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.
KORSCH America, a provider of tablet press technology offering solutions for product development, scale-up, high-speed production, multi-layer, mini-tablet, and WIP/high-containment applications, opened an INNOVATION CENTER at its headquarters facility in the Boston suburb of South Easton, MA.
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Amneal Pharmaceuticals, Inc announced that it has provided a Complete Response resubmission to the FDA for IPX203, a novel, oral formulation of carbidopa/levodopa (CD/LD) extended-release capsules for the treatment of Parkinson’s disease (PD).
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Today The World is voluntarily recalling two lots of Sustain herbal dietary supplement capsules and one lot of Schwinnng capsules to the consumer level. FDA analysis has found the products to contain undeclared Tadalafil and Nortadalafil (structurally similar to Tadalafil).
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Catalent, Inc. and Novo Holdings, a holding and investment company that is responsible for managing the assets and wealth of the Novo Nordisk Foundation, announced that they have entered into a merger agreement under which Novo Holdings will acquire Catalent in an all-cash transaction that values Catalent at $16.5 billion on an enterprise value ...
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Vanda Pharmaceuticals announced that on February 4, 2024, it received a notification from the FDA stating that as part of its ongoing review of Vanda's supplemental New Drug Application (sNDA) for HETLIOZ® (tasimelteon) in the treatment of insomnia characterized by difficulties with sleep initiation, the FDA identified deficiencies that preclude ...
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Eton Pharmaceuticals announced the commercial availability of Nitisinone Capsules for the treatment of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.
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Supernus Pharmaceuticals, Inc. announced that the United States District Court for the District of New Jersey ruled that Torrent Pharmaceuticals Ltd. and its subsidiary, Torrent Pharma Inc., infringed U.S. Patent Nos. 8,992,989; 9,549,940; and 9,622,983 by submitting to the FDA an Abbreviated New Drug Application (ANDA) seeking permission to market...
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Teva announced its intention to divest its active-pharmaceutical ingredient (API) business, or "TAPI". TAPI is a global leader in the small-molecule API industry, with approximately 4,300 employees worldwide.
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In partnership with Sumitomo Pharma Canada, Inc., Pfizer Canada ULC announced that supply of MYFEMBREE® (relugolix 40 mg, estradiol 1 mg and norethindrone acetate tablets 0.5 mg tablets) is now available in Canada by prescription for the management of moderate to severe pain associated
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Paladin Labs Inc., a subsidiary of Endo International plc announced that XCOPRI® (cenobamate tablets) is now available in Canada. XCOPRI is indicated as adjunctive therapy in the management of partial-onset seizures in adults with epilepsy who are not satisfactorily controlled with conventional therapy.
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Azurity Pharmaceuticals, Inc. is voluntarily recalling one lot (F230169A) of Zenzedi® CII (dextroamphetamine sulfate tablets, USP) 30 mg to the consumer level.
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Exelixis, Inc. announced it has successfully defended European Patent number EP2593090 (c-MET Modulator Pharmaceutical Compositions) against three opponents, STADA Arzneimittel AG, Teva Pharmaceutical Industries Ltd., and Generics (U.K.) Ltd. in a hearing before the Opposition Division of the European Patent Office (EPO).
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Vaxart, Inc. announced that the United States Biomedical Advanced Research and Development Authority (BARDA) has awarded the Company $9.27 million to fund preparation for a 10,000 subject Phase 2b clinical study evaluating Vaxart’s oral pill XBB COVID-19 vaccine candidate against an approved mRNA vaccine comparator.
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Bora Pharmaceuticals Co., Ltd. has officially sanctioned the acquisition of Upsher-Smith Laboratories, Inc., a generics manufacturer situated in Minnesota, USA.
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Vitaquest International, a product development and commercialization partner for nutraceuticals and functional foods, announced today that after an extensive review of its dietary supplement manufacturing systems and processes, the company has successfully completed the United States Pharmacopoeia (USP) Quality Systems GMP Audit Program for three ...
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