Overview To make up for arbitrary delays in the issuing of patents by the Canadian Intellectual Property Office, Canada has passed laws…
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2023 ApprovalsMay 2023Pharma ApprovalsU.S FDA
May 2023 Approval Update – Astellas’ VEOZAH™ (Fezolinetant) Gets U.S. FDA for Treatment of Vasomotor Symptoms Due to Menopause
by adminby adminOn May 12, the U.S. Food and Drug Administration (FDA) approved VEOZAHTM (Fezolinetant), 45 mg once daily for the treatment of moderate…
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2023 ApprovalsMay 2023Pharma ApprovalsU.S FDA
May 2023 Approval Update – Lexicon’s INPEFA™(Sotagliflozin) Notch FDA Approval for Treatment of Heart Failure
by adminby adminSummary:- INPEFA granted broad label across full range of left ventricular ejection fraction, including HFpEF and HFrEF, and for patients with or…
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RegulatoryU.S FDAVertex
Vertex Announces U.S. FDA Approval for ORKAMBI® (lumacaftor/ivacaftor) in Children With Cystic Fibrosis Ages 12 to 24 months
by adminby adminSummary: Orkambi was first approved in 2015 in the US and is now available in more than 30 countries. Vertex Pharmaceuticals Incorporated…
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Merger / Acquisition
Advanz Pharma Signs Acquisition Agreement for Intercept Pharmaceuticals
by adminby adminSummary: UK-headquartered pharma company, Advanz Pharma, has announced in a May 5, 2022 press release that it has signed an agreement with…
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Synopsis Zulfikar, Director LULU group of Hypermarket declared that due to positive approach of Assam Government and APEDA, it is decided to…
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Lupin PharmaRegulatoryU.S FDA
Lupin launches Sevelamer Hydrochloride tablets in the United States used in treatment of kidney disease
by adminby adminHighligts : Sevelamer Hydrochloride Tablets, 800 mg is a generic equivalent of Renagel Tablets, 800 mg of Genzyme Corporation used in the…
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Summary : Vaccine pioneers expand presence throughout Europe with a view to leveraging technology The biotechnology company, Moderna, has announced plans to…
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Global MarketPharma Science & Research
Lilly, Roche Push Back Against CMS Draft Guidance on Aduhelm
by adminby adminSummary The U.S. Centers for Medicare & Medicaid Services (CMS) just completed the open comment period for their draft national coverage decision…
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BiogenGlobal Market
Biogen Officially Weighs in On Medicare Draft Guidance for Aduhelm
by adminby adminSummary – In mid-January, the Centers for Medicare & Medicaid Services (CMS) issued a draft national coverage decision for Biogen’s Alzheimer’s drug…
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