Nexus Pharmaceuticals Receives FDA Approval for Succinylcholine Chloride Injection, USP

Nexus Pharmaceuticals announced it has received U.S. Food and Drug Administration (FDA) approval for Succinylcholine Chloride Injection, USP in 200mg/10mL Multiple-Dose Vials. It is an AP-rated generic to QUELICIN™¥.

“Nexus Pharmaceuticals is very pleased to announce the approval of Succinylcholine Chloride. This critical need drug has seen an increased demand due to the COVID-19 pandemic and Nexus will be ready to meet the challenge. This approval further cements Nexus’ commitment to alleviating the drug shortage crisis with sterile injectable products produced exclusively in the US and Europe,” said Mariam S. Darsot, CEO & President of Nexus Pharmaceuticals.

Nexus Pharmaceuticals’ Succinylcholine Chloride Injection will be available in cartons of 25 vials.

About Succinylcholine Chloride Injection, USP

Succinylcholine Chloride Injection, USP is a sterile, nonpyrogenic solution to be used as an ultra-short-acting, depolarizing, skeletal muscle relaxant. Succinylcholine is indicated as an adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.

For prescribing information, please see the following link.

About Nexus Pharmaceuticals Inc.

Nexus Pharmaceuticals Inc., a US-based healthcare company, specializes in innovative processes to make difficult-to-manufacture specialty and generic drugs that are easier to use, less labor intensive, and more streamlined in practice. Nexus ensures that its high-quality FDA-approved drugs fulfill a critical unmet medical need and delivers dependable life-saving treatment options when and where they’re needed most.

¥QUELICIN is a registered trademark of Hospira, Inc., a wholly-owned subsidiary of Pfizer Inc.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201029006301/en/

Contacts

Diana Lebiecki
847-996-3790
[email protected]

Source Article

Read more

P&G’s sanitizing spray to combat coronavirus wins EPA approval

In a time when the nation is racing to disinfect their homes, a new sanitizing product has won approval from the U.S. Environmental Protection Agency (EPA) for its ability to kill the novel coronavirus in 60 seconds.

Proctor and Gamble’s (P&G) Microban 24 Sanitizing Spray has won approval from the EPA, the consumer goods giant announced on Monday.

Microban 24 Sanitizing Spray is approved as effective at killing SARS-CoV-2, the virus that causes COVID-19. (Photo: Business Wire)

Mircoban was first released in February before the coronavirus crisis was officially declared a pandemic by the World Health Organization in March. However, the product had been in development for more than two years prior to its release, Kevin Wenzel, vice president of P&G’s North American Surface Care Design & Delivery unit, told FOX Business in a statement.

“Our goal was not to compete with other products but to provide something with a new benefit that will grow the category,” he said. “We know that consumers are more focused on keeping their homes sanitized in 2020 than they’ve ever been before, and that’s why we were thrilled to be able to introduce this remarkable 24-hour bacteria shield technology into a category that hadn’t seen a true breakthrough innovation in several decades. The EPA approval of Microban 24 Sanitizing Spray to kill the virus that causes COVID-19 brings trust to a young product.”

Ticker Security Last Change Change %
PG PROCTER & GAMBLE COMPANY 142.36 +1.06 +0.75%
RBGLY RECKITT BENCKISER GROUP PLC 18.23 -0.09 -0.49%
CLX CLOROX 214.18 +1.45 +0.68%

But as “Americans shifted from their standard sanitizing routine to one focused on protecting their homes against the COVID-19 virus,” said Martin Hettich, SVP North America Home Care, P&G, in a statement, “Procter & Gamble has been diligently working with scientists and health experts to ensure that Microban 24 Sanitizing Spray provides the effectiveness against the COVID-19 virus that people need.”

HOW COVID-SAFE IS DINING IN A RESTAURANT’S OUTDOOR TENT? 

For a product to claim it can kill a specific pathogen, or SARS-CoV-2 in this instance, the EPA “must conduct a data review and provide approval,” the company said in a news release, noting that Mircoban “has been tested by a third-party lab, in accordance with the EPA testing guidelines, and was shown to kill SARS-CoV-2 in 60 seconds.”

Additionally, the product is also approved to kill nearly all — 99.9%, to be exact — of bacteria and viruses, per P&G.

Bloomberg reported that Mircoban is already on track to reach $200 million in sales per year.

The product, which is part of the EPA’s list N, is now one of a select number of spray products that have been approved by the agency to kill the novel virus.

GET FOX BUSINESS ON THE GO BY CLICKING HERE

Source Article

Read more

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

Read more

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)

Source Article

Read more

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.

Source Article

Read more

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’

UP NEXT

UP NEXT

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

Read more

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

Read more

Moderna Says COVID-19 Vaccine Could Be Ready As Soon As December With FDA Approval

KEY POINTS

  • Moderna CEO Stéphane Bancel says its COVID-19 vaccine could begin distribution as soon as December
  • Phase three trial delays could push distribution into early 2021.
  • Moderna expects to meet U.S. demand for the drug. It will also manufacture it in Switzerland for international distribution

Moderna says its COVID-19 vaccine could be ready for U.S. distribution as early as December.

Speaking at a Wall Street Journal tech conference, CEO Stéphane Bancel said Moderna expects interim results from phase three clinical trials by November, a timetable that could place an emergency approval from the FDA in December.

There are still some possible wrinkles, however: Moderna needs a minimum number of their 30,000 volunteers to contract COVID-19 before it can prove those without the vaccine were more likely to do so. Low infection rates could delay results.

If the results from that first population aren’t conclusive, Moderna would need to wait for a larger number of sick volunteers before seeking FDA approval. That would likely push a vaccine timetable into early 2021.

Hopes for a rapid vaccine faced a setback by the suspension of trials for two candidates Hopes for a rapid vaccine faced a setback by the suspension of trials for two candidates Photo: AFP / Ludovic MARIN

Last week vaccine competitor Pfizer said it would be seeking FDA approval in late November, as well, which would put its distribution date in December. Two other potential vaccines from Johnson & Johnson and AstraZeneca have their trials on hold pending investigations into unexplained illnesses among volunteers.

New FDA regulations require that vaccine developers wait two months from the last dose of their drug to prove long-term safety and efficacy. President Donald Trump fought their implementation, hoping to get a vaccine out before the November presidential election.

Both Pfizer and Moderna are set to clear this bar, with Moderna’s trials starting in July. It typically takes several weeks for the FDA to arrive at a decision once the drug is submitted, although if there was ever a drug that would be given extra resources it would be these.

Bancel said that Moderna projects it can produce 20 million doses in 2020, and 500 million in 2021. Moderna and its manufacturing partner, Lonza Ltd. say they will be able to meet U.S. demand. They will also be manufacturing the drug in Switzerland to distribute internationally.

Despite their expectations, Bancel said that manufacturing vaccines is a complex process with many moving parts that need to come together simultaneously.

“Unlike sometimes when you make a recipe at home, if you miss one ingredient, you might decide to still go ahead and make your meal,” he said, “In our case we cannot do that. We need all the ingredients to be there on time to be able to make a lot of vaccine.”

“If one ingredient is missing, we cannot make a vaccine.”

Source Article

Read more

California Won’t Allow Virus Vaccines Without State Approval | Health News

By DON THOMPSON, Associated Press

SACRAMENTO, Calif. (AP) — California won’t allow any distribution of new coronavirus vaccines in the nation’s most populous state until it is reviewed by the state’s own panel of experts, Gov. Gavin Newsom said Monday.

Vaccinations for the pandemic “will move at the speed of trust,” said Newsom, a Democrat, and the state wants its own independent review no matter who wins the presidential election next month.

“Of course we won’t take anyone’s word for it,” Newsom said as he named 11 doctors and scientists to review any rollout of vaccines by the federal government or vaccine developers. They hail from top California universities and medical providers, along with state and local public health officials.

The pledge raises the possibility that California residents might not receive a vaccine as distribution begins in other states, though the governor said widespread vaccinations are unrealistic until sometime next year.

While there is always a risk that the vaccine could be delayed only in California, Dr. Jeffrey Klausner, a professor of epidemiology at the UCLA Fielding School of Public Health, said Newsom named a renowned group that should be able to quickly make credible decisions.

“I wouldn’t interpret this as a delay in distribution. I would interpret this as an effort to make sure that distribution is equitable and timely,” he said. “The people in this group are among the most reputable public health advocates in the state.”

As such, its finding that a particular vaccine was suitable or not suitable could have an outsize impact nationwide.

The group includes current and former members of the federal Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, Klausner said, so any disagreement with the federal panel “could have substantial impact on that particular vaccine product.”

New York Gov. Andrew Cuomo last month appointed a similar independent task force.

At most, 45 million doses will be available nationwide before the end of this year from the two most advanced vaccines, Newsom said. Each person must receive two doses, three weeks apart.

If California were to receive 12% of the doses, commensurate with its percentage of the nation’s population, that would be 5.4 million doses, or enough to treat 2.7 million of the state’s nearly 40 million residents.

Most would go to front-line medical workers and first responders, he said, then to the most vulnerable in the population.

Newsom’s announcement drew quick criticism from Republican state lawmakers, despite the governor’s contention that the panel is needed whoever is president.

“Politicizing the efficacy of a vaccine is shameful,” tweeted Sen. Melissa Melendez, who said the governor “used the virus to keep people from working, kids from going to school (and) families from being able to attend funerals.”

Newsom is “suggesting we can’t trust the FDA (but) Of course, we’ll continue trusting the FDA for every other drug whose distribution doesn’t threaten his hold on power,” tweeted Assemblyman Kevin Kiley, who has a court hearing this week challenging the governor’s authority to

Read more

California won’t allow virus vaccines without state approval

SACRAMENTO, Calif. (AP) — California won’t allow any distribution of new coronavirus vaccines in the nation’s most populous state until it is reviewed by the state’s own panel of experts, Gov. Gavin Newsom said Monday.

Vaccinations for the pandemic “will move at the speed of trust,” said Newsom, a Democrat, and the state wants its own independent review no matter who wins the presidential election next month.

“Of course we won’t take anyone’s word for it,” Newsom said as he named 11 doctors and scientists to review any rollout of vaccines by the federal government or vaccine developers. They hail from top California top universities and medical providers, along with state and local public health officials.


The pledge raises the possibility that California residents might not receive a vaccine as distribution begins in other states, though the governor said widespread vaccinations are unrealistic until sometime next year.

New York Gov. Andrew Cuomo last month appointed a similar independent task force.

At most, 45 million doses will be available nationwide before the end of this year from the two most advanced vaccines, Newsom said. Each person must receive two doses, three weeks apart.

If California were to receive 12% of the doses, commensurate with its percentage of the nation’s population, that would be 5.4 million doses, or enough to treat 2.7 million of the state’s nearly 40 million residents.

Most would go to front-line medical workers and first responders, he said, then to the most vulnerable in the population.

But the distribution and record-keeping logistics alone are massive, he said, including a requirement that the vaccines be kept in continuous cold storage until they are administered.

One of the two leading vaccines requires “ultra cold” storage — think dry ice — of minus 70 Celsius, or minus 158 degrees Fahrenheit. The other needs a minus 20 Celsius, or 68 degrees Fahrenheit below zero.

“They need to be stored in an extraordinarily challenging environment,” Newsom said, though the state has done so before with other medications. But he said that’s why the state needs an expert panel that understands the “panoply of issues that will be required to ultimately advance this effort.”

California last week gave the federal Centers for Disease Control and Prevention its early plans for how it would handle and distribute the vaccine, and in return received nearly $29 million to continue its planning efforts.

California is one of five jurisdictions doing what Newsom called “micro-planning” for mass distributions, which he predicted could come as soon as next spring, is more likely next summer, but could be as late as next fall.

Source Article

Read more
  • Partner links