GlaxoSmithKline

Senator Bill Cassidy urges FDA to clarify Orange Book patent listing requirements for drug delivery devices, criticizing FDA's inaction amidst FTC enforcement against improper listings, which creates confusion for drugmakers and generic drugmakers.

Alembic Pharmaceuticals shares rose 4% on Oct 3 after receiving US FDA approval for Lamotrigine Extended-Release Tablets, a generic version of GlaxoSmithKline's Lamictal XR. The shares have jumped 56% over the past 12 months, outperforming the Nifty 50 index.

The European Commission approves Ipsen's IQIRVO (elafibranor) for primary biliary cholangitis, the first new therapy in the EU in a decade. Other companies, including CymaBay, Zydus, and GlaxoSmithKline, are preparing to enter the market. The approval is based on the Phase III ELATIVE trial, showing a 47% clinical benefit of IQIRVO combined with UDCA. Additionally, Gilead Sciences' LIVDELZI (seladelpar) received FDA accelerated approval for PBC.

Biopharma 4.0 and 5.0 represent digitalization and human-machine collaboration in biomanufacturing, respectively. Industry 5.0 emphasizes sustainability, societal needs, and human-centric production, contrasting with Industry 4.0's focus on efficiency and productivity. The Center for Process Innovation supports Industry 5.0 through community building and data-driven decision-making, aiming to balance profitability with environmental and societal benefits.

Harvard-MGB identified 10 urgent healthcare priorities: integrated disease understanding, accurate data, underserved care, early detection, antibiotic resistance, aging population, systems integration, data-driven care, sensitive biomarkers, and precision medicine. These reflect healthcare's evolution to address modern challenges.

WuXi AppTec’s Dr Dave Madge predicts peptide-based radiotherapeutics could surpass antibody-based counterparts due to advantages like tissue penetration and low toxicity. Despite only two antibody-based radiopharmaceuticals being FDA-approved, the radiopharmaceutical space has seen significant deals, with theranostic radiopharmaceuticals combining diagnostics and therapy gaining traction. WuXi’s expansion in peptide manufacturing aims to meet global demand, but potential restrictions from the US BIOSECURE Act pose a challenge.

Asia is rapidly becoming a biomanufacturing powerhouse, with countries like China, Singapore, South Korea, and India leading the charge. These nations are investing heavily in infrastructure, fostering innovation, and improving regulatory environments to attract global biopharma investments. The Asia Pacific biopharmaceuticals market is projected to grow significantly, driven by government support, skilled workforce development, and strategic partnerships. Key initiatives include Singapore's BioPIPS, South Korea's Bio-Health Industry Promotion Plan, Australia's RNA Sector Development Plan, and India's BioE3 Policy, all aimed at enhancing biomanufacturing capabilities and positioning Asia as a global leader in the biopharma industry.

Scope of Things covers a Graves’ disease trial, diagnostic tampon recruitment, Walgreens-BARDA partnership, AI aiding trial diversity, and exclusions in cancer studies.

Precision Medicine Group appoints Margaret Keegan as CEO, succeeding Mark Clein who becomes Executive Chairman. Co-founders Clein and Ethan Leder remain on the Board. Precision, founded in 2012, specializes in drug development and commercialization services.

S.B., A.D., T.J.F., I.M.G., L.G., R.K.J., G.K., J.M.L., G.V.L., K.P.-J., H.I.S., J.T., R.R.W., M.W., Y.L.W. have disclosed various financial interests, including funding, advisory roles, patents, and equity. C.M.B., E.B., M.W.B., and K.P. declare no competing interests.