Amgen adds Aimovig and Amjevita to TrumpRx platform in latest move to defuse U.S. pricing pressure

Amgen adds Aimovig and Amjevita to TrumpRx platform in latest move to defuse U.S. pricing pressure

Amgen has expanded its direct-to-patient program, AmgenNow, to include Aimovig (erenumab-aooe) and Amjevita (adalimumab-atto), each now available at a flat monthly price of $299 for eligible U.S. patients. This development forms part of Amgen’s broader agreement with the Trump Administration, satisfying conditions laid out in the President’s July 31 policy letter and positioning the company […]

How Hansa Biopharma is targeting a transplant blind spot with Imlifidase

How Hansa Biopharma is targeting a transplant blind spot with Imlifidase

Hansa Biopharma AB has submitted a Biologics License Application to the U.S. Food and Drug Administration for imlifidase as a desensitization treatment in highly sensitized adult patients awaiting deceased donor kidney transplants. The submission is supported by the pivotal Phase 3 ConfIdeS trial, and the company is seeking a priority review that could lead to […]

Meiji Seika Pharma’s alliance with MBC BioLabs signals a bold shift in global R&D sourcing strategy

Meiji Seika Pharma’s alliance with MBC BioLabs signals a bold shift in global R&D sourcing strategy

Meiji Seika Pharma Co., Ltd. has announced a strategic partnership with MBC BioLabs, a leading biotech incubator based in California’s San Francisco Bay Area, to expand its global drug discovery initiatives. The Tokyo-headquartered pharmaceutical firm aims to deepen its open innovation approach by tapping into early-stage biotech talent in the United States, with a focus […]

Takeda’s zasocitinib hits key Phase 3 psoriasis goals, challenging oral and biologic rivals

Takeda’s zasocitinib hits key Phase 3 psoriasis goals, challenging oral and biologic rivals

Takeda Pharmaceutical Company Limited has reported positive topline results from two pivotal Phase 3 studies of its investigational drug zasocitinib (TAK-279), a once-daily oral tyrosine kinase 2 (TYK2) inhibitor, in adults with moderate-to-severe plaque psoriasis. The trials met all primary and secondary endpoints, with more than 50 percent of participants achieving near-complete skin clearance (PASI […]

PADCEV plus Keytruda meets survival endpoints in cisplatin-eligible bladder cancer patients

PADCEV plus Keytruda meets survival endpoints in cisplatin-eligible bladder cancer patients

Astellas Pharma Inc. and Pfizer Inc. have announced that their antibody-drug conjugate PADCEV (enfortumab vedotin), in combination with the PD-1 inhibitor pembrolizumab (marketed as Keytruda by Merck), met key survival endpoints in the Phase 3 EV-304 trial. In cisplatin-eligible patients with muscle-invasive bladder cancer (MIBC), the combination significantly improved both event-free survival and overall survival […]

FDA clears subcutaneous RYBREVANT FASPRO for first-line EGFR+ NSCLC: What this changes for patients and providers

FDA clears subcutaneous RYBREVANT FASPRO for first-line EGFR+ NSCLC: What this changes for patients and providers

The U.S. Food and Drug Administration has approved Johnson & Johnson’s RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj), the first subcutaneous version of its bispecific EGFR-MET antibody therapy, for patients with EGFR-mutated non-small cell lung cancer (NSCLC). The approval spans all current RYBREVANT indications and is based on the Phase 3 PALOMA-3 study, which demonstrated comparable pharmacokinetics […]

Innovent’s mazdutide earns Nature spotlight: Are dual GCG/GLP-1 agonists set to reshape diabetes and obesity care?

Innovent’s mazdutide earns Nature spotlight: Are dual GCG/GLP-1 agonists set to reshape diabetes and obesity care?

Innovent Biologics, Inc. has achieved a landmark moment in China’s clinical research trajectory with the back-to-back publication of two Phase 3 clinical trials of mazdutide, a dual GCG/GLP-1 receptor agonist, in Nature as Accelerated Article Previews. These studies, known as DREAMS-1 and DREAMS-2, evaluated the drug as monotherapy and as an add-on therapy in Chinese […]

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