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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

Labcorp wins FDA approval for PGDx elio tissue complete CDx companion diagnostic targeting BRAF-mutant advanced melanoma
Small molecule, cancer, companion diagnostic, melanoma, BRAF mutation, next-generation sequencing - Read more

AstraZeneca's Calquence (acalabrutinib) wins NICE backing for Ph3-supported chronic lymphocytic leukaemia and mantle cell lymphoma regimens
Small molecule, cancer, BTK inhibitor, chronic lymphocytic leukemia, mantle cell lymphoma, combination therapy - Read more

AstraZeneca Pharma India wins CDSCO approval for Enhertu (trastuzumab deruxtecan) in HER2-positive early breast cancer with residual invasive disease
Antibody-drug conjugate, cancer, breast cancer, HER2-positive, trastuzumab deruxtecan, adjuvant therapy - Read more

THE GOOD
Business Development & Partnerships

Novo Nordisk, Amazon Web Services partner on AI drug discovery, launch London innovation hub
Research collaboration, AI/ML, drug discovery, chronic disease, cloud computing - Read more

Sobi, Innate Pharma strike $580M deal to advance lacutamab through Phase III lymphoma trial
Licensing deal, oncology, antibody, milestone payments, royalties - Read more

Oculis acquires Accure Therapeutics' Privosegtor rights for $3.8M upfront plus 2,050,000 shares
Acquisition, neuro-ophthalmology, small molecule, milestone payments, equity investment - Read more

Almirall, CrystalO Biopharma Technology collaborate on small molecule discovery for medical dermatology, upfront payment plus milestones
Research collaboration, dermatology, small molecule, AI/ML, milestone payments, royalties - Read more

Innovent Biologics, Daiichi Sankyo enter exclusive commercialization agreement for Vanflyta in China
Commercialization agreement, oncology, small molecule, hematology - Read more

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More Good News

THE GOOD
Clinical Trials

Silence Therapeutics' (divesiran) hits primary endpoint in Ph2 trial targeting TMPRSS6 for polycythemia vera
Small molecule, cancer, siRNA, polycythemia vera, TMPRSS6, hematologic malignancy - Read more

AbCellera's (ABCL635) Ph2 data surpass rivals in NK3R-targeting therapy for menopause-related hot flashes
Antibody, women's health, monoclonal antibody, NK3R, menopause, hot flashes - Read more

THE GOOD
Earnings & Finances

Denali Therapeutics' Avlayah surpasses analyst expectations with $3.6M in Hunter syndrome therapy launch revenue
Enzyme replacement therapy, rare disease, revenue impact, competitive - Read more

THE GOOD
Fundraises

Latigo Biotherapeutics and BlossomHill Therapeutics raise combined $495.6M in IPOs, advancing pain and oncology programs
Pain, small molecule, oncology, non-small cell lung cancer, clinical-stage - Read more

AB Science raises €14.2M ($16.4M) private placement, funding AML and ALS drug development
Oncology, small molecule, rare disease, neurology, clinical-stage - Read more

THE GOOD
Market Reports

Eli Lilly's Zepbound leads physician satisfaction over Novo Nordisk's Wegovy despite new oral obesity drug launches
GLP-1 agonist, obesity, competitive, physician sentiment - Read more

THE GOOD
Product Launches

Samsung Bioepis launches OPUVIZ pre-filled syringe aflibercept biosimilar across European markets
Biosimilar, ophthalmology, operational, revenue impact - Read more

THE GOOD
Regulatory

FDA panel to review Grail's Galleri blood-based multi-cancer early detection test application
Liquid biopsy, oncology, regulatory, financial - Read more

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The Bad News

THE BAD
Clinical Trials

Sionna Therapeutics' (SION-719) Ph2 trial fails in cystic fibrosis, reinforcing Vertex Pharmaceuticals' NBD1 stabilizer dominance
Small molecule, respiratory disease, cystic fibrosis, NBD1 stabilizer, CFTR modulator - Read more

Tenax Therapeutics' TNX-103 fails Ph3 trial primary endpoint in pulmonary hypertension associated with heart failure with preserved ejection fraction
Small molecule, cardiovascular, heart failure, pulmonary hypertension, HFpEF, phase 3 trial - Read more

THE BAD
Company Shutdown

Arpeggio Biosciences shuts down after Nrf2 small molecule program fails to separate efficacy from off-target liability
Small molecule, oncology, operational, financial - Read more

THE BAD
Layoffs

Ensoma cuts more staff, pauses preclinical programs to focus on EN-374 gene therapy for X-CGD
Gene therapy, rare disease, cost reduction, operational - Read more

aTyr Pharma cuts 60% of workforce to conserve $58.9M cash for second phase 3 attempt in pulmonary sarcoidosis
Immunomodulator, pulmonary sarcoidosis, cost reduction, operational - Read more

THE BAD
Regulatory

FDA issues early alert on Becton Dickson Intraosseous needle sets after four deaths, 45 injuries
Medical device, emergency medicine, patient safety, operational - Read more

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

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