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FDA grants approval for Amylyx’s Relyvrio to treat ALS

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Amylyx Pharmaceuticals’ Relyvrio (sodium phenylbutyrate and taurursodiol) to treat adult patients with amyotrophic lateral sclerosis (ALS). The FDA approval is based on findings from the multicentre Phase II CENTAUR clinical trial that enrolled 137 ALS patients.

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A scientific approach to irrational consumer choices

World of DTC Marketing

GOOD MORNING: The FDA is taking a scientific approach to evaluating direct-to-consumer (DTC) drug advertising, focusing on measuring consumer perceptions of the information presented in ads. Ad recall is essential for CPGs, but for prescription drugs, the question that’s missing is “what action did it lead to?

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Pandemic Innovators: Pharma Marketing Strategies that Reinvent the In-Person Conversation

Pharmaceutical Representative Training

Before 2020, the landscape of drug marketing involved following drug approvals by the Food and Drug Administration ( FDA ), finding which patient population would benefit from therapy, and visiting specialized doctors in-person to advertise its advantages compared to current guidelines.

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GAMP 5 update: computerized system expectations for pharma manufacturers

European Pharmaceutical Review

As ISPE GAMP 5 Second Edition notes in the preface “Operating in a highly regulated industry may lead practitioners to apply prescriptive and rigid compliance-based approaches that are not commensurate with and not effective in managing any actual risk to the product and the patient.” FDA, 2022. . About the authors.

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Selling Effectively In Medical Sales With John Crowder

Evolve Your Success

— Watch the episode here Listen to the podcast here Selling Effectively In Medical Sales With John Crowder We have with us another special guest. A lot of organizations that may have a sales model don’t probably follow the prescription that we deliver or the method that we deliver to them, which is why they contract us.

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Industry Briefs November 2022

PM360

The two retail pharmacy giants have announced their intention to settle lawsuits regarding inappropriate opioid prescriptions at $5 billion each. Ketamine is FDA approved for anesthesia and pain management but not for depression or any other psychiatric disorder. Local and U.S. over the past two decades. The pandemic led the U.S.

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FDA AdCom votes unanimously in favour of OTC oral contraceptive

Pharmaceutical Technology

A US Food and Drug Administration (FDA) Advisory Committee (AdCom) has voted unanimously in favour of giving HRA Pharma’s Opill (norgestrel) over-the-counter (OTC) availability. The FDA has no obligations to follow the recommendation of AdComs, though the vote will likely be weighed in the agency’s final decision.

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