Ultragenyx’ Mepsevii has been cleared for use in Europe to treat the ultra rare disease mucopolysaccharidosis type VII (MPS VII), offering patients an approved treatment for the very first time.
News
Jazz’ Vyxeos wins EU nod for certain acute myeloid leukaemias
Dublin, Ireland-based Jazz Pharmaceuticals will be celebrating news of European approval of its leukaemia drug Vyxeos.
NICE u-turn recommends Ipsen’s Cabometyx for kidney cancer
NHS funding for Ipsen’s Cabometyx is now being recommended by the National Institute for Health and Care Excellence to treat kidney cancer.
Affimed ties with Roche in cancer immunotherapies deal
Shares in Affimed more than doubled on news that it has signed a deal with Roche group Genentech to develop immunotherapies for various cancers.
NHS England calls for mental health therapists in GP practices
NHS England says new guidance has been drawn up to encourage doctors to place mental health therapists in practice surgeries, to bring mental and physical health services “under one roof”.
NICE says ‘no’ to Gilead’s Yescarta in draft guidelines
NHS funding for Gilead’s freshly approved CAR-T therapy Yescarta has been turned down in draft guidelines by the National Institute for Health and Care Excellence.
Bayer, J&J’s Xarelto fails to hit PhIII targets
Bayer and Johnson & Johnson’s plans to expand the scope of blood thinner Xarelto have hit a setback after the drug failed to hit targets in two studies in venous thromboembolism and heart failure studies.
Bayer files marketing application for larotrectinib
Bayer has filed a marketing application in Europe seeking approval for larotrectinib as treatment for TRK fusion cancer.
EU approves first CAR-T therapies
European regulators have approved Novartis’ Kymriah and Gilead’s Yescarta, enabling patients to access CAR-T therapies across the region for the first time.
FDA rejects Akcea/Ionis’ rare disease drug Waylivra
US regulators have rejected Akcea/Ionis’ application to market Waylivra for the ultra-rare rare lipid disorder familial chylomicronemia syndrome (FCS).
Sales Awards: Less than two weeks left to enter – do it today
The all new Sales Awards will take place at The Tower Hotel, London on Thursday 15 November, alongside the Communications Team of the Year Awards and the 25th anniversary of Marketer of the Year. With the competition closing for entry in just two weeks and spaces filling up fast, PharmaTimes Media is calling on prospective candidates to reserve their places now to avoid missing out.
Communications Team of the Year: Nearly fully booked
Seize the opportunity to show off your skills and abilities as an agency in the Communications Team of the Year competition. With just one space left in the International Challenge, one in the NHS Challenge and limited availability in the Charity Challenge, agencies wishing to take part should reserve their place now to avoid missing out.
Marketer of the Year: Develop your skills and fulfil your potential
Marketer of the Year will celebrate its 25th anniversary at The Tower Hotel, London on Thursday 15 November, alongside Communications Team of the Year and the all-new Sales Awards. Designed to both assess and reward the competencies and potential of pharma marketers, the Marketer of the Year competition identifies and benchmarks marketing talent within pharma organisations against the wider industry.
Eisai/MSD’s Lenvima approved in Europe for liver cancer
Eisai and MSD’s Lenvima has won approval in the EU as a first-line treatment of patients with unresectable hepatocellular carcinoma (HCC).
Roche signs inclacumab deal with GBT
Roche has sold off rights to inclacumab to Global Blood Therapeutics, which intends to develop the treatment for vaso-occlusive crises (VOC) in patients with sickle cell disease (SCD).
