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FDA expands Pfizer and Astellas' Padcev (enfortumab vedotin-ejfv) plus Merck & Co.'s Keytruda (pembrolizumab) label to all muscle-invasive bladder cancer patients regardless of cisplatin eligibility
Antibody, cancer, antibody-drug conjugate, bladder cancer, PD-1 inhibitor, perioperative treatment - Read more

Roche's Columvi (glofitamab) combination backed by SMC for second-line relapsed or refractory diffuse large B-cell lymphoma in Scotland
Antibody, cancer, bispecific antibody, diffuse large B-cell lymphoma, combination therapy, relapsed or refractory - Read more

SMC recommends Astellas's VEOZA (fezolinetant) targeting neurokinin B for moderate to severe menopausal vasomotor symptoms
Small molecule, metabolic/hormonal, neurokinin B antagonist, vasomotor symptoms, menopause - Read more

Health Canada approves CLINUVEL's Scenesse (afamelanotide) for erythropoietic protoporphyria phototoxicity prevention
Protein therapy, metabolic, peptide therapy, erythropoietic protoporphyria, melanocortin receptor agonist, photoprotection - Read more

Managing investigator grants across large portfolios isn't just a tracking problem — it's a trial oversight issue. Limited visibility into site and procedural-level liabilities makes it nearly impossible to accurately forecast investigator expenses, which can exceed 50% of a trial's budget. Incorrect billing and surprise invoices follow. 

The good news: sponsors already have the data they need to get this under control. 

Join Auxilius on July 29th at 10am ET to learn how leading pharma and biotech teams are managing investigator spend using data they already have, building data taxonomies to organize and harmonize it, and using automation to operate at scale.

Register here

Bayer, Apollo strike €3B ($3.43B) equity deal for minority stake in LARC contraceptives business
Equity investment, contraceptives, women's health, minority stake - Read more

CMS, Insilico partner on AI-driven CNS drug discovery, $177M milestones
Research collaboration, neurological, AI/ML, milestone payments, royalties - Read more

Antengene, UCB close worldwide exclusive license for ATG-201, $60M upfront, $20M near-term milestones
Licensing deal, autoimmune, antibody, milestone payments, royalties - Read more

Santhera Pharmaceuticals, Biomedica expand AGAMREE distribution agreement to five Central Asian and Caucasus markets
Distribution agreement, rare disease, small molecule, commercialization - Read more

Eisai's etalanetug reduces plasma tau tangle biomarker eMTBR-tau243 in Ph1b/2 dominantly inherited Alzheimer's disease trial
Antibody, neurological, monoclonal antibody, Alzheimer's disease, tau protein, biomarker - Read more

Eisai, BioArctic's Leqembi (lecanemab) subcutaneous autoinjector shows comparable efficacy, safety to intravenous formulation in early Alzheimer's disease
Antibody, neurological, monoclonal antibody, Alzheimer's disease, amyloid clearance, subcutaneous administration - Read more

Hemab Therapeutics presents Ph1/Ph2 HMB-002 (unnamed) data showing proof of mechanism in Von Willebrand disease
Protein therapy, hematological disorders, Von Willebrand disease, antifibrinolytic, heavy menstrual bleeding, VWF/FVIII - Read more

Apnimed plans IPO to fund commercial launch of FDA-pending sleep apnea pill
Sleep apnea, small molecule, clinical-stage, neurology - Read more

LeoMab receives CHF 40,000 ($49.5K) Venture Kick Stage 2 funding to advance safer stem cell transplantation
Biologics, stem cell transplantation, gene therapy, preclinical - Read more

VeloGene Biotechnology closes Series A, expanding tetraploid complementation platform for gene-edited mice
Platform technology, preclinical, gene editing, CRO, drug development - Read more

Neothera raises $1.1M pre-seed, advancing skin health and dermatology startup in India
Dermatology, digital health, skincare, clinical-stage - Read more

Do you offer a biotech/pharma-focused product or service?

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FDA rejects Hengrui, Elevar Therapeutics' (camrelizumab)+(rivoceranib) combo for hepatocellular carcinoma a third time
Small molecule, cancer, antibody, hepatocellular carcinoma, PD-1 inhibitor, VEGFR inhibitor - Read more

Germany passes healthcare cost-saving law, doubling pharma rebate rate to 15.5% despite industry opposition
Pharmaceutical pricing, healthcare policy, cost reduction, financial, competitive - Read more

FDA posts new rejection letters days after confirming pause on CRL public disclosures
Monoclonal antibody, oncology, regulatory, operational - Read more

Agenus scraps Ph3 colorectal cancer Battman study, pivots to Ph3 Robbin trial in colon cancer with (botensilimab)+(balstilimab)
Antibody, cancer, monoclonal antibody, colorectal cancer, CTLA-4 inhibitor, PD-1 inhibitor - Read more

AB Science terminates Ph2/Ph3 (masitinib) trials in mast cell activation syndrome, mastocytosis, and progressive multiple sclerosis
Small molecule, autoimmune, tyrosine kinase inhibitor, multiple sclerosis, mastocytosis, mast cell activation syndrome - Read more

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