An antibody cocktail developed by Regeneron Pharmaceuticals Inc. has received emergency use authorization (EUA) from the FDA for the treatment of mild to moderate COVID-19. Monoclonal antibodies (Mabs) such as Regeneron's, called casirivimab and imdevimab, "have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load," the company said. Read More
LONDON – A third COVID-19 vaccine has turned in positive results in the phase III interim analysis, with Astrazeneca plc/Oxford University reporting an average of 70.4% efficacy across two dose regimens for AZD-1222. Read More
Although Eiger Biopharmaceuticals Inc. sees more would-be opportunities with ultra-rare disease-targeting Zokinvy (lonafarnib), the company’s vice president of clinical and development operations, Colin Hislop, said that “at the moment, we’re very clearly focused on the population identified in the label, because it fits most closely with the mechanism of action.” Read More
With its acquisition of privately held Oncoimmune Ltd. for an up-front $425 million in cash, Merck & Co. Inc. ups its COVID-19 game with CD24Fc, a recombinant fusion protein targeting the innate immune system that is faring well in treating pandemic patients. Read More
When the first chimeric antigen receptor T-cell (CAR T) therapy, Kymriah (tisagenlecleucel), was approved in 2016 for treating B-cell acute lymphoblastic leukemia, its developer, Novartis AG, confined the initial rollout to just 20 treating centers. Its label carried a black box warning, because of the risk of life-threatening cytokine release syndrome, and Basel, Switzerland-based Novartis put in place a comprehensive risk evaluation and mitigation system to ensure its safe use. Catamaran Bio Inc., a Boston-based startup that has raised $42 million in seed and series A financing, is considering the administration of similarly engineered natural killer cells in walk-in clinics. “If the product is safe, it can be given as an out-patient treatment,” Chief Scientific Officer Vipin Suri told BioWorld. “As a field, this absolutely has to be our ambition.” Read More
PERTH, Australia – Sydney-based Imugene Ltd.’s stock shot up 15% on news that an interim analysis of phase II data in its B-cell peptide vaccine, HER-Vaxx, in advanced gastric cancer showed positive survival data. Read More
Multiple companies have had their FDA reviews put on hold because coronavirus-related travel restrictions at the FDA has kept their manufacturing plants from being inspected. Read More
HONG KONG – Hutchison China Meditech Ltd. (also known as Chi-Med) has received a $100 million equity investment from the Canada Pension Plan Investment Board, which will fund ongoing research and clinical development and support the further growth of its commercialization capabilities both in China and globally. Read More
When U.S. President Donald Trump and Health and Human Services (HHS) Secretary Alex Azar announced last week the Jan. 1 launch of a Medicare Part B most-favored nation (MFN) drug pricing model and a final rule to end Medicare’s safe harbor for the rebates that create a black box around the pricing of Part D drugs, they called the reforms “historic.” Read More
Two U.S. federal agencies at the Department of Health and Human Services (HHS) have finalized rules that affect how drug and device makers interact with the health care system, but under the Congressional Review Act, neither rule can go into effect until February 2021. This timeline comes up a couple of weeks after President-elect Joseph Biden is sworn in, thus raising the risk that the new administration at HHS will either modify or overturn these rules altogether. Read More
New hires and promotions in the biopharma industry, including: Adamas, Cytokinetics, Genenta, Legend, Mereo, Oxford, Penrose, Pharming, Summit. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Anixa, Arca, Ascentage, Biontech, Brainever, Eiger, Genentech, Hillstream, Innovent, Kiniksa, Lilly, Merck, Neurelis, Onconova, Pfizer, Regeneron, Rigel, Sanofi, Theralase, VBI. Read More
