taken PM Modi’s message of  “converting disasters o […] Currently, Gujarat’s neighbouring state Maharashtra too is facing an acute Remdesivir shortage. READ | Maharashtra to set up control rooms for smooth supply of Remdesivir amid COVID crisis “About Surat, C R Paatil has arranged for 5,000 Remdesivir injections […]
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FREE Coronavirus Awareness Training – Free E-Learning Course
[…] trials are looking at the potential use of two HIV drugs as well as another antiviral called Remdesivir that was developed to tackle haemorrhagic fevers including Ebola […]

AstraZeneca Battles Supply Chain Issues, Denies Claims Its Covid-19 Vaccine Is Largely Ineffective In Seniors

Pharma giant AstraZeneca could face strict new export rules from the European Union that could restrict supply of its Covid-19 vaccine outside the bloc, as officials pressure the company to explain production shortfalls, while the company denies claims in German media that its vaccine is mostly ineffective in seniors.

Key Facts

Citing government sources, two German papers reported Monday that the efficacy of the vaccine AstraZeneca developed with the University of Oxford was “less than 10%” and 8% in those over 65.  

AstraZeneca said the claims are “completely incorrect” and go against published data from its clinical trials which showed a significant response in over-65s..

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Oxford University , which developed the vaccine with AstraZeneca, told the Financial Times there is “no basis for the claims of very low efficacy.”

The German health ministry also rejected the reports Tuesday, suggesting that the newspapers had got confused with the statistics. 

The confusion comes as tensions between AstraZeneca and the European Union soar to new levels, with the bloc furious at the company’s apparent inability or refusal to explain why it cannot honor its agreements and threatening to introduce new export rules for vaccines leaving the Union. 

Forbes has contacted  AstraZeneca to find out whether its supply chain issues and export rules could threaten vaccine supply to other parts of the world.

Key Background

On Friday, AstraZeneca informed Brussels that production issues meant it would be unable to honor its contractual commitments to provide doses to the EU. The vaccine is expected to be approved shortly and the delays mark another setback for the bloc’s vaccination efforts, which are already being hampered by a temporary reduction in deliveries from Pfizer while it makes changes to its production site.  

Chief Critic 

The EU stopped short of directly accusing AstraZeneca of reneging on its contracts in order to sell doses elsewhere, but said: “The European Union wants to know exactly which doses have been produced by AstraZeneca and where exactly so far and if or to whom they have been delivered,” Stella Kyriakides, the European Commissioner for Health and Food Safety, said in a statement.

Later, Kyriakides tweeted that discussions with the pharma giant “resulted in dissatisfaction” and there was a “lack of clarity and insufficient explanations.

What To Watch For

The EU may follow through on its threat to implement new vaccine export rules. This would require companies to seek permission before exporting internationally.   

Big Number 

31 million. This is how many doses the bloc is now expecting before the end of March, an EU official told Reuters. That amounts to a 60% cut.

Further Reading

Enraged at AstraZeneca over shortfall, EU calls for vaccine export controls (Politico)

AstraZeneca: German reports on low efficacy on over-65s ‘completely incorrect’ (DW)

Full coverage and live updates on the CoronavirusFollow me on Twitter. Send me a secure tip

Robert Hart

Robert Hart

I am a London-based reporter for Forbes covering breaking news. Previously, I have worked as a reporter for a specialist legal publication covering big data and as a freelance journalist and policy analyst covering science, tech and health. I have a master’s degree in Biological Natural Sciences and a master’s degree in the History and Philosophy of Science from the University of Cambridge. Follow me on Twitter @theroberthart or email me at rhart@forbes.com

.

CNBC Television

AstraZeneca has received more than $1 billion from the U.S. Health Department’s Biomedical Advanced Research and Development Authority (BARDA) to develop a coronavirus vaccine from the University of Oxford. Pascal Soriot, CEO of AstraZeneca, joins “Squawk Box” and CNBC’s Meg Tirrell to discuss the company’s efforts to develop a Covid-19 vaccine. For access to live and exclusive video from CNBC subscribe to CNBC PRO: https://cnb.cx/2JdMwO7​ » Subscribe to CNBC TV: https://cnb.cx/SubscribeCNBCtelevision​ » Subscribe to CNBC: https://cnb.cx/SubscribeCNBC​ » Subscribe to CNBC Classic: https://cnb.cx/SubscribeCNBCclassic​ Turn to CNBC TV for the latest stock market news and analysis. From market futures to live price updates CNBC is the leader in business news worldwide. Connect with CNBC News Online Get the latest news: http://www.cnbc.com/​ Follow CNBC on LinkedIn: https://cnb.cx/LinkedInCNBC​ Follow CNBC News on Facebook: https://cnb.cx/LikeCNBC​ Follow CNBC News on Twitter: https://cnb.cx/FollowCNBC​ Follow CNBC News on Instagram: https://cnb.cx/InstagramCNBC

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Billionaire Eric Lefkofsky’s Tempus Raises $200 Million To Bring Personalized Medicine To New Diseases

On the surface, Eric Lefkofsky’s Tempus sounds much like every other AI-powered personalized medicine company. “We try to infuse as much data and technology as we can into the diagnosis itself,” Lefkofsky says, which could be said by the founder of any number of new healthcare companies.. But what makes Tempus different is that it is quickly branching out, moving from a focus on cancer to additional programs including mental health, infectious diseases, cardiology and soon diabetes. “We’re focused on those disease areas that are the most deadly,” Lefkofsky says. 

Now, the billionaire founder has an additional $200 million to reach that goal. The Chicago-based company announced the series G-2 round on Thursday, which includes a massive valuation of $8.1 billion. Lefkofsky, the founder of multiple companies including Groupon, also saw his net worth rise from the financing, from an estimated $3.2 billion to an estimated $4.2 billion.

Tempus is “trying to disrupt a very large industry that is very complex,” Lefkofsky says, “we’ve known it was going to cost a lot of money to see our business model to fruition.” 

In addition to investors Baillie Gifford, Franklin Templeton, Novo Holdings, and funds managed by T. Rowe Price, Lefkofsky, who has invested about $100 million of his own money into the company since inception, also contributed an undisclosed amount to the round. Google also participated as an investor, and Tempus says it will now store its deidentified patient data on Google Cloud. 

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“We are particularly attracted to companies that aim to solve fundamental and complex challenges within life sciences,” says Robert Ghenchev, a senior partner at Novo Holdings. “Tempus is, in many respects, the poster child for the kind of companies we like to support.” 

MORE FOR YOUTony Hsieh’s American Tragedy: The Self-Destructive Last Months Of The Zappos VisionaryWhy 40 North Ventures Bought GE Ventures’ Stakes In 11 Industrial StartupsAt-Home Health Testing Company Everlywell Raises $175 Million Series D Round At A $1.3 Billion Valuation

Tempus, founded by Lefkofsky in 2015, is one of a new breed of personalized cancer diagnostic companies like Foundation Medicine and Guardant Health. The company’s main source of revenue comes from sequencing the genome of cancer patients’ tumors in order to help doctors decide which treatments would be most effective. “We generate a lot of molecular data about you as a patient,” Lefkofsky says. He estimates that Tempus has the data of about 1 in 3 cancer patients in the United States. 

But billing insurance companies for sequencing isn’t the only way the company makes money. Tempus also offers a service that matches eligible patients to clinical trials, and it licenses  de-identified patient data to other players in the oncology industry. That patient data, which includes images and clinical information, is “super important and valuable,” says Lefkofsky, who adds that such data sharing only occurs if patients consent. 

At first glance, precision oncology seems like a crowded market, but analysts say there is still plenty of room for companies to grow. “We’re just getting started in this market,” says Puneet Souda, a senior research analyst at SVB Leerink, “[and] what comes next is even larger.” Souda estimates that as the personalized oncology market expands from diagnostics to screening, another $30 billion or more will be available for companies to snatch up. And Tempus is already thinking ahead by moving into new therapeutic areas. 

While it’s not leaving cancer behind, Tempus has branched into other areas of precision medicine over the last year, including cardiology and mental health. The company now offers a service for psychiatrists to use a patient’s genetic information to determine the best treatments for major depressive disorder. 

In May, Lefkofsky also pushed the company to use its expertise to fight the coronavirus pandemic. The company now offers PCR tests for Covid-19, and has run over 1 million so far. The company also sequences other respiratory pathogens, such as the flu and soon pneumonia. As with cancer, Tempus will continue to make patient data accessible for others in the field— for a price. “Because we have one of the largest repositories of data in the world,” says Lefkofsky, “[it is imperative] that we make it available to anyone.” 

Lefkofsky plans to use capital from the latest funding round to continue Tempus’ expansion and grow its team. The company has hired about 700 since the start of the pandemic, he says, and currently has about 1,800 employees. He wouldn’t comment on exact figures, but while the company is not yet profitable he says Tempus has reached “significant scale in terms of revenue.” 

And why is he so sure that his company’s massive valuation isn’t over-inflated? “We benefit from two really exciting financial sector trends,” he says: complex genomic profiling and AI-driven health data. Right now, Lefkofsky estimates, about one-third of cancer patients have their tumors sequenced in three years. Soon, he says, that number will increase to two-thirds of patients getting their tumors sequenced multiple times a year. “The space itself is very exciting,” he says, “we think it will grow dramatically.” Follow me on Twitter. Send me a secure tip

Leah Rosenbaum

Leah Rosenbaum

I am the assistant editor of healthcare and science at Forbes. I graduated from UC Berkeley with a Master’s of Journalism and a Master’s of Public Health, with a specialty in infectious disease. Before that, I was at Johns Hopkins University where I double-majored in writing and public health. I’ve written articles for STAT, Vice, Science News, HealthNewsReview and other publications. At Forbes, I cover all aspects of health, from disease outbreaks to biotech startups.

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Eric Lefkofsky

To impact the nearly 1.7 million Americans who will be newly diagnosed with cancer this year, Eric Lefkofsky, co-founder and CEO of Tempus, discusses with Matter CEO Steven Collens how he is applying his disruptive-technology expertise to create an operating system to battle cancer. (November 29, 2016)

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Dosing Error By Researchers In The AstraZeneca-Oxford University Vaccine Trial Boosted Its Success Rate To 90%

  • AstraZeneca scientist Mene Pangalos says ‘serendipity,’ led to a break through 
  • ‘Mistake’ helped scientists discover half-dose was more effective than a full one 
  • More analysis needed to explain why an initial lower dose was more effective

A dosing error by researchers on the AstraZeneca-Oxford University Covid vaccine trial led to a huge boost in the jab’s success rate, the pharmaceutical company’s vice president has revealed.

Dr Mene Pangalos, head of AstraZeneca’s biopharmaceutical research, said the discovery that giving a half-dose at the start worked better was a lucky accident. He said: ‘The reason we had the half dose is serendipity.’ 

Volunteers were expected to receive two full doses of the vaccine. What happened with these participants would then be compared with the other half of the study group, who received a placebo.

Dr Pangalos said researchers were confused when they noticed volunteers in the vaccine group were reporting much milder side effects, such as fatigue, headaches and arm aches, than they originally predicted.  

He said: ‘So we went back and checked … and we found out that they had underpredicted the dose of the vaccine by half.’

Study results published yesterday showed that Oxford’s vaccine appeared to be up to 90 per cent effective in people who received the vaccine as a half-dose followed up by a full dose weeks later, compared to a lower 62 per cent when they were given two full doses.

Scientists explained this could be because the first smaller dose effectively prepared the immune system by showing it a small sample of the coronavirus, and then the full dose later on triggered a full-blown immune response.

Dr Pangalos said that despite the error the team decided to press ahead with the half-dose group, and to administer the second, full dose booster shot at the scheduled time.

The results showed the vaccine was 90 per cent effective among this group, while a larger group who had received two full doses produced an efficacy read-out of 62 per cent, leading to an average efficacy of 70 per cent across both dosing patterns, Dr Pangalos said.

‘That, in essence, is how we stumbled upon doing half dose-full dose (group),’ he told Reuters. ‘Yes, it was a mistake.’

It is now likely that doctors will be advised to use the 1.5 dose regimen of the vaccine rather than the full two doses because it appears to be more effective.

This will also mean that the jab, expected to cost around £2 per dose, will stretch further.

The 100million doses pre-ordered by the UK, for example, would have covered 50million people using a full two-dose system, but could now stretch to the entire population of 66million.

Although the clinical trial’s early results were published yesterday, the study is not completed.

Oxford researchers said they intend to publish the full results of the trial in a medical journal in the coming weeks and will then submit an application to the drugs regulator, the MHRA, for a licence to use the vaccine on members of the public.

This process could then take days or weeks for the MHRA to decide whether the jab is good enough to use before it can start to be given out – this is currently expected to be completed in December. 

The vaccine uses a harmless adenovirus to deliver genetic material that tricks the human body into producing proteins known as antigens that are normally found on the coronavirus’s surface, helping the immune system develop an arsenal against infection.

Dr Pangalos said more analysis was needed to explain why an initial lower dose bolstered protection. 

One possible explanation was that lower antigen levels to begin with triggered an overall better immune system build-up, he added.  

Oxford University confirmed its cheap, easy to store and simple to deliver jab could be approved by regulators in as little as a fortnight and start to be administered next month. 

Britain has ordered 100million doses, with almost 20million due by Christmas.

Professor Andrew Pollard, head of the Oxford Vaccine Group and a professor who has spent two decades running clinical trials, said that while speed of the Covid-19 vaccine’s development was in some ways extraordinary, 2020 had ‘been a very long year’ since the team started work on the vaccine in January.

That culminated this past weekend, Pollard said, in having ‘an enormous mountain to climb to pull all of the information together’ to be able to issue the early phase three trial results.

He added: ‘The last few weeks have been pretty exhausting. The feeling is absolutely one of extreme fatigue and tiredness at this point.

‘If the results have not met those regulatory requirements, they would have told us just to carry on with the trial. So it was a great relief.’

By Luke May For Mailonline and Sam Blanchard Senior Health Reporter For Mailonline

Source: DailyMail

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Affordable Steroids Could Reduce Some COVID-19 Deaths by One-Third, Says World Health Organization

You’d think a robust immune system would be an awfully good thing to have if you’re battling COVID-19—and much of the time it is. But in the most extreme cases—the ones the World Health Organization (WHO) labels as “severe and critical,” denoting the most extremely ill, typically hospitalized patients, with the highest risk of death—the system meant to protect the body from disease can make things worse, leading to inflammation and other damage to the lungs, which in turn can result in an often fatal case of acute respiratory distress syndrome (ARDS).

In June, a single large study of more than 6,200 patients found that corticosteroids, a class of drugs that reduce inflammation, could prevent at least some cases of coronavirus-related ARDS and the resulting deaths. Today, the WHO confirmed that preliminary report, announcing a new policy, based on a study published in JAMA, calling for the administration of steroids to all patients in the “severe and critical” category, based on findings that the treatment could reduce mortality by slightly more than one third.

The new conclusions were reached through a meta-analysis of seven different studies, each exploring the efficacy of corticosteroids in the most serious cases of COVID-19. The combined sample group from all seven studies included 1,703 severely ill patients, 678 of whom were administered steroids and 1,025 who received ordinary care (which did not include steroids) or a placebo. All of the patients were hospitalized and most were on ventilators. Over the course of 28 days, the death rate was 34% lower among the steroid-treated patients than among those in the control group.

“The consistent findings of benefit in these studies provide definitive data that corticosteroids should be first-line treatment for critically ill patients with COVID-19,” wrote Dr. Hallie Prescott, professor of medicine at the University of Michigan, and Dr. Todd Rice, professor of Medicine at Vanderbilt University, in a JAMA editorial that accompanied the publication of the study.

Inside Barcelona’s Unfinished Masterpiece

The findings come with limitations. Steroids should not be used prophylactically in people with less serious cases of COVID-19, since the very suppression of immune system action that helps prevent or treat ARDS would only worsen the condition of people whose immune systems are functioning as they should, battling the virus without damaging the lungs. WHO also warned against “indiscriminate use” of any anti-COVID-19 therapeutic, including steroids, for fear of creating global shortages.

One new therapy that is 34% effective against one subset of cases of a disease that has sickened nearly 26 million people worldwide is not yet the stuff of victory parades. But in the grinding war against COVID-19, it is an undeniable victory in one important battle.

By Jeffrey Kluger

Dr. Steven O’Day talks about treating COVID-19 with the steroid Dexamethasone. As seen on the NBC4 News at 4 p.m. on Tuesday, June 16, 2020. ——— Don’t miss an NBCLA video, subscribe here: https://bit.ly/2NnofFF For more, visit NBCLA.COM here: https://bit.ly/2uB6niE On Facebook: https://bit.ly/2uFU1px On Twitter: https://bit.ly/2JsBm5Y About NBCLA The West Coast flagship station of the NBCUniversal Owned Television Stations, serving the vast region since 1949. NBC4 produces 43 hours each week of local news and weather, and the station features the largest award-winning investigative unit in Southern California. NBC4’s news operation has received nearly every industry award bestowed on local news, including numerous Los Angeles Emmy and Golden Mike Awards, two national and two regional Edward R. Murrow Awards, and a Peabody Award. NBC4 news is delivered across the main broadcast on channel4, at http://www.nbcla.com, and through multiple interactive social media platforms 24/7. The NBC Owned Television Stations, a division of NBCUniversal, also operates COZI TV (www.cozitv.com), a national network that brings viewers some of America’s most beloved and iconic television shows and movies. #NBC#NBCLA

Painkillers Like Paracetamol Should Not Be Prescribed For Chronic Pain

US-HEALTH-OPIOID-OXYCODON-ILLUSTRATION

Painkillers such as paracetamol, ibuprofen, aspirin and opioids can do “more harm than good” and should not be prescribed to treat chronic pain, health officials have said.

Draft guidance from the National Institute for Health and Care Excellence (Nice) said that there was “little or no evidence” the commonly used drugs for chronic primary pain made any difference to people’s quality of life, pain or psychological distress.

But the draft guidance, published on Monday, said there was evidence they can cause harm, including addiction.

Chairman of the guidance committee Nick Kosky said that, while patients expected a clear diagnosis and effective treatment, the complexity of the condition means GPs and specialists can find it very “challenging” to manage.

The consultant psychiatrist at Dorset HealthCare NHS University Foundation Trust added: “This mismatch between patient expectations and treatment outcomes can affect the relationship between healthcare professionals and patients, a possible consequence of which is the prescribing of ineffective but harmful drugs.

“This guideline, by fostering a clearer understanding of the evidence for the effectiveness of chronic pain treatments, will help to improve the confidence of healthcare professionals in their conversations with patients.

“In doing so it will help them better manage both their own and their patients’ expectations.”

Chronic primary pain is a condition in itself which cannot be accounted for by another diagnosis or as a symptom of an underlying condition, Nice said.

It is characterized by significant emotional distress and functional disability with examples including chronic widespread pain and chronic musculoskeletal pain, it added.

Nice said an estimated third to half of the population may be affected by chronic pain while almost half of people with the condition have a diagnosis of depression and two-thirds are unable to work because of it.

The draft guidance, which is open to public consultation until August 14, said that people with the condition should be offered supervised group exercise programs, some types of psychological therapy, or acupuncture.

It also recommends that some antidepressants can be considered for people with chronic primary pain.

But it said that paracetamol, non-steroidal anti-inflammatory drugs such as aspirin and ibuprofen, benzodiazepines or opioids should not be offered because there was little or no evidence that they made any difference to people’s quality of life, pain or psychological distress.

There was evidence that they can cause harm, including possible addiction, it added.

The draft guideline also said that antiepileptic drugs including gabapentinoids, local anaesthetics, ketamine, corticosteroids and antipsychotics should not be offered to people to manage chronic primary pain because, again, there was little or no evidence that these treatments work but could have possible harms.

Paul Chrisp, director of the centre for guidelines at Nice, said: “”When many treatments are ineffective or not well tolerated, it is important to get an understanding of how pain is affecting a person’s life and those around them because knowing what is important to the person is the first step in developing an effective care plan.

“Importantly the draft guideline also acknowledges the need for further research across the range of possible treatment options, reflecting both the lack of evidence in this area and the need to provide further choice for people with the condition.”

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U.S. Buys The World’s Supply Of Breakthrough Coronavirus Drug Remdesivir

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Alex Azar, United States Secretary of Health and Human Services boasted of President Trump’s “amazing deal” that has bought the world’s entire supply of Gilead Sciences’ Remdesivir, a drug that some research suggests could speed the recovery of coronavirus patients.

The U.S. government will buy 100% of the California-based pharmaceutical company’s production in July, 90% of output in August and September in a move that should provide enough Remdesivir to treat around 80,000 patients. The deal between the U.S. government and Gilead means that low and middle-income countries can make their own generic version of Remdesivir, but European, and other, countries will be unable to buy, or produce it. Remdesivir sells for $390 per vial, or $2,340 per course of treatment sparking a backlash from consumer groups over its pricing pointing to $70 million of U.S. taxpayers’ support for Gilead’s development of the drug.

 

Gilead in May donated its entire stockpile of the drug, which was originally developed to treat hepatitis and respiratory viruses, to the U.S. government but doctors have faced having to ration the limited supply for the most needy patients, according to CNN.

Early research shows that the drug speeds recovery time for patients severely ill with coronavirus to 11 days from 15 days for those in the control group.

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KEY QUOTE

“President Trump has struck an amazing deal to ensure Americans have access to the first authorized therapeutic for COVID-19,” said HHS Secretary Alex Azar in a statement. “To the extent possible, we want to ensure that any American patient who needs Remdesivir can get it.

Key background

The Federal Drug Administration authorized emergency approval in May for the antiviral drug in May after early research showed that it could help patients infected with coronavirus recover faster.

The battle for access to a potentially crucial treatment plays out against the backdrop of Europe’s recovery from the pandemic, a surge of new infections in the U.S., and President Donald Trump’s reflexive nativism. The Trump administration’s trade war and diplomacy has repeatedly taxed even some of the U.S’s most long standing alliances, and the White House’s attempt in March to lure German company CuraVac to produce a coronavirus vaccine exclusively for Americans with financial incentives caused uproar.

Tangent

The U.S. has been the world’s worst affected nation and as 47,000 new cases of coronavirus were reported on Tuesday, the worst single day since the start of the pandemic, according to the New York Times.

Send me a secure tip.

I joined Forbes as the European News Editor and will be working with the London newsroom to define our coverage of emerging businesses and leaders across the UK and Europe. Prior to joining Forbes, I worked for the news agency Storyful as its Asia Editor working from its Hong Kong bureau, and as a Senior Editor in London, where I reported on breaking news stories from around the world, with a special focus on how misinformation and disinformation spreads on social media platforms. I started my career in London as a financial journalist with Citywire and my work has appeared in the BBC, Sunday Times, and many more UK publications. Email me story ideas, or tips, to iain.martin@forbes.com, or Twitter @_iainmartin.

Source: http://www.forbes.com

The US has bought up virtually all stocks of a drug shown to work against Covid-19 – raising fears Brits won’t be able to get hold of it until autumn. The decision by the Trump administration has sparked fury with leading scientists who have raised concerns over “fair access” to remdesivir. The anti-viral drug was originally developed for use against Ebola but trials showed that it helped patients hospitalised with coronavirus recover almost a third faster. Health Secretary Matt Hancock hailed it the “biggest step forward” in treating Covid-19 when it was given approval for use on the NHS in May.
But now there are concerns patients in the UK won’t get widespread access to the treatment after the US bought more than 500,000 doses. It makes up the entire global supply for July and 90 per cent of stocks for August and September. Read more Trump buys up ENTIRE stock of coronavirus drug remdesivir – sparking fury among medics https://www.thesun.co.uk/news/1199617…
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What to Consider Before Conducting Drug Tests On Your Employees

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Drug screening has now become an important tool for promoting a safe working environment. Be it absenteeism, low employee productivity, potential liabilities or healthcare costs, drug screening can help bring about a positive change within a few months. Make sure your drug screening policy meets all federal and state requirements for drug testing.

Here in this post, we’re listing out four most important considerations for administering a drug screening program:

Employee Drug Testing Consideration #1: How Often Should You Conduct Drug Tests On Your Employees?

The overall effectiveness of your drug testing policy will largely depend on how frequently you conduct drug tests on your employees. Some businesses may need to conduct drug tests more frequently than others.

  • Pre-employment drug testing: You can test a candidate, once an offer of employment has been made. In some states, businesses are legally required to make an offer of employment before a drug test is carried out on a candidate. Make sure the policy is consistent. Businesses shouldn’t be selective in drug testing certain individuals for the same position.
  • Random drug testing: Such drug tests can be conducted without any advance notice at any time of the year. Make sure the selection process is completely random. You can use a software program to generate a random set. In some states, businesses are required to engage a third-party for random selection of employees for drug testing.
  • Incident based drug testing: In case your organization employs people in safety-sensitive positions regulated by the government, you may be required to carry out post-accident testing. If the state law permits, an employee in the event of a fatality or accident should be drug tested within 24-32 hours. In some states such as in San Francisco, post-accident drug testing is illegal.
  • Regular drug testing: You may drug test employees once every month, six months or a year.

An organization may also want to have a policy of drug screening employees on the basis of reasonable suspicion.

Employee Drug Testing Consideration #2: Which Drug Testing Method Will You Adopt?

Different drug testing methods vary in cost and accuracy. Testing urine samples, for example, is cheaper in comparison to testing a hair sample.

Certain drug-testing methods may also be illegal in some states. For example, oral fluid or blood testing is illegal in many states (consider learning more about your local government laws regarding regulations and practices of workplace drug testing).

You will also need to decide on the type of substance (alcohol, cocaine, marijuana, etc.) that you want a drug test to detect. There are mutlple drug tests and some are meant to detect different illicit drugs, alcohol, tobacco, etc.

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While a credible drug testing kit supplier will patiently study your unique requirements and advise on the best possible drug testing methods for your organization, it is important that you understand the various options available and applicable state laws concerning drug testing.

Employee Drug Testing Consideration #3: How to Inspire Employees to Create a Drug-Free Workplace?

The fundamental objective of drug testing employees is to promote a drug-free workplace. Therefore, your HR department needs to devise strategies for making employees see drug screening in a positive light. Listed below are some useful tips:

  • Create a drug-free workplace policy; it should be easy to understand and free from any technical jargon. The policy should clearly state what’s expected from the employees. There should be no ambiguities on how a test positive employee would be dealt with or what happens in case an employee is found faking the test.
  • Conduct monthly sessions on the benefits and necessity of drug testing; the objective is to make employees understand and respect the drug testing policy of the organization.
  • Make sure your employees understand the entire drug testing process and its key objectives.
  • Allow a minimum of one month between implementation and enforcement of your company’s new drug testing policy; some states may require a longer time frame before an organization enforces drug testing policy on its employees.

Employee Drug Testing Consideration #4: What Happens When Some Employees Fail the Drug Test?

As you proceed with drug testing, some employees are likely to test positive. Your organization needs to have a clear policy on how to deal with test positive employees. While some may recommend a zero-tolerance policy and terminate employees who fail drug tests, others may devise an employee assistance program to keep valuable talent.

In some states, employers can legally fire employees who fail drug tests. In the case of ‘second-chance’ states, businesses are required to provide employee assistance programs. Typically, test positive employees who participate in such programs are offered to counsel and need to later pass the drug test.

Keep in mind that marijuana laws in the United States are continually evolving. It is advisable to have a good understanding of rules for drug testing in medical marijuana states. Make sure your company-wide drug testing policy adheres to the applicable state laws.

By: Leon Reingold

Postmedia reporter Reid Southwick experiences the drug testing process.

Pharmacies Don’t Know How to Dispose of Leftover Opioids and Antibiotics

Today (Dec. 30), a team of researchers from the University of California, San Francisco and the Children’s National Hospital in Washington, D.C., published the results of an investigation into whether or not pharmacy workers could provide accurate information on the disposal of two classes of drugs: opioids and antibiotics. The results are frightening:

The researchers enlisted volunteers to place calls to nearly 900 pharmacies in California, posing as parents with leftover antibiotics and opioids from a “child’s” recent surgery. They asked the pharmacy employees on the line—either pharmacists or pharmacy technicians—how to deal with these unused drugs, and then the researchers compared those answers to the guidelines for correct disposal published by the U.S. Food and Drug Administration (FDA).

The found that approximately 43% of pharmacy workers responded accurately on how to deal with antibiotics; just 23% knew what to do with opioids.

Drug disposal is one of those vexing problems where people generally want to do the right thing, but often simply don’t know how. As Hillary Copp, associate professor of urology at UCSF and the senior author of the study noted in a press release, “The FDA has specific instructions on how to dispose of these medications, and the American Pharmacists Association has adopted this as their standard. Yet it’s not being given to the consumer correctly the majority of the time.”

According to the FDA, unused medications should be put (without crushing any pills or capsules) in an “unappealing substance such as dirt, cat litter, or used coffee grounds;” that mixture should then be put into a sealed container like a secure plastic bag before it is thrown out. In addition, all personal information should be scratched out or otherwise destroyed.

Indeed, in 2017, a team of scientists from the U.S. Geological Survey and Environmental Protection Agency published a paper reporting the results of a study of 38 streams across the country. It found 230 human-created drugs and poisons. And there are significant knock-on effects of improper disposable: many of the drugs identified in the 2017 study are known to kill, harm the health of, or change the behavior of fish, insects and other wildlife. This, in turn, can impact the food chain, and eventually harm humans as well.

Antibiotics and opioids, the two drug classes that the Annals of Internal Medicine study looked at, are particularly malevolent when not disposed correctly.

When antibiotics are disseminated widely throughout the environment, it raises the chances of bacteria developing resistance to the drugs. Any bacteria that encounters an antibiotic, whether in the human body, or in a stream or pond, will attempt to survive. Those that do will pass their genes onto future generations of bacteria, fueling a growing global health concern: the World Health Organization has made it clear that antimicrobial resistance in microbes (which includes antibiotic-resistant bacteria), is one of the globes biggest impending public health challenges, given that it could eliminate some of medical science’s most effective tools against disease-causing organisms.

Meanwhile, research into the impacts of opioids on lab animals suggests that they respond to the drugs much like humans: by self-administering over and over, to their detriment. Scientists are still working on understanding how opioids in the waste stream impact animals living in the wild. One thing is for sure: opioids ARE in the global water supply. A 2018 review of the scientific literature found 22 opioids in wastewater and surface water samples from all over the world.

Perhaps the bigger issue with opioids, however, is that those prescribed them tend to keep them around. The results of a survey published in JAMA Internal Medicine in 2016 found that about 60% of Americans prescribed opioids kept their leftover meds for “future use,” and a number of recent studies and investigations have found that these drugs, when either shared with or surreptitiously taken by relatives and acquaintances, can lead to addiction and overdose.

On the flip side, other recent studies have noted that clearer guidance and take-back events can get people to not only get rid of unused opioids, but to do so in a way that’s environmentally sound. Given the ongoing American opioid crisis, any steps to get this class of deadly drugs off the street—and out of medicine cabinets—could be significant. This most recent study suggests that one place to start might be at the point-of-sale: the pharmacy.

By Elijah Wolfson December 30, 2019

Source: Pharmacies Don’t Know How to Dispose of Leftover Opioids and Antibiotics

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According to the Substance Abuse and Mental Health Services Administration, addiction to prescription opioid painkillers is real. Of the 21.5 million Americans 12 or older who had a substance use disorder in 2014, 1.9 million had a substance use disorder involving prescription pain pills. Addicts aren’t just the stereotypical shady figures hiding in dark alleys to get a fix. They are average people turning to health care providers for medication that is highly addictive. Mayo Clinic experts agree that an opioid epidemic exists in the U.S. In this Mayo Clinic Minute, reporter Vivien Williams talks to pain medicine specialist Dr. Mike Hooten about the changing face of addiction. More health and medical news on the Mayo Clinic News Network http://newsnetwork.mayoclinic.org/

 

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