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Clinical-stage oncology efficacy signals
Pumitamig (BNT327/BMS986545) plus chemotherapy delivered high response rates in ROSETTA Lung-02, a phase 2 study of first-line non–small cell lung cancer presented at the 2026 ASCO Annual Meeting....
HIF-2 and PD-1 adjuvant kidney cancer approval
Merck’s Welireg (belzutifan) combined with Keytruda (pembrolizumab) received FDA approval for intermediate-high or high-risk, recurrence-free adjuvant treatment in clear cell renal cell carcinoma...
Regulatory shift on AI/biometric and clinical trial governance
Clinical evidence and regulatory review frameworks moved again around Moderna’s seasonal mRNA flu vaccine mRNA-1010 (mFLUSIVA). FDA documents ahead of the Vaccines and Related Biological Products...
China regulatory momentum and dealmaking for late-stage assets
China’s National Medical Products Administration approved Suzhou Alphamab’s HER2 bispecific antibody anbenitamab (KN-026) via priority review for adults with locally advanced or metastatic...
Biotech financing and IPO momentum
Vedana Therapeutics emerged from stealth with a $46 million Series A to develop internally discovered anti-PACAP antibody programs for migraine prevention, positioning its platform around...
Big pharma expansion via acquisitions in pain and beyond
Eli Lilly continued its non-opioid pain acquisition sprint by buying 4E Therapeutics, adding early-stage MNK inhibitor programs designed to target chronic pain without addiction risk. 4E’s lead...
Cell therapy and platform expansion for solid tumors
Oricell Therapeutics advanced its glypican-3 (GPC3)-targeted autologous CAR T therapy, Ori-C101, into confirmatory registration phase II for patients with GPC3-positive advanced hepatocellular...
Trial failures and restructuring in mental health biopharma
Neumora Therapeutics discontinued navacaprant after two phase 3 flops in major depressive disorder, failing to meet primary and key secondary endpoints in KOASTAL-2 and KOASTAL-3. The company also...
Drug discovery and validation around epigenetic hepatitis B therapy
Tune Therapeutics’ TUNE-401 epigenome editing therapy advanced with strong early clinical signals in a phase 1 study, reporting antiviral activity and safety data for its approach to add...
AI drug design deal
Merck & Co. launched a multi-target discovery collaboration and license agreement with Protillion Biosciences, setting up new AI-discovered therapeutic candidates built on Protillion’s Prot-MaP...
Clinical-stage oncology signal
Pumitamig (BNT327/BMS986545) plus chemotherapy showed high response rates as first-line treatment in phase 2 ROSETTA Lung-02 (NCT06712316) for non–small cell lung cancer, with efficacy across both...
Regulatory approval (oncology)
China’s National Medical Products Administration approved Suzhou Alphamab’s anbenitamab (KN-026), a HER2 bispecific antibody, for adults with locally advanced or metastatic HER2-positive gastric...
Biotech financing / IPO-to-phase III momentum
Longbio Pharma advanced LP-003 in seasonal allergic rhinitis after reporting that the candidate met the primary endpoint of total nasal symptom scores during peak pollen season in a phase 3 study....
AI-enabled healthcare platform rollout
AMDI received FDA 510(k) clearance for its Fast PCR system and CLIA waiver for a mini respiratory panel that differentiates four viral pathogens from anterior nasal swabs. The company highlighted...
Trial failure triggers restructuring
Neumora Therapeutics terminated development of navacaprant after two late-stage failures in its phase 3 program for major depressive disorder, KOASTAL-2 and KOASTAL-3. Following the...
Corporate acquisition (pain)
Eli Lilly agreed to acquire 4E Therapeutics, adding early-stage non-opioid pain programs built around MNK inhibitors and an approach aimed at avoiding addiction and central nervous system...
Patent litigation (digital sequencing)
Guardant Health avoided trebled damages in a patent infringement dispute tied to TwinStrand Biosciences and University of Washington duplex consensus sequencing IP. In a US District Court ruling,...
Data breach (clinical trial privacy)
Novo Nordisk disclosed an “unauthorized access” incident involving certain clinical trial data for products including Ozempic and Wegovy. The company said direct identifiers such as patients’...
Regulatory and pricing policy shift (Germany)
Germany backed away from a planned variable discount pricing scheme for branded pharmaceuticals after industry opposition, opting instead for a fixed approach, according to Reuters. The original...
Lilly’s continued push into non-opioid pain
Eli Lilly agreed to buy 4E Therapeutics, a private, Austin-based non-opioid pain drug developer, adding early-stage pipeline assets focused on MNK inhibition. 4E’s lead program, 4ET1103, is in...