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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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Building a better future for people with rare diseases in all four UK nations

pharmaphorum

Published in January, the document replaces 2013’s UK Strategy for Rare Diseases and sets out four priorities for the next five years: faster diagnosis, increasing awareness among healthcare professionals, the better coordination of care, and improving access to specialist care, treatments, and drugs.

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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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It Finally Happened – FDA’s OPDP Issues First Letter of 2023

Eye on FDA

But the numbers began to dwindle and 2013 was the last time the office even issued 12 letters within a year (it did 23 that year). The label for the medicine includes a boxed warning regarding potential issues related to complications for the liver (toxicity) and heart (QT prolongation).

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

FDA Law Blog: Biosimilars

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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Episode 849: Should apixaban’s loading dose duration ever be shortened?

Pharmacy Joe

The trial that secured the approval of apixaban to treat VTE was published in 2013 in the New England Journal of Medicine. Dabigatran and edoxaban require 5 full days of parenteral anticoagulation therapy first, and apixaban and rivaroxaban have a period where a loading dose is given before dropping down to a lower maintenance dose.