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Takeda Group Begins Manufacturing COVID-19 Plasma Treatment Ahead of Approval | Top News

NEW YORK (Reuters) – The Takeda Pharmaceutical Co-led group that is developing a blood plasma treatment for COVID-19 has started manufacturing while the late-stage trial to determine whether it works is ongoing, Takeda Chief Executive Christophe Weber said on Monday.

The group, known as the CoVIg Plasma Alliance, enrolled its first patient in the Phase III trial on Friday after months of delays. It aims to enroll 500 adult patients from the United States, Mexico and 16 other countries and hope to have results by the end of the year.

“The likelihood it works is very high,” Weber said in an interview. “And that’s why we have launched a campaign in order to accelerate the donation of convalescent plasma to manufacture and produce this product.”

The alliance, which includes CSL Behring, Germany’s Biotest AG and other companies, is testing a hyperimmune globulin therapy, which is derived from blood plasma of people who have recovered from COVID-19. Hyperimmune globulin therapy offers a standardized dose of antibodies and does not need to be limited to patients with matching blood types.

That makes it more advanced and convenient than treatment with convalescent plasma drawn from recovered patients.

The manufacturing process is expensive.

Weber said the treatment could be slightly more costly to make than monoclonal antibody treatments like the ones Regeneron Pharmaceuticals Inc and Eli Lilly and Co have developed. The alliance does not intend to profit from the treatment, Weber said.

The Takeda CEO said he does not know how many doses of the treatment the group will be able to produce by the end of the year. That will depend on donations as well as the dosage size they decide to test in the clinical trial.

The trial will test the hyperimmune globulin therapy in combination with Gilead Sciences Inc’s antiviral drug remdesivir compared with patients who get remdesivir alone, he said.

(Reporting by Michael Erman; Editing by Bill Berkrot)

Copyright 2020 Thomson Reuters.

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South Korea’s Celltrion gets approval for Phase 3 trials of COVID-19 antibody drug

By Sangmi Cha

SEOUL (Reuters) – South Korean drugmaker Celltrion Inc <068270.KS> said on Monday it has received regulatory approval for Phase 3 clinical trials of an experimental COVID-19 treatment.

The approval comes as the company plans to seek conditional approval for its antibody drug, CT-P59, for emergency use by the end of this year.

The treatment, the most advanced antibody drug in terms of research in South Korea, is directed against the surface of the virus and designed to block it from locking on to human cells.

The third stage trials will be conducted on some 1,000 asymptomatic coronavirus patients and those who have come into close contact with COVID-19 patients in Korea, Celltrion said in a statement.

The Ministry of Food and Drug Safety recently approved a Phase 2/3 study on patients with mild and moderate cases of COVID-19, Lee Sang-joon, Celltrion’s senior executive vice president, told Reuters.

Celltrion began commercial production of the drug in September – likely to amount to around 1 million doses – in anticipation of demand in both domestic and overseas markets.

In July, Celltrion separately launched overseas human trials of its treatment in Britain.

(Reporting by Sangmi Cha; Editing by Kenneth Maxwell)

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Can Trump Really Speed Approval of Covid Treatments?

The Bioshield Act, along with the laws that later modified it, was not intended as a carte blanche. For instance, an E.U.A. can only be granted during a declared public health or national security emergency, and is supposed to be used only for products that have no adequate, approved or available alternatives. But the F.D.A. was granted wide discretion to decide whether a product ought to be made available to the public. By law, the agency can grant E.U.A.s to products that “may be effective,” whose “known and potential benefits” outweigh “the known and potential risks.” It is up to the agency, however, to determine what those criteria mean.

“It was deliberately a quite flexible kind of standard,” said Dr. Jesse Goodman, the director of the Center on Medical Product Access, Safety and Stewardship at Georgetown, and the F.D.A.’s chief scientist from 2009 to 2014. E.U.A.s are intended to be evaluated on a case-by-case basis; the F.D.A. might tolerate more risk for a drug designed to treat a disease with a high mortality rate, such as Ebola, than for a vaccine that would be given to healthy people to stop a disease like Covid-19, Mr. Goodman said.

But, he added, E.U.A.s were not meant as a substitute for traditional approvals: “The intent originally was that ultimately you should be collecting data and moving these products toward approval,” even after the emergency authorization was granted.

However, it can be difficult to fully enroll a product in clinical trials after it has received an E.U.A., Dr. Goodman said, because clinical trials typically impose more stringent requirements on patients than an E.U.A. would. “Now we have tens of thousands of people getting convalescent plasma” — a Covid-19 treatment that was granted an E.U.A. in August — “and we still don’t know whether it works,” he said.

Another potential hazard of emergency authorization became apparent not long after the Bioshield Act was signed into law, when the F.D.A. granted its first E.U.A., at the request of the Defense Department, for the use of an anthrax vaccine, in 2005. That authorization suggested to some people, including Chris Shays, then a Republican congressman from Connecticut, that the E.U.A. process provided an avenue for political interference. The apparent urgency “appears to be the product of preventable legal and regulatory failures,” Mr. Shays wrote in a letter to the Secretary of Health and Human Services, “rather than any validated external threat.”

The actions of the Trump administration during the Covid pandemic have renewed these concerns. In May, Rick Bright, the former head of the Biomedical Advanced Research and Development Authority, alleged in a whistle-blower complaint that he had arranged an E.U.A. request for hydroxychloroquine and chloroquine as a “compromise position” to head off pressure by administration officials to make the drugs available under a less-restrictive protocol known as “expanded access.”

In late September, Mr. Trump said that he was considering blocking the F.D.A.’s vaccine E.U.A. guidelines, which made it unlikely that a vaccine would be authorized before the

Weed goes on sale years after approval in Maine

SOUTH PORTLAND, Maine (AP) — Mainers are getting their first opportunity to legally buy marijuana for adult recreational use, but a supply shortage is a potential buzzkill.

Retailers blame the pandemic and a limited number of licensed manufacturers for reducing the variety of products available on Friday, the opening day. Licenses were issued only a month ago.

That didn’t dampen Matt Bourgeois’ enthusiasm for hitting two newly opening cannabis shops in South Portland.

“It’s the history that I’m excited about,” said Bourgeois, 40, of Hampton, New Hampshire, who wasn’t worried about limited products. “I’d like to take part in the historic moment. It’s important to me.”


Maine’s road to becoming the 10th state allowing the retail sale of marijuana for recreational use was exceptionally arduous.

A referendum was approved nearly four years ago, in November 2016, but the effort to set up a method for legally purchasing cannabis dragged on through two vetoes by the governor, two legislative rewrites, and a change in administrations.

Then came the coronavirus pandemic that created further delays as the state determined how to safely open stores.

Under state law, marijuana growers and product suppliers have to be licensed, and the products have to be certified by a state-licensed lab. For now, there are only a handful of manufacturers, and one laboratory.

And there are only seven stores at present, though the Maine Office of Marijuana Policy will be licensing more in coming months.

That’s a bit of a disappointment for advocates. But it’s better than nothing and it represents a starting point, said David Boyer, an independent marijuana industry consultant in Maine.

“To the state’s credit, there’s something to be said for planting a flag and breaking the ice and starting sales for thousands of adults who don’t have access for one reason or another. It’s a big day,” he said.

State law allows each customer to buy up to 2.5 ounces of cannabis, enough to roll more than 100 joints. Included within that limit, they may also purchase 5 grams of concentrate.

Many retailers, however, plan to limit customers to smaller amounts to stretch their supply, although many still expect to sell out quickly.

Co-founder Brandon Pollock from Theory Wellness, which has cannabis stores in South Portland and Waterville, agreed that supply is going to be limited but said he’s pleased that vendors are out of the “purgatory” of years and years of waiting for this day to come.

“It’s only going to get better from here. We should all appreciate that we have a legal access point, and we’re doing the best we can to get as much products on the shelves as quickly as possible,” he said.

For the time being, Maine’s medical marijuana market will be better stocked with edibles and other products. The state’s medical marijuana caregivers and eight dispensaries accounted for more than $111 million in sales last year.

All told, more than 87,000 Mainers already hold medical marijuana cards, allowing them to make legal purchases.

Maine becomes

Regeneron asks for emergency FDA approval for COVID-19 antibody treatment

Oct. 8 (UPI) — Biotechnology company Regeneron has requested emergency use authorization from federal regulators for a COVID-19 antibody treatment.

The REGN-COV2 treatment is a combination of two antibodies that’s designed to “block infectivity” of the SARS-CoV-2 virus that causes COVID-19.

“The two potent, virus-neutralizing antibodies that form REGN-COV2 bind non-competitively to the critical receptor binding domain of the virus’s spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population,” the company said in a statement.

Regeneron, which asked the Food and Drug Administration for the emergency authorization, said it has doses available for 50,000 patients and will have enough for another 300,000 in the coming months.

“If [emergency use authorization] is granted the government has committed to making these doses available to the American people at no cost and would be responsible for their distribution,” the company added.

President Donald Trump took a dose of the Regeneron cocktail last week after he tested positive for COVID-19, even though it hasn’t been approved by the FDA.

Regeneron said if its request is approved, it will distribute the treatment in the United States and partner Roche will distribute overseas.

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Reflow Medical Receives Approval in Japan for the Wingman Catheter to Cross Chronic Total Occlusions (CTOs) in Peripheral Artery Disease

Reflow Medical, Inc., a California-based medical device company, announced that Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has approved the Wingman™ CTO Catheter. Reflow Medical has partnered with Century Medical, Inc. (CMI), a leading medical device distributor based in Tokyo, to introduce the Wingman CTO Catheter in Japan.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201008005741/en/

Wingman CTO Catheter (Photo: Business Wire)

The Wingman Catheter crosses peripheral CTOs using an extendable beveled tip. The physician controls the advancement and activation of the tip to create a channel to help penetrate, or cross, the occlusion with a guidewire, enabling further treatment of the lesion with therapeutic devices. The catheter is compatible with the physician’s preferred guidewire and procedural technique.

Approval by Japan’s PMDA follows the completion of the Wing-IT CTO clinical trial, a prospective, international, multicenter study that treated 85 patients and followed them for 30 days. The Wingman Catheter was able to demonstrate a 90% crossing rate when up to two previous guidewires could not cross the CTOs, meeting its primary safety and efficacy endpoints.

“We are very excited to launch the Wingman CTO catheter in the Japanese market,” said CMI President and CEO Takahiko Motani. “This product should have a significant impact on the Japanese peripheral market by helping physicians address specific treatment challenges within a growing patient population. We look forward to providing this new and unique device in partnership with Reflow Medical, Inc.”

“Reflow Medical focuses their efforts on developing technologies based on physicians’ needs,” said John R. Laird, MD, of Adventist Heart and Vascular Institute in St. Helena, California. Dr. Laird was the principal investigator for the study. “We rely on Reflow for real clinical evidence when utilizing the technology.”

“It is an honor for our device to have gained approval by Japan’s PMDA,” noted Reflow Medical Co-founder and CEO Isa Rizk. “We are grateful for the opportunity to partner with a fantastic organization like Century Medical.”

Reflow’s Wingman Crossing Catheter received clearance from the U.S. Food and Drug Administration for the expanded CTO indication for the Wingman Crossing Catheter in March 2020 after completing the Wing-IT clinical trial.

About Reflow Medical, Inc.

Reflow Medical, Inc. is a private company focused on empowering physicians through the design and development of innovative and effective technologies for cardiovascular disease. Reflow is developing a family of products to treat cardiovascular disease.

About Century Medical, Inc.

Century Medical, Inc. (CMI) is one of the largest independent medical device distributors in Japan, with more than 40 years of experience marketing medical devices. CMI has been a pioneering force, successfully introducing many new technologies to the Japanese healthcare community. Century Medical, Inc, is a wholly owned subsidiary of ITOCHU Corporation.

About Chronic Total Occlusions (CTO) in Peripheral Artery Disease (PAD)

Chronic total occlusions (CTO) of the lower extremities are found in 40% of symptomatic peripheral artery disease (PAD) patients. Endovascular options for the treatment of a CTO can be complex; conventional wire and catheter technique have a

Eli Lilly Seeks FDA Approval On Coronavirus Treatment, Potentially Easing Rush For A Vaccine

KEY POINTS

  • Eli Lilly’s three trials over the summer yielded positive results in patients with mild- to moderate-cases of coronavirus
  • The company could have nearly 1 million doses ready for distribution by the end of 2020 with FDA approval
  • Temporary protections provided by the antibody treatment could potentially give pharmaceutical companies more time to develop stronger vaccines

Pharmaceutical company Eli Lilly & Co. asked the U.S. Food and Drug Administration Wednesday to authorize the use of a potential coronavirus treatment that’s shown promising results during clinical trials.

Eli Lilly asked the FDA to authorize the drug’s emergency use after results for their first three clinical trials all came back positive in people with mild- to moderate-cases of coronavirus. If approved, Eli Lilly said it could have 100,000 doses ready to go within a month and 1 million ready by the end of 2020.

However, it would not be used on more severe cases, since it has not proven to be as effective in treating those cases.

The drug, codenamed LY-CoV555, is in an antibody drug Eli Lilly has been developing with Canadian pharmaceutical company AbCellera Biologics Inc. AbCellera started by taking blood samples from one of the first coronavirus patients in the U.S. to recover when it began working with Eli Lilly. The two then started developing an antibody drug treatment based on the antibodies found in the patient’s blood sample.

Trials began in June, when hospitalized patients being treated for coronavirus were dosed randomly with either the drug or a placebo to measure the drugs effectiveness. After results showed the drug helps treat the virus, phase 2 trials were conducted among vulnerable populations who were randomly administered a placebo or one of two potential drugs, including alternate antibody treatment LY-CoV016.

The most recent trials were conducted in nursing homes and, as before, showed the drug helped treat the symptoms of coronavirus and could temporarily protect against it. The latter half of the results would be important because it could ease the pressure on other pharmaceutical companies to develop a full vaccine.

One company which would benefit from this, in that regard, is AstraZeneca Plc. U.S. trials for AstraZeneca’s potential vaccine have been on hold since September after one patient was diagnosed with unexpected neurological symptoms after being inoculated. Trials have continued overseas.

That said, AstraZeneca may still rush to get a vaccine out as its pledge not to profit from it runs through July 2021. Under its current contractual agreement, Astrazeneca could declare the pandemic over by then and begin profiting off its distribution. The period could be extended if AstraZeneca acts “in good faith” if the pandemic is not considered over.

The company said it expects to receive an update about possibly resuming its U.S. trials in the next two weeks.

Nita Patel, director of antibody discovery and vaccine development at Novavax, lifts a vial containing the company's experimental Covid-19 vaccine Nita Patel, director of antibody discovery and vaccine development at Novavax, lifts a vial containing the company’s experimental Covid-19 vaccine Photo: AFP / ANDREW CABALLERO-REYNOLDS

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Eli Lilly Applies For Emergency Approval For Covid-19 Antibodies

The US biotech firm Eli Lilly on Wednesday announced it was seeking an emergency use authorization (EUA) for its lab-produced antibody treatments against Covid-19, after early trial results showed they reduced viral load, symptoms and hospitalization rates.

“Our teams have worked tirelessly the last seven months to discover and develop these potential antibody treatments,” said Daniel Skovronsky, Lilly’s chief scientific officer.

“Lilly is diligently working with regulators around the world to make these treatments available,” he added.

The company said in a statement that its “combination therapy” of two antibodies working together was shown to be effective in a placebo-controlled study of 268 patients with mild to moderate Covid-19.

Their analysis showed the proportion of patients with high viral load at day 7 of their illness was 3.0 percent on the therapy, compared to 20.8 percent on the placebo arm.

Improvement in symptoms was seen as early as three days after dosing.

The rate of Covid-related hospitalization and emergency visits was 0.9 percent for patients treated with combination therapy versus placebo 5.8 percent on placebo, a relative risk reduction of 84.5 percent.

The company is also studying a “monotherapy” of just one of the two antibodies, and said that parallel research showed that this was similarly effective.

The trial is ongoing and Lilly wants to recruit a total of 800 people.

Aa transmission electron micrograph of SARS-CoV-2 virus particles, isolated from a patient,captured and color-enhanced Aa transmission electron micrograph of SARS-CoV-2 virus particles, isolated from a patient,captured and color-enhanced Photo: National Institute of Allergy and Infectious Diseases / Handout

Lilly said it expects to have 100,000 doses of the monotherapy available this month, and a million by the end of the year. It also expects to have 50,000 doses of the combination therapy by the end of 2020.

The findings have not yet been published in a peer-reviewed journal.

Both antibodies work by binding to different parts of spike proteins on the surface of the SARS-CoV-2 virus, distorting their structure so the virus can’t invade living cells.

Antibodies are infection-fighting proteins made by the immune system and can also be harvested from recovered patients, but it is not possible to make so-called “convalescent plasma” a mass treatment.

Researchers can also comb through the antibodies produced by recovered patients and select the most effective out of thousands, and then manufacture them at scale.

US President Donald Trump, who has Covid-19, received a dose of synthetic antibodies produced by the firm Regeneron last week.

Regeneron has also reported encouraging results from its early trials, but hasn’t yet applied for emergency approval and so remains an experimental treatment.

The US Food and Drug Administration has previously granted an EUA for the antiviral remdesivir, for convalescent plasma, and for hydroxychloroquine, which was subsequently revoked over safety fears.

In addition, US health authority’s guidelines recommend the use of the steroid dexamethasone to control a damaging inflammatory response seen in later stages of Covid-19.

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ARCA biopharma Announces FDA Approval of IND Application for AB201 as a Potential Treatment for COVID-19

Dr. Bristow

Dr. Michael Bristow, President and CEO, ARCA biopharma, Inc.
Dr. Michael Bristow, President and CEO, ARCA biopharma, Inc.
Dr. Michael Bristow, President and CEO, ARCA biopharma, Inc.
  • Initiation of Phase 2b clinical trial anticipated in Q4 2020

  • Trial to enroll approximately 100 patients hospitalized with COVID-19

  • Topline data anticipated Q2 2021

WESTMINSTER, Colo., Oct. 07, 2020 (GLOBE NEWSWIRE) — ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, today announced the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for AB201 (rNAPc2) as a potential treatment for patients hospitalized with COVID-19. ARCA anticipates initiating a Phase 2b/3 sequential clinical trial, ASPEN-COVID-19, of AB201 in approximately 100 patients hospitalized with COVID-19 in the fourth quarter of this year, with Phase 2b followed by a contiguous Phase 3 study that is dependent on Phase 2 results. The Company anticipates topline data from the trial in the second quarter of 2021.

The planned Phase 2b trial is anticipated to be a randomized comparison of two dose regimens of AB201 versus heparin prescribed per local standard of care. The clinical course of some patients with COVID-19 is complicated by a virus-triggered coagulopathy that includes thrombotic events and inflammatory processes, thought to be mediated in part by tissue factor production. AB201 is a potent tissue factor inhibitor anticoagulant with anti-inflammatory and antiviral properties. The primary endpoint of the trial will be change in D-dimer level from baseline to Day 8. D-dimer is a biomarker commonly used for assessing coagulation activation, which is elevated in approximately 50% of hospitalized COVID-19 patients and is directly associated with adverse clinical outcomes.   If Phase 2b indicates a favorable effect on D-dimer levels, following FDA review of the data and identification of the proposed Phase 3 AB201 dose, the Company anticipates that clinical investigative sites will begin enrolling in the planned Phase 3 clinical trial. The primary endpoint of Phase 3 will be clinical recovery as measured by the Adaptive COVID-19 Treatment Trial (ACTT-1) ordinal scale, with secondary endpoints that include D-dimer levels and the number of thrombotic events. Phase 3 will be event driven, with an estimated requirement of 450 patients. The Phase 2b and Phase 3 trials are described in a common protocol and use identical entry criteria and the same heparin regimen control.

Dr. Michael Bristow, ARCA’s President and Chief Executive Officer, who is also an American Heart Association (AHA) funded COVID-19 investigator, commented, “The ASPEN-COVID-19 trial will use the coagulopathy biomarker D-dimer to identify an optimal dose from AB201 regimens that are both within the therapeutic range as determined from Phase 2 trials investigating cardiovascular thrombosis prophylaxis. If successful, we anticipate using this dose in a planned Phase 3 trial to evaluate potential improvement in clinical outcomes. We believe that the combination of anticoagulant, anti-inflammatory and antiviral effects of AB201 may favorably impact clinical recovery of patients hospitalized with COVID-19.”

The trial is being managed in collaboration with the Colorado Prevention Center (CPC),

FDA issues new vaccine guidance that pushes approval past election

The Food and Drug Administration has released its long-awaited guidance on how it will issue Emergency Use Authorizations (EUAs) for COVID-19 vaccines. The FDA says safety data on any vaccine will need to be monitored for at least two months after Phase 3 clinical trials are completed, likely closing the door on the possibility of approving a vaccine before Election Day.

“Data from Phase 3 studies should include a median follow-up duration of at least two months after completion of the full vaccination regimen to help provide adequate information to assess a vaccine’s benefit-risk profile,” the agency wrote in a briefing document for an upcoming vaccine advisory committee meeting. 

An EUA does not require as much proof as the more exhaustive, standard FDA approval process, but can expedite treatments deemed beneficial in an emergency.

The FDA’s Center for Biologics Evaluation and Research oversees the vaccine approval process and often consults with an outside advisory committee. The expert committee, set to meet on October 22, is made up of scientists, physicians, biostatisticians, and a consumer representative who are tasked with advising the FDA on the safety and efficacy of the vaccine. According to the FDA, the purpose of the meeting is not to “discuss any particular vaccine candidate.”

By providing the committee with two months of data on risks and benefits after the Phase 3 trial is completed, the panel of experts will have more time to screen for severe COVID-19 disease and adverse events among study participants, according to the guidance. 

FDA Commissioner Stephen Hahn said in a statement that he hoped the guidelines would help “the public understand our science-based decision-making process that assures vaccine quality, safety and efficacy.”

Time is essential in vaccine trials. Most adverse effects from a vaccine occur within the first month or two, but issues can also crop up long after they are administered, which is why companies continue to follow participants for at least two years, according to William Moss, executive director of Johns Hopkins’ International Vaccine Access Center. 

Approval of any EUA will require a “trade-off decision” between a vaccine’s societal value and “potential, rare, delayed side effects,” Moss told CBS News. 

President Trump has repeatedly asserted that a vaccine is imminent. On Labor Day, he said it could be ready “during the month of October.” On Monday, upon returning to the White House after a four-day stint in the hospital for his own coronavirus diagnosis, the president said that a vaccine is coming “momentarily.” 

“We have the best medicines in the world. And they all happened very shortly, and they’re all getting approved, and the vaccines are coming momentarily,” he said.


COVID-19, Trump and the race to a vaccine: Vo…

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The FDA noted in its briefing document that the guidance is not legally enforceable. “Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited,” it said. 

The agency almost always follows the panel’s advice,