Bristol Myers Squibb's Reblozyl (luspatercept-aamt) failed to meet its primary endpoint in a Phase III trial for myelofibrosis-associated anaemia, though the company says patients experienced clinically meaningful improvements that could still pave the way for approval.The randomised INDEPENDENCE trial enrolled 313 patients with myeloproliferative neoplasm-associated myelofibrosis who were also receiving standard JAK inhibitor therapy and needed regular red blood cell (RBC) transfusions. Reblozy

The FDA's concerns with the data package behind Otsuka Pharmaceutical's post-traumatic stress disorder (PTSD) candidate proved to be founded, with an advisory panel for the US regulator declining to back brexpiprazole on Friday. The Psychopharmacologic Drugs Advisory Committee (PDAC) voted 10 to 1 that the available data did not establish efficacy for brexpiprazole when given in combination with sertraline to treat PTSD. "Although today’s outcome was disappointing, we remain fully committed to c

Viatris announced Friday that a Phase III study of pimecrolimus 0.3% ophthalmic ointment in people with blepharitis failed to meet its primary endpoint. Philippe Martin, chief R&D officer, said "we are evaluating the appropriate next steps…which may include revising the planned additional Phase III study."The MR-139 3001 trial randomised 477 patients suffering from blepharitis to receive pimecrolimus or placebo, self-administered to the eyelids twice daily, treated and observed over 12 weeks. Th

The European Commission has conditionally approved Ezmekly (mirdametinib) as a treatment for inoperable, symptomatic plexiform neurofibromas (PN) in paediatric and adult patients with neurofibromatosis type 1 (NF1) aged two and older. The oral MEK inhibitor was developed by SpringWorks Therapeutics before its recent $3.9-billion takeout by Merck KGaA.The approval, which follows backing by the EU's drug advisory panel in May, is supported by results from the single-arm Phase IIb ReNeu trial. In t

SEOUL, South Korea, July 17, 2025 /PRNewswire/ -- DeepQure announced today that South Korea's Ministry of Food and Drug Safety (MFDS) has approved a clinical trial of HyperQure™ RDM System, the company's novel laparoscopic renal denervation (RDN) system, for the treatment of atrial fibrillation (AF). The trial is designed to evaluate the safety and efficacy of laparoscopic RDN in patients with recurrent AF following pulmonary vein isolation (PVI) and resistant hypertension. It will be conducted

New Delhi: Glenmark Pharmaceuticals will turn net cash positive on its licensing deal with AbbVie Inc, according to S&P Global Ratings on Thursday. The agreement will further strengthen the company's financial position and liquidity, reversing results that led to a reported net debt of Rs 4.9 billion last year, it said in a statement. On July 11, 2025, Glenmark, through wholly-owned subsidiary IGI Therapeutics SA, announced an exclusive licensing agreement with AbbVie for ISB 2001 , a lead inves

Activity Report for Quarter Ended June 30, 2025 (Appendix 4C)NEW YORK, July 17, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced gross revenue from sales of Ryoncil® (remestemcel-L-rknd) through the first quarter post product launch. Ryoncil® is the first and only FDA approved mesenchymal stromal cell (MSC) product in the Unites States and became commercially available for purchase o

We are all familiar, in some shape or form, with the idea of wanting to feel comfortable in our own skin. For most, these feelings are psychological, but imagine if your skin itself was uncomfortable to live in? For the 230 million people worldwide living with atopic dermatitis, this can be their reality.1 Atopic dermatitis, more commonly known as eczema, is a chronic, inflammatory skin disease.1,2 It is common, so we have all likely heard someone in our lives talking about eczema before, but we

July 18, 2025 –Shionogi & Co., Ltd. (Head Office: Chuo-ku, Osaka, Japan; hereinafter, “Shionogi”), in collaboration with the Global Antibiotic Research & Development Partnership (Head Office: Geneva, Switzerland; hereinafter “GARDP”), has agreed to collaborate with the Ministry of Health of the Republic of Kenya (hereinafter, “Kenya”) on a project aiming to facilitate the introduction of cefiderocol, a treatment for serious Gram-negative bacterial infections in adults with limited treatment opti

The prefilled syringe formulation is approved in the US for the vaccination of adults aged 50 and older,and individuals aged 18 and above at greater risk. Credit: Spino Kim/Shutterstock.com. The US Food and Drug Administration (FDA) has approved GSK’s Shingrix vaccine (recombinant zoster vaccine or RZV) in a prefilled syringe presentation to prevent shingles (herpes zoster). This development will streamline the process for healthcare professionals by eliminating the need to mix components before