Biogen Inc.’s problematic trip with Aduhelm (aducanumab-avwa) for Alzheimer’s disease (AD) at last came to an end as the company, probably surprising few on Wall Street, said it’s quitting sales and development of the amyloid-beta directed antibody. The drug won accelerated approval by the U.S. FDA in July 2021. The phase III Envision study with Aduhelm will be stopped, and Cambridge, Mass.-based Biogen chalked a one-time charge of about $60 million related to close-out costs for the program in the fourth quarter of 2023. AD efforts have turned toward Leqembi (lecanemab-irmb), also an amyloid-beta directed antibody. Read More
The EU’s proposed update of its pharmaceutical legislation will break the model of small companies acting as the vehicle for translating Europe’s rich research base for onward development by pharma, according to an analysis looking specifically at the impact the new rules would have on the biotech sector. Read More
In 2023, the BioWorld Drug Developers Index (BDDI) concluded the year down 11.35%. Although its performance trailed behind the Nasdaq Biotechnology Index (up 3.74%) and the Dow Jones Industrial Average (up 13.7%), BDDI nonetheless made a recovery from the end of October when it was down 31.4%. Notably, the top two performers on BDDI in 2023 had stock rises attributed to approvals in rare disorders. In 2022, the index concluded the year down 20.13%, and in 2021 BDDI was up 7.06% at year-end. Read More
The U.S. SEC denied a petition asking it to amend its 50-year-old no-admit/no-deny settlement policy that slaps a perpetual gag on parties that opt to resolve SEC allegations through settlements rather than in court. Read More
Halia Therapeutics Inc. has, its CEO confidently asserts, taken an atypical road to building its infrastructure and financing. The Lehi, Utah-based company just completed a $30 million series C financing to further develop its lead asset, a selective and orally bioavailable first-in-class NLRP3/NEK7 inflammasome inhibitor. Read More
Newly approved gene therapies targeting sickle cell disease will be the first focus of the U.S. Centers for Medicare & Medicaid Services’ (CMS) Cell and Gene Therapy Access Model, the agency said Jan. 30. Read More
Celltrion Inc. has taken under its wing four Korean biotech startups as part of its joint “Open Innovation” program co-run with Seoul Biohub since October 2023, adding to its efforts to grow into a Korean biopharma giant with incubating prowess. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Eicosis, Hyloris, Iterum, Jnana, Kairos, Kura, Matisse, Mindbio, Mink, Qilu, Spectral, Uvax, Vertex. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Almirall, Harmonic Discovery, Glenmark, Ichnos, Microsoft, Teva, Vanda, Windtree. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bristol Myers Squibb, Cellvax, Cidar, Eilean, Halozyme, Hutchmed, Inmune, Gilead, Kite, Lexaria, Microbion, Neoimmunetech, Pfizer, Revolo, Takeda. Read More
