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THE GOOD
Approvals & Labels

European Commission approves Roche's Itovebi (inavolisib) for PIK3CA-mutated, ER-positive, HER2-negative advanced breast cancer
Small molecule, cancer, PI3K inhibitor, breast cancer, PIK3CA mutation, combination therapy - Read more

J&J's BTK inhibitor Imbruvica wins European Commision’s approval for front-line mantle cell lymphoma, backed by Ph3 data
Small molecule, cancer, BTK inhibitor, mantle cell lymphoma, combination therapy, hematologic malignancy - Read more

European Commission approves Johnson & Johnson's Darzalex as first treatment for high-risk smouldering multiple myeloma
Monoclonal antibody cancer, multiple myeloma, CD38 target, smouldering multiple myeloma - Read more

THE GOOD
Business Development & Partnerships

Roche's Flatiron Health triples oncology network across UK, Germany and Japan to expand real-world cancer data collection capabilities
Research collaboration, oncology, data analytics, global, digital health - Read more

Alloy Therapeutics and Kansai Startup Academia Coalition partner to accelerate Japanese life science startups' global expansion through academic-industry connections
Research collaboration, drug discovery, global, academic-industry partnership, biotechnology, startup ecosystem - Read more

Sunflower Therapeutics, Alflow Scandinavia A/S partner on exclusive distribution of Daisy Petal Bioreactor System across Nordic countries
Distribution agreement, manufacturing, protein production, bioreactor technology - Read more

Arrowhead Pharmaceuticals, Sarepta Therapeutics partnership continues despite investor concerns over $550M deal with annual payments
Licensing deal, rare disease, milestone payments, R&D, myotonic dystrophy - Read more

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✅ More Good News ✅

THE GOOD
Clinical Trials

Apnimed's AD109, an oral norepinephrine/antimuscarinic therapy for obstructive sleep apnea, succeeds in second Ph3 trial
Small molecule, neurological, fixed-dose combination, sleep apnea, neuromuscular modulation, antimuscarinic - Read more

Legacy Healthcare's Cinainu shows positive Ph2/3 results for moderate to severe alopecia areata without immunosuppression-related events
Small molecule, autoimmune, botanical drug, alopecia areata, pediatric, JAK pathway - Read more

THE GOOD
Earnings & Finances

Lonza reports 19% sales growth as turnaround strategy yields results, powered by Roche plant acquisition
CDMO, operational, financial, strategic, major transaction - Read more

THE GOOD
Fundraises

Dispatch Bio raises $216M Series launch, developing universal solid tumor CAR T therapy
Oncology, cell therapy, solid tumors, CAR T therapy, platform technology, preclinical - Read more

Phlow raises $37M Series C, scaling US pharma manufacturing and AI technologies
CDMO, pharmaceutical manufacturing, services, AI-driven - Read more

DiaMedica raises $30.1M private placement for preeclampsia and stroke treatments
Clinical-stage, preeclampsia, stroke, cardiovascular, neurological - Read more

Dash Bio raises $11M funding for automated, GLP-compliant bioanalysis platform
Bioanalysis, CRO, platform technology, clinical-stage, services - Read more

Tharimmune raises $1.74M registered direct offering, immunology biotech for working capital
Immunology, inflammation, clinical-stage, biotechnology - Read more

THE GOOD
Regulatory

FDA launches national priority voucher program offering expedited two-month reviews for domestic manufacturing and affordability initiatives
Regulatory, healthcare policy, operational, competitive - Read more

THE BAD
Approvals & Labels

FDA delays Blenrep decision to October, reviewing additional data for GSK's BCMA-targeting multiple myeloma therapy
Antibody, cancer, monoclonal antibody, multiple myeloma, BCMA target, ocular toxicity - Read more

THE BAD
Layoffs

Genentech cuts 87 jobs in South San Francisco, marking fourth layoff wave in 15 months
Organizational restructuring, cost reduction, operational, workforce reduction - Read more

THE BAD
Withdrawals & Recalls

Orient Pharma and AvKARE recall nearly 80,000 pitavastatin bottles due to impurity test failures
Small molecule, cardiovascular, regulatory, operational, quality control - Read more

THE UGLY
Regulatory

HHS Secretary Kennedy approves removal of thimerosal from multi-dose flu vaccines following CDC panel recommendation
Vaccine preservative, infectious disease, regulatory, operational - Read more

THE UGLY
Strategic Plans

Roche halts shipments of Sarepta's Elevidys gene therapy in FDA-referencing countries following patient deaths
Gene therapy, rare disease, regulatory, operational - Read more

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

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