Biogen

Australia's TGA won't approve Eisai and Biogen's Alzheimer's therapy Leqembi, citing insufficient efficacy and safety risks like ARIA. Eisai Australia plans to request a reconsideration. Leqembi is already approved in the US, Japan, China, and other countries.

GITEX GLOBAL's GITEX DIGI_HEALTH 5.0 Dubai showcased AI-driven health tech solutions, aligning with UAE's digital health market growth to $487.30 million. Focus areas included AI in healthcare, robotics, genomics, and neurology advancements, with innovations like smart contact lenses and AI-powered clinical assistants. The event also announced GITEX DIGI_HEALTH 5.0 Expo-Summit in Thailand in 2025.

Concerns over Alzheimer’s drug donanemab (Kisunla) approval include lack of transparency, underreporting of side effects, and advisory panel replacements. Critics argue for stricter FDA oversight and caution against industry influence on patient advocacy groups.

AstraZeneca's Farxiga, initially approved for type 2 diabetes, has exceeded $6 billion in sales and is projected to reach $7.4 billion next year. Success factors include addressing unmet needs, clear value propositions, and strategic market access. Farxiga expanded its indications to chronic kidney disease and heart failure, driving sales. Keytruda exemplifies a blockbuster drug with multiple indications. Market access strategies and pricing considerations are crucial for drug commercialization. The definition of a blockbuster is evolving, focusing on high-value drugs that justify R&D investments.

Nodenza Venture Partners launched to support early-stage and pre-commercial biotech & medtech companies, focusing on disruptive technologies and therapies with potential for exceptional patient benefits. The team, led by Ross Morton, combines expertise in drug development and commercialization to invest in 3-4 opportunities in the first year.

Tau Inhibitors Clinical Trial Pipeline Analysis shows 25+ key companies expected to transform treatment, with increased funding accelerating advancements in neurodegenerative disease therapies.

Roche's SMA drug Evrysdi helped pre-symptomatic babies reach milestones in a Phase II trial, with all 26 children able to swallow and feed orally after two years, contrasting untreated Type 1 SMA. Cognitive development was comparable to non-SMA babies. Evrysdi, an oral SMN2 splicing modifier, was approved by the FDA in 2022 and generated CHF 1.4bn in 2023, with projections of $2.8bn by 2030, surpassing Biogen's Spinraza due to its oral delivery.

Roche's SMA drug Evrysdi helped pre-symptomatic babies reach milestones in a Phase II trial, with all 26 children able to swallow and feed orally without permanent ventilation after two years. Cognitive development was comparable to non-SMA babies. Evrysdi, an oral SMN2 splicing modifier, was approved by the FDA in 2022 and generated CHF 1.4bn in 2023, with projections of $2.8bn by 2030.

Pfizer withdrew Oxbryta from global markets due to increased risk of death, joining other drugs like Aduhelm, Exkivity, Ukoniq, and Zydelig that were approved under the FDA's accelerated pathway but later withdrawn. The pathway, implemented in 1992, has helped bring nearly 300 drugs to market but faces scrutiny over delayed confirmatory trials and surrogate endpoints. Sarepta's Elevidys is an exception, securing full approval despite missing primary efficacy endpoints.

Samsung Bioepis wins Asia-Pacific Company of the Year at 2024 Global Generics & Biosimilars Awards for the third consecutive year. The company achieved milestones in 2024, including approvals for biosimilars Pyzchiva and Epysqli, and a robust portfolio of 11 biosimilar products.