GlaxoSmithKline has filed for approval of a subcutaneous formulation of its lupus drug Benlysta on both sides of the Atlantic.
News
NICE clears Gilead’s pan-genotypic hep C drug Epclusa
The National Institute for Health and Care Excellence is endorsing Gilead’s pan-genotypic hepatitis C drug Epclusa for routine NHS use in England and Wales.
Latest SBRI comp offers £1.1m for GP innovations
NHS England investment fund SBRI Healthcare has launched its autumn competition offering entrepreneurs the opportunity for funding to drive forward their innovations within general practice.
FDA approves the first Humira biosimilar
US regulators have issued a green light for the first biosimilar of AbbVie’s biologic Humira, the world second best-selling drug.
EU approves Truberzi for IBS-D
European regulators have issued a green light for Allergan’s Truberzi, giving patients potential access to the first approved treatment for irritable bowel syndrome with diarrhoea (IBS-D).
Lundbeck reveals Alzheimer’s drug trial failure
Lundbeck has announced that the first late-stage trial of its experimental Alzheimer’s disease candidate idalopirdine failed to hit its primary targets.
NHS England unveils funding plan for general practice
NHS England has published guidance confirming further local recurrent funding to improve and increase capacity in general practice.
Trial shows personalised medicine benefit in cancer patients
A clinical trial involving patients with advanced cancers is the first of its kind to show the benefit precision medicine can have on delaying tumour recurrence.
AstraZeneca pulls application for ovarian cancer drug
AstraZeneca is pulling back its application to market ovarian cancer drug cediranib in Europe, marking the end of the line for the drug’s development in combination was chemotherapy.
Gilead pulls plug on ulcerative colitis drug
Gilead Sciences has pulled the plug on a combined Phase II/III clinical study of GS-5745 testing the investigational anti-MMP9 antibody in patients with moderately to severely active ulcerative colitis.
UN signs historic declaration to fight AMR
A historic declaration to combat antimicrobial resistance has been signed by 193 countries at a United Nations General Assembly.
NICE backs restricted use of Alexion’s Strensiq
Cost regulators for NHS treatments in England and Wales have recommended use of Alexion’s Strensiq to treat a rare and often fatal condition called hypophosphatasia (HPP), but have restricted its reach to children with certain forms of the condition.
Bayer and Evotec form kidney disease research pact
Bayer and Evotec have signed a five-year, multi-target research pact to develop clinical candidates for the treatment of chronic kidney diseases.
Allergan buys Tobira for up to $1.7bn
Ireland-based Allergan is buying US biotech Tobira Therapeutics in a deal potentially worth up to $1.7 billion, as well as Akarna Therapeutics in a deal worth at least $50 million, securing itself access to a batch of experimental therapies for nonalcoholic steatohepatitis (NASH).
BMS’ Opdivo gets EU review for bladder cancer
Bristol-Myers Squibb’s immunotherapy Opdivo has taken big step towards European approval in bladder cancer, after regulators validated the firm’s marketing application, kick-starting the European Medicines Agency’s centralised review process.
