approval

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China’s Fosun to seek approval for BioNTech’s COVID-19 second vaccine, ends trials on first

SUZHOU, China (Reuters) – BioNTech’s Chinese partner Shanghai Fosun Pharmaceutical Group does not plan to run further clinical trials of the German firm’s coronavirus vaccine candidate that has completed early-stage trials in China, an executive said.

Fosun will focus instead on seeking Chinese approval for BioNTech’s other experimental vaccine which is in final-stage human trials in the United States, Fosun’s Chief Medical Officer Hui Aimin told Reuters in an interview.

The vaccine candidate developed by BioNTech and U.S. drugmaker Pfizer Inc is under real-time regulatory review in Europe and could seek emergency use authorisation in the United States after enough safety data is provided as early as this month.

But the candidate known as BNT162b2 missed an earlier window to be tested in China, as Fosun had rushed into Phase 1 trials of a slightly less satisfactory candidate, BNT162b1, before early trials data overseas showed BNT162b2 is safer.

Hui said he did not regret testing BNT162b1 without waiting for more complete data.

“For ordinary vaccines, it does not matter if you wait for a few days, or a month,” Hui said. “But for (COVID-19 vaccines), how many more people would have died had you waited just for one day?”

Hui said Fosun was applying for a bridge study for BNT162b2, designed to evaluate whether the large trial data gathered overseas could be extrapolated to the populace of China.

A bridge clinical trial is required for pharmaceutical products which are approved abroad but do not have data to show that ethnic differences can affect their efficacy and safety, China’s National Medical Products Administration said.

Hui expected the late-stage candidate could be greenlighted for use in China “around the same time” as the vaccine’s global clearance.

Fosun is licensed to exclusively develop and commercialize COVID-19 vaccine products developed by using BioNTech’s mRNA technology in mainland China, Hong Kong, Macau and Taiwan. In return it agreed to pay up to $85 million in licensing fees and invest $50 million for a stake in the German firm.

(Reporting by Roxanne Liu in Suzhou and Tony Monroe in Beijing; Editing by Miyoung Kim, Stephen Coates and Raju Gopalakrishnan)

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China’s Fosun to end BioNTech’s COVID-19 vaccine trial, seek approval for another

SUZHOU, China (Reuters) – BioNTech’s Chinese partner Shanghai Fosun Pharmaceutical Group does not plan to run further clinical trials of the German firm’s coronavirus vaccine candidate that has completed early-stage trials in China, an executive said.

Fosun will focus instead on seeking Chinese approval for BioNTech’s other experimental vaccine which is in final-stage human trials in the United States, Fosun’s Chief Medical Officer Hui Aimin told Reuters in an interview.

The vaccine candidate developed by BioNTech and U.S. drugmaker Pfizer Inc is under real-time regulatory review in Europe and could seek emergency use authorisation in the United States shortly after enough safety data is provided as early as this month.

But the candidate known as BNT162b2 missed an earlier window to be tested in China, as Fosun had rushed into Phase 1 trials of a slightly less satisfactory candidate, BNT162b1, before early trials data overseas showed BNT162b2 is safer.

Hui said he did not regret testing BNT162b1 without waiting for more complete data. “For ordinary vaccines, it does not matter if you wait for a few days, or a month,” Hui said. “But for (COVID-19 vaccines), how many more people would have died had you waited just for one day?” Hui said Fosun was applying for a bridge study for BNT162b2, designed to evaluate whether the large trial data gathered overseas could be extrapolated to the populace of China.

A bridge clinical trial is required for pharmaceutical products which are approved abroad but do not have data to show that ethnic differences can affect their efficacy and safety, China’s National Medical Products Administration said.

Hui expected the late-stage candidate could be greenlighted for use in China “around the same time” as the vaccine’s global clearance.

(Reporting by Roxanne Liu in Suzhou and Tony Monroe in Beijing; Editing by Miyoung Kim and Stephen Coates)

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Nicox’s NCX 470 Receives Approval by Chinese Authorities for Local Start of Mont Blanc Phase 3 Trial

 

October 26, 2020 – release at 7:30 am
Sophia Antipolis, France

 

Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced that its partner, Ocumension Therapeutics, has received approval from China’s Center for Drug Evaluation of the National Medical Products Administration to carry out the Chinese part of the ongoing Mont Blanc trial, the first Phase 3 clinical trial on NCX 470 for the lowering of intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension.

 

NCX 470, Nicox’s lead clinical product candidate, is a novel second generation nitric oxide (NO)-donating bimatoprost analog exclusively licensed to Ocumension Therapeutics for the Chinese, Korean and South East Asian markets.

 

Dr. José Boyer, VP and Interim Head of R&D at Nicox, said: “We are pleased with this second Chinese IND approval in our collaboration with Ocumension.  NCX 470 development remains on track, with first results from the Mont Blanc trial expected in Q4 2021.  Initiation of Chinese sites in this trial will be essential in preparing the way for Denali, the second Phase 3 trial with NCX 470, which will include a larger number of Chinese patients.”

 

The Press Release by Ocumension can be found here:

The NCX 470 Mont Blanc Phase 3 clinical trial is a 3-month trial to evaluate the safety and efficacy of NCX 470 ophthalmic solution, 0.1%, versus the current standard of care, latanoprost ophthalmic solution, 0.005%, for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension.  The Mont Blanc trial is expected to randomize approximately 670 patients, at around 50 clinical sites in the U.S. and at a small number of clinical sites in China.  The Mont Blanc trial was initiated in the U.S. in June 2020 and top-line results are currently expected in Q4 2021. 

Nicox and Ocumension will jointly fund the second NCX 470 Phase 3 glaucoma trial, Denali, which is expected to start by end of 2020 and will also evaluate NCX 470 ophthalmic solution, 0.1%, versus latanoprost ophthalmic solution, 0.005%.  The Denali trial will include clinical sites in both the U.S. and China, with the large majority of the patients to be recruited in the U.S.  The Denali trial was designed to fulfill the regulatory requirements to support New Drug Application (NDA) filings in the U.S. and China.

 

NCX 470 is a novel, potential best-in-class, second generation nitric oxide (NO)-donating bimatoprost analog in development to reduce intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.  Glaucoma is a group of ocular diseases in which the optic nerve is injured, leading to peripheral and, ultimately, central visual field loss and it can eventually lead to blindness if not treated. It is frequently linked to abnormally high IOP (~90% of patients) due to blockage or malfunction of the eye’s aqueous humor drainage system in the front of the eye.  In 2019, worldwide sales of treatments targeting glaucoma were over $6.0 billion out of a $21.9 billion worldwide market for ophthalmic drugs. 

NCX 470 is designed

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The FDA and CDC Promised Transparency in the Vaccine Approval Process. Here’s How Congress Can Hold Them to It

A view of the U.S. Capitol Building as demonstrators march to the Department of Health and Human Services (HHS) headquarters during a protest organized by groups calling for safe vaccines on Oct. 21
A view of the U.S. Capitol Building as demonstrators march to the Department of Health and Human Services (HHS) headquarters during a protest organized by groups calling for safe vaccines on Oct. 21

A view of the U.S. Capitol Building as demonstrators march to the Department of Health and Human Services (HHS) headquarters during a protest organized by groups calling for safe vaccines on Oct. 21 Credit – Graeme Sloan—Sipa USA

The COVID-19 pandemic continues to have a devastating impact on the health and economic well-being of families and communities across the country, and this virus will remain a significant threat until a safe and effective vaccine can be made available to all.

While we all hope to get potential vaccines reviewed, produced and distributed as quickly as possible, we can’t sacrifice safety and efficacy for speed. It is also critically important that the public has confidence in the federal government’s vaccine review process, which includes assurances that the Food and Drug Administration (FDA) has followed the necessary protocols to ensure vaccine safety and effectiveness. Together, we’ve introduced the Safe Authorization for Vaccines during Emergencies (SAVE) Act to ensure that the FDA and the Centers for Disease Control and Prevention (CDC) follow well-established measures so that COVID-19 vaccines meet rigorous standards that the public can rely on.

The FDA and CDC have existing vaccine review processes that are considered the gold standard by public-health experts around the world. During the normal vaccine approval process, the CDC and FDA each have advisory committees that meet and issue findings and recommendations on the safety and effectiveness of vaccines before they enter the market, including whether specific vaccines are safe for certain populations such as children or seniors.

For the COVID-19 vaccine, however, an expedited review process called an emergency use authorization is being used. There’s never been an emergency use authorization for a new vaccine before, and it is important to ensure that any expedited review process does not come at the expense of safety and efficacy.

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By taking key oversight measures, we can ensure the safety and effectiveness of a potential vaccine and promote transparency, even during an expedited process. By extension, we can also help bolster public confidence in the vaccine review process, as well as any vaccine product that enters the market. However, we have a lot of work ahead of us. Public trust in the vaccine approval process is critical to achieving widespread use, and right now, the public is skeptical.

A CBS poll released in September found that two-thirds of Americans would think the process had been rushed if a vaccine enters the market this year, and only one in five plan to get vaccinated as soon as possible. Another poll from the Kaiser Family Foundation showed that 62% of Americans worry that political pressure will lead to premature approval of a vaccine. If a majority of Americans are unwilling to take

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Gilead’s remdesivir gets U.S. FDA approval for hospitalized COVID-19 patients

By Deena Beasley

(Reuters) – The U.S. Food and Drug Administration on Thursday approved Gilead Sciences Inc’s antiviral drug remdesivir for treating patients hospitalized with COVID-19, making it the first and only drug approved for the disease in the United States.

Remdesivir, given intravenously, was one of the drugs used to treat U.S. President Donald Trump during his bout with COVID-19.

The FDA’s formal approval comes just hours before the president’s final debate with Democratic rival Joe Biden ahead of the Nov. 3 presidential election.

Remdesivir has been available under an FDA emergency use authorization (EUA) since May, after a study led by the National Institutes of Health showed it reduced hospital stays by five days.

However, the World Health Organization (WHO) last week said its global trial of COVID-19 therapies found that remdesivir did not have a substantial effect on patients’ length of hospital stay or chances of survival. That study has not been reviewed by outside experts.

Gilead has questioned the potential for bias in the WHO study, which was not “blinded,” meaning that patients and their doctors were aware of which treatments were being used.

Remdesivir, which will be sold under the brand name Veklury, costs $3,120 for a five-day treatment course, or $2,340 for government purchasers such as the Department of Veterans Affairs. Shares of Gilead rose 4.3% in after hours trading to $63.30.

Remdesivir has become the standard of care for patients hospitalized with severe COVID-19 even though it has not been shown to improve survival. The drug also has not been proven to significantly help moderately-ill patients, and many doctors remain wary of using it in patients with less severe illness.

“The formal FDA approval doesn’t change our (sales) estimates or outlook for remdesivir given it has already been branded standard-of-care prior to formal approval,” Raymond James analyst Steven Seedhouse said in a research note, calling the prescribing guidelines and approval “pretty much a best case for Gilead,” given the WHO results questioning remdesivir’s benefits.

Gilead said it is currently meeting demand for the drug in the United States and anticipates meeting global demand by the end of October.

The company said Veklury has regulatory approvals or temporary authorizations in about 50 additional countries.

Also on Thursday, the FDA issued a new emergency use authorization for remdesivir to treat hospitalized pediatric patients under age 12 who weigh enough to receive an intravenous drug.

Gilead said it is still working to understand the full potential of remdesivir, in different settings and as part of combination therapy approaches. The company is also developing an inhaled version of the drug that might be used outside a hospital setting, if approved.

(Reporting by Vishwadha Chander in Bengaluru and Deena Beasley in Los Angeles; Editing by Cynthia Osterman and Bill Berkrot)

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Gilead’s remdesivir gets U.S. FDA approval [Video]

The U.S. Food and Drug Administration on Thursday approved Gilead’s antiviral drug remdesivir for treating patients hospitalized with COVID-19, making it the first and only drug approved for the disease in the United States.

Remdesivir, given intravenously, was one of the drugs used to treat President Donald Trump, who tested positive for the respiratory disease earlier this month.

The FDA’s formal approval came just hours before the president’s final debate with Democratic rival Joe Biden ahead of the Nov. 3 presidential election.

Trump’s seemingly dismissive approach to the coronavirus has clouded his re-election prospects, with polls showing Americans losing confidence in his ability to handle the pandemic.

Remdesivir has been available under an FDA emergency use authorization since May, after a study led by the National Institutes of Health showed it reduced hospital stays by five days.

However, the World Health Organization last week said its global trial of COVID-19 therapies found that the drug did not have a substantial effect on patients’ length of hospital stay or chances of survival.

At $3,120 for a five-day treatment course, remdesivir has become the standard of care for patients hospitalized with severe COVID-19 even though it has not been shown to improve survival.

Doctors have remained wary of using it in patients with less severe illness.

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Remdesivir, first COVID-19 drug treatment, gets FDA approval

U.S. regulators on Thursday approved the first drug to treat COVID-19: remdesivir, an antiviral medicine given to hospitalized patients through an IV.

The drug, which California-based Gilead Sciences Inc. is calling Veklury, cut the time to recovery by five days — from 15 days to 10 on average — in a large study led by the U.S. National Institutes of Health.

It had been authorized for use on an emergency basis since spring, and now becomes the first drug to win full Food and Drug Administration approval for treating COVID-19. President Donald Trump received it when he was sickened earlier this month.

Veklury is approved for people at least 12 years old and weighing at least 88 pounds (40 kilograms) who are hospitalized for a coronavirus infection. For patients younger than 12, the FDA will still allow the drug’s use in certain cases under its previous emergency authorization.

The drug works by inhibiting a substance the virus uses to make copies of itself. Certain kidney and liver tests are required before starting patients on it to ensure it’s safe for them and to monitor for any possible side effects. And the label warns against using it with the malaria drug hydroxychloroquine, because that can curb its effectiveness.

“We now have enough knowledge and a growing set of tools to help fight COVID-19,” Gilead’s chief medical officer, Dr. Merdad Parsey, said in a statement.

The drug is either approved or has temporary authorization in about 50 countries, he noted.

Its price has been controversial, given that no studies have found it improves survival. Last week, a large study led by the World Health Organization found the drug did not help hospitalized COVID-19 patients, but that study did not include a placebo group and was less rigorous than previous ones that found a benefit. The FDA’s approval statement noted that, besides the NIH-led one, two other studies found the drug beneficial.

Gilead charges $2,340 for a typical treatment course for people covered by government health programs in the United States and other developed countries, and $3,120 for patients with private insurance. The amount that patients pay out of pocket depends on insurance, income and other factors.

So far, only steroids such as dexamethasone have been shown to cut the risk of dying of COVID-19. The FDA also has given emergency authorization to using the blood of survivors, and two companies are currently seeking similar authorization for experimental antibody drugs.

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FDA opens private Covid vaccine meetings to the public in bid to gain trust as Trump pressures for fast approval

The FDA took the unusual step Thursday in opening to the public a routine meeting with an advisory group that’s weighing in on approving the coronavirus vaccine as the agency battles public concerns about its safety as well as political pressure from President Donald Trump to approve it before the Nov. 3 election.



a person in a blue shirt: A health worker injects a person during clinical trials for a Covid-19 vaccine at Research Centers of America in Hollywood, Florida.


© Provided by CNBC
A health worker injects a person during clinical trials for a Covid-19 vaccine at Research Centers of America in Hollywood, Florida.

The Vaccines and Related Biological Products Advisory Committee, an outside group of researchers and physicians who are advising the Food and Drug Administration on whether to approve a Covid-19 vaccine, debated the standards needed to ensure a Covid-19 vaccine is safe and effective in a meeting broadcast on YouTube and C-SPAN. Those are key questions among medical experts who worry the U.S. will approve a vaccine before it has been adequately tested.

Officials at the meeting Thursday said the public forum was “critical” to build public trust and confidence in the development of potential vaccines, which are being developed in record time. FDA officials promised that any vaccine would undergo rigorous testing before being distributed to the public.

“Vaccine development can be expedited. However, I want to stress that it cannot, and must not, be rushed,” said Dr. Marion Gruber, director of FDA’s Office of Vaccines Research and Review, adding the agency would not lower its standards.

Trump has pushed the FDA to approve a drug in time to distribute by the Nov. 3 election — a daunting task even his closest advisors have said is near impossible.

“I think we should have it before the election, but frankly the politics gets involved and that’s okay. They want to play their games, it’s going to be right after the election,” Trump said in a video he posted on Twitter on Oct. 7. “The FDA has acted as quickly as they’ve ever acted in history. There’s never been a time, and no president’s ever pushed them like I’ve pushed them either, to be honest.”

The agency is approving drugs “in a matter of weeks” that used to take years, he added.

Video: Dr. Patel on how the White House should be dealing with the virus outbreak: ‘This should go well beyond what’s standard’ (MSNBC)

Dr. Patel on how the White House should be dealing with the virus outbreak: ‘This should go well beyond what’s standard’

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Four drugmakers backed by the U.S. are still conducting their late-stage trials, and medical experts don’t expect to see trial data needed for FDA authorization until later this month at the earliest.

Because of the pandemic, U.S. health officials and researchers have been accelerating the development of vaccine candidates by investing in multiple stages of research even though doing so could be for naught if the vaccine ends up not being effective or safe.

The FDA, under pressure from the White House, has faced skepticism from medical experts that the vaccine approval

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The Health 202: Emergency approval for a coronavirus vaccine could undermine efforts to keep researching it

A panel of independent experts is evaluating how the Food and Drug Administration is shepherding coronavirus vaccine development. 

This type of meeting would normally only attract interest from Wall Street analysts and those closely involved with vaccine development. But today’s gathering is attracting widespread attention given the pandemic’s high stakes and lagging public trust in the vaccine development process. 

The meeting, which will be live-streamed today, is widely viewed as reassurance that science, not the White House, is guiding the endeavor.

The unprecedented speed at which the vaccines are being developed has raised an ethical question.

Instead of waiting months or years to fully collect data on trial participants, developers are expected to apply to the FDA through an alternative pathway known as emergency use authorization. If an EUA is granted for a coronavirus vaccine, the vaccine could be given to certain high-risk populations to be spelled out by regulators.

The plan is to continue Phase 3 trials even while the vaccine is being distributed to select people, so researchers can get a fuller picture of how long the vaccine works and whether it causes side effects — and eventually apply for full authorization. 

But continuing the trials requires maintaining a placebo group of patients. One question the panel is likely to consider today is whether to allow the placebo group to get the vaccine once it’s available. 

If an EUA is approved, participants in that trial may want to know whether they received the vaccine – and if they didn’t, to get inoculated. 

But vaccinating the placebo group could undermine the ability of researchers to make ongoing, longer-term comparisons that help determine the efficacy and safety of the vaccine. 

There’s another challenge, too. There are currently 10 vaccine candidates in final-stage trials, according to The Washington Post’s tracker. If one gets emergency approval, patients in the other clinical trials may also want to know whether they received a placebo. If so, they also may be tempted to drop out of that trial so they could receive the approved vaccine.

“Issuance of EUA will likely slow down the trials,” said former FDA scientist Luciana Borio.

Vaccine manufacturers and other groups have raised concerns about this possibility.

The Biotechnology Innovation Organization wrote that it has an ethical obligation to inform trial participants that a vaccine may be available, saying “additional discussion is needed to determine how placebo-controlled trials can be maintained after an EUA is granted.”

“It is likely that any EUA issued for a covid-19 vaccine will have a broad impact on other covid-19 vaccines in development,” BIO wrote in comments submitted to the review panel.

Janssen Pharmaceuticals, which owns coronavirus vaccine developer Johnson & Johnson, submitted a letter outlining similar concerns.

“Once the first vaccines are licensed/authorized, this may lead willing volunteers to seek available vaccines over participating in ongoing trials,” the company wrote.

If the FDA approves use of the vaccine only for a narrow group of people, it could potentially minimize this risk. For example, if it

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ProMIS Neurosciences Offers its Perspective on the Likelihood of Regulatory Approval of Aducanumab

Regulatory progress is spurring the development of safe and effective therapies for Alzheimer’s disease

TORONTO and CAMBRIDGE, Mass., Oct. 21, 2020 (GLOBE NEWSWIRE) — ProMIS Neurosciences, Inc. (TSX: PMN) (OTCQB: ARFXF), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, released a white paper today that offers its perspective on aducanumab’s likelihood of regulatory approval in advance of its U.S. Food and Drug Administration Advisory Committee (AC) review on November 6. The white paper, available at www.promisneurosciences.com, chronicles aducanumab’s history, regulatory support, positive data outcomes and potential impetus for development of improved second-generation therapies. If approved, aducanumab would be the first disease-modifying treatment for Alzheimer’s disease, offering a therapeutic option for the millions of Americans living with the disease.

Aducanumab was originally designed to target amyloid-beta plaque, now believed to be an ineffective drug target for AD. An accumulating body of data has shifted the drug development focus to a different species of amyloid-beta called the toxic oligomer which has since been shown to be the real culprit in driving disease progression. Aducanumab’s ability to cross-react and partially neutralize toxic oligomers results in its modest treatment benefit. By contrast, published data show that PMN310, ProMIS’ antibody candidate for Alzheimer’s disease, is highly selective for the toxic oligomer of amyloid-beta, positioning it as a second-generation drug candidate with more precise targeting capabilities and a potentially improved safety and efficacy profile.

Despite aducanumab’s modest treatment benefit, the white paper argues that FDA approval is likely based on the following:

  1. FDA has encouraged Biogen to submit its application, granting it Priority Review; has endorsed continued clinical use of aducanumab in an open-label study, and; has demonstrated a willingness in the past to approve drugs despite limited data in instances where the unmet medical need is significant.

  2. Aducanumab’s phase 3 EMERGE trial was unequivocally positive and additional evidence for effectiveness is confirmed by results from the Phase 1b PRIME trial and subset data from the phase 3 ENGAGE trial.

  3. We anticipate the Advisory Committee members will most likely conclude that aducanumab’s data demonstrate the requisite “substantial evidence of effectiveness” and acceptable safety.

“Aducanumab represents a milestone treatment, and we applaud Biogen’s unrelenting commitment to its advancement,” said Dr. Elliot Goldstein, ProMIS Neurosciences’ President and CEO. “We and many others in the Alzheimer’s community look forward to the upcoming FDA Advisory Committee meeting and subsequent regulatory actions in support of addressing the unmet need for disease modifying therapies for Alzheimer’s disease.”

The FDA’s Advisory Committee will be virtually convened and streamed via internet on November 6, 2020.

About ProMIS Neurosciences
ProMIS Neurosciences, Inc. is a development stage biotechnology company whose unique core technology is the ability to rationally predict the site and shape (conformation) of novel targets known as Disease Specific Epitopes (DSEs) on the molecular surface of proteins. In neurodegenerative diseases, such as Alzheimer’s, ALS and Parkinson’s disease, the DSEs are misfolded regions on toxic forms of otherwise normal

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