A US House Committee has strongly criticised the Food and Drug Administration (FDA) for carrying “in excess of $1,000,000,000 in unobligated [industry] user fees” halfway through the current financial year.
News
Elan raises eyebrows with ‘for sale’ move
The Elan-Royalty Pharma takeover saga has taken yet another turn after the Irish drugmaker announced that it is now officially up for sale.
Positive survival data for B-MS/AbbVie’s blood cancer drug
Bristol-Myers Squibb and AbbVie have unveiled new data from a mid-stage trial of their experimental monoclonal antibody elotuzumab, raising hopes that the drug could offer a signifiant benefit in progression-free survival (PFS) in patients with the blood cancer multiple myeloma.
Spain’s austerity healthcare cuts “putting lives at risk”
The austerity reforms being made by the Spanish government could lead to the effective dismantling of large parts of the country’s healthcare system, with potentially detrimental effects on the health of the Spanish people, researchers have warned, writing in the British Medical Journal (BMJ).
US Supremes compromise in landmark gene patent case
In an eagerly-watched case that will have a major bearing on future medical research, the US Supreme Court has ruled that human genes cannot be patented, but synthetic, or complementary, DNA can be.
Discount sees NICE yes for Alimera’s Iluvien
In draft guidance published today NICE says it is recommending Alimera’s Iluvien for certain patients with chronic diabetic macular oedema after the firm offered a price cut for its treatment.
Lilly halts AD trial, baricitinib impresses in RA
Eli Lilly has stopped a Phase II study for an investigational Alzheimer’s disease treatment due to potential liver problems.
Amgen’s Xgeva gets US nod for bone tumour
US regulators have given the green light for Amgen’s Xgeva in patients with a type of rare but not usually cancerous bone tumour.
ePharmaSolutions tools to support AZ iMed neuroscience trials
ePharmaSolutions, the US-based provider of eClinical solutions for trial sites, has teamed up with AstraZeneca’s ‘virtual’ neuroscience R&D unit to help the iMed researchers share and manage complex data on a common portal with investigators and other external partners.
Improvements in eight areas “could save CCGs £1.6B+ a year”
New research shows that improvements in just eight areas of NHS activity could save England’s 212 clinical commissioning groups (CCGs) more than £1.6 billion a year, or 2.5% of current hospital spend.
inVentiv Health partners With Medikly for physician engagement
inVentiv Health, the US-based provider of clinical development, commercialisation and consulting services, has boosted its capacity to recruit investigators for clinical research by teaming up with Medikly, a cloud-based platform for physician engagement.
ISPE survey to probe patient experiences with study IPs
Patient experiences with investigational products (IPs) are an important factor in ensuring clinical trials are conducted with optimal efficiency and safety, particularly in relation to protocol compliance.
New PhIII data raises hopes for Celgene’s apremilast
Celgene has unveiled late-stage data showing that its experimental drug apremilast induced “meaningful improvements” in the signs and symptoms of psoriatic arthritis in the long term, adding further weight to the package of data being used to seek regulatory approval.
NICE still backing GSK’s bleeding disorder drug
Patients with the bleeding disorder chronic immune (idiopathic) thrombocytopenic purpura are a giant step closer to being able to access GlaxoSmithKline’s Revolade (eltrombopag) on the National Health Service.
Pfizer/Takeda accept $2.15 billion to settle Protonix case
Pfizer shares were given a lift yesterday after it announced that a near 10-year patent infringement battle over Protonix has been laid to rest with a settlement of $2.15 billion.
