Leucovorin is now approved for cerebral folate deficiency months after FDA Commissioner Marty Makary claimed the decades-old generic drug had promise for treating autism. The FDA’s review was based on published literature and real-world evidence.
GSK licensed to Alfasigma global rights to linerixibat, a drug developed to treat the rare liver disease primary biliary cholangitis (PBC). The move follows Alfasigma’s 2025 voluntary market withdrawal of Ocaliva, a PBC drug that had sparked safety concerns from U.S. and European regulators.
How to turn analytics into actual policy outcomes.
The conversation between MedCity News Editor-in-Chief Arundhati Parmar and Samir Batra, managing partner of Health Innovation Pitch, highlighted news from the J.P. Morgan Healthcare Conference, particularly how technology and biopharma companies are shaping AI in healthcare.
Pfizer’s stake in ViiV Healthcare will be taken over by Shiongi, another minority shareholder in the HIV medicines company. GSK remains remain the majority shareholder in ViiV, which the pharmaceutical giant formed in partnership with Pfizer in 2009.
Rapt Therapeutics brings to GSK ozureprubart, a long-acting antibody that inhibits the validated immunology target immunoglobulin E (IgE). If GSK is able to bring this drug to the market, it would complete with the blockbuster Genentech and Novartis allergy drug Xolair.
GSK’s bepirovirsen met the main goal of two Phase 3 studies, achieving functional cure rates for patients with chronic hepatitis B infection after six months of treatment. This antisense oligonucleotide therapy could provide a treatment alternative to antiviral drugs that patients must take for life.
MedCity News was at the Vive conference and spoke with executives who shared their insights for the healthcare industry.
GSK’s Exdensur requires just two injections a year to treat severe asthma. Less frequent injections give this new biologic medicine a dosing edge over one of GSK’s own blockbuster respiratory products as well as severe asthma drugs from companies such as AstraZeneca, Sanofi, and Amgen.
GSK submitted the same Blenrep clinical trial data to global regulators and the FDA, but received a slightly more limited regulatory approval in the U.S. In an interview during the annual meeting of the American Society of Hematology, GSK oncology executive Hesham Abdullah explained what else the FDA wants from Blenrep clinical trials.
GSK paid $85 million up front for global rights to a small-interfering RNA therapy discovered and developed by startup Empirico. The pharmaceutical giant said this drug candidate could be used as a monotherapy and as part of drug combinations for treating COPD and other inflammatory respiratory diseases.
GSK drug Blenrep, which exited the market in 2022 after failing a confirmatory study, now has a new FDA approval as a third-line multiple myeloma treatment. The U.S. regulatory decision is more limited than the recent European approval for the blood cancer drug.
Arbiter’s Anjali Jameson on hospital and payer alignment.
President Trump has been pursuing policies intended to entice drugmakers to bring manufacturing and jobs to the U.S. GSK’s announcement makes it the latest big pharma company to unveil a multi-billion dollar plan for new U.S. facilities.
The deal helps move BioNTech’s proposed acquisition of CureVac closer to completion. With the settlement, GSK said it will tender the CureVac shares it owns in support of the $1.25 billion acquisition.
GSK drug Nucala has expanded its FDA-approved uses to include maintenance treatment of chronic obstructive pulmonary disease that’s driven by eosinophils, a type of immune cell. The antibody drug will compete against the blockbuster Sanofi product Dupixent, which expanded its FDA approval to COPD last year.
GSK is acquiring Boston Pharmaceuticals’ efimosfermin, which posted Phase 2 results showing improvement in fibrosis and resolution of MASH. GSK said this fusion protein will complement an siRNA drug it is currently developing for liver diseases.
Solu Therapeutics’ platform technology, which was licensed from GSK, pairs a small molecule with an antibody to address elusive disease targets. Cancer is Solu’s initial focus, but the startup is also exploring applications of its platform to immunology.