Nubeqa is the first and only in the U.S. and FDA-approved androgen receptor inhibitor (ARi) for the treatment of patients with hormone-sensitive prostate cancer (mHSPC), in combination with androgen deprivation therapy (ADT), with or without chemotherapy This third approval is based on positive results from the pivotal Phase III ARANOTE trial and broadens the indication profile of darolutamide in mHSPC, enabling its use in... Read More

In FINE-HEART, the incidence for the primary endpoint of cardiovascular (CV) death was numerically lower in patients treated with finerenone versus placebo, but narrowly missed statistical significance FINE-HEART is a prespecified pooled analysis of all completed finerenone Phase III studies in around 19,000 high-risk patients across a broad range of cardio-kidney-metabolic (CKM) conditions FINE-HEART results indicate... Read More

Finerenone is the first mineralocorticoid receptor (MR) antagonist to demonstrate definitive cardiovascular benefits in a Phase III study in patients with heart failure (HF) with a left ventricular ejection fraction (LVEF) of ≥40%, i.e. mildly reduced or preserved LVEF Finerenone showed a 16% relative risk reduction of the composite primary endpoint of cardiovascular death and total (first and recurrent) heart failure events... Read More

Pivotal OASIS 1 and 2 Phase III studies of investigational compound elinzanetant achieved a statistically significant reduction in frequency and severity of vasomotor symptoms (VMS; also known as hot flashes) over 12 weeks compared to placebo Consistent benefits were also seen across both studies in all three key secondary endpoints, with significant reduction in frequency of VMS at week 1, improvement in sleep disturbances... Read More

Development of next-generation sequencing companion diagnostics (CDx) Goal is to help increase patient access to Bayer’s precision cancer therapies by offering decentralized genomic testing and rapid turnaround time BERLIN & CARLSBAD, Calif.--( BUSINESS WIRE )-- Bayer AG and Thermo Fisher Scientific Inc. today announced a collaboration to develop next-generation sequencing (NGS)-based companion diagnostic assays (CDx)... Read More

OASIS 3 study provides additional supporting efficacy data as well as long-term safety data of elinzanetant, complementing positive topline results of OASIS 1 and 2 studies Bayer will submit data from OASIS 1, 2 and 3 studies to health authorities for approval of marketing authorizations of elinzanetant for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause Elinzanetant is the first dual... Read More

OASIS 1 and 2 pivotal studies evaluating investigational compound elinzanetant met all primary endpoints demonstrating a statistically significant reduction in frequency and severity of moderate to severe vasomotor symptoms (VMS) compared to placebo in postmenopausal women Both studies also showed superiority over placebo for all key secondary endpoints with a statistically significant reduction in frequency of VMS at week... Read More

AB-1005 (AAV2-GDNF), an investigational gene therapy for the treatment of Parkinson’s disease, was well tolerated with no attributed serious adverse events in all 11 patients at 18 months 18-month assessment of all patients demonstrated feasibility of administration of AB-1005 to the putamen via one-time bilateral convection-enhanced delivery AskBio plans to present 18-month study data, including secondary endpoints, at a... Read More

Independent Data Monitoring Committee (IDMC) recommends stopping the OCEANIC-AF study due to an inferior efficacy of asundexian versus the control arm OCEANIC-AF is one trial which evaluates asundexian versus apixaban in patients with atrial fibrillation at risk for stroke within the overall OCEANIC phase III program IDMC recommends continuing the OCEANIC-STROKE phase III as planned Berlin, November 19, 2023 – OCEANIC-AF, a... Read More

Recommendation by Committee for Medicinal Products for Human Use (CHMP) based on positive results from PULSAR clinical trial in neovascular (wet) age-related macular degeneration (nAMD) and PHOTON trial in diabetic macular edema (DME) If approved by European Commission, aflibercept 8 mg will be the only drug providing extended treatment intervals of up to 5 months for patients with nAMD and DME Extended treatment intervals... Read More

New study includes patients aged ≥65 years with atrial fibrillation (AF) at high risk for ischemic stroke or systemic embolism who are deemed ineligible for oral anticoagulant (OAC) treatment due to increased risk of bleeding / OCEANIC-AFINA, the latest Phase III study in the OCEANIC clinical trial program, will investigate asundexian in this specific patient group OCEANIC-AFINA complements the ongoing OCEANIC-AF study,... Read More

Investigational VVD-130037 is highly specific, potent Kelch-like ECH Associated Protein 1 (KEAP1) activator developed for treatment of advanced solid tumors Major milestone for Vividion’s chemoproteomics innovative technology platform First-in-class clinical candidate to target cancers with activation of KEAP1-NRF2 pathway Berlin, Germany, San Diego, CA, USA, September 18, 2023 – Vividion Therapeutics, Inc. (Vividion),... Read More

Investigational cellular therapy, bemdaneprocel (BRT-DA01), was well tolerated with no major safety issues in all 12 participants in low dose and high dose cohorts through one year At one-year, exploratory clinical endpoints improved overall, with participants in the high dose cohort showing greater improvement One year assessment of all participants demonstrated feasibility of transplantation, cell survival, and engraftment... Read More

Leverkusen, August 21, 2023 – The Supervisory Board of Bayer AG has unanimously appointed Heike Prinz to Bayer’s Board of Management effective September 1, 2023. She will become the company’s Chief Talent Officer and Labor Director. This follows the mutual agreement by Board member Sarena Lin and Bayer’s Supervisory Board to not extend her contract beyond January 31, 2024. Heike Prinz (58), most recently Head of Commercial... Read More

Berlin, February 10, 2023 – The European Commission granted approval for a label extension for Kerendia ™ (finerenone) in the European Union (EU) to include results on cardiovascular (CV) outcomes from the Phase III FIGARO-DKD study. The study demonstrated that Kerendia reduced the risk of CV events in a broad population of patients with stages 1-4 CKD and T2D. The indication of Kerendia (10 mg or 20 mg), a non-steroidal,... Read More

Leverkusen, February 8, 2023 – The Supervisory Board of Bayer AG has appointed Bill Anderson to become CEO of Bayer, effective June 1, 2023. He will join Bayer as a member of the Board of Management on April 1, 2023. Bill Anderson was elected unanimously after a thorough selection process which began mid last year. Werner Baumann (60), current CEO of Bayer, will work closely with him on a smooth transition before retiring... Read More

Berlin, January 27, 2023 – The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended darolutamide, an oral androgen receptor inhibitor (ARi), plus ADT in combination with docetaxel for marketing authorization in the European Union (EU) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). Darolutamide is already approved under the brand name... Read More

Strong market uptake of Nubeqa™ and Kerendia™ Asundexian projected peak sales of more than five billion euros as treatment option for thrombosis and stroke prevention High-value late-stage development portfolio Positive study outcomes from cell & gene therapy pipeline would provide potential upside Shift of resources enhances commercialization and competitiveness Acquired arm’s length platform companies progress well and... Read More