Aurobindo Pharma USA, Inc.’s Post

Thoughts on this? >> Novo Nordisk doubles US Wegovy prescriptions as shortages start to ease, but earnings fall below expectations  >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #healthcare #biotech #pharma #pharmaceutical #productmarketing

Dr. Raza Bokhari, Executive Chairman and CEO of Medicus Pharma Ltd. (TSX-V:MDCX) joined Steve Darling from Proactive to share significant updates regarding the company's interaction with the U.S Food and Drug Administration (FDA). Medicus Pharma has received comments from the FDA, pertaining to its recent study findings and regulatory submissions. The FDA's feedback regarding the study results is considered exploratory, with specific requests directed towards providing additional data from clinical studies to support the doses of 100μg and 200μg of micro-array needles containing doxorubicin. Additionally, the FDA has requested an updated investigator brochure, incorporating insights from the clinical studies SKNJCT-001 and SKNJCT-002, focusing particularly on adverse events and dose-limiting toxicities at each dose level. Watch at #Proactive #ProactiveInvestors #TSXV #MDCX http://ow.ly/MvXt105nj9w

Today, the FDA hosted a CE program on "Bad Ads". It was very informative. It provided an overview of prescription drug promotion and its regulation along with information on how healthcare professionals can report potentially false or misleading prescription drug promotion to the FDA. See some of the following misconceptions that were discussed below. To learn more about the FDA's initiative on calling out "Bad Ads", check out https://lnkd.in/eaUtWM-i The slides for today's webinar are posted there as well. The webinar will be archived on this site soon. #FDA #badads #pharmaceuticaladvertising #Pharma #DTC

Thoughts on this? >> FDA gives accelerated approval to PBC drug at the center of Gilead’s $4.3B CymaBay deal >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharma #healthcare #biotech #productmarketing #pharmaceutical

Thoughts on this? >> FDA gives accelerated approval to PBC drug at the center of Gilead’s $4.3B CymaBay deal >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #biotech #healthcare #pharma #pharmaceutical #productmarketing

In 2023, the Center for Drug Evaluation and Research (CDER) demonstrated exceptional regulatory efficiency, approving 55 new drugs. 49 of these approvals met or exceeded their Prescription Drug User Fee Act (PDUFA) goal dates—an 89% success rate. This performance illustrates the strength of our regulatory environment and the evolving processes that support it. #Pharmaceuticals #Healthcare #CDER #FDA #DrugApproval #PDUFA

Thoughts on this? >> Novo Nordisk doubles US Wegovy prescriptions as shortages start to ease, but earnings fall below expectations  >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #healthcare #productmarketing #pharmaceutical #biotech #pharma

Lifecycle management of combination products at post-authorisation

USFDA approval granted for generic drug for Scalp Psoriasis Treatment #Affordablehealthcare #AlembicPharmaceuticals #BetamethasoneValerateFoam #Chronicautoimmunecondition #Drugapproval #genericmedication #LuxiqFoam #Pharmaceuticalindustry #Scalppsoriasis #USFDAApproval

USFDA approval granted for generic drug for Scalp Psoriasis Treatment #Affordablehealthcare #AlembicPharmaceuticals #BetamethasoneValerateFoam #Chronicautoimmunecondition #Drugapproval #genericmedication #LuxiqFoam #Pharmaceuticalindustry #Scalppsoriasis #USFDAApproval