Amgen Shores up Tavneos’ FDA Defense with Duke Data Analysis
Amgen has asked the FDA for a hearing to contest the agency’s demand that it withdraw Tavneos, its rare‑inflammatory disease drug. The company engaged the Duke Clinical Research Institute to conduct a fully blinded, independent re‑adjudication of the Phase 3 ADVOCATE trial data. Amgen will submit Duke’s findings and data from more than a dozen ongoing studies by June 29, while the FDA has already issued safety alerts citing eight deaths and 76 liver‑injury cases. The dispute follows earlier reviews by the European Medicines Agency and safety concerns raised in Japan.
SonoThera Bags $125M Series B to Advance Safer Gene Therapies
San Francisco‑based SonoThera announced a $125 million Series B round to fund its non‑viral gene‑therapy platform. The capital will accelerate lead programs for Duchenne muscular dystrophy and autosomal dominant polycystic kidney disease into clinical trials and expand the pipeline to other organs....
Portugal, Spain and the New Biotech Frontier
BioSpace’s Denatured podcast released an episode focusing on the burgeoning biotech ecosystem in Portugal and Spain. Guests Hannah Franklin of Biovance Capital and Pablo Gabriel Cironi Lopez of Caixa Capital Risc highlighted Portugal’s push to translate strong scientific research into...
Sanofi Cans Late-Stage Study for Rare Autoimmune Disease on Underwhelming Efficacy
Sanofi has halted the Phase 3 MOBILIZE trial of its complement inhibitor riliprubart in chronic inflammatory demyelinating polyneuropathy (CIDP) after an independent data‑monitoring board deemed the interim results unlikely to demonstrate sufficient efficacy. The study, which enrolled roughly 140 patients and...
Disc’s FDA Meeting Sets ‘Clear Path’ for Embattled Rare Blood Disease Drug
Disc Medicine has secured an FDA agreement to resubmit its rare‑blood‑disorder drug bitopertin using data from the ongoing Phase 3 APOLLO trial. The agency previously rejected the drug in February 2026 over concerns that the surrogate endpoint did not reliably predict...
Lilly Tees Off with Novo at ADA, GSK’s $10.6B Deal, FDA Reform Continues in Makary’s Absence
Eli Lilly dominated the American Diabetes Association meeting with positive data on its new obesity pill Foundayo and the multi‑indication candidate retatrutide, showing benefits for weight loss, sleep apnea, knee pain and menopause. Novo Nordisk used the same forum to present expanded...
Lilly’s $25B+ M&A Spree Captures Half of Pharma’s 2026 Capacity
Eli Lilly has led 2026 pharma mergers, spending $25.27 billion on ten deals—more than half of the $46.38 billion total outlay by the sector's top 12 companies. The acquisitions range from a $3.8 billion vaccine‑biotech trio to the $8.14 billion Centessa purchase, reflecting a strategy...
Merck, Gilead Serve ‘Sweet and Sour’ Spread After HIV Win, Cancer Stumble
Merck and Gilead reported that their once‑weekly oral HIV combo of islatravir and lenacapavir (IS/LEN) achieved non‑inferior virologic suppression versus Biktarvy and other standard regimens in two Phase 3 trials. At the same time, they halted the Phase 3 KEYNOTE‑D46 study of...
ADA: Lilly Bests Novo Again, Takes GLP-1 Pill Foundayo to FDA for Diabetes Approval
Eli Lilly’s oral GLP‑1 drug orforglipron, marketed as Foundayo, demonstrated superior blood‑sugar control and greater weight loss than Novo Nordisk’s oral semaglutide and AstraZeneca’s Farxiga in three Phase 3 ACHIEVE trials. In the 52‑week ACHIEVE‑3 study, a 9 mg dose cut HbA1c by 1.9%...
City Therapeutics Builds RNAi Pipeline with $99.5M Series B
City Therapeutics announced a $99.5 million Series B financing to accelerate its RNA‑interference pipeline. The round backs its lead candidate CITY‑FXI, a Factor XI inhibitor in Phase 1 aimed at preventing clots without increasing bleed risk. Funds will also support a next‑generation trigger‑molecule platform...
ADA: Novo Boasts Deep Pipeline, ‘Breadth of Assets’ After Analysts Award Lilly Weight Loss Gold
Novo Nordisk showcased more than 40 abstracts at the American Diabetes Association meeting, emphasizing post‑hoc analyses that link semaglutide (Wegovy/Ozempic) to fewer asthma events, lower systolic blood pressure, and improved fatty‑liver scores. The company highlighted its broad cardiometabolic pipeline, including...
J&J Glows with $1B Buyout of Firefly and Its Degrader Platform Tech
Johnson & Johnson announced a $1 billion cash acquisition of California‑based Firefly Bio, securing its degrader antibody conjugate (DAC) platform. The technology merges antibody‑drug conjugate precision with protein‑degrader capability to target KRAS‑driven solid tumors, a class long deemed undruggable. Firefly, founded...
Busy FDA Gives Rare Disease Sector Complementary Pathways, Unanswered Questions
The FDA has rolled out two new rare‑disease frameworks—the plausible mechanism pathway and Rare Disease Evidence Principles (RDEP)—to complement its longstanding expedited programs. Both aim to speed approval for individualized gene‑editing, RNA, and ultrarare therapies by allowing narrower evidence sets....
Post-Makary, New Rare Disease Framework Faces Fresh Uncertainty
The FDA’s plausible mechanism pathway—designed to fast‑track individualized rare‑disease therapies—faces uncertainty after the departures of Commissioner Marty Makary and CBER director Vinay Prasad. A May 4 workshop clarified that the framework is not a new approval route but a set...
ADA: Lilly’s Weight Loss Mastery Shows Benefits in Menopause, Sleep Apnea, More
Eli Lilly showcased its obesity portfolio at the ADA meeting, highlighting the triple‑hormone agonist retatrutide and the oral GLP‑1 Foundayo. Retatrutide delivered a 28.3% body‑weight reduction (about 70 lb) after 80 weeks, slashed knee‑pain by 73%, cut moderate‑to‑severe sleep‑apnea events by 60%...