Sun.May 14, 2023

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US FDA audit at Hikal’s Panoli facility concludes with zero observations

Express Pharma

Hikal’s pharma manufacturing facility located at Panoli, Gujarat, was recently inspected by the US Food and Drug Administration (US FDA) in compliance with their requirements. The five-day preapproval inspection of an API was conducted from May 8-12, 2023 was concluded with ‘Zero 483 observations’ from the US FDA. The Panoli facility was earlier audited twice by the US FDA and successfully approved for manufacturing advanced intermediates and key starting materials.

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FDA advisors narrowly back Sarepta’s Duchenne gene therapy

pharmaphorum

FDA advisors narrowly back Sarepta’s Duchenne gene therapy Phil.

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Episode 817: How to Predict Failure of Insulin Transition in Critically Ill Patients with Diabetic Ketoacidosis

Pharmacy Joe

In this episode, I’ll discuss how to predict failure of insulin transition in critically ill patients with diabetic ketoacidosis. Episode 817: How to Predict Failure of Insulin Transition in Critically Ill Patients with Diabetic Ketoacidosis Subscribe on iTunes , Android , or Stitcher When patients with diabetic ketoacidosis (DKA) are treated and develop a normal anion gap, common practice is to transition the patient to subcutaneous insulin.

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New patent expiration for Celgene drug REVLIMID

Drug Patent Watch

Annual Drug Patent Expirations for REVLIMID Revlimid is a drug marketed by Celgene and is included in one NDA. It is available from one supplier. There are fifteen patents protecting… The post New patent expiration for Celgene drug REVLIMID appeared first on DrugPatentWatch - Make Better Decisions.

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Position Your Pharmacy for Expansion

Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

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LaNova Medicines Entered into an Exclusive License Agreement with AstraZeneca for LM-305 to Treat Multiple Myeloma

PharmaShots

Shots: LaNova Medicines will receive an up front and near-term fees of ~$55M and is eligible to receive additional development and commercial milestones of ~$545M along with royalties on net sales globally AstraZeneca to get an exclusive license globally to research, develop, and commercialize LM-305, a pre-clinical stage ADC targeting G protein-coupled receptor, class C, group 5, member D (GPRC5D) The collaboration focuses on discovering and developing innovative therapies in ADC and Immuno-Onc

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150+ Page Paperback MPJE Book For Less Than 5$ – Ending Soon!

Med Ed 101

A week ago or so I released the MPJE Master 2nd Edition Ebook. The PAPERBACK Edition is now available. You can literally get a 150+ page book for less than 5$. I will end this initial offer to my followers this week and the price will increase significantly. There are a ton of updates from […] The post 150+ Page Paperback MPJE Book For Less Than 5$ – Ending Soon!

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Which pharmaceutical drugs have the most drug patents in Hong Kong?

Drug Patent Watch

This chart shows the drugs with the most patents in Hong Kong. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is… The post Which pharmaceutical drugs have the most drug patents in Hong Kong? appeared first on DrugPatentWatch - Make Better Decisions.

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