The European Medicines Agency will undertake an accelerated review of bluebird bio’s LentiGlobin, a gene therapy for the treatment of transfusion-dependent beta-thalassemia.
News
Gilead strikes deal with NHS England on Yescarta access
Gilead has struck a deal with NHS England that allows some adults with lymphoma access to its “game-changing” CAR-T therapy Yescarta.
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The highly anticipated Medical & Scientific Excellence Awards close for entry in just a few weeks (31 October). This is your chance to stand out against the competition, enter now to get the recognition you deserve.
MHRA consults on new regulatory framework for ‘no-deal’ scenario
The Medicines and Healthcare products Regulatory Agency has launched a consultation seeking views on how its legislation and regulatory processes would have to be modified if the UK leaves the EU under a ‘no-deal’ scenario.
Use of Roche’s haemophilia A therapy Hemlibra expanded in the US
Roche’s Hemlibra has been approved in the US for routine prophylaxis of bleeding episodes patients with haemophilia A without factor VIII inhibitors.
EU accepts marketing application for Paratek’s antibiotic
European regulators have accepted an application from Paratek Pharmaceuticals seeking approval of the broad-spectrum antibiotic omadacycline for two types of infection.
PRIME status for Orchard’s gene therapy
The European Medicines Agency has granted Orchard Therapeutics’ experimental gene therapy OTL-300 PRIME designation as a potential treatment for the most severe form of beta-thalassemia.
NHS England widens GP recruitment drive to Australia
NHS England is targeting Australia in its latest drive to boost GP numbers.
Roche unveils PhIII data for flu drug
Roche has unveiled late-stage data showing that its experimental antivrial drug baloxavir marboxil hit efficacy and safety targets in patients with flu.
Sandoz launches second digital health competition
Novartis’ generics arm Sandoz has launched the second Healthcare Access Challenge (HACk), which is looking to support digital solutions to local healthcare access challenges.
Gov’t unveils intent to improve cancer diagnosis
The government has announced plans to improve the diagnosis of cancer, with the aim of detecting three out of four cases at an early stage by 2028.
Recardio halts UK heart trial on Brexit uncertainty
Medical research group Recardio has reportedly halted a trial of an experimental heart drug because of uncertainties surrounding the UK’s departure from the European Union.
Medherant awarded manufacturing grant from Innovate UK
Medherant has been awarded a grant by Innovate UK to help it upscale production of its TEPI Patch drug delivery system for clinical trials.
Preliminary NICE ‘no’ for Takeda’s Alunbrig
Draft guidelines from the National Institute for Health and Care Excellence do not recommend NHS funding for Takeda’s lung cancer drug Alunbrig.
Green light for acne drug Seysara in the US
US regulators have approved Paratek’s Seysara for the treatment of acne in patients aged nine years or older.
