Delivers up-to-date industry news on topics like drug approvals, product recalls, company expansions and acquisitions, market trends for all OSD forms, as well as excipients, packaging and supply chain issues. Monitors market trends in specific drug categories as well as in supplements/nutraceuticals. Provides updates on clinical trials. Includes alerts about new or upcoming regulatory issues.
Months after agreeing to pay $2.2 billion to resolve Zantac product liability cases, GSK faces a class action lawsuit from investors.
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The San Francisco-based biotech has paused enrollment and dosing in a phase 2b trial of its lead candidate in patients with idiopathic pulmonary fibrosis.
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Axsome has resolved patent litigation related to Teva’s generic version of its top-selling tablet, Auvelity.
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Plant-based ingredients and excipients provider Roquette has launched a new and refreshed coatings platform for pharma and nutraceuticals.
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The San Diego-based biotech has raised $94.2 million to fund the development of its oral small molecule therapeutics for the treatment of metabolic diseases.
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Romvimza oral capsules will provide a new therapeutic option for a subset of patients with symptomatic tenosynovial giant cell tumor.
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The expansion of the Niederlenz facility will provide a dedicated space for customers to conduct trials and optimize their processes.
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Arcus announced that Gilead’s time-limited exclusive option rights to experimental oral small molecule, casdatifan, have expired.
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In a recent trial, dsm-firmenich’s solid CBD formulation showed comparable absorption results to a liquid oil-based reference product.
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FibroGen has sold its China subsidiary to long-time partner, AstraZeneca, for approximately $160 million.
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Cosette will acquire all the outstanding shares of the Australia-based women’s health and dermatology company for approximately $430 million.
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Dr. Patrizia Cavazzoni, who retired as director of CDER in January, will head back to Pfizer.
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The FDA has approved Mirum’s Ctexli tablets for the treatment of cerebrotendinous xanthomatosis, a rare, progressive and debilitating disease.
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An undisclosed buyer will pick up Zevra’s rare pediatric disease PRV obtained from the approval of Miplyffa for Niemann-Pick disease.
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The FDA has expanded the approval of Odactra tablets to include the treatment of house dust mite allergies in children ages five through 11 years.
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