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STAT+: Former Sage executives join biotech VC Cure Ventures

STAT

The two men worked together from 2013 until 2022, when Jonas left to start a biotech incubator with funding from investment giant CBC Group. The VC firm has hired Jeff Jonas, Sage’s former chief executive, and Al Robichaud, Sage’s former chief scientific officer, as partners, the team told STAT exclusively.

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How does HTA for orphan drugs differ across Europe?

pharmaphorum

The study reviewed all 80 European Medicines Agency (EMA) authorised drugs receiving an orphan designation between 1 January 2013 and 31 December 2019, analysing their HTA outcomes and time to reimbursement across France, Germany, England and Scotland. Rates of approval. A more favourable outcome from the German regulator took on average 1.4

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What is Special about September 24, 2023 for the UDI System?

The FDA Law Blog

Such codes need to be placed on device labels and packages to allow devices to be easily identified and tracked throughout their lifecycle, except where the rule provided for an exception or alternative. The compliance dates were first published in 2013, and subsequently updated in various guidance documents and regulations published by FDA.

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Quiet on the Set? Forbidding FDA To Take Photographs During An Inspection Can Be Regrettable

The FDA Law Blog

To be clear, as we discussed in a blogpost back in 2013 , the Federal Food, Drug, and Cosmetic Act does not explicitly require companies to permit photographs to be taken. FDA reports that it told the company that “failure to allow photography would be documented as a refusal,” and the company “acknowledged the refusal.”

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Is gabapentin a controlled substance?

The Checkup by Singlecare

Doctors prescribe gabapentin off-label for several other medical conditions, including general neuropathic pain, bipolar disorder, anxiety, fibromyalgia, and migraines. At this time, seven states label gabapentin as a controlled substance. In 2021, 70.9 million gabapentin prescriptions were dispensed by U.S. pharmacies.

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Transition Plans for Covid-19 Products are Amongst CDRH FY2023 Priorities

The FDA Law Blog

Also part of FDA’s FY2023 guidance document plan is a retrospective review of guidance documents issued in 1993, 2003, and 2013. FDA’s retrospective review of the 2003 guidance documents will include user labeling for devices that contain natural rubber and premarket approval application modular review.

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Smartphone-powered trial backs J&J’s Invokana for heart failure

pharmaphorum

Updated labelling for Invokana has already been approved to include data showing that it can reduce the risk of hospitalisation for heart failure and diabetic kidney disease in patients with type 2 diabetes, based on the CREDENCE trial. . billion in 2016 before the product was linked to an increased risk of lower limb amputation.

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