Pfizer Inc. is paying Innovent Biologics Co. Ltd. $650 million up front and up to $9.85 billion in milestones, plus royalties, to collaborate across 12 early-stage and de novo antibody-drug conjugates (ADCs) and multispecific antibodies for oncology. Under the terms of the mega-licensing and collaboration agreement, Pfizer and Suzhou, China-based Innovent agreed to codevelop and share costs for a portfolio of 12 programs comprising eight early-stage programs from Innovent and four discovery programs from Pfizer. The companies will codevelop and share costs for selected programs through clinical development, with Innovent leading development through phase I and Pfizer taking over subsequent development globally.
Replimune tries again with melanoma drug post FDA shakeup
Shares of Replimune Group Inc. (NASDAQ:REPL) soared by more than 90% in morning trading as the company reported it had reached alignment with the U.S. FDA for resubmitting the BLA for RP-1 (vusolimogene oderparepvec) seeking approval for use in combination with nivolumab in advanced melanoma. The news came less than two months after Replimune disclosed a second complete response letter citing insufficient data, though the FDA has undergone changes in that short time, notably Vinay Prasad stepping down as head of the agency’s Center for Biologics Evaluation and Research followed by Marty Makary’s resignation as FDA commissioner. Whether the change in leadership will prove an advantage for Replimune remains to be seen, but the company noted the FDA said it plans to treat the BLA resubmission as an “urgent matter upon receipt and will prioritize its review in recognition of the significant unmet need for patients.”
ASCO: BMS’ mezigdomide doubles PFS in multiple myeloma
At the 2026 American Society of Clinical Oncology Annual Meeting, Bristol Myers Squibb Co. released data from the phase III portion of the seamless phase II/III Successor-2 study showing mezigdomide in combination with carfilzomib and dexamethasone (MeziKd) produced a 52% reduction in the risk of disease progression or death compared to carfilzomib and dexamethasone alone (Kd) in patients with relapsed or refractory multiple myeloma. The median progression-free survival (PFS) more than doubled to 18 months for MeziKd compared to 8.3 months for Kd. Mezigdomide, a cereblon E3 ligase modulator, targets two lymphoid transcription factors, Ikaros (IKZF1) and Aiolos (IKZF3), for degradation, leading to apoptosis of the myeloma cells.
WHO selects vaccines, therapeutics for Ebola outbreak field trials
“I need to be honest with you about something important. Most previous Ebola outbreaks in the Democratic Republic of Congo (DRC) were caused by a virus called Ebola Zaire, for which we have vaccines and treatments. This outbreak is caused by a different virus called Ebola Bundibugyo. There are currently no approved vaccines or treatments for it.” This was the stark message from Tedros Adhanom Ghebreyesus, director general of the World Health Organization (WHO) in an open letter to the people of the DRC, as he traveled to the country on Friday, May 29. The conclusions the experts reached on possible vaccine and therapeutics for preventing and treating Bundibugyo, published on May 29, point to very limited options.
China launches long-awaited drug data protection rules
China’s National Medical Products Administration has issued final implementation measures for drug trial data protection that mark a significant step toward aligning China’s pharmaceutical intellectual property framework with global standards. The measures formalize China’s regulatory data protection system that includes patent linkage and market exclusivity that will have major implications for global filing strategies, licensing deals, and generic competition. The rules, which became effective May 15, establish a fully operational regulatory data protection regime, offering up to six years of exclusivity for qualifying products.
Daraxonrasib, emactuzumab headline April's phase III cancer wins
Revolution Medicines Inc.’s daraxonrasib nearly doubled overall survival versus chemotherapy in previously treated metastatic pancreatic cancer, clearing what analysts called a “home-run” threshold. Synox Therapeutics Ltd. is heading toward an FDA filing for emactuzumab in tenosynovial giant cell tumor after a short-course dosing regimen produced rapid, durable responses in a phase III trial.
Pancreatic lesions show cancer traits but lack stromal support
The human pancreas often contains lesions that are common in the population and that, although they can become malignant, usually do not. To understand when this occurs and how these pancreatic cancer precursor lesions, known as pancreatic intraepithelial neoplasias (PanIN), evolve, scientists at the University of Michigan analyzed their gene expression patterns and their cellular microenvironment. The results show that although these lesions express some cancer‑associated genes, the surrounding cells do not undergo reprogramming, which could help explain why most PanINs do not progress to cancer.
Ongoing coverage of the Ebola outbreak
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