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. Because PTSD is a prevalent condition, the FDA said it would typically require at least two positive adequate and well-controlled investigations to reach a conclusion that a drug is effective. If approved, Rexulti would be the first new therapeutic option for PTSD in more than 20 years. Two drugs are approved for PTSD, paroxetine (Paxil) and sertraline (Zoloft).

Sino to acquire Lanova and pipeline for up to $950M

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. Upon close, Lanova will become an indirect wholly owned subsidiary of Sino, with the latter gaining Lanova’s oncology portfolio of monoclonal antibody, bispecific antibody and antibody-drug conjugate candidates.

Rx tariffs a few weeks away?

“Pharmaceuticals will be tariffed, probably at the end of the month,” U.S. President Donald Trump said yesterday, 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.” Although that schedule would give drug companies scant time to bring new U.S.-based manufacturing facilities online, Trump’s impromptu remarks to reporters when he deplaned from Air Force One seemed to have little impact on industry, with several large biopharmas trading flat or slightly up this morning. Even as the president’s biopharma tariff messaging has continued to morph since April, industry has been preparing. Today, “we believe most pharmaceutical companies have stockpiled enough inventory to shield themselves from the tariff impact for approximately one year,” Leerink Partners LLC analyst David Risinger said.

Biopharma deal value surges past $138B in first half of 2025

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.

Life sciences strategy to reduce UK approval costs by 25%

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. The plan is linked to a wider industrial strategy aiming to boost eight high growth sectors, and to a 10-year plan to apply science and technology to the reform of the National Health Service (NHS). The three main objectives are to support and enable world class R&D; to improve the environment for startups and for scaling up; and to drive health innovation to underpin the NHS reform.

CMS’ gene therapy access model goes live, with 33 states on board

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 (CGTs), starting with therapies for sickle cell disease. Known as the Cell and Gene Therapy Access Model, the plan marks the first time the federal government has negotiated outcomes-based agreements with CGT manufacturers on behalf of state Medicaid agencies.

IAS 2025: All eyes still on the HIV reservoir

People living with HIV can lead virtually normal lives thanks to antiretroviral therapy (ART), which suppresses the virus to undetectable levels in the blood. This is a major breakthrough. Still, there is no cure. HIV persists in a latent state within cellular reservoirs that scientists do not know how to eliminate. While ART prevents the virus from replicating, it doesn’t fully block its transcription in already infected cells. As a result, ART cannot be stopped. If interrupted, the virus would restart its cycle within days or weeks by activating the transcription of new viral particles. Ending the reservoir remains the greatest challenge in HIV research.

UK Biobank project complete, supports research with 100,000 scans

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. Combined with information on lifestyle, whole genome sequences, blood and urine biomarkers and up to date medical histories collected from the same volunteers over the 15 to 19 years since they were first recruited to UK Biobank, the images have “made the invisible, visible,” said Rory Collins, chief executive of UK Biobank.

Also in the news

23andMe, 365mc, 4Teen4, 60 Degrees, Acumen, Agilent, Alumis, Alzecure, Ascendis, Ascentage, Atara, Cantargia, Cel-Sci, Draig, Gilead, Hengrui, Immorta, Iovance, JCR, Kailera, Kairos, Karolinska, Mink, Neuronetics, OSR, Otsuka, Pierre Fabre, Polypid, Rani, Raziel, Relmada, Sanofi, Sellas, Shorla, Synendos, Tract, Umecrine, Vaximm, Verano, Viiv, Zyus