BAYER AG

The CHMP recommended acoramidis, an orally administered TTR stabilizer, for EU marketing authorization in adult patients with ATTR-CM. Acoramidis showed near-complete TTR stabilization in vitro and benefits on cardiovascular endpoints in the Phase III ATTRibute-CM study. The CHMP's positive opinion offers hope for ATTR-CM patients, with a final EU decision expected soon. Bayer plans to launch acoramidis in Europe in early 2025.

Editas Medicine lays off 65% of staff, shelving its sickle cell disease treatment Reni-Cel; Ionis Pharmaceuticals shifts to in-house drug commercialization; GLP-1 drugs spark debate in Trump's circle; investors sue Bristol Myers Squibb over Padlock Therapeutics milestone payments.

Bayer AG gains EU regulator backing for acoramidis, an oral medicine treating transthyretin amyloidosis in cardiomyopathy patients. Acquired from BridgeBio Pharma for $310M, it aims to offset expiring patents of top-selling drugs. Approved by the FDA, Bayer plans to launch in Europe by H1 2025.

Larotrectinib (Vitrakvi) is highly effective in children with newly diagnosed infantile fibrosarcoma (IFS) or other solid tumors, according to a study by Children’s Hospital of Philadelphia and Children’s Oncology Group. The drug targets tumors with NTRK gene fusion without acquired resistance mutation, potentially reducing or eliminating the need for chemotherapy.

The global Duchenne muscular dystrophy market was valued at US$2.2 billion in 2023 and is projected to grow at a CAGR of 11.7% to reach US$7.4 billion by 2034, driven by advancements in gene therapy, novel treatment approvals, and increased awareness.

Bayer likely to launch heart drug Acoramidis in EU soon, CHMP recommends approval based on Phase III results. The drug treats ATTR-CM, showing positive impact on cardiovascular endpoints. Bayer acquired European marketing rights in March. Analysts estimate peak sales at EUR 260 million by 2030, aiding in offsetting declining sales of Xarelto.

The CRISPR and Cas gene market was valued at $3.3 billion in 2023, with a CAGR of 20.38% since 2018. It's projected to reach $8.8 billion by 2028 and $24.6 billion by 2033. Growth drivers include personalized medicine, genetic disorders, and synthetic biology. Challenges include regulatory complexities and healthcare access in developing countries. The market is segmented by type, application, product type, end use, and service type, with various segments showing significant growth potential. North America leads the market, but Asia-Pacific and Africa are expected to grow fastest. The market is dominated by large players like Danaher Corporation and Agilent Technologies Inc.

BridgeBio Pharma announced CHMP recommended EU approval of acoramidis for ATTR-CM, following Phase 3 ATTRibute-CM study results showing a 42% reduction in mortality and cardiovascular hospitalization events, and a 50% reduction in cumulative hospitalization events at Month 30. The drug was FDA-approved as Attruby™ in 2024, the first near-complete stabilization treatment for ATTR-CM in the US. Bayer plans to launch acoramidis in Europe in H1 2025.

CHMP recommended EU approval of acoramidis based on ATTRibute-CM Phase 3 study results, showing rapid benefits in ATTR-CM patients. Acoramidis, a near-complete TTR stabilizer, was FDA-approved as Attruby™ in 2024 for reducing cardiovascular death and hospitalization in ATTR-CM. European Commission approval expected soon, with Bayer planning a 2025 European launch.

The five-day Pre-Clinical Toxicology and Risk Assessment course at University of Hyderabad, organized by FABA, ASPIRE, and the university, advanced specialized training in India. It featured distinguished speakers, hands-on site visits, and sessions on emerging trends, addressing critical gaps in academic programs and industry readiness.