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Product Development

Oct. 6 Quick Takes: BARDA whistleblower quits NIH; plus COVID-19 updates from Vir-GSK, BioNTech, Pfizer, $115M B round for Talaris and more

Oct 7, 2020 | 1:30 AM GMT

Former BARDA Director Bright leaving NIH
Rick Bright, the former director of the Biomedical Advanced Research and Development Authority and HHS deputy assistant secretary for preparedness and response, has resigned from NIH, according to a statement by his attorneys. Bright also filed an updated complaint “alleging constructive discharge based on the failure of NIH leadership to assign him any meaningful work.” In a whistleblower complaint filed in May, Bright alleged that cronyism has crippled the U.S. pandemic response, enriching undeserving entrepreneurs and politically potent consultants who siphoned funds that could and should have been used to mount a defense against COVID-19. 

Vir-GSK mAb advancing into Phase III for COVID-19
Vir Biotechnology Inc. (NASDAQ:VIR) and GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) said the Phase II/III COMET-ICE study of VIR-7831, their mAb targeting SARS-CoV-2, is proceeding into its Phase III portion on the recommendation of an IDMC. The companies expect data on the primary endpoint next quarter, although interim data could be available around year-end.

BioNTech, Pfizer start rolling submission of coronavirus vaccine to EMA
BioNTech SE (NASDAQ:BNTX) and Pfizer Inc. (NYSE:PFE) said Tuesday the partners started a rolling submission of an MAA with EMA for COVID-19 vaccine candidate BNT162b2, allowing EMA’s CHMP to begin the review of preclinical data for the vaccine. BioNTech and Pfizer expect this month to conduct the first interim analysis of the Phase III trial of BNT162b2, which the partners said has enrolled 37,000 patients, with more than 28,000 having already received a second dose of the vaccine.

Japanese regulator to offer scientific advice for COVID-19 products
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) said it has begun offering sponsors free scientific advice on the development of vaccines for COVID-19, including discussions of overall strategy and clinical trial protocols. The agency has provided access to relevant forms and information on its website.

ATCC joins BARDA’s trials network
In further COVID-19 news, BARDA has awarded ATCC a contract of up to 10 years and $250 million to provide the agency’s Clinical Studies Network with a biological specimen and investigational product storage facility with centralized services for collection, receipt, storage, protection, processing, tracking, retrieval, packaging and distribution.  

Surveyor, Viking lead Talaris’ megaround 
Talaris Therapeutics Inc. raised $115 million in a series B round co-led by Citadel’s Surveyor Capital and Viking Global Investors. New investors Cormorant Asset Management, Invus, BlackRock, Eventide Asset Management, Logos Capital, Aisling Capital and Pamoja Capital, as well as Talaris’ series A investors Blackstone Life Sciences, Longitude Capital and Qiming Venture Partners USA participated. The financing will go support testing of Talaris’ lead candidate, FCR001, including a Phase III trial in first-time living donor kidney transplant recipients.

End of the road for Santhera’s Puldysa in DMD
Santhera Pharmaceuticals Holding AG (SIX:SANN) fell CHF1.63 (27%) to CHF4.50 Tuesday after it discontinued development of Puldysa idebenone to treat Duchenne muscular dystrophy. A DSMB said the Phase III SIDEROS trial was unlikely to meet its primary endpoint. Santhera will also withdraw an MAA for Puldysa for the indication. The short-chain benzoquinone is marketed as Raxone to treat Leber’s hereditary optic neuropathy (LHON).

At R&D day, Alexion reveals plans to lift guidance
Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) said it will raise its 2020 revenue guidance by more than $200 million when it announces 3Q20 results. The company had expected full-year revenues of $5.55-$5.60 billion when it reported 2Q20 earnings. The update came as Alexion showcased a pipeline of more than 20 development programs across seven rare disease franchises at its R&D day; the company said it could have as many as 10 launches in progress by the end of 2023.

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