Biotech & Life Sciences
Datroway TNBC Approval and the ADC Platform Sweep That Is Reshaping Oncology
The FDA had a productive week. Two ADC approvals from the same partnership in two weeks. A Phase 3 trial in a rare skeletal disorder with no approved treatment. A Breakthrough Therapy Designation in a market already served by two blockbusters. And the first oral drug approved to prevent COVID-19 after exposure. None of these…
Ivonescimab posted a 34% survival benefit at ASCO — the FDA decides in November
ASCO week closed with one result that changed the conversation about lung cancer. Ivonescimab cut the risk of death by 34% in squamous NSCLC. The data landed in a Plenary Session. It was published simultaneously in The Lancet. It was the first time in the 61-year history of ASCO that a China-originated drug has been…
Biotech Weekly: Lung Cancer Data, Emerging Stock Drug Launch, Stroke Trial
Three biotech stories this week that most people missed. A clinical-stage oncology company posted Phase 2 lung cancer data that sent its stock up 16% and earned an ASCO podium. A under-the-radar stock with a real FDA-approved product secured national pharmacy coverage and launched a real-world evidence study. And a micro-cap developing a stroke drug…
Enhertu Double Approval, Regeneron Miss: What It Means for Smaller Biotechs
Two FDA decisions landed on the same Monday and pulled the sector in opposite directions. AstraZeneca and Daiichi Sankyo’s Enhertu picked up two new approvals in early breast cancer. Regeneron dropped 12% after its melanoma trial missed statistical significance against Keytruda. One validated a platform that smaller biotechs are actively building on. The other confirmed…
Biotech & Health Weekly: FDA Loses Its Commissioner
Marty Makary resigned on May 12. Three of the FDA’s top drug review positions are now held by acting officials. All three have a 210-day time limit under federal law before the White House has to make a decision on who fills them permanently. That did not slow the calendar. ENHERTU got a landmark approval…
How LOTTE Biologics Plans to Become a Top-Ten Global Biomanufacturing CDMO
LOTTE Biologics did not exist four years ago. Today it is operating a 40,000-litre biomanufacturing campus in New York, running a dedicated antibody-drug conjugate facility, breaking ground on a $3.3 billion manufacturing campus in South Korea, and expanding its second antibody manufacturing agreement with a clinical-stage biotech targeting dual-paratopic cancer immunotherapy. The pace is intentional.…
Canada Becomes First G7 Country to Get Generic Ozempic
Apotex Inc. announced Wednesday that Apo-Semaglutide Injection is now shipping to wholesalers across Canada, with pharmacy availability expected within weeks. It is the commercial launch that follows from a remarkable regulatory opening: Canada became the first G7 country to approve generic semaglutide in April 2026 after Novo Nordisk failed to maintain a key Canadian patent…
Mabwell Receives FDA IND Clearance for Novel IBD Antibody 9MW5211
The Shanghai-based biopharmaceutical company announced this week that 9MW5211 received FDA IND clearance to begin clinical studies in inflammatory bowel disease. Simultaneously, China’s National Medical Products Administration accepted clinical trial applications for multiple indications including IBD and multiple sclerosis for review. The compound is described as the world’s first clinical-stage drug candidate for its specific…
Biotech & Health Weekly: The Week a New Drug Class Got Approved
Thirteen years of research. One FDA approval. Arvinas crossed the finish line on May 1 with the first PROTAC therapy ever cleared by a regulator. The same day, Eli Lilly reported the most dominant quarter in GLP-1 history. A week later, Novo Nordisk answered with its own numbers. The biotech M&A machine kept running in…
Australia Just Approved the First Drug to Prevent Hearing Loss From Childhood Chemotherapy
Cisplatin works. That is both its value and its problem. The chemotherapy drug has been a cornerstone of treatment for childhood solid tumors for decades. It is effective against a wide range of cancers including hepatoblastoma, neuroblastoma, and osteosarcoma. It is also one of the most reliably ototoxic drugs in oncology, meaning it damages the…
