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THE GOOD
Approvals & Labels

Bayer's Hyrnuo (sevabertinib) receives FDA accelerated approval targeting HER2-mutated non-small cell lung cancer
Small molecule, cancer, tyrosine kinase inhibitor, non-small cell lung cancer, HER2 - Read more

Regeneron's Libtayo (cemiplimab) wins EU approval as first adjuvant immunotherapy for high-risk cutaneous squamous cell carcinoma
Antibody, cancer, monoclonal antibody, cutaneous squamous cell carcinoma, adjuvant therapy, PD-1 inhibitor - Read more

Roche's Lunsumio (mosunetuzumab) subcutaneous formulation wins EU approval for relapsed or refractory follicular lymphoma
Bispecific antibody, cancer, follicular lymphoma, CD20xCD3, subcutaneous formulation - Read more

Sinovac's Anflu influenza vaccine receives China approval for expanded age indication covering infants six months and older
Vaccine, infectious disease, influenza vaccine, pediatric population, seasonal influenza - Read more

Bayer's Lynkuet (elinzanetant) wins EU approval for menopausal vasomotor symptoms targeting neurokinin receptors
Small molecule, women's health, neurokinin receptor antagonist, menopause, vasomotor symptoms - Read more

Merck & Co.'s KEYTRUDA SC (pembrolizumab) subcutaneous formulation wins European Commission approval for all adult cancer indications
Antibody, cancer, monoclonal antibody, non-small cell lung cancer, PD-1 inhibitor, subcutaneous administration - Read more

FDA grants full approval for Amgen's IMDELLTRA (tarlatamab) targeting extensive stage small cell lung cancer
Antibody, cancer, bispecific T-cell engager, small cell lung cancer, DLL3 target - Read more

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THE GOOD
Business Development & Partnerships

Teva Pharmaceutical Industries launches global innovation platform Teva Rise for startups, tens of millions in funding
Open innovation platform, R&D, manufacturing, startup mentorship, equity investment - Read more

GSK, LTZ Therapeutics partner on myeloid cell engagers for cancer, $50M upfront
Licensing deal, oncology, antibody, milestone payments - Read more

Celltrion, TriOar partner on antibody platform technology, $680K upfront, $350M potential milestones
Licensing deal, oncology, antibody, milestone payments - Read more

Tempest, Factor Bioscience merge CAR-T programs with all-stock transaction giving Factor 65% control
Acquisition, oncology, cell therapy, CAR-T, equity investment - Read more

AstraZeneca, Sun Pharma partner to expand hyperkalaemia therapy access in India via dual branding
Commercialization partnership, nephrology, small molecule, co-marketing - Read more

Onco-Innovations, Kuano collaborate on AI and quantum drug discovery to accelerate PNKP inhibitor development
Research collaboration, oncology, AI/ML, small molecule, drug discovery - Read more

Nona Biosciences, Pfizer announce strategic research collaboration to accelerate antibody discovery using HCAb platform
Research collaboration, antibody, drug discovery, milestone payments - Read more

ARC at Sheba Medical Center, Mount Sinai, NVIDIA launch three-year AI genomics collaboration to decode human genome
Research collaboration, AI/ML, genomics, drug discovery, personalized medicine - Read more

THE GOOD
Clinical Trials

Merck & Co.'s doravirine/islatravir (HIV combo) matches Gilead's Biktarvy in Ph3 trial for treatment-naive human immunodeficiency virus patients
Small molecule, infectious disease, nucleoside reverse transcriptase translocation inhibitor, HIV, combination therapy - Read more

Protara Therapeutics reports positive Ph2 interim results for TARA-002 in pediatric lymphatic malformations
Protein therapy, rare disease, oncolytic virus, lymphatic malformations, pediatric population - Read more

Innovent's mazdutide achieves 20.1% weight loss in Chinese adults with obesity in Ph3 GLORY-2 trial
Protein therapy, metabolic, dual GCG/GLP-1 receptor agonist, obesity, weight management - Read more

THE GOOD
Fundraises

Rafa Laboratories awarded $186M BARDA contract for intramuscular tranexamic acid injection development
Government contract, small molecule, emergency medicine, manufacturing - Read more

Profluent raises $106M Series B, AI-driven protein design for therapeutics and agriculture
AI/ML platform, protein design, CRISPR, platform technology - Read more

Hermes Biosciences raises undisclosed Seed funding for extracellular vesicle isolation technology
Life science tools, extracellular vesicles, platform technology, diagnostic development - Read more

THE GOOD
Investments

Eli Lilly opens fourth US Gateway Labs biotech incubator facility in Philadelphia
Early-stage innovation, strategic, operational, investment - Read more

Novartis plans $771M North Carolina manufacturing hub expansion, adding 700 jobs by 2028
Biologics, strategic, major transaction, operational - Read more

Moderna invests $140M in Massachusetts plant for complete end-to-end mRNA drug manufacturing capabilities
mRNA vaccine, manufacturing, operational, major transaction - Read more

Celltrion invests $478M to expand New Jersey plant, responding to US pharmaceutical tariff policies
Biosimilar, strategic, major transaction, operational - Read more

THE GOOD
Market Reports

Eli Lilly's obesity drug trio projected to reach $101B peak revenue with oral orforglipron driving growth
Small molecule, metabolic disease, strategic, revenue impact - Read more

THE GOOD
Mergers & Acquisitions

Alkermes wins bidding war for Avadel with $2.37B offer, beating Lundbeck's competing proposal
Small molecule, neurological, strategic, major transaction - Read more

Hanmi Pharmaceutical agrees to acquire Aptose Biosciences for $2.41 per share in $30M deal
Small molecule, oncology, strategic, major transaction - Read more

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THE BAD
Clinical Trials

Agios Pharmaceuticals' Pyrukynd (mitapivat) shows mixed Ph3 results in sickle cell disease, missing pain crisis reduction endpoint
Small molecule, blood disorders, sickle cell disease, hemoglobin, anemia - Read more

THE BAD
Regulatory

FDA's Makary proposes higher user fees for companies conducting Phase I trials outside U.S.
Regulatory, strategic, operational, financial - Read more

THE UGLY
Politics & Policy

US commission warns China could weaponize pharmaceutical supply chain chokepoints threatening American healthcare system
Supply chain, strategic, competitive, operational - Read more

You’re all caught up on the latest Pharma & Biotech News!

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