AstraZeneca

FDA revoked EUA for Evusheld (tixagevimab co-packaged with cilgavimab) on Nov 21, 2024, as all lots expired and non-susceptible variants frequency exceeded 90% in the U.S.

The ZEST trial, evaluating niraparib for breast cancer recurrence prevention, was terminated early due to low ctDNA detection post-treatment. Lessons include starting ctDNA testing during treatment and focusing on high-risk patients for future trials.

The Breakthrough Therapies Market was valued at USD 150.6B in 2024, projected to reach USD 287.5B by 2029, growing at a CAGR of 13.80%. The report analyzes BTD's risks, benefits, fast-track drug development, therapy areas, leading companies, and market dynamics.

The Global Antimicrobial Peptides Market is projected to grow from US$223.90 Mn in 2023 to US$532.02 Mn by 2031, driven by biotechnology advances and health awareness. Key players include Novozymes A/S, Pfizer Inc., and GlaxoSmithKline plc. Challenges include stringent regulations and microbial resistance.

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.

In early December, the FDA approved Bizengri for advanced NRG1 fusion-positive NSCLC and pancreatic cancer, and expanded Imfinzi's use to treat limited-stage SCLC after chemotherapy and radiation, marking significant advancements in lung cancer treatment.

Ionis Pharmaceuticals awaits FDA decision on olezarsen by Dec. 19, a therapy for familial chylomicronemia syndrome with potential for broader use. CEO Brett Monia shifted strategy to develop drugs independently, aiming to maximize value for both company and patients.

AstraZeneca and Merck's OlympiA trial showed Lynparza (olaparib) improved overall survival, invasive disease-free survival, and distant disease-free survival for germline BRCA-mutated HER2-negative high-risk early breast cancer patients. The benefits persisted after six years, with Lynparza reducing death risk by 28% and maintaining a favorable safety profile. Lynparza is approved in multiple countries for this indication.

aTyr Pharma appoints Eric Benevich to its Board of Directors, effective December 10, 2024. Benevich, currently Chief Commercial Officer at Neurocrine Biosciences, brings over 30 years of pharmaceutical commercial experience. aTyr is a clinical-stage biotech focused on tRNA synthetase biology for fibrosis and inflammation therapies.

Hosts discuss PARASOL Initiative's efforts to establish surrogate endpoints for FSGS trials, focusing on proteinuria as a robust predictor of kidney failure, potentially enabling smaller, faster trials.