Pharminent · Daily Brief
November 10, 2026
Regulatory & Approvals
FDA approves Bayer’s Sunharbo, first factor XIa inhibitor
FDA approved Sunharbo (asundexian) 50 mg tablets, the first factor XIa inhibitor, for use in combination with antiplatelet therapy to reduce the risk of stroke in adults following a recent mild-to-moderate non-cardioembolic ischemic stroke or a high-risk transient ischemic attack.
FDA →$BAYRY
FDA orders blindness risk warning on GLP-1 drug labels
FDA has ordered all manufacturers of GLP-1 receptor agonists to add a label warning for a rare eye condition that can cause blindness, after finding evidence of a potential increased risk with the drugs used for weight management and diabetes.
Pharmaphorum →
Clinical Data
Vir’s hepatitis D combination meets all pivotal study objectives
Vir Biotechnology reported that its hepatitis delta program combining tobevibart and elebsiran met all objectives in its first pivotal study, and appeared more potent than a rival drug also in late-stage development.
BioPharma Dive →
PepGen reports early data for myotonic dystrophy candidate
PepGen said its candidate PGN-EDODM1 is correcting more of the genetic stutter found in myotonic dystrophy type 1, according to early trial results.
STAT →
Deals & Partnerships
Argenx acquires Unnatural Products for $550 million
Argenx is acquiring Unnatural Products for $550 million, gaining a macrocyclic peptide discovery platform for developing oral peptide drugs. The deal brings a new modality to argenx, whose immunology R&D had focused on antibodies.
MedCity News →
Charles River to buy Frontage bioanalysis and DMPK units for $470M
Charles River Laboratories signed definitive agreements to acquire Frontage’s bioanalysis and DMPK operations in Exton, Pennsylvania, for roughly $470 million in cash.
Pharmaceutical Technology →
Fresenius signs WuXi Biologics biosimilar development agreement
Fresenius announced on November 2, 2026 an exclusive development agreement with WuXi Biologics for the research, development and manufacturing of biosimilars, giving Fresenius exclusive access to up to 37 identified biosimilar candidates across 13 therapeutic areas including neurology, nephrology, cardiopulmonary, oncology and immunology.
Big Molecule Watch →
Teva licenses two Samsung Bioepis biosimilars for US market
Teva announced on November 3, 2026 a licensing agreement with Samsung Bioepis to commercialize RENFLEXIS (infliximab-abda), a biosimilar to Johnson & Johnson’s REMICADE, and ETICOVO (etanercept-ykro), a biosimilar to Amgen’s ENBREL, in the United States.
Big Molecule Watch →$JNJ$AMGN
Business & Finance
Ionis’ shares fall after Tryngolza sales forecast cut
Ionis Pharmaceuticals lost more than $1 billion in market value on Monday after the company slashed sales projections for its triglyceride-lowering drug Tryngolza following a slow rollout.
STAT →$IONS
Delix Therapeutics raises $100M Series C for zalsupindole
Delix Therapeutics secured $100 million in an oversubscribed Series C financing round to fund development of zalsupindole, an orally bioavailable neuroplastogen.
Pharmaceutical Technology →
BIO proposes seven-part plan to accelerate US drug development
Industry lobby group BIO released a seven-part proposal laying out initiatives to accelerate drug development in the United States and counter China’s rise in biotech.
BioPharma Dive →
Hims & Hers to sell unapproved peptides to customers
Telehealth firm Hims & Hers will begin selling certain unapproved peptides that are subject to the FDA’s enforcement discretion policy announced last month.
Pharmaphorum →
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