Talk turned skeptical well before lunchtime in the meeting of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee to consider Biogen Inc.’s aducanumab for Alzheimer’s disease, and it stayed that way until the end, when panelists voted thumbs down. Read More
Lenzilumab, the lead candidate from Humanigen Inc., has taken two large steps forward with positive interim phase III data and some support from the federal government. That, along with an Asia-Pacific region licensing from earlier in the week, has the relatively small company successfully “punching above our weight,” the CEO told BioWorld. Read More
DUBLIN – Canakinumab, an interleukin-1 beta (IL-1beta) inhibitor, has joined a growing list of immunomodulatory therapies that have failed to demonstrate efficacy in COVID-19. Novartis AG said that an interim analysis showed the drug did not meet the primary endpoint of clinical response. Read More
If not for the coronavirus and a highly contested U.S. presidential election, 2020 might just be the year of the biopharma financing. With 1,320 transactions tallied and the amount raised hitting $115.77 billion, the year represents the highest volume and value for the industry to date. Read More
Assembly Biosciences Inc., a company testing the limits of sustained virologic response in people with chronic hepatitis B virus infection after they discontinue treatment, said nearly all participants in an ongoing phase II study returned to having detectable viral loads after going off a regimen featuring the company's core inhibitor, vebicorvir. Read More
DUBLIN – Memo Therapeutics AG raised CHF13.8 million (US$15.3 million) in a first close of a series B round to take forward a patient-derived monoclonal antibody therapy for COVID-19, MTX-Covab, which will move into a phase I/II trial in Germany in the new year. Read More
Fochon Pharmaceuticals Ltd., a subsidiary of Shanghai Fosun Pharmaceutical Co. Ltd., out-licensed FCN-338, a BCL-2 inhibitor, to Eli Lilly and Co. for an up-front payment of $40 million along with milestones and royalties. The deal marks another example of Chinese biotech companies reversing the licensing flow. Read More
LONDON – After a year in the mill, the U.K. National Institute for Health and Care Excellence (NICE) has put proposals for how it intends to evaluate drugs, devices and diagnostics in the future out for consultation. Read More
The Coalition for Epidemic Preparedness Innovations (CEPI) said that it would fund a SARS-CoV-2 vaccine under development by Sichuan Clover Biopharmaceuticals Inc., of Chengdu, China. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Anavex, Assembly, Boehringer Ingelheim, Equillium, Homology, Humanigen, Janssen, Novartis, Pfizer, Puma, Seres, Viela. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Affimed, Artiva, Astrazeneca, Felix Bio, ICER, Kannalife, OM Pharma, Roche, TFF, Vaccibody, Vir. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Astellas, Basilea, Gosun, Bristol Myers Squibb, Lipocine, Sarepta, Sedor, Senhwa. Read More
