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.
Recipharm announced a significant investment in its Oral Solid Development and Pilot Scale Centre in Zwickau, Germany. The investment includes three new GMP Pilot Scale suites for blending, tableting and hard capsule filling, which will complement the existing GMP pilot scale capabilities in dry granulation and wet granulation and related tools for...
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Evonik has opened a new facility for drying aqueous dispersions of EUDRAGIT® polymers at its site in Darmstadt. The new double-digit million-euro excipient manufacturing facility enables Evonik to meet the increasing demand from pharmaceutical customers for oral drug delivery solutions.
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Apotex Corp. announced the launch of dasatinib tablets, a generic version of Sprycel®1, in the United States, with 180-days of exclusivity.
Dasatinib is a kinase inhibitor used to treat certain types of leukemia in both adults and children 1 year of age and older, including cases where previous treatment were not effective or tolerated.
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KalVista Pharmaceuticals, Inc. announced that the FDA accepted its New Drug Application (NDA) for sebetralstat, a novel, investigational oral plasma kallikrein inhibitor for the on-demand treatment of hereditary angioedema (HAE) attacks in adult and pediatric patients aged 12 years and older.
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Obsidian Therapeutics, Inc. announced that the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to OBX-115 for the treatment of patients with unresectable or metastatic melanoma that is resistant to immune checkpoint inhibitor (ICI) therapy.
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Bayer and NextRNA Therapeutics announced that they have entered into a collaboration and license agreement to develop small molecule therapeutics targeting lncRNAs in oncology. lncRNAs represent a vast class of therapeutic targets that recruit RNA-binding proteins (RBPs) to drive pathological processes across diseases.
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Merck announced the initiation of Shorespan-007, a pivotal Phase 3 clinical trial evaluating bomedemstat, an investigational orally available lysine-specific demethylase 1 (LSD1) inhibitor, for the treatment of patients with essential thrombocythemia (ET) who have previously not received cytoreductive therapy.
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Sirio Pharma, a nutraceutical contract development and manufacturing organization (CDMO), launched a new range of ready-to-market, organic gummies and softgels. Named PureOrganix™, the company’s new concepts include three gummies and one softgel, each of which utilizes top-trending ingredients and is formulated to meet stringent EU-Organic ...
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The former Schenck Process Food and Performance Materials (FPM) group of companies have officially changed their name to Coperion. The transition follows the September 2023 acquisition of the companies by Hillenbrand (NYSE: HI), the parent company of Coperion.
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Aurobindo Pharma USA, Inc., on behalf of AuroHealth, is voluntarily recalling one lot (AC2523005A) of Healthy Living Migraine Relief, Acetaminophen 250mg, Aspirin (NSAID) 250mg & Caffeine 65mg tablets, to the consumer level as sold through Amazon to known within the US market due to the product missing the manufacturer label.
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Grünenthal announced the acquisition of US-based Valinor Pharma, LLC and its product Movantik® (naloxegol), with a total deal value of approx. $250 million inclusive of all royalty obligations. Grünenthal will finance the transaction using available liquidity.
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GURU is recalling Infla-650 Herbal Dietary Supplement Capsules, Lot No. IN-032, 700 mg because Infla-650 capsules has been found to be tainted with acetaminophen, diclofenac and phenylbutazone, which are not listed on the label.
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Phathom Pharmaceuticals, Inc. announced that the FDA approved VOQUEZNA® (vonoprazan) 10 mg tablets for the relief of heartburn associated with Non-Erosive Gastroesophageal Reflux Disease (Non-Erosive GERD) in adults.
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SoloVital.com is recalling all lots of Umary Acido Hialuronica, Suplemento Alimenticio – 30 Capletas de 850 mg because FDA laboratory analysis confirmed that UMARY has been found to be tainted with the drug ingredients, diclofenac and omeprazole.
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Vertex Pharmaceuticals Incorporated (announced that Health Canada has granted Marketing Authorization for the expanded use of PrTRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for the treatment of cystic fibrosis (CF) in patients aged 2 years and older who have a mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) ...
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