Blackstone Life Sciences made an investment of up to $750 million in Moderna Inc.’s influenza program created with mRNA technology. Blackstone will manage the money and is eligible for milestone and royalties payments from products emerging from the program. Moderna keeps full rights and control over the program. Moderna CEO Stéphane Bancel said the goal was to launch “multiple vaccine products in the next few years.” No other details were disclosed. During its Vaccine Days program on the morning of March 27, Moderna reminded investors that it has five vaccines currently in phase III studies and three more vaccines that are approaching phase III trials.

New approach for PAH as Merck’s Winrevair wins FDA nod 

Merck & Co. Inc. is looking to a fast launch for sotatercept, its newly U.S. FDA-approved pulmonary arterial hypertension (PAH) drug. The agency cleared the drug, branded Winrevair, under priority review on its March 26 PDUFA date, marking the first in a new class of therapies the company has touted for its potential for disease modification. Considered one of – if not the most – consequential of Rahway, N.J.-based Merck’s commercial launches for 2024, Winrevair is approved for use as an add-on to background therapy for treating PAH, also known as WHO Group 1, caused by arteries in the lung becoming narrowed, thickened or stiff. Winrevair, cleared at 45-mg and 60-mg doses, is given once every three weeks by subcutaneous injection and is indicated to increase exercise capacity, improve WHO functional class and reduce the risk of clinical worsening events.

Astellas wins first approval of Vyloy in gastric cancer in Japan 

Japan’s Ministry of Health, Labor and Welfare approved Astellas Pharma Inc.’s Vyloy (zolbetuximab) to treat a type of advanced gastric cancer on March 26, making it the first anti-claudin 18.2 (CLDN18.2) monoclonal antibody to gain regulatory clearance worldwide. The approval indicates the use of Vyloy in combination with chemotherapy to treat HER2-negative, CLDN18.2-positive, unresectable, advanced or recurrent gastric cancer. The news comes two months after the U.S. FDA first issued a rejection of Astellas’ BLA for zolbetuximab in early January, after citing unresolved deficiencies related to a pre-license inspection of a third-party manufacturing facility of the drug.

VISTA still viable as cancer target? Sensei busy in phase I/II

Among big pharma players to try tackling the V-domain Ig suppressor of T-cell activation (VISTA) as a target in cancer is Johnson & Johnson, though the firm quickly ran into toxicity problems in phase Ib trials. Sensei Biotherapeutics Inc. is taking aim at VISTA with SNS-101. The drug is in a phase I/II study as a monotherapy and in combination with Regeneron Pharmaceuticals Inc.’s PD-1 inhibitor Libtayo (cemiplimab) in patients with advanced solid tumors.

Australian researchers discover gene mutation that causes psoriasis

Scientists from the Australian National University have discovered the gene mutation responsible for causing psoriasis, and the findings could lead to improved diagnosis and treatment for patients with psoriasis and psoriatic arthritis, a chronic inflammatory skin disease.

US FDA: Fewer reserve drug samples needed

Thanks to technological advances, the U.S. FDA is reducing the quantity of reserve drug samples that must be retained from bioavailability (BA) and bioequivalence (BE) studies. Given that the tests used today are more sensitive and less destructive, the agency said it can detect the identity and composition of the study drug and reference standard with fewer samples. The FDA’s updated sample policy is spelled out in its new guidance, “Handling and retention of BA and BE testing samples.” While most of the guidance is a draft revision of older guidance, the section discussing the quantity of reserve samples that must be retained is final and goes into effect immediately. The new policy “is applicable to all reserve samples for BA and BE studies held to date, including reserve samples from previously completed BA or BE studies,” the FDA said.

Also in the news

Acedra, Allarity, Alterity, Amneal, Aptamer, Argenx, Astellas, Astralbio, Atamyo, Beam, Cinfina, Corteria, Eledon, Entera, Essential, Galapagos, Galderma, Gamida Cell, Hoth, Ibio, Idrx, IGC, Intrabio, Intravacc, Johnson & Johnson, Juvisé, Keiferx, Mannkind, Marinus, Medexus, Mei, Merveille.Ai, Mesoblast, Moderna, Nanoscope, Nkgen, Noetik, One Biosciences, Opus Genetics, Osivax, PDS, Pieris, Praxis, Protagonist, Pyxis Oncology, Rocket, Scilex, Sellas, Stoke, Synthego, Synthekine, Takeda, Tectonic, Tevogen, Tiumbio, Vaccinex, Valneva, Verrica, Viking, Xortx