UK – Otsuka’s Lupkynis receives NICE green light
Recommendation applies across England and Wales and the treatment is available now
Otsuka Pharmaceuticals has revealed that the National Institute for Health and Care Excellence...
Europe – Review of transparency rules for the EU Clinical Trials Information System (CTIS)
EMA has opened a public consultation to review the transparency rules for the publication of information on clinical trials submitted through the Clinical Trials Information System (CTIS) in the European Union...
Europe – GSK’s RSV vaccine candidate recommended by CHMP for older adults
There are currently no vaccines available to help protect older adults from RSV, a common contagious virus characterised by several mild, cold-like symptoms. Although...
Europe – European Health Union: Commission proposes pharmaceuticals reform for more accessible, affordable and...
Today, the Commission is proposing to revise the EU's pharmaceutical legislation - the largest reform in over 20 years - to make it more agile, flexible,...
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...
