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GLP-1 oral obesity approvals ignite a new competitive era
The U.S. FDA approved Eli Lilly’s once-daily oral GLP-1 receptor agonist orforglipron, branded Foundayo, for adults with obesity or overweight with weight-related comorbidities. The approval...
Trump’s 100% drug tariffs—carveouts and pricing deals reshape leverage
President Donald Trump signed an executive order imposing 100% tariffs on imported brand-name drugs, citing U.S. reliance on imports as the rationale and positioning the action under Section 232...
EMA endorses first virtual controls approach for toxicity testing (NAM milestone)
The European Medicines Agency (EMA) gave initial endorsement to a new approach methodology aimed at early toxicity testing that replaces live animal controls with “virtual counterparts.” The...
Orca Bio’s cell therapy approval timeline shifts after manufacturing data update
The U.S. FDA delayed its decision on Orca Bio’s T cell therapy, pushing the deadline three months to July 6 after the company filed additional manufacturing information. The original timeline...
CAR T for the first time built on-campus gains FDA IND clearance
The University of Colorado Anschutz Gates Institute received FDA Investigational New Drug (IND) clearance for a novel CAR T-cell therapy designed and built on campus, marking a first-in-the-U.S....
SCLC trial biomarker analysis spotlights AZD2811 response monitoring
New Phase I dose-expansion findings in relapsed or refractory small-cell lung cancer (SCLC) highlight how biomarker analysis can be used to track treatment efficacy in the AZD2811 program. The...
Cancer immunotherapy science: St. Jude study points to dendritic cell ‘gatekeeper’ suppression mechanism
Researchers at St. Jude Children’s Research Hospital published findings in Science identifying a mechanism by which tumors suppress dendritic cells, the immune system’s antigen-presenting...
Biotech M&A momentum: Biogen to buy Apellis for $5.6B
Biogen agreed to acquire Apellis Pharmaceuticals in a deal valued at $5.6 billion, a move framed as accelerating Biogen’s expansion in nephrology and complementing its existing late-stage...
Drug delivery and formulation innovation: Pfizer’s new fluid program? (AAV manufacturing process stability)
A manufacturing-focused report described an approach to improve prolonged transfection complex stability for large-scale AAV production, targeting a major upstream bottleneck: adding transfection...
Regenerative medicine platform: UCL hydrogel axon model reshapes MS remyelination testing
University College London (UCL) researchers developed a hydrogel-based axon model designed to improve preclinical testing for multiple sclerosis remyelination therapies by matching more realistic...
Oncology early-stage biomarker strategy for AZD2811 in SCLC
Phase I dose-expansion data in relapsed or refractory small-cell lung cancer point to a role for biomarker analytics alongside treatment with AZD2811. The work, led by Johnson, Fabbri, Ciardullo...
Regulatory pathway shifts for organoid-supported drug development
The FDA has endorsed a new approach where an IND can be supported solely by human vascularized organoid-based combination studies, without traditional animal efficacy proof-of-concept testing. The...
FDA dates and setbacks for oncolytic virus and Treg cell therapies
CBER remains on track for multiple April PDUFA decisions, with Replimune’s oncolytic virus Vusolimogen oderparepvec among the scheduled calls. The excerpt also notes that an Orca Biosystems Treg...
US trade policy raises the cost and complexity of brand-name drug imports
President Trump signed an executive order imposing a 100% ad valorem tariff on imported brand-name patented pharmaceuticals and associated ingredients under Section 232, with exemptions and...
FDA approval expands oral GLP-1 competition for obesity
The FDA approved Eli Lilly’s oral obesity pill orforglipron, branded Foundayo, clearing a fast-track path under the commissioner’s National Priority Review voucher program. The approval sets up...
Ambrosia lands Series B funding for oral obesity small-molecule pipeline
Ambrosia Biosciences secured a $100 million oversubscribed Series B round to advance its oral obesity drug pipeline. The financing is earmarked for progression of the company’s lead oral...
CAR T program moves forward with first campus-developed FDA approval
The University of Colorado Anschutz Gates Institute achieved FDA IND clearance for a novel CAR T-cell therapy. The submission is framed as the first US FDA approval for a campus-developed CAR...
Biopharma dealmaking accelerates: Biogen buys Apellis for $5.6B
Biogen agreed to acquire Apellis Pharmaceuticals for $5.6 billion, positioning the deal as a way to accelerate expansion in immunology and rare disease. The acquisition adds commercialized...
Europe’s EMA signals a first step toward NAM acceptance in toxicity testing
The EMA gave initial endorsement to a new approach to early toxicity testing designed to replace live animal controls with “virtual counterparts.” The virtual groups are derived from historical...
Biotech manufacturing and platform signals: Hydrogel axon model improves remyelination screening
Researchers at UCL developed a hydrogel-based axon model to improve early testing for multiple sclerosis remyelination therapies. Published in Nature Methods, the platform uses tunable...