BAYER AG

Illumina's TruSight Oncology Comprehensive, an FDA-approved IVD biomarker test kit, detects variants in 517 genes across nearly 30 solid tumor types, enabling personalized targeted therapies and faster treatment interventions within 4-5 days.

Roivant's Pulmovant launches with a plan to develop Bayer's mosliciguat for PH-ILD, with a deal worth up to $294 million. Phase 1b trial results showed sustained reduction in PVR, suggesting potential differentiation in efficacy, safety, and convenience. Pulmovant aims to start a phase 2 trial in 2026.

Transgene announces the appointment of Dr. Emmanuelle Dochy as Chief Medical Officer and Dr. Maurizio Ceppi as Chief Scientific Officer to advance cancer immunotherapies and precision medicine. Both appointees bring extensive experience in oncology and clinical development. Dr. Dochy succeeds Dr. Maud Brandely, and Dr. Ceppi succeeds Eric Quéméneur, who are both retiring or pursuing other interests. The new leadership positions Transgene to deliver innovative treatments to cancer patients.

Various drugs and their statuses are listed, including IN-001 for anaphylaxis (Fast Track), Finereonone for heart failure (Phase 3), Tirzepatide for heart failure and obesity (Phase 3), TMB-001 for congenital ichthyosis (Phase 3), Bentracimab for ticagrelor reversal (Priority Review), Fabhalta for immunoglobulin A nephropathy (accelerated approval), RLS-0071 for acute graft-vs-host disease (Fast Track and Orphan Drug), CHIKV VLP for chikungunya (Priority Review), Diazoxide choline for Prader-Willi syndrome (Priority Review), Mirdametinib for neurofibromatosis type 1 (Priority Review), Setmelanotide for genetic obesity (Priority Review), AR882 for gout (Fast Track), SPN-830 for Parkinson disease (NDA review), BGB-16673 for chronic lymphocytic leukemia (Fast Track), Cabozantinib for neuroendocrine tumors (NDA review), Linvoseltamab for multiple myeloma (Complete Response Letter), Nivolumab plus ipilimumab for hepatocellular carcinoma (BLA review), Midomafetamine for PTSD (Complete Response Letter), and Tezepelumab-ekko for COPD (Breakthrough Therapy).

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Bayer presents Phase III study OASIS 3 results for elinzanetant at The Menopause Society 2024 annual meeting, showing sustained efficacy and safety over 52 weeks.

HAYA Therapeutics, a biotech company in Switzerland and San Diego, collaborates with Eli Lilly to develop weight-loss drugs targeting RNA. The partnership leverages HAYA's RNA-guided genome platform for preclinical drug discovery, aiming to create more effective and safer treatments for obesity.

Bayer introduces Age Factor ecosystem combining a dietary supplement, wellness app, and Chronomics' saliva-based biological age test to support healthy ageing, addressing consumer needs from awareness to action with a science-led approach.

Bayer announced positive results from the phase I/II SOHO-01 study on BAY 2927088, an oral TKI for HER2-mutant NSCLC, showing a 72.1% ORR and manageable safety profile. The EU also approved Eylea 8mg for nAMD and DME, extending treatment intervals up to five months. Bayer aims to strengthen its pharma portfolio through label expansions and new drug development, despite recent stock declines.

Roivant Sciences launched Pulmovant, focusing on mosliciguat for pulmonary hypertension with interstitial lung disease, in a $14M upfront deal with Bayer for worldwide rights, aiming for potential approval via a single registrational trial. Mosliciguat, an inhaled sGC activator, showed significant reductions in pulmonary vascular resistance in early studies, with a 40-hour half-life for practical dosing.