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THE GOOD
Approvals & Labels

AstraZeneca's Calquence (BTK inhibitor) nabs FDA approval for first-line treatment of mantle cell lymphoma, combined with bendamustine (alkylating agent) and rituximab (targeting CD20)
Small molecule, lymphoma, cancer - Read more

Amgen snags FDA approval for Lumakras (targeting KRAS G12C) plus Vectibix (targeting EGFR) combination for metastatic colorectal cancer
Small molecule, colorectal cancer - Read more

AstraZeneca, Daiichi Sankyo score FDA approval for Datroway (targeting HER2) in breast cancer
Monoclonal antibody, breast cancer - Read more

Innovent Biologics, ASK Pharm's limertinib (targeting EGFR TKI-sensitizing mutations, T790M) scores Chinese NMPA approval in non-small cell lung cancer
Small molecule, lung cancer - Read more

IMPACT Therapeutics, Huadong Pharmaceutical’s senaparib (PARP inhibitor) lands Chinese NMPA approval in ovarian cancer
Small molecule, ovarian cancer, fallopian tube cancer, primary peritoneal cancer - Read more

Foundation Medicine's FoundationOne CDx test approved as companion diagnostic for Day One Biopharmaceutical's Ojemda (pan-RAF kinase inhibitor) in glioma
Companion diagnostic, glioma, cancer - Read more

THE GOOD
Business Development

U.S. government hands Moderna $590 million to develop bird flu and influenza vaccines
Vaccine, mRNA, bird flu, influenza - Read more

THE GOOD
Clinical Trials

Novo Nordisk's high-dose Wegovy (semaglutide) delivers greater weight loss in obesity patients versus standard dose in Ph3 trial
GLP-1, obesity - Read more

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THE GOOD
Market Reports

Analysts predict Alzheimer's market to grow from $2.4B to $19B by 2033, led by Eisai/Biogen's Leqembi and Lilly's Kisunla.
Alzheimer’s disease - Read more

THE GOOD
Mergers & Acquisitions

WuXi AppTec sells US medical device testing facilities in Atlanta and St. Paul to regulatory consulting firm NAMSA
Medical device, testing, facility sale - Read more

THE GOOD
Partnerships

Henlius Biotech, Deep Potential Technology partner to leverage AI to develop novel cancer meds across modalities
Antibody-drug conjugate, antibody, small molecule, cancer, AI, drug development - Read more [Press release in Mandarin]

Fermion Technology, Simcere Pharmaceutical partner to develop non-opioid pain hopeful FZ002-037 (SSTR4 agonist)
Small molecule, pain management - Read more

Cytiva, Cellular Origins partner to integrate automated platforms for scalable cell therapy manufacturing
Cell therapy, gene therapy, automated manufacturing, robotic manufacturing - Read more

OpenAI, Retro Biosciences partners to develop AI model GPT-4b micro for protein engineering in longevity research
Protein engineering, longevity, AI - Read more

THE GOOD
Research

UMass Amherst researchers develop BacID, a non-toxic bacterial therapy to deliver cancer drugs directly into tumors, with clinical trials expected in 2027
Bacterial therapy, cancer, drug delivery - Read more

THE GOOD
Strategic Plans

Lykos Therapeutics doesn’t give up on potential FDA approval for their MDMA therapy for PTSD, planning independent data review and an additional Ph3 trial
Small molecule, post-traumatic stress disorder, psychedelic - Read more

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THE BAD
Clinical Trials

Neurizon Therapeutics' IND application for NUZ-001 placed under clinical hold by FDA, awaiting clarification on safety and dosing information
Small molecule, amyotrophic lateral sclerosis - Read more

THE BAD
Layoffs

Notch Therapeutics cuts jobs to save cash, biding time as part of partner/investor search
Cell therapy, cancer, iPSC-derived cell therapy, T cell therapy - Read more

THE BAD
Politics & Policy

Medicare adds Novo Nordisk’s Ozempic and 14 other drugs to price negotiation list, with new prices effective in 2027
Inflation reduction act, drug pricing, drug pricing negotiations - Read more

THE UGLY
Lawsuits

Sage Therapeutics sues Biogen to block $442M takeover attempt, citing violation of standstill agreement despite 30% premium offer
Small molecule, Alzheimer’s disease, Parkinson’s disease, major depressive disorder - Read more

DOJ sues Walgreens for allegedly filling millions of illegitimate prescriptions over a decade-long period starting in 2012
Pharmacy, prescription - Read more

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

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