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Dual and even triple or quadruple track processes have come roaring back in 2026 thanks to a glut of M&A that has refilled investors’ wallets. Big Pharma is being put on notice that time is critical if they want to acquire.
Policymaking at FDA has been anything but business as usual under the Trump administration, but former regulators cite the agency’s new investigational new drug pilot program as a sign of normalcy.
The FDA’s recently altered outlook on the evidence required for approval of rare disease drugs could have immediate benefits for companies including Skyhawk Therapeutics, Capricor Therapeutics and Biohaven.
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If cell and gene therapy makers are going to achieve their mission to improve patients’ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers to payers.
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Jefferies analysts forecast a $1 billion market opportunity for each of Sarepta’s siRNA programs for facioscapulohumeral muscular dystrophy and myotonic dystrophy type 1.
Facing the loss of exclusivity on key products, Pfizer has pulled forward its lead obesity asset into Phase III and targeted a 2028 launch. CEO Albert Bourla explained the pharma’s strategy at J.P. Morgan on Monday.
Obesity took center stage on the first day of the 2026 J.P. Morgan Healthcare Conference, with industry frontrunners Eli Lilly and Novo Nordisk providing supply chain, regulatory and pricing updates.
The FDA initially placed the Phase III IDeate-Lung02 study on hold due to a “higher than expected” number of deaths in patients treated with ifinatamab deruxtecan.
AbbVie has also pledged to participate in TrumpRx and offer many of its products, including Humira, on a direct-to-patient basis. In exchange, the pharma secured exemptions from tariffs and other future pricing directives.
Drugmakers told the FDA that inflexible post-approval change requirements are among the top regulatory barriers to the reshoring of pharmaceutical manufacturing.
Former European Trade Commissioner Phil Hogan and former U.S. Senator Richard Burr, speaking on a panel at the J.P. Morgan Healthcare Conference, pushed to see a larger picture beyond the Trump administration’s year of chaos and confusion.
Mature biopharma deals are stealing all the headlines, but Bristol Myers Squibb’s Robert Plenge says the company’s deals with insitro, Orbital and more are building the future.
The deal, which sees AbbVie paying RemeGen $650 million upfront, gives the pharma ex-China rights to the biotech’s PD-1/VEGF bispecific antibody—a modality being targeted by companies including BMS, Merck and Pfizer.
While Moderna’s full-year sales landed in the upper end of its target range, Jefferies analysts said further reductions are needed if the biotech hopes to hit its 2028 break-even target.