Sun.Jun 30, 2024

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New tentative approval for Alembic drug dabigatran etexilate mesylate

Drug Patent Watch

Dabigatran etexilate mesylate is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Apotex, Hetero Labs Ltd Iii, and Boehringer Ingelheim and, and is included in five NDAs.

Drugs 59
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FDA’s Accelerated Approval Program: Empowering Timely Access to Critical Treatments and the role of eClinical

Cloudbyz

The Accelerated Approval Program of the FDA provides for conditional approval of drugs that show an effect sufficiently desirable, compared to available medications, based on surrogate endpoints considered reasonably likely to predict clinical benefit. This path acknowledges the urgency that some medical conditions carry and tries to provide earlier access to potentially life-saving therapies for patients.

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First intranasal Epipen alternative backed in EU

pharmaphorum

After FDA rejection last year, ARS Pharma closes on EU approval for intranasal epinephrine product for anaphylaxis

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RAPS Convergence 2024 to Feature Session on Accelerating Breakthrough Device Commercialization — Led by HPM Medical Device Regulatory Expert Adrienne Lenz

FDA Law Blog

RAPS Convergence 2024 is set to host a must-attend session on CDRH’s Total Product Life Cycle Advisory Program (TAP), promising attendees an exclusive insight into a pioneering initiative aimed at improving the medical device commercialization landscape. Session Details: A Path to Faster Breakthrough Device Commercialization – CDRH’s Total Product Life Cycle Advisory Program (TAP) Thursday, September 19, 2024, 4:30 PM – 5:30 PM Session Leader: Adrienne Lenz, RAC – Principal Medical Device Regula

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Which pharmaceutical companies have the most drug patents in Lithuania?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most patents in Lithuania. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is desired.

Drugs 59