GSK Functionally Cures Hepatitis B, Lilly's $3.8B Vaccine Pivot, and Base Editing Holds for 18 Months – This Week in...
GSK and Ionis reported Phase 3 data showing bepirovirsen achieved roughly a 20% functional cure rate in chronic hepatitis B, a potential paradigm shift for a disease affecting over 250 million people. Eli Lilly announced up to $3.8 billion in vaccine acquisitions targeting shingles, Staphylococcus aureus surgical infections, and Epstein‑Barr virus, expanding its modality portfolio. CVS Caremark reversed its obesity formulary, adding Lilly’s oral Foundayo and reinstating Zepbound, giving the company coverage across all major PBMs. Daiichi Sankyo’s Datroway ADC secured first‑line approval in triple‑negative breast cancer, while Verve’s base‑editing therapy demonstrated up to 62% LDL reduction lasting 18 months after a single dose.
Makary Resigns, BMS Bets $15B on China R&D, and Regenxbio Wins Phase 3 in Duchenne – This Week in Biotech...
Bristol Myers Squibb announced a $15.2 billion strategic licensing agreement with China’s Hengrui Pharma, front‑loading $600 million and targeting faster trial timelines. FDA Commissioner Marty Makary resigned, leaving acting head Kyle Diamantas—who lacks drug‑review experience—in charge and heightening regulatory uncertainty. Regenxbio reported clean...
FDA Approves the First PROTAC in History, a $1B siRNA Wave Hits Cardiometabolic Disease, and Cytokinetics Cracks Non-Obstructive HCM –...
The FDA granted its first-ever approval for a PROTAC drug, Arvinas’ Veppanu, targeting ESR1‑mutated metastatic breast cancer, marking a regulatory milestone for targeted protein degradation. In parallel, precision‑medicine siRNA deals surged: Madrigal paid $25 million upfront (up to $975 million in milestones)...
Revolution Medicines' Daraxonrasib Cuts Pancreatic Cancer Death Risk by 60% – This Week in Biotech #96
Revolution Medicines announced Phase 3 RASolute 302 results for its oral RAS‑ON inhibitor daraxonrasib in second‑line metastatic pancreatic ductal adenocarcinoma. The trial reported a median overall survival of 13.2 months versus 6.7 months with standard chemotherapy, a hazard ratio of 0.40 and a 60%...
100% Pharma Tariffs, Lilly's Oral GLP-1 Approval, and a $12B Week in Biotech M&A – This Week in Biotech #94
The White House announced 100% tariffs on branded drug imports from countries lacking trade agreements, prompting biotech firms to reassess supply‑chain and pricing strategies. Eli Lilly secured a rapid FDA approval for Foundayo, the first oral small‑molecule GLP‑1 for chronic weight...
Fed Rate Cut Tailwind, Lilly’s Triple Agonist Delivers Big, Vaccine Policy Turmoil — This Week in Biotech #81
The episode highlights how the Fed’s recent rate cut creates a macro‑tailwind for biotech, reviving valuations and financing opportunities. It discusses mixed public‑health signals around COVID‑19 vaccination in children and warns that U.S. skepticism could erode its mRNA leadership. Landmark...
Inside NImmune’s Phase 3 Push in Ulcerative Colitis
In this episode, Dr. Josep Bassaganya‑Riera discusses NImmune's strategy to launch omilancor, a gut‑restricted LANCL2 agonist, into Phase 3 for ulcerative colitis, emphasizing its mechanism as an immune “thermostat” that rebalances gut immunity rather than broadly suppressing it. He highlights...