Two more companies, Novavax Inc. and Regeneron Pharmaceuticals Inc., are on the receiving end of U.S. federal government funding to develop and deliver a COVID-19 vaccine in 2021. Read More
Corvus Pharmaceuticals Inc.’s success in treating a COVID-19 patient previously diagnosed with non-small-cell lung cancer (NSCLC) with CPI-006 helped boost shares (NASDAQ:CRVS) to $4.96, up $2.21, or 181%, as the Burlingame, Calif.-based company disclosed the start of a phase I study to investigate the anti-CD73 immunotherapy prospect. Read More
Bharat Biotech International Ltd. has successfully developed India’s first indigenous vaccine candidate for COVID-19 to enter human trials. Named Covaxin, the vaccine has been cleared by the Drug Controller General of India (DCGI) and Ministry of Health & Family Welfare for phase I and II trials after the company submitted positive preclinical study results regarding safety and immune response. Read More
Despite the SARS-CoV-2 pandemic, biopharma dealmaking values in the second quarter of 2020 increased by 22.4% since the first quarter, and M&A values – thanks to Abbvie Inc. completing in May its $63 billion buyout of Allergan plc – are at a four-year high. A total of 529 deals, including licensings, collaborations and joint ventures, reported during the second quarter had projected values of nearly $49 billion, a step up from the 471 deals and $40.8 billion value of the first quarter. Read More
Cellectis SA said the FDA has placed a clinical hold on a phase I study of UCART-CS1A, an allogenic CAR T-cell therapy it has been testing in patients with relapsed or refractory multiple myeloma, after one person enrolled in the study died from a case of treatment-emergent cardiac arrest. Cellectis' chief medical officer, Carrie Brownstein, told BioWorld she supported the move, which formalized a decision she'd already taken with her team. Read More
DUBLIN – Gesynta Pharma AB raised SEK190 million (US$20.6 million) in new funding to move GS-248, a selective inhibitor of microsomal prostaglandin E synthase-1 (mPGES-1), into a phase IIa trial in systemic sclerosis. The study is due to get underway toward the year end. “It’s going to be in the second half of the fourth quarter,” said Patric Stenberg, CEO of Lund, Sweden-based Gesynta. Read More
Biopharmas raising money in public or private financings, including: Algernon, Allovir, Ascendis, Evolus, Inventiva, Molecular Partners, Oryzon, Pear, Poseida, Revolution, Tenax, Vor. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Algernon, Annovis, Apellis, Cohbar, Corvus, Curis, Cyteir, Entera, Evive, Lipidor, Inmed, Novocure, Onconova, Otonomy, Outlook, Viiv. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aldeyra, Cellectis, Cybrexa, Diffusion, Endo, Mallinckrodt, Neurogene, Novartis, Otonomy, Otsuka, Propeller, Senhwa, Sosei. Read More