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All the top Biotech & Pharma news in one daily newsletter.

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The Good News

THE GOOD
Approvals & Labels

Merck KGaA's Erbitux (cetuximab) wins EC approval for first-line BRAF V600E-mutant metastatic colorectal cancer based on Ph3 data
Antibody, cancer, monoclonal antibody, colorectal cancer, BRAF V600E mutation, EGFR inhibitor, combination therapy - Read more

Biogen, Eisai win FDA approval for subcutaneous Leqembi (lecanemab) initiation therapy in Alzheimer's disease
Antibody, neurological, monoclonal antibody, Alzheimer's disease, anti-amyloid, subcutaneous delivery - Read more

THE GOOD
Business Development & Partnerships

Avere Therapeutics, NextCure, Hansoh Pharmaceutical merge publicly, license oral IL-23 drug AVR-001 for $120M upfront, $2.18B milestones
Reverse merger, licensing deal, autoimmune, small molecule, milestone payments, royalties - Read more

AstraZeneca, Dizal Pharmaceutical strike exclusive global lung cancer license deal, $600M upfront, up to $1.5B total
Licensing deal, oncology, small molecule, milestone payments, royalties - Read more

Spero Therapeutics licenses Innovent Biologics' CD40L antibody SP001 for autoimmune diseases, deal worth up to $1.1B
Licensing deal, autoimmune, antibody, rare disease, milestone payments, royalties - Read more

Chai Discovery, Novartis partner on AI-driven therapeutic antibody discovery across multiple targets
Research collaboration, AI/ML, drug discovery, antibody, R&D - Read more

Ardigen, VERAXA Biotech launch AI-driven partnership to optimize T cell engager and ADC drug discovery
Research collaboration, oncology, AI/ML, drug discovery, antibody, cell therapy - Read more

Summit Therapeutics sells ridinilazole to Biossil for $500K upfront, $104.5M milestones
Licensing deal, infectious disease, AI/ML, small molecule, milestone payments - Read more

Mylan sells up to $363M stake in Biocon, representing 5.64% of outstanding shares
Equity investment, secondary offering, commercialization, generics - Read more

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More Good News

THE GOOD
Clinical Trials

GSK's Jemperli (dostarlimab) meets Ph2 primary endpoint in dMMR/microsatellite instability-high locally advanced rectal cancer, global submissions planned
Antibody, cancer, monoclonal antibody, colorectal cancer, PD-1 inhibitor, dMMR/MSI-H - Read more

Q32 Bio's bempikibart meets Ph2 goal, helping 40% of alopecia areata patients achieve significant hair regrowth
Antibody, autoimmune, monoclonal antibody, alopecia areata, IL-7/TSLP pathway inhibitor - Read more

Freenome's SimpleScreen CRC blood test shows improved sensitivity for colorectal cancer screening in pivotal validation study
Diagnostic test, cancer, liquid biopsy, colorectal cancer, cancer screening - Read more

Biogen's (diranersen) Ph2 results show tau-targeting antisense oligonucleotide slows decline in Alzheimer's disease
Antisense oligonucleotide, neurological, Alzheimer's disease, tau protein, small molecule - Read more

Ipsen's IQIRVO (elafibranor) hits primary endpoint in Ph3b trial for primary biliary cholangitis, achieving 85% alkaline phosphatase normalization
Small molecule, autoimmune, PPAR agonist, primary biliary cholangitis, ALP normalization, cholestasis - Read more

THE GOOD
Fundraises

Chai Discovery raises $400M Series C to advance AI molecule models for drug discovery
AI/ML platform, drug discovery, antibody design, platform-enabled - Read more

Drug Farm completes $55M Series D first closing, advancing clinical and preclinical pipeline
Clinical-stage, first-in-class, preclinical, drug discovery - Read more

Draig Therapeutics raises $65M Series B to advance neuropsychiatric AMPA and GABAA receptor modulators
Neuropsychiatric, small molecule, clinical-stage, major depressive disorder - Read more

Erasca plans $500M public offering to fund RAS/MAPK pathway cancer therapy development
Clinical-stage, precision oncology, RAS/MAPK pathway, small molecule - Read more

THE GOOD
Product Launches

Real Chemistry launches Anatomi AI platform to streamline healthcare commercialization across marketing and medical workflows
AI tools, healthcare commercialization, operational, competitive - Read more

THE GOOD
Regulatory

FDA proposes streamlined "hub-and-spoke" registration rules to ease distributed manufacturing burdens for biopharma companies
Manufacturing, operational, regulatory, strategic - Read more

FDA releases final psychedelics guidance, signaling flexibility for Compass Pathways and Definium Therapeutics
Small molecule, neurological, regulatory, competitive - Read more

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The Bad News

THE BAD
Layoffs

Merck KGaA's EMD Serono mandates in-office work, risking 70 layoffs among remote R&D staff
Workforce restructuring, operational, cost reduction, strategic - Read more

THE BAD
Regulatory

Lupin Pharmaceuticals recalls 2.5M+ prescription eye drop bottles due to foreign substance contamination
Small molecule, ophthalmology, operational, regulatory - Read more

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

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