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The FDA previously rejected Zycubo for Menkes disease in October last year, citing issues with the drug’s manufacturing facility.

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.

The deal will see Novartis gain global rights over SciNeuro’s potentially disease-modifying anti-amyloid antibody, which leverages the latter’s proprietary shuttle platform to allow delivery into the brain.

Acceptance of TempraMed’s products by Meuhedet Health Services strengthens TempraMed’s B2B institutional commercialization strategy as the Company advances reimbursement initiatives and expands relationships with leading healthcare organizations globally Highlights Meuhedet Health Services, Israel’s third-largest Health Maintenance Organization (HMO), serving more than one million insured members, has accepted TempraMed’s flagship VIVI Cap™ and VIVI Epi™ products. TempraMed products are now accepted by two of Israel’s four national HMOs—Maccabi Healthcare Services and Meuhedet—providing institutional access to approximately four million insured lives. The Company is executing a global B2B institutional strategy focused on healthcare organizations, insurers, distributors and government healthcare systems.