At ASCO, Merck Makes Case for a ‘Cornerstone’ Cancer Drug
Merck is positioning sacituzumab tirumotecan (sac‑TMT), an ADC discovered by China’s Kelun‑Biotech, as a potential cornerstone therapy as its blockbuster Keytruda nears patent expiry. The drug entered a 17‑study Phase 3 program and showed a 65% reduction in disease progression or death versus Keytruda alone in a Chinese lung‑cancer trial. Early safety data appear cleaner than expected, prompting a 5%+ rise in Merck’s share price. Analysts caution that global trial results will determine whether the promise translates beyond China.
Process Intensification: Separating Fact From Fiction
Process intensification—boosting throughput and efficiency in biopharma manufacturing—is gaining traction, but misconceptions still hinder adoption. A survey of more than 150 industry veterans, conducted with Thermo Fisher Scientific and BioPharma Dive, debunks four myths: regulatory backlash, the need for full‑scale...
Measuring What Matters: New Priorities in COA Selection
Clinical outcome assessments (COAs) are increasingly essential for demonstrating patient benefit in CNS and rare‑disease trials, where small sample sizes limit statistical significance. A new Pearson report shows more than half of researchers now prioritize COAs that are sensitive to...
ASCO26: 5 Data Snapshots Ahead of the Year’s Biggest Cancer Drug Meeting
Ahead of the ASCO Annual Meeting, several late‑stage oncology trials were previewed in newly released abstracts. Merck’s antibody‑drug conjugate sacituzumab tirumotecan (sac‑TMT) combined with Keytruda cut disease‑progression risk by 65% and achieved a 70% response rate in first‑line non‑small cell...
RA Capital Banks $75M for a Biotech SPAC
RA Capital Management launched Research Alliance III, a biotech-focused SPAC that raised $75 million by selling 7.5 million shares at $10 each and began trading on Nasdaq under the ticker RACC. The vehicle seeks to merge with a China‑based drug development and diagnostic...
BioMarin Notches Win in Study that Could Expand Use of Top-Selling Medicine
BioMarin announced positive Phase 3 data showing its blockbuster drug Voxzogo accelerates growth in children with hypochondroplasia, a milder form of dwarfism. The trial reported significant gains in standing height and arm span after one year versus placebo. Analysts estimate the...
Lilly Snaps up Engage to Advance Non-Viral Genetic Medicines
Eli Lilly agreed to acquire Engage Biologics for up to $202 million in cash, adding the company’s non‑viral DNA delivery platform called Tethosome. The technology combines lipid‑nanoparticle shells with an mRNA‑encoded transport protein to move genetic payloads into cell nuclei without viral vectors....
BioMarin Drug Acquired in Buyout Misses Goal in Rare Disease Study
BioMarin Pharmaceutical’s BMN 401, an enzyme‑replacement therapy for ENPP1 deficiency, met its primary biochemical endpoint by raising plasma PPi levels but failed the co‑primary skeletal health goal in a Phase 3 trial of 27 children. The miss on clinical benefit and all...
A Migraine Drugmaker Heads to the Public Markets Through Reverse Merger
Mentari Therapeutics will go public via a reverse merger with InMed Pharmaceuticals, creating a combined company valued at roughly $421 million. The transaction includes a $290 million private placement led by Fairmount and backed by investors such as Blackstone and a16z Bio + Health,...
Høeg Fired in Latest FDA Shakeup; 20 People Die After Taking Amgen Drug
The FDA announced a leadership overhaul, firing acting CDER director Tracy Beth Høeg and installing Michael Davis as acting head, while Karim Mikhail now leads CBER. In Japan, 20 patients died after receiving Amgen’s rare‑disease drug Tavneos, prompting a warning and an existing U.S....
Unlocking More Value From Mature Drug Products Through Strategic Outsourcing
Pharmaceutical firms are confronting the largest patent cliff in history, threatening up to 40% of their revenue that comes from mature, off‑patent drugs. As legacy brands become a larger share of earnings, companies are shifting from low‑effort maintenance to strategic...
Lilly Data Point to ‘Maintenance’ Strategies for GLP-1 Weight Loss
Eli Lilly presented new data showing its GLP‑1 therapies can help patients maintain weight loss after injectable treatment. In the Surmount‑Maintain trial, patients who stayed on the highest Zepbound dose lost an additional two pounds over a year, while a reduced...
Assertio Accepts New Buyout Bid; AI Biotech Isomorphic Banks $2B
Assertio Holdings rejected Garda Therapeutics’ $21.80‑per‑share offer and accepted a superior bid from Zydus Worldwide, which values the company at $23.50 per share, roughly $166.4 million, with no financing contingencies. The board expects the transaction to close in Q2, positioning Assertio’s...
![[Podcast] Closing the Distance in Cancer Care](https://hixhlmpcokxhartfkpyi.supabase.co/storage/v1/object/public/images/thumbnails/1de993d39766949bff010a720911f297.webp)
[Podcast] Closing the Distance in Cancer Care
The BioPharma Dive podcast, sponsored by McKesson, spotlights how community oncology is reshaping cancer treatment in the United States. It highlights that patients can now receive advanced therapies, clinical‑trial options, and personalized care close to home, reducing the need for...
The Capacity Crunch in Biopharma Is a Location Problem
Biopharma manufacturers are hitting a capacity crunch as demand for cell and gene therapies outpaces the construction of new GMP‑ready plants, which can take years. Companies are therefore prioritizing locations where compliant facilities, utilities and cold‑chain logistics already exist. Middlesex...