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After inking a T cell engager pact with Chimagen Biosciences a few years ago, GSK is back for more, this time acquiring a multiple myeloma program from the antibody specialist.
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Following their blowout win in melanoma last month, Merck and Moderna are leading the way among a new crop of personalized cancer vaccines. Here are five companies with similar therapies hoping to break through where others have previously failed.
A year to the day after the Trump administration slashed $500 million in funding from mRNA-based programs, the FDA approved Moderna’s flu vaccine based on the technology. Weeks later, Moderna and Merck revealed positive Phase 3 results for their personalized mRNA-based cancer vaccine. In the words of one mRNA specialist, “science won.”
Novartis’ shares fell 13% this week after the report of three separate late-stage asset setbacks. The impact went beyond the Swiss drugmaker, dragging peers down across the market.
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Newly solidified in their roles as the heads of CBER and CDER, Karim Mikhail and Michael Davis have been working for months to right the ship that had begun to capsize under former Commissioner Marty Makary. Meanwhile, Jared Seehafer will become the first-ever deputy commissioner focused on artificial intelligence.
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Analysts tentatively welcomed Novo’s new corporate rebrand—so long as it comes with a larger change to the company’s overall business strategy.
SERENA-4 was assessing AstraZeneca’s Etcamah as a first-line option for certain patients with advanced breast cancer—a setting that could have meant a $2.9 billion opportunity for the drug.
Scholar Rock’s spinal muscular atrophy drug, now to be called Isembyld, was originally rejected in September 2025, when the FDA cited compliance problems at a third-party manufacturer.
With oral cyclic peptides offering small molecule convenience and antibody‑like selectivity, the modality is gaining momentum. But bioavailability below 1%, minimal PK data and fragile synthesis still slow progress. Viva Biotech’s experts outlined how hybrid synthesis, ADME/PK modeling and AI‑guided design are expanding what peptide therapeutics can reach.
Heading into an FDA hearing on Monday regarding the future of psychedelic treatments, public comments show wide support for further exploring the therapeutic potential of these compounds—to match rising support within the agency.
The agreement, which runs through 2033, comes as Samsung Biologics continues to expand its large manufacturing footprint in South Korea.
The polycythemia vera field is heating up, with Disc Medicine and Silence Therapeutics each advancing next-generation therapies, playing catch-up to Takeda and Protagonist Therapeutics, who won the FDA’s approval last month for Mimrylo.
Frazier’s life science fund has already benefited several successful biotechs, including Verona Pharma, which was acquired by Merck for $10 billion, and Carmot Therapeutics, which Roche bought for $2.7 billion.
Newly solidified in their roles as the heads of CBER and CDER, Karim Mikhail and Michael Davis have been working for months to right the ship that had begun to capsize under former Commissioner Marty Makary. Meanwhile, Jared Seehafer will become the first-ever deputy commissioner focused on artificial intelligence.
Back-to-back failures of multiple late-phase trials have raised questions about how Novartis has deployed capital in pursuit of drugs to drive growth through the 2030s.