The US Food and Drug Administration has approved a new drug from CSL Behring in Germany to reverse anticoagulation in adults with acute major bleeding. To date, plasma has been the only other approved treatment in the US for this condition.
In another example of Big Pharma collaboration in the area of diabetes, Merck & Co Inc has announced plans to collaborate with Pfizer in the development and commercialisation of ertugliflozin, a Phase 3-ready diabetes drug in the SGLT2 class.
GlaxoSmithKline Plc has ended a collaboration with Impax Pharmaceuticals on a late-stage Parkinson’s disease drug, citing delays in the drug’s anticipated regulatory review and launch dates in countries where GSK has commercialisation rights.
The European Medicines Agency is recommending approval of a new advanced therapy medicinal product which is intended for the repair of cartilage defects. The product had been available in some EU countries, but now it will be widely traded.
MorphoSys AG has initiated a Phase 2 study of its proprietary antibody, MOR208, for patients with B-cell acute lymphoblastic leukaemia. The antibody is one of three in the clinic from the company’s internal portfolio. The study is taking place in the US.
Cytos Biotechnology AG has added senior staff in anticipation of its immune modulator for allergic asthma obtaining proof-of-concept. In its report for the first quarter, the company said it will investigate the product in 90 centres in Europe and North America.
Galápagos NV has raised €53.9 million in a private placement of its shares to institutional investors in the US and Europe. The proceeds will be used to fund its internal pipeline as well as to enable possible in-licensing deals.
Novartis has confirmed that sales will be flat this year as the loss of revenue from generic competition offsets growth from its patent-protected portfolio. The revenue impact of generic competition is expected to be about $3.5 billion.
The loss of patents on big revenue-generating medicines continued to weigh on AstraZeneca Plc as first-quarter revenue declined by 12% at constant exchange rates to $6.4 billion and core operating profit declined by 21% to $2.3 billion. The company expects that revenue for the year as a whole will decline by a mid-to-high single digit percentage.
GlaxoSmithKline Plc said it expects sales to grow by around 1% at constant exchange rates this year, despite a first-quarter outturn in which both turnover and operating profit declined. The quarterly performance was affected by one-off developments including the divestment of the group’s non-core over-the-counter medicines.