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Phase 3 failures reshape cardiovascular and oncology outlooks
Novo Nordisk’s Phase 3 Zeus trial of IL-6 inhibitor ziltivekimab failed to improve outcomes in a broad cardiovascular inflammation population, according to the company’s update. While the drug...
Regulators and approvals: FDA panel dynamics for advanced melanoma
Replimune’s RP1 plus nivolumab attempt to move in anti–PD-1–refractory advanced melanoma saw a key shift after an FDA advisory committee vote, with the panel supporting RP1 despite negative...
Biotech M&A expands surgical footprint and deals move through
Mimedx agreed to buy Sanara Medtech for an enterprise value of about $350 million, aiming to move beyond its wound-care-heavy profile as reimbursement pressures hit skin substitute sales. In the...
Revenue and competitive pressure in immunology blockbuster franchises
AbbVie reported continued strength for Skyrizi as the IL-23 inhibitor navigates intensifying psoriasis competition. The company highlighted that quarterly Skyrizi sales reached $5.55 billion, a...
Radiopharmaceutical and clinical-stage funding moves
Ratio Therapeutics raised $70 million in a Series C to advance radiopharmaceutical trials, according to the company’s disclosed deal terms. The funding included both existing investors—Duquesne...
AI for drug discovery evaluation reaches new productization
Insilico Medicine launched what it calls the drug discovery and development benchmark-as-a-service for frontier AI models, designed to test whether AI systems make meaningful scientific decisions...
Oncology diagnostics and liquid biopsy workflow upgrades
GenomOncology said it will integrate Pacific Biosciences’ HiFi whole-genome sequencing secondary analysis pipeline into its Pathology Workbench reporting platform. The workflow is meant to...
Immunology drug price policy and market access pressure
HHS outlined details of a revised 340B rebate pilot allowing some drug manufacturers to deny rebates for a subset of products, after earlier implementation approaches faced scrutiny. The changes...
Diagnostics approvals: CE-IVD registrations expand infectious disease testing menu
ABL Diagnostics obtained CE-IVD registration for molecular tests covering HIV-1, respiratory pathogens, and viral meningitis, expanding its portfolio in Europe. The company described updated...
Biopharma market financing and IPO pipeline continues to build
Apnimed priced an upsized IPO at $16 per share for gross proceeds of $192 million, with an over-allotment option that could add $24 million more, according to the company’s disclosed launch terms....
Novo Nordisk IL-6 heart drug trial failure
Novo Nordisk’s Phase 3 Zeus trial of ziltivekimab missed its primary endpoint, dealing a setback to the Danish company’s inflammation-linked cardiovascular strategy. Novo reported the antibody...
Replimune RP1 regains momentum after FDA advisory support
Replimune Group’s RP1 plus nivolumab revived momentum after an FDA advisory committee supported the therapy for anti–PD-1-refractory advanced melanoma, despite negative briefing documents. The...
Karyopharm endometrial cancer failure and cash pressure
Karyopharm’s bid to expand Xpovio (selinexor) into endometrial cancer stumbled again as top-line Phase 3 results failed to meet the primary progression-free survival endpoint. The company...
Seer takeover bids intensify after CEO raises offer
Seer’s takeover contest escalated as its CEO, Omid Farokhzad, raised the company’s acquisition offer to $2.55 per share plus contingent value rights. The improved bid followed an earlier increase...
I-SPY2 preoperative dual immunotherapy improves tumor eradication in HER2-negative breast cancer
A preoperative combination of two immunotherapies plus chemotherapy produced substantially higher tumor eradication rates in patients with high-risk, early HER2-negative breast cancer in the...
Alliance for Clinical Trials in Oncology opens QUANTUM bispecific trial for rare leukemia
The Alliance for Clinical Trials in Oncology activated the QUANTUM trial (Alliance A062401) to evaluate a bispecific immunotherapy approach in primary plasma cell leukemia, a rare and aggressive...
Nabsys and Indiana University partner on electronic genome mapping
Nabsys and Indiana University entered a research partnership that will use Nabsys’ OhmX platform for electronic genome mapping in blood cancer research. The collaboration will be led by Kevin...
Create Medicines CRT-402 clears Australia clinic start
Create Medicines secured Human Research Ethics Committee approval in Australia to initiate a first-in-human study of CRT-402, its lead in vivo CAR T candidate for autoimmune diseases. The...
TAS: AB2 Bio milestone as Nippon Shinyaku takes U.S. rights for tadekinig alfa
Nippon Shinyaku took up its option on U.S. rights to AB2 Bio’s interleukin-18 neutralizing drug tadekinig alfa, triggering a $30 million milestone and setting up further development and...
Funding: Ratio Therapeutics raises $70M for radiopharma trials; Vogenx IPO plans $67M
Ratio Therapeutics raised $70 million to support radiopharmaceutical trials, marking a continuation of capital investment in radioisotope-driven oncology programs. The Boston biotech’s Series C...