BAYER AG

FDA accepted elinzanetant NDA for menopause VMS treatment, showing symptom reduction. Breast cancer linked to reproductive health factors in Caribbean women. Lower estradiol levels increase abdominal aortic calcification risk in postmenopausal women. Opioid dispensing decreased post-surgery among youths. Vaccinations have transformed public health, but hesitancy rises, emphasizing the need for combating misinformation.

Recursion's AI platform developed REC-1245, a drug for solid tumors and lymphoma, progressing from target to preclinical candidate in under 18 months. The drug selectively degrades RBM39, offering a new therapeutic approach for resistant tumors. Industry experts note the potential of AI in speeding up drug discovery timelines, though the impact on phase transition likelihood remains uncertain.

The FDA accepted a new drug application for elinzanetant, a non-hormonal treatment for moderate-to-severe vasomotor symptoms (VMS) related to menopause. Elinzanetant, a dual neurokinin-1 and 3 receptor antagonist, aims to modulate estrogen-sensitive neurons in the hypothalamus. Positive phase 3 study results support its efficacy and safety, offering a potential new treatment option for women experiencing VMS.

AstraZeneca to pay $2B to CSPC for a cardiovascular drug, Astellas Pharma licenses gene therapy from AviadoBio, Merck partners with Mestag Therapeutics for fibrosis treatments, Insitro signs three agreements with Eli Lilly for metabolic diseases, MiNK Therapeutics and Autonomous Therapeutics collaborate on metastatic tumors, Bayer and MOMA Therapeutics partner in oncology, Wonderskin names 5W Public Relations as AOR, Eversana signs with Oracle Argus Cloud, Qinotto and Eli Lilly collaborate, Onspire Health acquires Aesthetic Brand Marketing, Reunion Neuroscience partners with Seleni Institute, Danco Laboratories to seek FDA approval for Mifeprex use in miscarriages, Exact Sciences' Cologuard Plus wins FDA approval, Boehringer Ingelheim's survodutide gets Breakthrough Therapy designation, Lunds & Byerlys recalls Lone Star Dip, Kezar Life Sciences' zetomipzomib development halted by FDA, Bayer's elinzanetant NDA accepted by FDA, Biogen's felzartamab gets Breakthrough Therapy Designation, Black Diamond Therapeutics to cut jobs, Upstream Bio targets $182M for IPO, City Therapeutics launches with $135M, Purespring Therapeutics raises $105M, Judo Bio launches with $100M, Orasis Pharmaceuticals raises $78M, CAMP4 Therapeutics targets $67M for IPO, Basecamp Research closes $60M Series B, Arda Therapeutics raises $43M Series A, Crinetics Pharmaceuticals announces public offering, GSK to pay $2.2B to settle Zantac lawsuits, Scholar Rock's SMA drug shows muscle function improvement, CDC to screen travelers due to Marburg virus outbreak in Rwanda, Ad Council, AMA, and CDC launch flu vaccination campaign, Sage Therapeutics' Sage-718 fails in Alzheimer's study, WeightWatchers adds GLP-1 obesity treatments, Gritstone Bio files for Chapter 11, BioPharmCatalyst launches AI-powered chatbot Aiden, Otsuka Precision Health and Amalgam Rx launch Alzheimer's app Elevmi, PatientPoint unveils interactive communication solution, Curia rebrands, Switzerland's COMCO terminates Novartis investigation, Bluebird Bio's Skysona linked to blood cancer in seven children, Solera Health rebrands, HearingLife launches pickleball sweepstakes, Alfasigma launches Morpho brand, Healthy Minds Innovations launches Our World Of Emotions campaign.

The FDA accepted Bayer's NDA for elinzanetant, a non-hormonal treatment for menopause-related VMS. Supported by OASIS 1, 2, and 3 trials, elinzanetant showed efficacy in reducing VMS frequency and severity, improving sleep and quality of life, with a favorable safety profile. Approval could offer a new treatment option by July 2025.

Maven Clinic raises $125M in Series F, becoming the highest valued digital health company in women’s and family health. Other highlights include Levy securing $4.5M seed funding for fertility diagnosis, Rezilient Health raising $10M Series A for tech-enabled family healthcare, and Marlow securing $1.9M for a novel lubricated tampon product. Panasonic Well launches a Family Wellness Innovation Challenge with $1 million in equity-free prizes.

The global High Potency APIs (HPAPIs) market is projected to reach $46.9 Billion by 2030, driven by the expansion of oncology, hormonal, and endocrine therapies. Key factors include the rise in cancer diagnoses, targeted therapies, advancements in drug delivery, and the expansion of CMOs specializing in HPAPI production.

Recent acquisitions of cancer drug developers RayzeBio and Fusion Pharmaceuticals highlight radiotherapy's resurgence. Oncology sees advancements in genetics, immunology, AI, and personalized treatments. Funding remains robust, with potential for highest corporate rounds since 2021. Combination therapies and AI are crucial, with cancer vaccines and precision treatments offering hope. Despite challenges, progress in treating specific cancers has improved patient outcomes.

The precision medicine market is projected to grow from $75.2 billion in 2023 to $168.3 billion by 2032, driven by advancements in genomics, rising chronic disease prevalence, and personalized healthcare. Key trends include AI integration and companion diagnostics. Challenges like high costs and complex regulations offer opportunities for innovation. North America leads in market share, with Europe and Asia-Pacific also showing significant growth.

FDA accepts NDA for elinzanetant, a dual NK-1,3 receptor antagonist, for treating moderate to severe VMS in menopause. Positive phase 3 OASIS trials show elinzanetant reduces VMS frequency and severity, improves sleep and quality of life, with favorable safety data. Elinzanetant could offer a non-hormonal treatment option if approved.