A Phase 3 study of an experimental treatment for chronic lymphocytic leukaemia and small lymphocytic lymphoma has been stopped early on efficacy grounds. The treatment, Imbruvica (ibrutinib) has been developed by Janssen Research & Development LLC.
The US Food and Drug Administration has issued a complete response letter (CRL) to Sanofi SA saying it can’t approve the company’s supplemental Biologics License Application for Lemtrada (alemtuzumab) for relapsing multiple sclerosis.
A group of international researchers has described how abnormalities in the human genome affect cognition, explaining why some people develop neurological diseases such as schizophrenia and autism, and others do not. The findings were reported online in the journal Nature on 18 December.
Europe’s political leaders have reached an agreement on a new set of rules for conducting clinical trials in the EU. A key feature of the new legislation will be the introduction of a single authorisation procedure for all trials instead of multiple procedures at present.
The European Medicines Agency is recommending that Sirturo (bedaquiline) be granted a conditional market authorisation for pulmonary multidrug-resistant tuberculosis as part of a combination therapy. The new drug has been developed by Janssen Therapeutics.
AstraZeneca Plc is to take full control of a portfolio of diabetes assets being managed jointly with Bristol-Myers Squibb (BMS) in order to strengthen its position in the market. The upfront payment to BMS is $2.7 billion with potential milestones of $1.4 billion.
The board of Algeta ASA is recommending that shareholders agree to a takeover offer from Bayer that values the company at NOK 362 ($58.7 per share) for a total of $2.9 billion. Bayer is Algeta’s partner for Xofigo, a recently approved radiopharmaceutical.
The US Food and Drug Administration has approved Anoro Ellipta, a new medicine for chronic obstructive pulmonary disease (COPD) developed by GlaxoSmithKline Plc. It is the second COPD medicine from GSK to receive US approval this year.
GlaxoSmithKline Plc has become the first Big Pharma company to eliminate individual targets for its sales executives, an incentive that critics say has distorted prescribing. It has also started a process to stop direct payments to doctors to attend medical conferences.
Cubist Pharmaceuticals Inc said that top-line results from a Phase 3 trial of its antibiotic candidate ceftolozane/tazobactam in complicated intra-abdominal infections met its primary endpoint of statistical non-inferiority compared with meropenem.