OSAKA, Japan and CAMBRIDGE, MA, USA I July 14, 2025 I Takeda ( TSE:4502/NYSE:TAK ) today announced that all primary and secondary endpoints were met in two Phase 3 randomized, double-blind, placebo-controlled studies of oveporexton (TAK-861), a potential first-in-class investigational oral orexin receptor 2 (OX2R)-selective agonist, in narcolepsy type 1 (NT1). NT1 is caused by the loss of orexin-producing neurons in the brain. Orexin agonists are designed to address this underlying orexin defici

WHIPPANY, NJ, USA I July 14, 2025 I Bayer today announced that the U.S. Food and Drug Administration (FDA) approved KERENDIA ® (finerenone) to treat patients with heart failure (HF) with left ventricular ejection fraction (LVEF) ≥40%, 1 following the agency’s Priority Review of its supplemental New Drug Application (sNDA). Even with guideline-directed medical treatment, the approximately 3.7 million adults in the U.S. with HF with LVEF ≥40%, also known as mildly reduced ejection fraction (HFmrEF

Clinical study in Scientific Reports shows Bridge Capture™ detects key mutations from blood samples in metastatic colorectal cancer patients TURKU, Finland, July 14, 2025 /PRNewswire/ -- Genomill Health, a biotechnology company pioneering simplified targeted library preparation for next-generation sequencing announces the results of a clinical pilot study published in Scientific Reports, demonstrating the high sensitivity of its Bridge Capture™ technology for mutation profiling in cell free DNA

Complete Response Letter (CRL) cited specific chemistry, manufacturing and controls (CMC) related observations that are resolvable FDA clinical reviews acknowledged that the clinical data are robust and biomarker data are supportive NOVATO, CA, USA I July 11, 2025 I Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for its Biologics License Application (BLA) for UX111 (ABO-102) AAV gene ther

Since the February update, an additional 5 patients have been dosed, resulting in 2 Complete Responses (CR) and 3 Partial Responses (PR) 75% Overall Response rate (ORR): 6 total CR and 3 PR in Phase 1b trial of azer-cel, an allogeneic off-the-shelf CD19 CAR T therapy in relapsed diffuse large B-cell lymphoma (DLBCL), an aggressive type of blood cancer First patient remains cancer free at 15 months and ongoing with additional patients having durable responses at 2, 5, and 11 months+ and durabil

Bayer's Kerendia (finerenone) gained another approval in the US, expanding the potential market for one of the company's main growth drivers in its prescription drug unit. The new FDA nod allows use of the non-steroidal mineralocorticoid receptor antagonist (MRA) to treat patients with heart failure (HF) with left ventricular ejection fraction (LVEF) ≥40%.Kerendia was first approved in 2021 to reduce the risk of cardiovascular (CV) death, hospitalisation for HF, non-fatal myocardial infarction,

Takeda is "rapidly advancing" the submission of marketing application for oveporexton (TAK-861) after the oral orexin receptor 2 agonist met all primary and secondary goals in a pair of Phase IIIl trials for patients with narcolepsy type 1 (NT1).“The studies were accelerated at an unprecedented pace…to bring this potential treatment to people living with narcolepsy type 1 as quickly as possible,” said Andy Plump, president of R&D at Takeda. Filings to the FDA, as well as other regulatory bodies,

Valneva said the European Medicines Agency (EMA) will lift the temporary restriction on vaccinating individuals aged 65 and above with its live attenuated chikungunya vaccine Ixchiq.The decision follows an assessment conducted by the agency's Pharmacovigilance Risk Assessment Committee (PRAC), which determined that the benefits of Ixchiq outweigh its risks when administered with appropriate clinical assessment and careful benefit-risk consideration across all age groups.In April, French health a

LEO Pharma on Monday agreed to pay Boehringer Ingelheim €90 million ($105 million) upfront for a global license to the German pharma's dermatology drug, Spevigo (spesolimab).Boehringer is eligible for additional milestone payments and tiered royalties, which were undisclosed. The deal is expected to close this half. Under the deal, LEO Pharma will be responsible for commercialising the anti–IL-36 antibody, which is approved in more than 40 countries, including the US and EU, to treat generalised

Bristol Myers Squibb is scaling up its radiopharmaceutical game with the opening of a $160-million manufacturing site in Indianapolis, a key investment since entering the space through its 2024 takeout of RayzeBio for $4.1 billion. The Pike Township facility will have the capacity to manufacture tens of thousands of doses of radiopharmaceutical treatments annually when scaled to support commercial supply."We believe this technology has an important role to play," said Chris Boerner, BMS's chief