What is USFDA Tentative Approval?
Posted on28 Jun 2019
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If a generic drug product is ready for approval before the expiration of any patents or exclusivities accorded to the reference listed... Read More
Case Analysis: Insight on AbbVie’s acquisition of Allergan
On June 25, 2019, AbbVie Inc. and Allergan announced that the companies have entered into a definitive transaction agreement under which AbbVie... Read More
Glenmark’s licensing deal with Novartis to distribute three respiratory drugs in Brazil
Glenmark Farmacêutica, has entered into an exclusive partnership agreement with Novartis to distribute latter’s three respiratory products in Brazil. Under the terms... Read More
What is CRL – Complete Response Letter by USFDA?
Complete response letter is issued by USFDA to new drug / abbreviated application holder, if they determines that we will not approve... Read More
Case Study: Vyleesi™ (Bremelanotide Injection) for HSDD in Premenopausal Women
Posted on24 Jun 2019
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U.S. Food and Drug Administration (FDA) has approved Vyleesi™ (bremelanotide injection), a melanocortin receptor agonist, to treat acquired, generalized hypoactive sexual desire... Read More
FDA Approval of sNDA for DEXTENZA for the Treatment of Ocular Inflammation Following Ophthalmic Surgery
U.S. Food and Drug Administration (FDA) approved a Supplemental New Drug Application (sNDA) for DEXTENZA to include the treatment of ocular inflammation... Read More
A triple-combination therapy for COPD – Breztri Aerosphere’s of AstraZeneca received approval in Japan
Posted on21 Jun 2019
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AstraZeneca announced that Breztri Aerosphere (budesonide/ glycopyrronium/ formoterol fumarate), formerly PT010, has been approved in Japan as a triple-combination therapy to relieve... Read More
Case Study: Why Pfizer acquiring Array Biopharma?
Pfizer Inc. and Array BioPharma Inc. have entered into a definitive merger agreement under which Pfizer will acquire Array, a commercial stage... Read More
Case analysis: 483 observations – Data Integrity issues in Aurobindo Pharma’s finished dosage formulation plant
Posted on17 Jun 2019
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The US Food and Drug Administration has pointed out data integrity lapses at Aurobindo Pharma Limiteds finished dosages plant at Bachupally, Telengana... Read More
USFDA Approves Amgen’s Trastuzumab Biosimilar, Kanjinti
The FDA has approved Amgen’s ABP 980, a trastuzumab biosimilar referencing Herceptin. The drug, trastuzumab-anns, will be sold as Kanjinti. Kanjinti was approved for... Read More