Emergent slumps as U.S. terminates COVID-19 vaccine manufacturing deal

 Shares of Emergent BioSolutions Inc tumbled 15% on Friday, following the termination of a U.S. government contract to reserve capacity and expand manufacturing of third-party COVID-19 vaccines at its sites.

The contract manufacturer has come under regulatory fire after an accidental mix-up of ingredients ruined about 15 million doses of Johnson & Johnson's COVID-19 vaccine and prompted the U.S. Food and Drug Administration to halt operations at its Baltimore plant earlier this year.

The modification of terms with the U.S. Department of Health and Human Services will reduce the contract's value to $470.9 million from $650.8 million, Emergent said in a regulatory filing late on Thursday.

Emergent said in late July it would resume production of J&J's vaccine at the plant following additional FDA reviews.

The termination of contract with the U.S. government further decreases revenue for Emergent's deteriorating contract drug manufacturing business, Cowen analyst Boris Peaker said in a note.

The material manufactured for the J&J vaccine at the Baltimore plant prior to the April shutdown and awaiting FDA approval could be enough to produce as many as 50 million shots, Reuters reported last month.

Emergent said on Thursday it was expecting to continue supporting J&J out of its Bayview site.

Emergent shares have fallen 41% this year up to Thursday's close.

https://finance.yahoo.com/news/emergent-slumps-u-terminates-covid-113116337.html

FDA: Breakthrough Device Tag to ReWalk ReBoot Soft Exo-Suit

 Soft exoskeleton device for stroke survivors will be for use at home and in the community to help with walking and mobility

 ReWalk Robotics, Ltd. (Nasdaq: RWLK) ("ReWalk" or the "Company"), a leading global manufacturer of robotic medical devices for individuals with lower limb disabilities, today announced its ReBoot device has been granted designation as a Breakthrough Device by the Food and Drug Administration (FDA). The ReBoot is a lightweight, battery-powered orthotic exo-suit intended to assist ambulatory functions in individuals with reduced ankle function related to neurological injuries, such as stroke. The ReBoot is a customizable personalized device intended for home and community use. It is a sister product to the ReStore device, which received FDA clearance in 2019 for use in the rehabilitation setting.

“Breakthrough device designation from the FDA is a critical milestone for the ReBoot, as it provides a more streamlined review pathway that can get this uniquely innovative device to market faster,” said Larry Jasinski, CEO of ReWalk. “The ReBoot will give stroke survivors a device customizable for each individual user, giving them the opportunity for regular assistance at home and in the community. ”

The ReBoot works in conjunction with the muscles of the affected leg to assist individuals not only with maintaining safe foot positioning but also with pushing off the ground, which means it may improve their gait. It may also:

• Facilitate muscle re-education, particularly of plantarflexor function;

• Prevent/retard disuse atrophy;

• Maintain or increase joint range of motion;

• Improve walking speed and endurance independent of the device; and

• Reduce incidence of falls due to poor foot positioning secondary to footdrop.

https://finance.yahoo.com/news/fda-awards-breakthrough-device-designation-203000853.html

Ocugen Submits Emergency Use Authorization Request for Investigational COVID-19 Vaccine for Ages 2-18 Years

 

• COVAXIN™ (BBV152) was recently awarded Emergency Use Listing by the World Health Organization
  

• Pediatric EUA submission based on immuno-bridging clinical trial in children, ages 2-18, demonstrating comparable neutralizing antibody response as seen in a large adult Phase 3 clinical trial conducted in India

• COVAXIN™ (BBV152) uses same Vero Cell manufacturing platform as other childhood vaccines, including the inactivated polio vaccine

• COVAXIN™ (BBV152) elicited antibody titers against multiple antigens (S1, RBD, and N); and provided durable immunity against COVID-19 in Phase 3 adult trial in India

• No serious adverse events or hospitalizations were observed in Phase 2/3 pediatric study of COVAXIN™ (BBV152), including no events of special interest such as Guillain-Barre Syndrome, anaphylactic reactions, myocarditis, pericarditis, and vaccine-induced thrombotic thrombocytopenia.
  

Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing novel therapeutics and vaccines, announced today that it has submitted a request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of Ocugen’s COVID-19 vaccine candidate BBV152, known as COVAXIN™ outside of the U.S., for pediatric use. The vaccine candidate was developed by the company’s partner, Bharat Biotech, and was studied in an immuno-bridging clinical trial conducted in India with children 2-18 years of age.

COVAXIN™ (BBV152) is a whole-virion, inactivated vaccine, manufactured using a Vero Cell manufacturing platform, as has been used in the production of the inactivated polio vaccine for the past 35 years, as well as of other traditional childhood vaccines.

The submission is based on results of a Phase 2/3 pediatric clinical trial conducted by Bharat Biotech in India with 526 children 2-18 years of age, which bridged immunogenicity data to a large, Phase 3 safety and efficacy clinical trial in nearly 25,800 adults in India.

https://finance.yahoo.com/news/ocugen-inc-announces-submission-emergency-103800362.html

Pfizer: Covid pill with HIV drug cuts risk of hospitalization or death by 89%

 Pfizer said Friday that its easy-to-administer Covid-19 pill, used in combination with a widely used HIV drug, cut the risk of hospitalization or death by 89% in high-risk adults who’ve been exposed to the virus.

It’s now the second antiviral pill behind Merck’s to demonstrate strong effectiveness for treating Covid at the first sign of illness. If cleared by regulators, it would likely be a game changer in the ongoing global pandemic fight. Pfizer said it plans to submit its data to the Food and Drug Administration “as soon as possible.” 

Pfizer’s pill, scientifically known as PF-07321332, is part of a class of medicines called protease inhibitors and works by inhibiting an enzyme the virus needs to replicate in human cells. Protease inhibitors are used to treat other viral pathogens such as HIV and hepatitis C.

The HIV drug helps slow the metabolism, or breakdown, of Pfizer’s pill in order for it to remain active in the body for longer periods of time at higher concentrations, the company said.

The company said its data on the drug is based on a mid-to-late stage study of 1,219 adults who had at least one underlying medical condition and a laboratory-confirmed infection within a five-day period. Participants were also given a low dose of ritonavir, a medication commonly used in combination treatments for HIV.

Pfizer said there were six hospitalizations and zero deaths out of the 607 trial participants who received the pill in combination with the HIV drug within five days of symptom onset. That compares with 41 hospitalizations and 10 deaths out of the 612 people who received a placebo.

“These data suggest that our oral antiviral candidate, if approved by regulatory authorities, has the potential to save patients’ lives, reduce the severity of COVID-19 infections, and eliminate up to nine out of ten hospitalizations,” Pfizer CEO Albert Bourla said in a statement.

Unlike Gilead Sciences’ intravenous drug remdesivir, Pfizer’s and Merck’s drugs can be taken by mouth. While vaccinations remain the best form of protection against the virus, health experts hope pills like these will keep the disease from progressing in those who do get infected and prevent trips to the hospital.

Merck and Ridgeback Biotherapeutics said Oct. 1 that they’ve developed a drug that, when administered alone, reduces the risk of hospitalization or death by around 50% for patients with mild or moderate cases of Covid.

The antiviral pill made by Merck was approved by Britain’s medicines regulator on Thursday.

June Raine, chief executive of the U.K.’s Medicines and Healthcare products Regulatory Agency, said that Merck’s pill will greatly facilitate the treatment of Covid, a disease that has killed more than 5 million people globally and caused tremendous strain on health systems.

Bourla told CNBC in April that Pfizer’s pill could be available to Americans by the end of this year.

https://www.cnbc.com/2021/11/05/pfizer-says-its-covid-pill-with-hiv-drug-cuts-the-risk-of-hospitalization-or-death-by-89percent.html

Docs' Burning Questions About the COVID Vaccine for Young Kids

 The formulation of Pfizer's COVID-19 vaccine for kids ages 5 to 11 provoked the most questions among clinicians at a call hosted by CDC staff.

Unlike the vaccine for people ages 12 and up ("purple cap"), this vaccine ("orange cap") has greater stability. It can be stored in the refrigerator for up to 10 weeks, and does not require ultra-cold storage. But while the formulation has changed, the active ingredient remains the same.

"The two formulations are not interchangeable, and children should get the age-appropriate vaccine rather than drawing up a third of the [higher] dose," said Kate Woodworth, MD, MPH, of the CDC.

Sara Oliver, MD, also of the CDC, chimed in, saying that the other difference between the pediatric and adult vaccine is the type of buffer.

"Both of these ... buffers are very safe, well-studied ... and used in a variety of medications. It's not a novel, never-used-before buffer," she noted.

Oliver added that as they adjusted the dose down, they needed a different buffer to "ensure they were getting the exact dose." Other CDC staff said that it is in fact the same buffer used in the Moderna COVID-19 vaccine.

Woodworth also addressed a frequent question among clinicians about dosing an 11-year-old who turns 12 prior to their second dose, saying that the agency recommends "the child receive the vaccine based on their age the day of vaccination."

However, Woodworth noted that the FDA emergency use authorization (EUA) states that this child "may receive ... the formulation for ages 5-11 or individuals ages 12 and older."

If their second dose at age 12 is the lower dose, she said that clinicians do not need to repeat the dose, and this is not considered an error under the EUA.

In addition, she stressed that the vaccine is given based on age, not size or weight, so if a child is 12 years old, they should receive the higher dose of vaccine.

Woodworth also emphasized that even if a child has previously had COVID, they should be vaccinated. If the child has active COVID infection, vaccination can be deferred until after the child has recovered and met criteria to discontinue isolation. This amounts to 10 days after a positive test if asymptomatic or 10 days after symptom onset and resolution of fever for at least 24 hours.

The only population that the vaccine is contraindicated for are those with severe allergic reactions to the vaccine ingredients, she said. Underlying medical conditions are not a contraindication to vaccination. However, booster doses or additional doses are not recommended for immunocompromised children at this time.

Clinicians also inquired about the looming issue of vaccine-associated myocarditis. Oliver noted that incidence of myocarditis tends to be lower in this population, as its higher incidence in teenagers may be "driven by an adolescent/puberty/boy thing."

She also stressed that vaccine-associated myocarditis is not the same as "regular" myocarditis.

"Vaccine-associated myocarditis is mild and tends to resolve quickly," Oliver said, adding that data from a survey of cardiologists showed that over 90% said vaccine-associated myocarditis in their patients had completely resolved 3 months after symptom onset.

Oliver contrasted this with multi-system inflammatory syndrome in children (MIS-C), heart inflammation, and myocarditis associated with COVID infection, which lead to "long-term consequences."

https://www.medpagetoday.com/infectiousdisease/covid19vaccine/95449

Arena: Key Program Updates

 Phase 3 ELEVATE UC 52 and 12 on course for Q1 2022 topline data readout

– First participant randomized in the Phase 2 trial for temanogrel in Raynaud’s phenomenon secondary to systemic sclerosis

– Strong liquidity position to support continued pipeline progress

https://finance.yahoo.com/news/arena-reports-third-quarter-financial-200500949.html

NRx: FDA Nixes Emergency Use for Critical COVID-19 with Respiratory Failure Med

  NRx Pharmaceuticals Has Requested a Type A Meeting with US Food and Drug Administration (FDA) to Include Treating Physicians and Patients

- FDA Commits to Working with NRx to Develop ZYESAMI®

- ZYESAMI Clinical Trials Funded by the US National Institutes of Health and BARDA Continue and Advance Towards Enrollment in Brazil and Europe

NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company (NRx), today announced that the US Food and Drug Administration (FDA) has declined to issue an Emergency Use Authorization (EUA) for ZYESAMI® (aviptadil). The FDA stated that it was unable to issue the EUA at this time due to insufficient data regarding the known and potential benefits of the medicine and the known and potential risks of ZYESAMI in patients suffering from Critical COVID-19 with respiratory failure. In its letter, the FDA noted that so far, it has reviewed safety in only 131 randomized patients treated with ZYESAMI. NRx will attempt to coordinate a review by the FDA of the 150 or more additional patients already treated with ZYESAMI in the NIH ACTIV-3b trial. Last week, the study's Data Safety and Monitoring Board reviewed the ongoing NIH ACTIV-3b trial and found no new safety issues.

"Yesterday, more than 1,500 Americans and many more around the world died lonely deaths from COVID-19, isolated from their loved ones in ICUs despite widespread vaccination and currently-available approved treatments," said Jonathan Javitt, MD, MPH, Chief Executive Officer and Chairman of the Board of NRx. "We believe that ZYESAMI has demonstrated a high degree of safety and a two-fold increase in the odds of surviving the ICU. Patients treated at the nation's top hospitals with ZYESAMI had a four-fold increase in odds of survival. We will work actively with the FDA to deliver the data it has requested so that we may offer those patients another chance at life, and have asked the FDA for a Type A meeting that will include the experience of physicians who have witnessed the effects of our medicine firsthand and the experience of patients who are alive today because they were given one last chance at life. In the meantime, we are actively engaged with regulators and potential partners on multiple continents to advance ZYESAMI towards regulatory approval. Now that we have completed the Chemical and Manufacturing Controls (CMC) required for traditional approval pathways, we will move towards filing for accelerated approval based on the unexpectedly strong biomarker results seen in our two clinical trials."

https://finance.yahoo.com/news/us-food-drug-administration-declines-220800549.html