UK – Pfizer’s Litfulo recommended by NICE as first treatment for severe alopecia areata
NICE’s decision, which could benefit up to 14,000 patients, makes Litfulo the first treatment for severe alopecia areata to be recommended by the agency...
Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...
10 new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended 10 medicines for approval at its October 2022 meeting.
The CHMP recommended granting a marketing authorisation for Dengue Tetravalent...
Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 26-29 September 2022
New measures for terlipressin-containing medicines in the treatment of hepatorenal syndrome
EMA’s safety committee (PRAC) recommended new measures to reduce the risk of respiratory failure...
Europe – EMA recommends standard marketing authorisations for Comirnaty and Spikevax COVID-19 vaccines
EMA’s human medicines committee (CHMP) has recommended converting the conditional marketing authorisations of the COVID-19 vaccines Comirnaty (BioNTech/Pfizer’s vaccine) and Spikevax (Moderna’s vaccine) into standard marketing authorisations....
Europe – EMA pilot offers enhanced support to academic and non-profit developers of advanced...
EMA is launching a pilot to support the translation of basic research developments into medicines that could make a difference in patients’ lives in...
Europe – EMA alerts EU patients and healthcare professionals to reports of falsified Ozempic...
The European Medicines Agency has been notified by relevant national competent authorities that pre-filled pens falsely labelled as the diabetes medicine Ozempic (semaglutide, 1 mg, solution...
UK – NICE publishes draft guidance not recommending CSL’s haemophilia B gene therapy
The company has been seeking approval for use of the therapy in adults with severe or moderately severe haemophilia B without a history of...
UK – NICE fails to recommend Boehringer Ingelheim and Lilly Alliance’s empagliflozin
In a blow to patients who currently lack recommended treatment options for chronic heart failure with preserved or mildly reduced ejection fraction, Boehringer Ingelheim...
UK – Kidney Research UK concerned by NICE process
Kidney Research UK has responded to the National Institute for Health and Care Excellence (NICE) draft guidance on therapeutics for patients with COVID-19.
It follows...
Europe – EMA recommends approval of adapted Nuvaxovid COVID-19 vaccine targeting Omicron XBB.1.5
EMA’s human medicines committee (CHMP) has recommended authorising an adapted Nuvaxovid vaccine targeting the Omicron XBB.1.5 subvariant of the SARS-CoV-2 virus.
The vaccine, known as Nuvaxovid XBB.1.5, is to...
