| Today’s Big NewsJun 3, 2025 |
| By Gabrielle Masson Several analysts are hailing Merus as the sure winner in the race to a new treatment for head and neck squamous cell carcinoma. But the chase is still in its early days and is likely too soon to call. |
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By Darren Incorvaia Almost a full month before hitting the June 30 deadline set by Commissioner Martin Makary, M.D., the FDA has unveiled a new generative AI tool meant to be incorporated into day-to-day work across the agency. |
By Nick Paul Taylor Barreling toward the loss of exclusivity on Keytruda, Merck & Co. has reportedly offered $3 billion to buy MoonLake Immunotherapeutics to add an inflammatory disease prospect to its late-phase pipeline. |
Sponsored by Thermo Fisher Scientific Austin Read of Thermo Fisher Scientific discusses how combining biospecimens with real-world data is advancing diagnostics, treatment and the future of patient care. |
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From gene therapy pipelines to early-stage VC deals, biotech leaders are seeking clarity in the chaos. That’s why companies are sharing their insights through Fierce content hubs — with weekly features right here in your inbox. See how others are shaping the narrative. 
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By Darren Incorvaia The Trump administration's proposed funding cuts to the National Institutes of Health, including the National Cancer Institute, “would be devastating to the pace and progress of cancer research in America” if they are implemented, the CEO of the American Society of Clinical Oncology said in a May 30 statement. |
Sponsored by WCG When clinical trial steps are managed separately, the study suffers from compounded delays. Discover proven solutions from trusted industry experts. |
By James Waldron Kura Oncology and Kyowa Kirin have shared details of the phase 2 win for their oral leukemia treatment ziftomenib as the FDA mulls whether to greenlight the selective menin inhibitor. |
Sponsored by Bayer Discover how Bayer and BlueRock are redefining biotech partnerships. From breakthrough Parkinson’s therapies to a unique “arm’s-length” model, this episode of The Top Line dives into what makes their collaboration a blueprint for the future. |
By Darren Incorvaia Ernexa Therapeutics’ “Trojan Horse” stem cells can infiltrate ovarian tumors in mice, boosting T cell activity and leading to shrunken tumors and improved survival, the company announced in a June 2 presentation at the American Society of Clinical Oncology Annual Meeting in Chicago. |
Sponsored by Marken, UPS Healthcare Precision Logistics Radiopharma is revolutionizing modern medicine. Discover how precision logistics empowers faster, safer delivery of life-impacting therapies when every second counts. |
By James Waldron Transpire Bio has licensed an inhaled PDE4 inhibitor from China’s Intragrand Pharma as a potential treatment for idiopathic pulmonary fibrosis, investigating a target already being pursued by Boehringer Ingelheim. |
By James Waldron OSE Immunotherapeutics has shared the survival data behind its therapeutic vaccine’s phase 2 pancreatic cancer win, backing up its claims of a “pipeline in a product” potential for the asset. |
By Angus Liu Johnson & Johnson’s Akeega is giving the PARP inhibitor class a first win in castration-sensitive prostate cancer, although the drug’s benefit in a patient subgroup remains unclear. |
By Angus Liu Despite its success in advanced melanoma, Bristol Myers Squibb’s fixed-dose PD-1/LAG-3 combo, Opdualag, failed to move the needle in resected skin cancer. |
By Joseph Keenan Agenus, which has been going through a reorganization after the FDA put the brakes on the biotech's regulatory plan for its cancer combo, inked a deal that transfers two California manufacturing plants to Indian drugmaker Zydus Lifesciences. |
By Kevin Dunleavy Sanofi’s Sarclisa has had difficulty competing with Johnson & Johnson’s Darzalex, largely because it reached the market five years later. But one advancement that could help Sanofi close some of the gap is its on-body delivery system for its CD38 antibody. |
By Heather Landi The acquisition tackles one of healthcare's most vexing challenges: ensuring accurate information about doctors is available so patients can find the right care, said H1 CEO Ariel Katz. |
Fierce podcasts Don’t miss an episode |
| This week on "The Top Line," we break down first-quarter Big Pharma earnings, recap the latest gene therapy developments and preview what’s ahead at ASCO. |
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Whitepaper We analyzed ~300 launches to identify the factors most correlated with commercial success & built a framework for peak go-to-market performance. Presented by Blue Matter, strategic consultants in the life sciences |
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