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.
AmpliPhi BioSciences Corp, which is developing new antibacterial therapies, has reached an agreement with funders to raise $18 million in a private share placement to support development of therapies that target Gram-negative bacterial infections.
The US Food and Drug Administration is tightening the oversight of antibiotics for the treatment of diseases in animals, and is calling on animal pharmaceutical companies to voluntarily stop their use as growth enhancers.
The proposed takeover of Elan Corporation Plc by Perrigo Company, a large US wholesaler of healthcare products and generic prescription drugs, has been approved by the Irish High Court paving the way for the completion of the deal on 18 December.