BAYER AG

FDA approved zolbetuximab-clzb (Vylov) plus chemotherapy for HER2-negative, CLDN18.2-positive gastric/GEJ adenocarcinoma, addressing unmet need in PD-L1–low/HER2-negative patients. Routine CLDN18.2 testing is crucial for targeted therapy in previously non-targetable populations.

Attruby, the first FDA-approved near-complete TTR stabilizer, reduces cardiovascular death and hospitalizations in ATTR-CM patients, with rapid benefits seen in as few as 3 months. BridgeBio will provide Attruby free for life to U.S. clinical trial participants and offers extensive access programs.

FDA approves BridgeBio Pharma's Attruby (acoramidis) for transthyretin amyloidosis cardiomyopathy, priced at $244,000 annually. The approval positions ATTR cardiomyopathy as a commercial battleground, with Pfizer's tafamidis and Alnylam's vutrisirian as competitors. BridgeBio aims for a 30% market share and plans a head-to-head trial against tafamidis.

Drug Store News and The CPG Guys announce Total Store Awards recipients at the 26th annual Issue Summit on Dec. 4 in NYC. Categories include Best AI-Enabled Digital Customer Experience (Ulta), Cross-Functional Leadership in Health & Wellness (Wakefern), Best OTC Omnichannel Product Launch (Amazon and Bayer), Best Marketing Merchandising Collaboration in Consumer Engagement (CVS Health), Best Retailer Consumer Wellness Program (Walmart), Best Brand Loyalty-Enabled Retail Media Platform (Kroger Precision Marketing), and Best Full Funnel Media Platform (Walgreens). The event features leading retailer executives discussing emerging care models and AI-driven healthcare with keynote by Ethan Mollick.

BridgeBio's Attruby, an orally-administered near-complete stabilizer of Transthyretin, received FDA approval for treating ATTR-CM, reducing cardiovascular death and hospitalization. Based on the ATTRibute-CM Phase 3 study, Attruby mimics a natural 'rescue mutation' to stabilize TTR, preserving its function and improving outcomes. BridgeBio submitted a Marketing Authorization Application to the EMA, with a decision expected in 2025, and granted Bayer exclusive rights to commercialize acoramidis in Europe.

The FDA's medical device center launched a pilot program to expedite public notices about high-risk product recalls, aiming to improve transparency and reduce notification time. The program focuses on cardiovascular, gastrorenal, general hospital, obstetrics and gynecology, and urology devices, without affecting other recall processes. This initiative follows public scrutiny over recent high-profile recalls and criticism of the FDA's recall process.

BridgeBio Pharma's Attruby™ (acoramidis) approved by FDA for ATTR-CM, reducing cardiovascular death and hospitalization by 42% at 30 months, with rapid benefits within 3 months and 50% reduction in cardiovascular-related hospitalizations. Attruby is the first near-complete TTR stabilizer (≥90%) preserving native TTR function.

The premature ejaculation treatment market is projected to grow by USD 1.46 billion from 2024-2028, driven by high efficacy of off-label drugs and nanotechnology advancements. Key players include A. Menarini, Absorption Pharmaceuticals, Alembic Pharmaceuticals, and others. Challenges include side effects and pandemic-related access issues, with AI and telemedicine offering potential solutions.

FDA accepted a sNDA for darolutamide (Nubeqa) plus ADT for metastatic hormone-sensitive prostate cancer (mHSPC), supported by ARANOTE trial data showing superior radiographic progression-free survival (rPFS) compared to placebo plus ADT. If approved, this would expand darolutamide's indication in mHSPC, offering an additional treatment option.

The Antihistamine Drugs Market is projected to grow from USD 279.74 million in 2024 to USD 381.39 million by 2030, driven by rising allergies, a growing geriatric population, and innovations in drug formulation. Key players include Johnson & Johnson, Sanofi, Pfizer, and Bayer. Challenges include market saturation, side effects, and stringent regulations.