AstraZeneca

AstraZeneca and Sanofi's drug, Beyfortus, for preventing RSV in infants, received unanimous FDA advisory panel support. It's a single-dose, long-acting monoclonal antibody aimed at newborns and infants during their first RSV season. The panel also supported its use for children up to two years old. The drug is already approved in the U.K., EU, and Canada.

AI advancements are transforming drug discovery, with tools like AlphaFold2 enhancing protein-structure prediction. Biopharma firms are building AI capabilities through in-house expertise, acquisitions, and partnerships. Despite a decline in new AI-driven biotech companies, capital deployment has surged, with significant partnerships and some clinical trial successes. However, challenges in integration and competition persist, suggesting a future of increased M&A activity and a focus on unsaturated niches like RNA-based therapeutics.

Atezolizumab and bevacizumab showed improved recurrence-free survival in early-stage HCC in the phase 3 IMBrave050 trial, potentially changing treatment standards. The combination, previously approved for unresectable HCC, demonstrated a 78% 12-month RFS rate, up from 65% with surveillance, with safety consistent with known profiles.

NHS England secures a deal for olaparib, a targeted therapy for BRCA-mutated breast and prostate cancers, benefiting over 1,500 patients annually. Olaparib, developed by AstraZeneca, extends life expectancy and reduces cancer recurrence risk, marking a significant advancement in cancer treatment.

MitoRx Therapeutics appoints Christine Charman as Chief Development Officer, David Richardson as Finance Director, and four experts to its Scientific Advisory Board: Prof Chas Bountra, Prof Dame Kay Davies, Prof Laurent Servais, and Dr Bernd C Schwahn. These appointments aim to advance the company's mission to develop treatments for diseases caused by mitochondrial dysfunction.

The Type 1 Diabetes Market, valued at US$ 7.59 billion in 2022, is projected to grow to US$ 13.64 billion by 2030, with a CAGR of 7.6%. Treatment involves external insulin support, primarily through parenteral administration. The market is competitive, with major players investing in R&D for effective treatments. Key segments include devices, end-users, and products.

Evusheld's authorization was revoked by the FDA on January 26, 2023, due to inefficacy against newer COVID-19 variants. CDC recommends immunocompromised individuals follow prevention measures like masking and vaccination. AstraZeneca is developing a new antibody mix for broader variant neutralization, aiming for availability in late 2023.

FDA has paused AstraZeneca’s Evusheld for COVID-19 prevention in the US due to its ineffectiveness against prevalent SARS-CoV-2 variants. AstraZeneca is testing a new long-acting antibody, aiming for 2023 availability, to protect immunocompromised individuals against all tested variants.

FDA has temporarily revoked emergency use authorization for AstraZeneca's EVUSHELD for COVID-19 pre-exposure prophylaxis in the US due to its ineffectiveness against prevalent SARS-CoV-2 variants. AstraZeneca is developing a next-generation antibody, with trials underway, aiming for availability in late 2023. EVUSHELD remains authorized in other countries for COVID-19 prevention and treatment.

Evusheld, the only authorized COVID-19 preexposure prophylaxis, may not neutralize subvariant XBB.1.5, responsible for nearly 30% of cases, as per FDA. Efficacy against several dominant omicron subvariants remains undetermined. FDA advises healthcare providers to inform patients of increased risk with variants not neutralized by Evusheld.