Insight on USFDA Approves Vitrakvi® (larotrectinib), the First Ever TRK Inhibitor
Posted on29 Nov 2018
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The U.S. Food and Drug Administration (FDA) today approved Vitrakvi® (larotrectinib), the first ever oral TRK inhibitor, for the treatment of adult... Read More
Case Study: Pfizer’s Lyrica’s patent extension with paediatric exclusivity
USFDA granted 6-month pediatric exclusivity to Lyrica, which helps to Lyrica to extent the patent expiration by additional 6 month. Lyrica received... Read More
What is pediatric exclusivity?
Posted on29 Nov 2018
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Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and may run concurrently with a patent but... Read More
Case Study: Insight on DRL-Indivior Suboxone Patent Battle
June 2018 : DRL got the generic approval for Suboxone Dr Reddy’ s Laboratories received approval from the USFDA for generic version... Read More
Insight on Strides – SUDA Pharma Strategic Deal
Strides Pharma Science’s wholly owned subsidiary, Strides Pharma Global Pte Limited, Singapore has entered into an exclusive product development, licensing and supply... Read More
Hikma Pharmaceuticals and Vectura codevelopment and commercialization of GSK’s Breo Ellipta generics
Hikma Pharmaceuticals and Vectura have signed a deal to develop and market generic versions of GlaxoSmithKline’s Ellipta portfolio, utilising the latter’s Open-Inhale-Close... Read More
Glenmark’s anti-myeloma drug to start phase 1 trial in solid tumors
Glenmark Pharmaceuticals on Thursday said it will launch phase 1 trial in solid tumors for its bispecific antibody GBR 1342, indicated for... Read More
Pfizer gets US FDA approval for Lorbrena for previously-treated ALK-positive metastatic NSCLC
Posted on06 Nov 2018
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Pfizer Inc announced that the US Food and Drug Administration (FDA) has approved Lorbrena [lor-BREN-ah] (lorlatinib), a third-generation anaplastic lymphoma kinase (ALK)... Read More
Adalimumab Biosimilar Litigation: Sandoz’s settlement with AbbVie
Sandoz, a Novartis division and the global leader in biosimilars, announced a global resolution of all intellectual property (IP) related litigation with... Read More
Case Study – Quick Look up at DCGI approval of Lundbeck’s Brintellix
Posted on15 Oct 2018
TagsBrintellix, CDSCO, codevelopment deal in pharma, comarketing deal in pharma, copromotion deal in pharma, DCGI, Lundbeck, vortioxetine
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Lundbeck India Private Limited (LIPL) announces the launch of Brintellix (vortioxetine) in India for the treatment of patients suffering from major depressive... Read More