GlobalData's AI Tool Predicts Pharmaceutical Drug Approvals with 85 Percent Success Rate
GlobalData’s enhanced AI-powered Likelihood of Approval (LoA) model boosts its predictive power, providing probability of a drug receiving market authorisation.
Trump's 100 Percent Pharma Tariff to Have Twofold Impact on Indian Drugmakers
The proposed tariffs target only branded and patented medicines, leaving India’s generic exports largely unaffected. While companies making branded drugs for the US may face challenges, domestic generic producers could benefit from increased demand for affordable alternatives.
Moderna Opens mRNA Vaccine Manufacturing Facility in the UK
The Moderna Innovation and Technology Centre (MITC) has officially opened at the Harwell Science and Innovation Campus in Oxfordshire, becoming the UK’s first facility to manufacture an onshore supply of mRNA vaccines.
French Court Orders Sanofi to Pay Euro 177 Million for Anti-Competitive Practices Over Plavix
A French court has ordered Sanofi to pay 177 million euro after ruling that the company engaged in anti-competitive behaviour to protect sales of its blockbuster blood thinner, Plavix. The decision follows a long-running investigation into allegations that Sanofi misled doctors and pharmacists about the safety of generic versions of the drug.
Copan Diagnostics Invests USD 7 Million to Expand US Manufacturing Footprint
Copan Diagnostics, part of the privately held Italy-based Copan Group, has announced more than USD 7 million in new US manufacturing investments across its facilities in California and Puerto Rico.
US FDA Grants Priority Review for Enhertu + Pertuzumab in HER2+ Metastatic Breast Cancer
The US FDA has granted Priority Review to Enhertu + Pertuzumab for HER2+ metastatic breast cancer, following DESTINY-Breast09 trial results showing a 44 percent reduction in risk of disease progression or death and over three years’ median Progression-Free Survival (PFS), positioning it as a potential new first-line standard of care.
Alembic Wins USFDA Clearance for Paroxetine ER Tablets for Depression and Anxiety Disorders
Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Paroxetine Extended-Release Tablets USP, 25 mg and 37.5 mg.
Lupin Receives Tentative Approval from US FDA for its HIV treatment tablets
Lupin has received tentative US FDA approval for Bictegravir, Emtricitabine and Tenofovir Alafenamide Tablets to treat HIV, bioequivalent to Gilead’s Biktarvy, for adults and paediatric patients over 25 kg.
Glenmark Secures USD 1.0 Billion Licensing Deal for Next-Gen Cancer Drug with Chinese Partner
Under the terms of the deal, Glenmark will make an upfront payment of USD 18 million and may pay up to USD 1.093 billion in regulatory and commercial milestone payments, in addition to royalties tied to future sales.
Bartronics India Invests INR 50 Crore in Huwel Life Sciences to Advance Affordable Diagnostics
Under the MoU, Bartronics India will acquire a 15 percent equity stake in Huwel Life Sciences, with an option to increase its equity stake by an additional 15 percent.
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