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.
Phase 2 data in hand, Alkermes will pursue “rapid initiation” of a phase 3 program for its OX2R agonist, alixorexton, in patients with narcolepsy type 1.
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FDA commissioner Makary has tapped former biotech exec George Tidmarsh to lead one of the agency's largest divisions.
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Sanofi has finalized its deal to buy the rare disease specialist, picking up an approved drug for systemic mastocytosis.
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The Bristol Myers Squibb-Pfizer Alliance will offer a new direct-to-patient option for purchasing Eliquis.
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AstraZeneca picked up the asset through its $1.3 billion acquisition of CinCor in January 2023.
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Ekterly's approval comes shortly after the drug got the nod from the U.S. FDA.
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The phase 3 trials will evaluate MK-8527, an investigational once-monthly, oral nucleoside reverse transcriptase translocation inhibitor for HIV pre-exposure prophylaxis.
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The cost-saving initiative will expand access to Contrave, Currax’s branded oral non-GLP-1 weight loss medication.
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Novartis says it plans to introduce the infant-friendly treatment on a largely not-for-profit basis in areas where malaria is endemic.
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The approval comes after rumors swirled that agency head Marty Makary initially directed staff members to issue a complete response letter.
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Torrent will buy KKR’s 46.39% equity stake in J. B. Chemicals and Pharmaceuticals in a deal worth roughly $1.38 billion.
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Zegfrovy is the only approved targeted oral treatment for NSCLC with EGFR exon20ins.
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The study highlights how AI tools like ChatGPT are shaping reputation and consumer perception of OTC brands.
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The MEAI-based oral candidate is a novel psychoactive aminoindane derivative that exerts a euphoric, alcohol-like experience.
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According to the company, a third-party manufacturing vendor of its main CDMO was cited for deficiencies following a CGMP inspection.
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