Schering-Plough Europe has withdrawn its European marketing authorisation application for the proposed asthma treatment, Zenhale (mometasone furoate/formoterol fumarate), the European Medicines Agency announced.
The US Food and Drug Administration has approved Kombiglyze, a new Type 2 diabetes drug that combines saxagliptin and metformin XR in a single tablet, according to the drug’s sponsors, AstraZeneca Plc and Bristol-Myers Squibb Co.
Privately-owned Biocartis SA of Switzerland and bioMerieux of France have entered into a strategic collaboration to co-develop assays for use in a number of healthcare-associated infections, sepsis and oncology.
The US Food and Drug Administration has approved a new indication for Cymbalta (duloxetine hydrochloride) to treat chronic musculoskeletal pain, including discomfort from osteoarthritis and chronic lower back pain.
The German biotech company, 4SC AG, has reported preliminary Phase 2a data for its small molecule drug for inflammatory bowel disease that showed a total response rate of 88.5% in patients who had been dependent on corticosteroids.
Wilex AG as become the latest company to invest in antibody-drug conjugate technology with the proposed acquisition of Heidelberg Pharma AG, a privately-held German company with a conjugate platform.
H. Lundbeck A/S has taken the unusual step of issuing minimum revenue and profit forecasts for the period 2012 to 2014, a time during which it will face increased generic competition and higher product sales and promotion costs.
Shire Plc reported strong third quarter results, partly because it was able to nearly triple sales of two drugs that compete directly with products that Genzyme Corp is having trouble supplying.
GlaxoSmithKline Plc is to pay approximately $60 million upfront for a licensing agreement and equity investment in the US-listed biopharmaceutical company, Amicus Therapeutics Inc, which is developing a product for Fabry disease.
The US Food and Drug Administration has issued a ‘complete response letter’ to Biodel Inc of Danbury, Connecticut rejecting its new drug application for Linjeta, a rapid-acting injectable regular human insulin for Types 1 and 2 diabetes.