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Negative FDA AdCom vote for Intercept’s obeticholic acid in NASH

Pharmaceutical Technology

Additionally, when asked whether the FDA should consider a potential accelerated approval, panellists voted 15 to one against that regulatory pathway for the drug. Additionally, when asked whether the FDA should consider a potential accelerated approval, panellists voted 15 to one against that regulatory pathway for the drug.

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Key Developments from AMCP 2023 on Blockbuster Generics, Diabetes Drugs, PBM Legislation, and More

PM360

Jeff Casberg, MS, RPh, Senior Vice President of Clinical Pharmacy at IPD Analytics, a managed care and pharmaceutical consultancy, highlighted a wide range of 2023 key events that will affect managed care professionals by the end of the year. This product is expected to have three generic launches in 2023.

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Healthcare Watch October 2023

PM360

Of the eight FDA-approved weight loss drugs on the market, these two are making waves for doctors who believe they represent “a new era for weight loss medications,” and “changing options and giving hope.” “They are effective but too expensive for the majority of patients, even with insurance coverage,” said one primary care physician (PCP).

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Futura eyes FDA filing as topical ED drug passes phase 3 test

pharmaphorum

Futura Medical’s development of a topical treatment for erectile dysfunction (ED) is approaching the finish line in the US, as the UK biotech reports confirmatory phase 3 data ahead of an FDA filing later this month. ” The post Futura eyes FDA filing as topical ED drug passes phase 3 test appeared first on.

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10 New Solutions, Strategies, and Devices to Boost Adherence

PM360

The combined solution enables health plans and self-insured employers to realize immediate pharmacy cost savings and near-term medical cost reductions by integrating Levrx’s plan-specific and real-time prescription insights into the Adhere Platform medication optimization offerings. The Andaman7 Platform Solution. Vincent Keunen.

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Female sexual interest drug reaches tipping point with Phase III plans

Pharmaceutical Technology

The company is aiming to enrol the first patient in the ALETTA Phase III trial in Q1 or Q2 of 2023, says Dr. Jan van der Mooren, Freya’s chief medical officer (CMO). The company plans to submit a request for advice from the FDA at the end of this year or the start of 2023, he adds.