UK – NICE approval for Janssen’s Darzalex combination
Recommendation concerns routine use across the NHS as therapy for multiple myeloma
The Janssen Pharmaceutical Companies of Johnson & Johnson have announced that the National...
UK – Kite’s CAR-T therapies recommended by NICE for certain blood cancers
The treatments, both given as one-off infusions, have been specifically recommended for use within the Cancer Drugs Fund (CDF), which pays for cancer treatments...
UK – Janssen and AbbVie’s Imbruvica combination recommended by NICE for leukaemia
CLL is the common type of leukaemia in adults, with around 3,800 people in the UK diagnosed with the disease each year.
While patient outcomes...
Europe – Single-arm trials as pivotal evidence for the authorisation of medicines in the...
EMA has opened a public consultation on a reflection paper that discusses key concepts for single-arm clinical trials that are submitted as pivotal evidence in support of marketing authorisation...
UK – AstraZeneca’s Lynparza recommended by NICE for breast and prostate cancer
The anti-cancer medicine will now be routinely available for adults with HER2-negative, high-risk early breast cancer who have inherited faults in their BRCA1 or...
UK – Ipsen reacts to NICE’s Cabometyx verdict
Ipsen has expressed its disappointed regarding the National Institute for Health and Care Excellence’s (NICE) preliminary guidance which does not recommend Cabometyx – also...
Europe – New features further strengthen Priority Medicines scheme (PRIME)
EMA is introducing a number of new features to the PRIority Medicines (PRIME) scheme to strengthen its support for the development of medicines in areas of...
Europe – EU recommendations for 2023-2024 seasonal flu vaccine composition
EMA has issued the recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from...
Europe – EMA recommends approval of Bimervax as a COVID-19 booster vaccine
EMA’s human medicines committee (CHMP) has recommended authorising the COVID-19 vaccine Bimervax (previously COVID-19 Vaccine HIPRA) as a booster in people aged 16 years...
UK – AstraZeneca and Amgen’s Tezspire recommended by NICE for severe asthma
The final draft guidance from the National Institute for Health and Care Excellence (NICE) specifically applies to patients who are inadequately controlled with high...
