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THE GOOD
Approvals & Labels

EU approves Bayer, Orion's Nubeqa with ADT for metastatic hormone-sensitive prostate cancer based on Ph3 ARANOTE results
Small molecule, cancer, androgen receptor inhibitor, prostate cancer, hormone-sensitive, combination therapy - Read more

Health Canada approves Merck & Co.'s KEYTRUDA (pembrolizumab), PD-1 inhibitor, for Stage III-IVA cervical cancer with chemoradiotherapy
Antibody, cancer, monoclonal antibody, cervical cancer, PD-1 inhibitor, combination therapy - Read more

THE GOOD
Business Development & Partnerships

Cycle Pharmaceuticals, Handa Therapeutics partner for U.S. commercialization of leukemia drug PHYRAGO (dasatinib)
Licensing deal, oncology, commercialization, US, leukemia, small molecule - Read more

Cycle Pharmaceuticals, LeMed Specialty Pharmacy partner for exclusive US distribution of HARLIKU™ for rare disease alkaptonuria
Distribution agreement, rare disease, small molecule, US, specialty pharmacy - Read more

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THE GOOD
Clinical Trials

AstraZeneca's Tagrisso-chemotherapy combo shows statistically significant survival benefit in Ph3 trial for EGFR-mutated lung cancer
Small molecule, cancer, EGFR inhibitor, non-small cell lung cancer, combination therapy, overall survival - Read more

Alkermes' orexin-targeting drug alixorexton achieves Ph2 success in narcolepsy type 1, advancing to Ph3 trials
Small molecule, neurological, orexin receptor agonist, narcolepsy, sleep disorder, clinical trials - Read more

AlzeCure's TRPV1 antagonist ACD440 meets Ph2 trial endpoints for peripheral neuropathic pain treatment
Small molecule, neurological, TRPV1 antagonist, neuropathic pain, topical therapy - Read more

Taran's lenzilumab shows promising Ph2/3 results for chronic myelomonocytic leukemia targeting inflammatory pathways
Monoclonal antibody, cancer, hematologic malignancy, chronic myelomonocytic leukemia, acute myeloid leukemia, combination therapy - Read more

Sun Pharma's ILUMYA meets Ph3 endpoints for psoriatic arthritis; IL-23 inhibitor shows efficacy in dual trials
Antibody, autoimmune, monoclonal antibody, psoriatic arthritis, IL-23 inhibitor, Phase 3 clinical trial - Read more

THE GOOD
Fundraises

Omega Funds raises $647M eighth fund, targeting innovative life sciences companies for unmet needs
Venture capital, life sciences, biotech investments, unmet medical needs, company creation - Read more

Drugs Made In America Acquisition II files for $500M SPAC IPO, targeting pharmaceutical companies
SPAC, pharmaceutical, investment vehicle - Read more

DiaMedica raises $30.1M private placement for preeclampsia and fetal growth restriction pipeline
Recombinant protein, preeclampsia, fetal growth restriction, clinical-stage, neurological, acute ischemic stroke - Read more

Ostia Sciences raises $1.46M seed funding for microbiome therapeutics and next-gen probiotics
Microbiome therapeutics, probiotics, oral health, clinical-stage, platform technology - Read more

Ribo Life Science raises ¥200M ($1.35M) private equity, advancing siRNA drug pipeline and R&D
siRNA, platform technology, RNA therapeutics, biotechnology, drug discovery, clinical-stage - Read more

THE GOOD
Investments

AstraZeneca commits $50B to US expansion, including $4B Virginia factory, as company emphasizes American presence
Cell therapy, strategic, manufacturing expansion, financial investment, US market growth - Read more

Biogen commits $2 billion to expand North Carolina production amid Trump's pharmaceutical tariff threats
Antisense oligonucleotide, strategic, operational, major investment, manufacturing expansion - Read more

THE GOOD
Mergers & Acquisitions

Concentra acquires struggling iTeos for $10.05 per share following TIGIT drug failure and planned wind-down
anti-TIGIT antibody, oncology, strategic, major transaction - Read more

THE GOOD
Regulatory

FDA appoints former La Jolla Pharmaceutical CEO George Tidmarsh to lead CDER
Regulatory leadership, operational, strategic - Read more

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THE BAD
Approvals & Labels

FDA rejects Roche's bid to expand Columvi for second-line lymphoma treatment due to insufficient US data
Bispecific antibody, oncology, regulatory, DLBCL, treatment expansion - Read more

THE BAD
Company Shutdown

Hookipa winds down after selling vaccine rights to Gilead for $10M upfront
Acquisition, infectious disease, vaccine, R&D, milestone payments - Read more

THE BAD
Clinical Trials

Roche's astegolimab fails Ph3 trial for chronic obstructive pulmonary disease, showing insufficient ST2-targeting efficacy
Antibody, respiratory disease, monoclonal antibody, COPD, IL-33 pathway, Phase III failure - Read more

THE BAD
Layoffs

GSK cuts 150 Massachusetts manufacturing jobs, transitions Cambridge site to R&D-only by 2026
Vaccine, operational, manufacturing consolidation, strategic, cost reduction - Read more

THE UGLY
Approvals & Labels

Sarepta pauses Elevidys shipments after FDA safety concerns, avoiding regulatory standoff
Gene therapy, rare disease, regulatory, operational - Read more

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

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