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.
LSPedia has been granted a contract by the U.S. Department of Veterans Affairs to deliver solutions ensuring compliance with the FDA's Drug Supply Chain Security Act (DSCSA). Enacted in 2013, the DSCSA mandates end-to-end traceability for pharmaceutical products, guarding against counterfeit or illegitimate products infiltrating the supply chain.
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In 2022, the global revenue from active pharmaceutical ingredients (API) reached $192.3 billion, and it's expected to grow at a rate of 4.2% annually, reaching $300.2 billion by 2033, as per Persistence Market Research.
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XOMA Corporation has acquired an economic interest in DSUVIA® (sufentanil sublingual tablet) from Talphera, Inc., for $8 million. DSUVIA® was approved in 2018 by the FDA for use in adults in certified medically supervised healthcare settings.
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ViiV Healthcare has submitted a New Drug Submission (NDS) to Health Canada for the investigational long-acting (LA) injectable and tablets of cabotegravir for PrEP. This submission is currently undergoing review under the Priority Review Policy.
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Bayer has unveiled positive top-line outcomes from the pivotal Phase III studies, OASIS 1 and 2, assessing the efficacy and safety of the investigational compound Elinzanetant compared to a placebo.
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Olema Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for women’s cancers, announced the selection of a development candidate for the Company’s program targeting KAT6, an epigenetic target that is dysregulated in breast cancer and other cancers.
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Bristol Myers Squibb has announced that the European Medicines Agency (EMA) has validated the marketing authorization application for repotrectinib, a next-generation tyrosine kinase inhibitor (TKI).
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The FDA issued a guidance for industry titled, "Rare Diseases: Considerations for the Development of Drugs and Biological Products" This guidance clarifies the FDA's thinking on important considerations in rare disease drug development to ultimately assist rare disease drug and biologic product developers in conducting successful drug development ...
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Biora Therapeutics, Inc. has officially received an Issue Notification from the U.S. Patent and Trademark Office, marking a significant milestone in its pursuit of innovative gastrointestinal (GI) disorder treatments.
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USWM, LLC announced that the FDA approved IWILFIN™ (eflornithine) 192 mg tablets, a groundbreaking oral maintenance therapy for high-risk neuroblastoma. IWILFIN is indicated to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma who have demonstrated at least a partial response to prior multiagent, multimodality ...
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Merck announced that the FDA approved WELIREG, an oral inhibitor of hypoxia-inducible factor-2 alpha (HIF-2a), for treating adult patients with advanced renal cell carcinoma (RCC) who have undergone treatment with a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine ...
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Sanofi, in collaboration with DNDi and the HAT-r-ACC consortium, announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive scientific opinion for Fexinidazole Winthrop.
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Biora Therapeutics, Inc. announced a new research collaboration with a large pharmaceutical company for its BioJet™ Systemic Oral Delivery Platform. The new agreement provides funding to test the BioJet platform’s ability to achieve bioavailability through oral delivery of the undisclosed collaborator’s molecules to the small intestine in animal ...
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Phathom Pharmaceuticals, Inc. has proudly disclosed that the FDA accepted the New Drug Application (NDA) for VOQUEZNA (vonoprazan).
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Vanda Pharmaceuticals Inc. announced that it has acquired U.S. and Canadian rights to PONVORY® (ponesimod) from Actelion Pharmaceuticals Ltd. (Janssen), a Johnson & Johnson Company. PONVORY® is approved by the US FDA and Health Canada to treat adults with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, ...
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