Europe – European Parliament committee proposes changes to pharma legislation
The European Parliament’s health committee is set to debate and vote on changes to the proposed pharmaceutical legislation on 19 March, including provisions that...
USA – FDA unveils draft guidance on REMS logic models
The US Food and Drug Administration (FDA) has released a draft guidance outlining the agency’s risk evaluation and mitigation strategy (REMS) logic model.
FDA described...
UK – Bristol Myers Squibb’s Sotyktu recommended by NICE for plaque psoriasis
The new guidance specifically applies to patients with a Psoriasis Area and Severity Index score of ten or more, a Dermatology Life Quality Index...
USA – NCI official raises concerns about FDA’s cancer drug dose optimization guidance
The head of the National Cancer Institute’s (NCI) investigational drug research branch said that recent draft guidance from the US Food and Administration (FDA)...
Europe – First nasal adrenaline spray for emergency treatment against allergic reactions
EMA’s human medicines committee (CHMP) has recommended granting a marketing authorisation in the European Union for Eurneffy (epinephrine), the first medicine to be taken through the...
UK – MHRA instructs health organisations to prepare now for new measures to reduce...
Healthcare organisations are being instructed by the Medicines and Healthcare products Regulatory Agency (MHRA) now to put in place a plan to implement the first phase...
France – Expérimentation du cannabis médical : quelle continuité de la prise en charge...
Le Décret n° 2024-259 du 23 mars 2024 modifiant le décret n° 2020-1230 du 7 octobre 2020 relatif à l'expérimentation de l'usage médical du cannabis et...
UK – Recommendation from NICE for PTC Therapeutics gene therapy
Eladocagene exuparvovec, the only gene therapy for children with the ultra-rare genetic disorder, aromatic L-amino acid decarboxylase (AADC) deficiency, has been recommended by the...
Europe – EMA advises about risks of using weight loss medicine Mysimba with opioids
Following a routine review of the safety of the weight loss medicine Mysimba (naltrexone/bupropion), EMA recommends strengthening existing advice to minimise the risks from...
Europe – EU pharmaceutical policy: MEPs support comprehensive reform
On Tuesday, the Environment, Public Health and Food Safety Committee adopted its position on the new directive (66 votes in favour, two against and...
