The U.S. FDA is insisting that another study is needed to bolster the sNDA for Rexulti (brexpiprazole) from Otsuka Pharmaceutical Co. Ltd. in treating adults with post-traumatic stress disorder (PTSD). The agency’s Psychopharmacologic Drugs Advisory Committee and the company, one of Japan’s biggest pharmas, will discuss this during July 18’s adcom hearing regarding the efficacy of Rexulti in combination with sertraline. Read More
Sino Biopharmaceutical Ltd. agreed to fully acquire Lanova Medicines Ltd. by buying an additional 95.09% stake in Lanova at a valuation of up to $950.92 million. Considering Lanova’s estimated cash and deposit of $450 million, Hong Kong-headquartered Sino agreed to pay $500.9 million to Lanova on the date of the transaction, set to close within 30 days of all conditions being satisfied, or July 31, 2025. Read More
“Pharmaceuticals will be tariffed, probably at the end of the month,” U.S. President Donald Trump said, as he provided a few more details about his proposed global biopharma sector tariff. “We’re going to start off with a low tariff and give the pharmaceutical companies a year or so to build. And then we’re going to make it a very high tariff.” Read More
Biopharma dealmaking gained momentum in the second quarter (Q2) of 2025, surpassing the previous quarter and staying well above the 2024 quarterly average of $57.63 billion. Total deal value reached $71.45 billion across 278 transactions in Q2, rising from $66.86 billion and 333 deals in Q1. The quarter also marked a notable jump from Q2 of 2024, when $55.3 billion was raised through 360 agreements. Read More
The U.K. government has committed to reduce the cost of drug and device approvals by 25% as part of a long-awaited life sciences strategy which sets out a 10-year plan for the sector. Read More
A total of 33 states, plus the District of Columbia and Puerto Rico, agreed to participate in the U.S. CMS’ voluntary, outcomes-based program aimed at helping state Medicaid programs cover high-priced cell and gene therapies, starting with therapies for sickle cell disease. Read More
While people living with HIV can lead virtually normal lives thanks to antiretroviral therapy (ART), HIV persists in a latent state within cellular reservoirs that scientists do not know how to eliminate. “Transcription is a critical step in the viral life cycle. … But there are currently no drugs suppressing HIV transcription, and that may be one of the reasons why current antiretroviral therapy is not curative,” Melanie Ott told the audience at the 13th IAS Conference on HIV Science this week in Kigali, Rwanda. Read More
After a 10-year project and a £60 million (US$80 million) investment, the UK Biobank has completed the whole body scans of 100,000 volunteers and is making the 1 billion images available for researchers worldwide. Read More
New hires and promotions in the biopharma industry, including: Agilent, Alumis, Draig, Immorta, Iovance, Neuronetics, OSR, Relmada, Synendos, Tract, Vaximm, Verano, Zyus. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 4Teen4, Ascendis, Gilead, Hengrui, Kailera, Kairos, Sellas, Viiv. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: 23andMe, 365mc, Acumen, Atara, Cantargia, JCR, Mink, Otsuka, Pierre Fabre, Polypid, Raziel, Sanofi. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alzecure, Shorla. Read More
