Sun.Aug 11, 2024

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FDA shoots down Lykos' MDMA therapy for PTSD

pharmaphorum

The FDA has denied Lykos Therapeutics' marketing application for its post-traumatic stress disorder (PTSD) therapy based on MDMA, also known as ecstasy, in a setback for the emerging psychedelic medicines category.

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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 52
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Plant and Animal Fat Intake and Overall and Cardiovascular Disease Mortality

JAMA Internal Medicine

This cohort study evaluated the associations of plant and animal fat intake with cardiovascular disease and overall mortality outcomes.

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New patent expiration for Takeda Pharms drug NINLARO

Drug Patent Watch

Annual Drug Patent Expirations for NINLARO Ninlaro is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug.

Drugs 52
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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It’s a Cruel Summer – Two New OPDP Untitled Letters

FDA Law Blog

By Sarah Wicks & Dara Katcher Levy — FDA’s Office of Prescription Drug Promotion (OPDP) has issued two new Untitled Letters this summer after 5 months without any letter activity. The letters are vastly different from one another in subject matter, but together they make a cruel summer of OPDP enforcement against industry. [Editorial note – the Gen X’er included that link first – for the arguably more popular reference, read on.

Drugs 59
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The Role of Patent Attorneys in Generic Drug Development

Drug Patent Watch

The development of generic drugs is a crucial aspect of the pharmaceutical industry, as it provides affordable alternatives to expensive […] Source