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.
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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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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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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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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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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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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Adare Pharma Solutions, a CDMO focused on oral dosage forms, announced that work has begun to add packaging capabilities and further warehousing capacity at its Pessano facility in Milan, Italy.
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Perrigo Company announced that Opill® has shipped to major retailers and pharmacies and will be available on shelves nationwide and online later this month. Approved by the FDA for OTC use for all ages in July 2023, Opill® is the first-ever daily birth control pill available without a prescription in the U.S.
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According to Straits Research, “The global softgel capsules market size was valued at USD 7.55 billion in 2021. It is projected to reach USD 14.86 billion by 2030, growing at a CAGR of 7.81% during the forecast period (2022–2030).”
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Bristol Myers Squibb recently announced that the FDA accepted for priority review the supplemental new drug application (sNDA) for KRAZATI® (adagrasib) in combination with cetuximab for the treatment of patients with previously treated KRASG12C-mutated locally advanced or metastatic colorectal cancer (CRC).
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