Following a recent string of emergency use authorizations (EUA) for their jointly developed COVID-19 vaccine, BNT-162b2, Pfizer Inc. and Biontech SE said Dec. 14 that results from an ongoing German trial have helped illustrate "the multiple arms of the immune system that are activated" by the product to fight SARS-CoV-2. Separately, Moderna Inc. raised to 200 million the number of doses of its COVID-19 vaccine candidate it will supply to the U.S. government. Read More
A day after the FDA granted emergency authorization for the use of the Pfizer Inc./Biontech SE COVID-19 vaccine, the U.S. CDC’s Advisory Committee on Immunization Practices (ACIP) gave a thumb’s up for the vaccine, as did the Western States Scientific Safety Review Workgroup. Read More
LONDON – The U.K. Medicines and Healthcare products Agency (MHRA) has given approval for the first-in-human study of Codagenix Inc.’s COVI-VAC, a live, attenuated whole virus COVID-19 vaccine, which is engineered to be structurally identical to wild-type SARS-CoV-2, but is much slower to replicate. Read More
In the biggest deal of a year packed with massive deals, Astrazeneca plc will buy Alexion Pharmaceuticals Inc. in a cash and stock transaction at $175 per share totaling $39 billion. Read More
Cambridge, Mass.-based Relay Therapeutics Inc. has signed a lucrative worldwide license and collaboration agreement with Genentech, a member of the Roche Group, for the development and commercialization of its compound, RLY-1971, a potent inhibitor of Src homology region 2 domain-containing phosphatase-2 (SHP2) that is being investigated in a phase I dose-escalation study in patients with advanced or metastatic solid tumors. Read More
Scineuro Pharmaceuticals, based in Shanghai and Philadelphia, launched with a $100 million series A financing to focus on tackling central nervous system diseases. CEO Min Li told BioWorld the startup is “building a CNS portfolio through a combination of internal R&D and strategic collaborations.” Lilly Asia Ventures Fund and Arch Venture Partners co-led the round. Read More
PERTH, Australia – Chimeric Therapeutics Ltd. closed an IPO on the Australian Securities Exchange (ASX:CHM), raising AU$35 million (US$26.5 million) to fund its CAR T trial in glioblastoma. Read More
LONDON – Innoskel has arrived on the scene with a €20 million (US$24.3 million) series A funding to advance development of gene therapies for type 2 collagenopathies, a group of rare skeletal disorders that affect the structure of connective tissues, leading to short stature. Read More
HONG KONG – Takeda Pharmaceutical Co. Ltd. has received Chinese approval for Takhzyro (lanadelumab), its fully human monoclonal antibody, delivered via subcutaneous injection, for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients 12 and older. Read More
Three months after completing what it said was the largest development and commercialization deal by a Chinese biotech, I-Mab Biopharma Co. Ltd. is moving the monoclonal antibody at the heart of the deal deeper into the clinic. At the end of November, Chinese regulators gave it a green light to move forward with an open-label, multicenter trial for lemzoparlimab, in combination with azacitidine. Read More
The latest global regulatory news, changes and updates affecting biopharma, including: Health Canada to extend COVID-19 flexibilities; USTR seeking input on nations with poor IP protections. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Acceleron, Amag, Ascletis, Antengene, Astrazeneca, Avelas, Biontech, Codagenix, Daiichi Sankyo, EMD, Gamida, Gannex, Graphite, Legend, Merck KGaA, Mindmed, Open Orphan, Pfizer, Sobi. Read More
