AstraZeneca

Ascentage Pharma announced that APG-2449, a FAK/ALK/ROS1 TKI, has been cleared by China's NMPA to enter two Phase III studies for NSCLC patients resistant to or naïve to ALK TKIs. APG-2449 showed preliminary efficacy and safety, with potential to inhibit brain metastases, addressing unmet needs in NSCLC treatment.

AstraZeneca and Avillion's phase 3b trial of Airsupra (albuterol/budesonide) showed significant reduction in asthma exacerbations, meeting primary endpoint. Safety and tolerability consistent with established profile. Airsupra is the first anti-inflammatory rescue medication approved in the US for asthma patients aged 18 and older.

The FDA approved a self-administered nasal flu vaccine, FluMist, for adults 18-49 and children 2-17 with caregiver assistance, available online. This follows the CDC's recommendation for nasal flu sprays in children. Researchers anticipate more vaccines in nasal form, including for Alzheimer's and heart rhythms, due to superior airway immunity.

Scholar Rock shares surged 319% on positive phase III data for apitegromab in spinal muscular atrophy. Astrazeneca acquired a preclinical Lp(a) disruptor from CSPC for up to $2B. The 2024 Nobel Prize in Physiology or Medicine was awarded for the discovery of microRNA. PBMs' private labels in biosimilars raise antitrust concerns. Judo Bio showcased its kidney-targeted siRNA platform at OTS. Astellas' Claus Zieler predicts gene and cell therapies will drive innovation. Novo Nordisk plans to launch Wegovy in South Korea in mid-October.

Michael, with 16+ years in writing/editing, covers cardiology, radiology, AI, and other healthcare topics.

Airsupra (albuterol/budesonide) significantly reduced severe asthma exacerbations in patients with intermittent or mild persistent asthma compared to albuterol alone, according to the Phase IIIb BATURA trial. The FDA approved Airsupra in January 2023 for as-needed treatment to prevent bronchoconstriction and reduce exacerbation risk in asthma patients aged 18 and older.

Albuterol/budesonide (Airsupra) significantly reduced severe asthma exacerbations in intermittent or mild persistent asthma patients in the BATURA trial, demonstrating a 27% reduction compared to albuterol alone. The combination addresses both symptoms and inflammation, reducing the need for systemic corticosteroids and offering a first-in-class rescue treatment.

New UK-created cancer therapies to be trialled, benefiting NHS patients through partnerships with pharmaceutical companies and universities. Innovations include AI for early cancer detection and flexible medical scanners, aiming to transform treatment and boost the UK's life sciences industry.

Oncolytics Biotech seeks accelerated approval for pelareorep, its lead cancer therapy, based on positive Phase II BRACELET-1 trial data. A registrational Phase II trial is planned for 2025, evaluating pelareorep combined with paclitaxel in breast cancer patients. Oncolytics' stock rose 18.22% on the news, reflecting investor optimism. Oncolytic virus therapies are projected to see significant growth, from $114m in 2023 to $2.4bn by 2029.

The drug and biotech industry thrives on M&A, new drug launches, and pipeline successes, with obesity drugs from Novo Nordisk and Eli Lilly leading. Large drugmakers like Eli Lilly, AstraZeneca, Pfizer, Sanofi, and Bayer are profitable and innovative, focusing on areas like weight loss, inflammation, and Alzheimer’s. Despite headwinds such as pipeline setbacks and macroeconomic uncertainty, investment in drug/biotech stocks has surged. The Zacks Large Cap Pharmaceuticals industry ranks in the top 19% of Zacks industries, outperforming the Zacks Medical Sector but slightly underperforming the S&P 500.