The European Medicines Agency has started an infringement procedure against Roche for alleged deficiencies in its medicine-safety reporting system. It is the first time the agency has started a procedure of this kind against a company.
Eli Lilly and Company said that three Phase 3 studies of dulaglutide, its glucagon-like peptide 1 (GLP-1) treatment for Type 2 diabetes, met their primary endpoints and showed superiority in reducing blood sugar levels compared with exenatide and two other drugs.
The US Food and Drug Administration has expanded the approved indication for an artificial heart valve manufactured by Edwards Lifesciences Corp to include patients with aortic valve stenosis who are eligible for surgery but at a high risk of complications.
The US Food and Drug Administration has approved ocriplasmin (Jetrea), the first pharmaceutical product for treating for symptomatic vitreomacular adhesion, which occurs when the vitreous gel of the eye fails to detach from the retina.
Roche reported a 15.3% increase in turnover to CHF 11.3 billion (€9.3 billion) in the third quarter on the strength of sales of three established drugs, MabThera (rituximab), Herceptin (trastuzumab) and Avastin (bevacizumab).
Wilex AG’s lead cancer product – an antibody for renal cell carcinoma – has failed in a Phase 3 trial. The antibody, Rencarex (girentuximab), was already partnered and had been given fast track review status by the US Food and Drug Administration.
Johnson & Johnson Development Corp, a unit of Johnson & Johnson Inc, has completed the DKK 475 million ($82 million) purchase of 10.7% of the enlarged share capital of Genmab A/S as part of a previously announced collaboration.
Merck & Co. Inc has agreed to pay €110 million upfront to AiCuris GmbH & Co of Germany to gain access to its medicines targeting human cytomegalovirus, including a candidate antiviral which has been given ‘fast track’ designation by the FDA.
Addex Therapeutics Ltd of Switzerland has raised $10.3 million in a private placement of its shares with international, institutional investors to support the development of its pipeline of small molecule drugs based on allosteric modulation technology.
The non-profit drug developer, Aeras, has signed an agreement with GlaxoSmithKline Vaccines SA to advance the clinical development of a new vaccine against tuberculosis. A Phase 2b trial of the vaccine is scheduled to start in Kenya, India and South Africa.