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Home » Newsletters » BioWorld

BioWorld

Nov. 7, 2023

View Archived Issues
Woman itching wrist

Psoriasis, arthritis scratched but CD still plays in Ventyx TYK2 bid

Having rolled out less-than-stellar phase II data with oral TYK2 inhibitor VTX-958 in moderate to severe plaque psoriasis, Ventyx Biosciences Inc. faces Wall Street speculation regarding the odds for the ongoing effort in Crohn’s disease (CD), due for an interim analysis in the first quarter of next year. Read More

Paxmedica rebounds on published autism results for PAX-101

Paxmedica Inc.’s shares (NASDAQ:PXMD) surged by 179% in early trading Nov. 7 after reporting the publication of phase II autism spectrum disorder results for PAX-101 (suramin) intravenous infusions. Suramin, an anti-trypanosomal and anti-purinergic agent introduced in 1923 for East African sleeping sickness, showed a statistically significant improvement at the 10-mg/kg dose in a secondary endpoint of Clinical Global Impressions – Improvement scale vs. placebo. Read More
Antibodies and red blood cells

BMS to acquire Orum’s blood cancer DAC candidate in $100M+ deal

Hitching onto the emerging drug class of degrader-antibody conjugates (DAC), U.S. pharma giant Bristol Myers Squibb Co. (BMS) is picking up rights to the U.S. and Korean biotech Orum Therapeutics Inc.’s blood cancer candidate, ORM-6151, in a potential $180 million deal. Read More

Otsuka’s sibeprenlimab meets endpoints in phase II IgAN trial

Otsuka Pharmaceutical Co. Ltd.’s sibeprenlimab (VIS-649) met the primary efficacy endpoint in a phase II trial for treating immunoglobulin A nephropathy (IgAN), demonstrating that 12 months of treatment resulted in significant reductions in proteinuria compared to placebo. Read More
Monica Bertagnolli, nominee for NIH director

Bertagnolli confirmed as next US NIH director

After nearly two years with an acting director, the U.S. NIH now has a confirmed leader. The Senate voted 62-36 Nov. 7 to confirm Monica Bertagnolli, a cancer surgeon and researcher, as the next director of the research agency. Read More

When is 12.5 a 13? US Fed Circuit wades into the math of rounding

Wading into the “muddied waters” of rounding the numbers used in a range claimed in two drug patents, the U.S. Court of Appeals for the Federal Circuit refused to set a “bright line rule.” Instead, it tossed a lower court win for Actelion Pharmaceuticals Ltd. against Mylan Pharmaceuticals Inc. and sent the case back to that court with instructions to consider the extrinsic evidence and its impact on the claim construction. Read More

US CMS proposes more Medicare flexibility to increase biosimilar competition

In another step that blurs the distinction between biosimilars and interchangeables, the U.S. Centers for Medicare & Medicaid Services (CMS) is proposing a rule to give Medicare Part D plans more flexibility to substitute biosimilars for the reference biologics so Medicare beneficiaries can have timelier access to the lower-cost drugs. The rule would permit the plans to treat the biosimilar substitutions as “maintenance changes” that don’t require prior Medicare approval. Such changes would enable the substitutions to apply to all enrollees – and not just those who begin the therapy after the effective date of the change. Read More

Appointments and advancements for Nov. 7, 2023

New hires and promotions in the biopharma industry, including: Arbor, Arbutus, Immunocore. Read More

Financings for Nov. 7, 2023

Biopharmas raising money in public or private financings, including: Alpine, Amyl, Aura, Essa, Kynexis, Sequoia. Read More

In the clinic for Nov. 7, 2023

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adverum, Alkeus, Apellis, Astellas, Astrazeneca, Bayer, Belite, Bloomsbury, Boehringer, Cassava, Celldex, Equillium, Faron, Fluoguide, Gannex, Idorsia, Immutep, Inflarx, Innovent, Iveric, Karyopharm, Kodiak, Maat, Mannkind, Moleculin, Moonlake, Neurosense, Nido, Qilu, Regenxbio, Soleno, Sellas, Sunstone, Tonix, Toragen, Vera, Verastem. Read More

Other news to note for Nov. 7, 2023

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Avior, Celest, Dewpoint, Evotec, Fibrogen, Futura, Hillhurst, Intelgenx, Jazz, M8, Menarini, Nemysis, Resother, Sage, Sciclone, Senti, Tilray, Tharimmune. Read More

Regulatory actions for Nov. 7, 2023

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations:  Acorda, Ayala, Biopas, Cabaletta, GC Biopharma, Kangabio, Mirati, Sanyou. Read More

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