Britain’s GlaxoSmithKline and France’s Sanofi on Monday said they had started a new clinical trial of their protein-based COVID-19 vaccine candidate and aim to reach the final testing stage in the second quarter.
The move comes after the drugmakers in December said their vaccine would be delayed after clinical trials showed an insufficient immune response in older people.
French healthcare company Sanofi will provide COVID-19 vaccine manufacturing support to U.S. peer Johnson & Johnson, Sanofi said on Monday.
Once authorized, Sanofi will provide Johnson & Johnson access to the established infrastructure and expertise of its vaccine manufacturing plant in Marcy l’Etoile, France, to formulate and fill vials of Johnson & Johnson’s Janssen COVID-19 vaccine candidate in 2021 at a rate of approximately 12 million doses per month.
CytoDyn expects to release CD12 data and complete discussions with various regulatory agencies within 2 to 3 weeks
CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing Vyrologix™ (leronlimab-PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today the CD12 COVID-19 trial data has been unblinded and the results will be reported when the Company has concluded its ongoing discussions with regulators.
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, commented, “We are eager to reach conclusion in our discussions with all the regulatory agencies for the path going forward and will release the details of our data and the results of our discussions with regulatory agencies in the coming weeks.” Details of the Company’s ongoing discussions with the regulatory agencies are confidential.
https://finance.yahoo.com/news/cytodyn-discussions-u-fda-mhra-110000789.html
* ASTRAZENECA PLC - VOLUNTARY WITHDRAWAL IMFINZI US BLADDER INDICATION
* ASTRAZENECA - DECISION WAS MADE IN CONSULTATION WITH FOOD AND DRUG ADMINISTRATION
* ASTRAZENECA - WITHDRAWAL DOES NOT IMPACT INDICATION OUTSIDE US
* ASTRAZENECA - WITHDRAWAL IS ALIGNED WITH FDA GUIDANCE FOR EVALUATING INDICATIONS WITH ACCELERATED APPROVALS THAT DID NOT MEET POST-MARKETING REQUIREMENTS
* ASTRAZENECA - HEALTHCARE PROVIDERS ARE BEING NOTIFIED OF THIS UPDATE
* ASTRAZENECA - WITHDRAWAL DOES NOT IMPACT OTHER APPROVED IMFINZI INDICATIONS WITHIN OR OUTSIDE US
-Biohaven's proprietary MATE™ conjugation platform has been used to generate a new class of antibody-based therapies to target COVID-19
-BHV-1200, a COVID-19 targeting MATE compound, recently completed in vitro testing that demonstrated activity against SARS-CoV-2 wild-type as well as mutants associated with reduced susceptibility to therapeutic monoclonal antibodies and emerging strains including the "English" and "South African" variants
-Based upon the in vitro profile against SARS-CoV-2 wild-type and variants, Biohaven will advance BHV-1200 into the clinic
Drug developer Novavax Inc said on Monday it has completed patient enrollment in the late-stage study of its COVID-19 vaccine in the United States and Mexico.
The company said last month its vaccine was 89.3% effective in preventing COVID-19 in a trial conducted in the United Kingdom, and was nearly as effective in protecting against the more highly contagious variant first discovered in the UK.
Novavax said it had enrolled 30,000 volunteers across the United States and Mexico.
In the late-stage trial, the company said 20% of participants were Latinx, 13% were African American, and 13% were 65 and older.
Oscar Health, a health insurance start-up backed by Google parent Alphabet Inc, will raise as much as $1.05 billion in its initial public offering, according to a regulatory filings on Monday.
The offering is expected to be priced between $32 and $34 per share, valuing the company at $6.7 billion at the upper end of the pricing range.
The company, founded in 2012, allows patients to schedule physician visits, check lab results, make emergency virtual appointments and refill prescriptions through its mobile app or online platform.
The IPO comes at a time when the COVID-19 pandemic has helped boost demand for telehealth services and companies are looking to expand their footprint.
Oscar Health, which serves 529,000 members, has not been profitable since its inception, and reported a net loss of $406.8 million in 2020. (bit.ly/37AeU9M)
The company was founded by Mario Schlosser, Kevin Nazemi, who is no longer a part of the company, and Josh Kushner, brother of former U.S. President Donald Trump’s adviser and son-in-law Jared Kushner.
