UK – NICE recommends Santen’s Roclanda to treat glaucoma and ocular hypertension

The National Institute for Health and Care Excellence (NICE) has issued guidance recommending Santen’s Roclanda for use in patients with primary open-angle glaucoma (POAG)...

UK – AstraZeneca’s Voydeya recommended by NICE to treat rare blood disorder PNH

The oral factor D inhibitor has been recommended for use alongside AZ’s complement component 5 (C5) inhibitors, Ultomiris (ravulizumab) or Soliris (eculizumab) to treat...

UK – Ipsen’s Iqirvo recommended by NICE to treat rare liver disease primary biliary...

The drug can now be used in combination with ursodeoxycholic acid (UDCA) in patients with an inadequate response to UDCA, or as a monotherapy...
MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies

UK – Eli Lilly’s Alzheimer’s drug Kisunla approved by MHRA but not recommended by...

Kisunla (donanemab-azbt), administered as an intravenous infusion every four weeks, has been approved by the UK regulator to treat mild cognitive impairment and mild...

UK – Merck’s Keytruda recommended by NICE to reduce risk of lung cancer recurrence

The anti-PD-1 therapy has been specifically recommended for use in combination with platinum-based chemotherapy as a neoadjuvant treatment before surgery and then as a...

UK – Roche’s Alecensa receives NICE recommendation to treat ALK-positive lung cancer

The drug has been specifically recommended by the health technology assessment agency as an adjuvant treatment for adults with stage 1B to 3A ALK-positive...
TÜV Rheinland Becomes 5th Notified Body Designated Under MDR

Europe – Règlement d’exécution (UE) 2024/2699 de la Commission du 18 octobre 2024

LA COMMISSION EUROPÉENNE, vu le traité sur le fonctionnement de l’Union européenne, vu le règlement (UE) 2021/2282 du Parlement européen et du Conseil du 15 décembre 2021 concernant...

Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...

Ten new medicines recommended for approval The committee recommended granting a marketing authorisation for Alhemo (concizumab), a medicine for routine prophylaxis of bleeding in patients with...

Europe – EMA drafts concept paper for future radiopharmaceuticals guideline

The European Medicines Agency (EMA) last week released a new concept paper for a future guideline on the clinical evaluation of therapeutic radiopharmaceuticals (tRPs)...

UK – Johnson & Johnson receives updated NICE recommendation for Tecvayli in multiple myeloma

The final draft guidance applies to RRMM patients in England and Wales who have received at least three lines of therapy, including an immunomodulatory...

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