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THE GOOD
Approvals & Labels

FDA approves Eisai's Leqembi IQLIK autoinjector for at-home maintenance in early Alzheimer's disease
Antibody, neurological, Alzheimer's disease, amyloid therapy, autoinjector, subcutaneous administration - Read more

UK approves Eli Lilly's Jaypirca (pirtobrutinib), BTK inhibitor for relapsed mantle cell lymphoma and chronic lymphocytic leukemia
Small molecule, cancer, kinase inhibitor, blood cancer, chronic lymphocytic leukemia, mantle cell lymphoma - Read more

FDA approves Foresee's CAMCEVI ETM (leuprolide) for advanced prostate cancer treatment
Small molecule, cancer, hormone therapy, prostate cancer, LAI - Read more

FDA approves Sanofi's Wayrilz (rilzabrutinib), BTK inhibitor for adult persistent or chronic immune thrombocytopenia
Small molecule, autoimmune, BTK inhibitor, immune thrombocytopenia, oral therapy, immunology and inflammation - Read more

THE GOOD
Business Development & Partnerships

Fosun Pharma, Accro Bioscience pen $21.7M China licensing deal for TYK2/JAK1 inhibitor in inflammatory diseases
Licensing deal, inflammatory disease, small molecule, milestone payments - Read more

Eli Lilly partners with JD Health to sell obesity and diabetes medications directly to Chinese consumers
Direct-to-consumer, chronic disease management, diabetes, obesity, digital health, China - Read more

MEDIPAL and JCR partner on GM2 gangliosidosis therapy JR-479, expanding their rare disease collaboration with global licensing and Japan co-development agreement
Licensing deal, co-development, rare disease, drug discovery, Japan, milestone payments - Read more

Santhera, Ikris Pharma partner on AGAMREE distribution in India for Duchenne muscular dystrophy treatment; revenue-sharing agreement
Distribution agreement, rare disease, emerging markets, commercialization, milestone payments - Read more

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THE GOOD
Clinical Trials

BeOne's BCL2 inhibitor sonrotoclax achieves Ph1/2 success in relapsed mantle cell lymphoma, heading to regulators
Small molecule, cancer, BCL2 inhibitor, mantle cell lymphoma, blood cancer, BTK inhibitor - Read more

Zydus' saroglitazar PPAR agonist hits Ph3 primary endpoint in primary biliary cholangitis, filing planned
Small molecule, liver disease, PPAR agonist, primary biliary cholangitis, oral therapy - Read more

AstraZeneca's baxdrostat shows strong Ph3 results for hypertension, FDA filing planned for aldosterone synthase inhibitor
Small molecule, cardiovascular, aldosterone synthase inhibitor, hypertension, treatment-resistant hypertension, blood pressure - Read more

Cytokinetics' Ph3 trial shows aficamten superior to metoprolol in obstructive hypertrophic cardiomyopathy patients
Small molecule, cardiovascular, cardiac myosin inhibitor, hypertrophic cardiomyopathy, comparative efficacy - Read more

Novartis' Leqvio demonstrates significant LDL-C reduction and fewer muscle-related side effects in Ph4 hypercholesterolemia trial
Small molecule, cardiovascular, hypercholesterolemia, PCSK9 inhibitor, LDL-C lowering, statin intolerance - Read more

Immedica's Loargys shows favorable 5-year data for Arginase 1 deficiency patients in long-term studies
Protein therapy, metabolic, enzyme replacement therapy, rare disease, urea cycle disorder, Arginase 1 deficiency - Read more

Novo Nordisk's Wegovy shows 57% cardiovascular risk reduction versus Lilly's Zepbound in real-world Ph4 study
Small molecule, cardiovascular, peptide therapy, obesity, GLP-1 agonist, cardiovascular disease - Read more

AMI Pharm's AYP-101 fat-targeting injectable demonstrates significant efficacy in Ph2 submental fat reduction trial
Small molecule, metabolic, injectable fat reduction, submental fat, Phase 2 trial, body contouring - Read more

ABL Bio's ABL301 α-synuclein antibody shows safety in Ph1 trial for neurodegenerative diseases
Antibody, neurological, bispecific antibody, neurodegenerative disease, α-synuclein target - Read more

Ionis Pharmaceuticals' Tryngolza demonstrates triglyceride reduction in Ph3 trial for hypertriglyceridemia patients targeting apolipoprotein C-III
Antisense oligonucleotide, cardiovascular, hypertriglyceridemia, apolipoprotein C-III target, lipid-lowering agent - Read more [Paywall]

THE GOOD
Fundraises

MicrobiotiX raises $15M Series B to develop bacteriophage therapeutics for multidrug-resistant bacteria
Infectious disease, bacteriophage therapeutics, antimicrobial resistance, clinical-stage - Read more

Patient Square raises $3.1B interim close, healthcare investment firm building second fund
Healthcare investment, services, venture capital, life sciences investor - Read more [Paywall]

CEL-SCI raises $10M public offering, advancing cancer immunotherapy Multikine and operations
Cancer immunotherapy, clinical-stage, oncology, platform technology - Read more

Modus Therapeutics raises SEK 28.3M ($3M) rights issue for phase II clinical study financing
Clinical-stage, platform technology, therapeutics - Read more

THE GOOD
Market Reports

Novo's Wegovy gains swift physician acceptance in MASH market following FDA approval alongside Madrigal's Rezdiffra
GLP-1 agonist, liver disease, strategic, competitive, market expansion - Read more

THE GOOD
Mergers & Acquisitions

CapVest acquires majority stake in Stada from Bain Capital and Cinven in €10 billion ($11.7B) deal
Generic pharmaceuticals, consumer healthcare, financial, major transaction, strategic - Read more

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THE BAD
Clinical Trials

J&J discontinues nipocalimab (FcRn blocker) for rheumatoid arthritis after Ph2 trial shows no added benefit
Antibody, autoimmune, monoclonal antibody, rheumatoid arthritis, FcRn inhibitor, TNF-alpha combination therapy - Read more

Roche's zilebesiran misses Ph2 KARDIA-3 hypertension trial endpoint, still plans Ph3 for Alnylam's RNA therapeutic
Small molecule, cardiovascular, RNAi therapy, hypertension, kidney dysfunction, angiotensin pathway - Read more

Bayer's Verquvo fails Ph3 VICTOR trial in chronic heart failure, but pooled analysis suggests sGC efficacy
Small molecule, cardiovascular, heart failure therapy, sGC stimulator, chronic heart failure, reduced ejection fraction - Read more

THE BAD
Layoffs

Celyad Oncology halts R&D activities, cuts workforce amid cash constraints; will focus on IP licensing
CAR-T, oncology, strategic, cost reduction, operational - Read more

THE BAD
Politics & Policy

Senate calls Kennedy Jr. to testify amid CDC turmoil following Monarez firing and leadership exodus
Public health, regulatory, operational, leadership turmoil - Read more

THE BAD
Strategic Plans

Pfizer to discontinue low-dose ATTR drug Vyndaqel in US by 2025, maintaining only Vyndamax version
Small molecule, rare disease, strategic, operational, patent expiry - Read more

THE UGLY
Lawsuits

University of Michigan sues AstraZeneca for $50M+ over FluMist vaccine strains developed at university
Nasal spray vaccine, infectious disease, legal dispute, royalties, intellectual property - Read more

THE UGLY
Regulatory

Unichem recalls Cyclobenzaprine lot after mislabeling Meloxicam tablets, posing serious health risks
Small molecule, pain management, operational, regulatory, product recall - Read more

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

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