Biogen

Lupus disproportionately affects racial and ethnic minorities, yet they're underrepresented in clinical trials. LuCIN aims to bridge this gap by enhancing diversity through investigator and research staff engagement, addressing barriers like socioeconomic factors and mistrust, and promoting culturally appropriate communication and education.

JFK, PL, CCW, TYW, XZ, PMW, SL, LB, ZH, SF, KWC, KR, and SS have various consulting roles, advisory board memberships, or research support from numerous pharmaceutical and medical technology companies.

The global multiple sclerosis (MS) diagnosis and treatment market, valued at USD 22.14 billion in 2023, is projected to reach USD 28.48 billion by 2031. North America led with a 38.3% market share in 2023, driven by advanced healthcare and R&D. Asia Pacific is expected to grow rapidly, with a 7% CAGR. Relapse-Remitting MS dominated the market, accounting for over 70% share. Medications held 81% of the treatment segment. Innovations and high R&D investments are fueling market growth, despite challenges like high drug costs.

The global biotechnology market, valued at USD 1.55 trillion in 2024, is projected to reach USD 4.61 trillion by 2034, growing at a CAGR of 11.5%. North America led with a 37.79% revenue share in 2023, driven by strong R&D and healthcare spending. Asia-Pacific is expected to grow at over 12.4%, supported by healthcare improvements and government regulations. Key growth factors include technological advancements, rising disease prevalence, and increased R&D investments. Bio-pharmacy dominates the market, with bio-informatics expected to grow rapidly. Tissue engineering and regeneration lead in technology, with chromatography growing fastest.

Novo Nordisk launches Wegovy® in Australia for weight loss. Xbrane regains certolizumab biosimilar rights. BMS’ Opdivo® gains new NSCLC indication in Australia. Teva’s Q2 revenue grows 7%. Celltrion’s ustekinumab biosimilar approved in Canada. Zydus’ trastuzumab biosimilar approved in Mexico. PBAC agenda includes denosumab & ustekinumab biosimilars. UPC hears omalizumab patent dispute. Biogen’s Leqembi® shows Alzheimer’s benefits. Samsung Bioepis revokes Janssen’s Stelara® patent in UK. Bio-Thera/Sandoz’s bevacizumab biosimilar approved in EU. Roche’s Vabysmo® approved for RVO in EU. FDA approves J&J’s Darzalex Faspro® for multiple myeloma. Formycon’s pembrolizumab biosimilar enters Phase III. US indicts for counterfeit cancer drugs. Roche’s Vabysmo® approved for RVO in Canada. NICE against trastuzumab deruxtecan for HER2-low breast cancer. Amgen’s Xgeva® PFS approved in Korea. FDA alerts on compounded semaglutide imitations. Regeneron disclaims aflibercept patent after adverse IPR decision.

The global biotechnology market is projected to grow from USD 1.38 trillion in 2023 to USD 4.25 trillion by 2033, at a CAGR of 11.8%. Growth is driven by chronic disease prevalence, personalized medicine, and R&D. North America leads with a 37.79% market share in 2023, followed by Asia Pacific at 23.99%. Key applications include bio-pharmacy, which dominated in 2023, and technologies like tissue engineering and regeneration.

Sage Therapeutics and Biogen announce topline results from Phase 2 KINETIC 2 study of SAGE-324 (BIIB124) for essential tremor, showing no statistically significant dose-response relationship on primary endpoint. No further clinical development planned for SAGE-324 in essential tremor.

Bio-Thera's BAT2206, a biosimilar to Stelara®, has its BLA accepted by the FDA and MAA by the EMA, marking a milestone as the first ustekinumab biosimilar from a Chinese company submitted for approval in the US and EU. The applications are supported by comprehensive analytical, non-clinical, and clinical data.

The biosimilars market is expanding, with the global market projected to hit $43.8 billion by 2024 and exceed $100 billion in a decade. Recent FDA and EMA approvals include biosimilars for Johnson & Johnson’s Stelara and Bayer’s Eylea, following patent expirations. Notable approvals include Pyzchiva, Ahzantive, Yesafily, Opuviz, Hercessi, Selarsdi, Wyost, Jubbonti, Simlandi, and Uzpruvo, targeting various conditions and expected to launch by 2025.

Eli Lilly's Alzheimer's drug, Kisunla, received FDA approval, expected to generate billions. However, the stock didn't surge as the approval was already priced in. The company's focus and investor excitement are more on its GLP-1 treatments for obesity and diabetes, indicating future growth potential beyond Kisunla.