SUNNYVALE, Calif., May 22, 2015 /PRNewswire/ — Pharmacyclics, Inc. (NASDAQ: PCYC) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending a change to the terms of the marketing authorization for IMBRUVICA® (ibrutinib) in the European Union to indicate the treatment of adult […]

  German drugmaker Bayer expects the world’s largest economies to pool billions of euros in funding for the development of antibiotics against the growing threat of drug-resistant superbugs, its chief executive said on Friday.   “I expect a multinational fund for antibiotics research. One country alone can’t shoulder it,” CEO Marijn Dekkers told Germany’s Der […]

Amgen Inc said it will terminate a collaboration with AstraZeneca Plc to develop a psoriasis drug after it observed suicidal thoughts in the subjects of a trial.   Amgen said such safety concerns would likely result in a restrictive label that could limit the number of patients using the late-stage experimental drug, brodalumab. The company […]

  Amgen Inc’s closely watched new cholesterol drug, Repatha, has been recommended for approval in Europe, putting the U.S. drugmaker ahead in a race with rival Sanofi SA. Repatha, or evolocumab, belongs to a new class of cholesterol-lowering drugs known as PCSK9 inhibitors that have the potential to drastically reduce the risk of heart attacks when used […]

European regulators have recommended approval of Merck & Co Inc’s immune system-boosting cancer drug Keytruda, following a similar green light last month for Bristol-Myers Squibb Co’s rival product Opdivo. Merck’s drug, also known as pembrolizumab, was endorsed on Friday by the European Medicines Agency (EMA) for the treatment of melanoma. Both Keytruda and Opdivo are […]

Entresto. That’s the brand name Novartis has chosen for LCZ696, its new heart failure drug that is expected to be a blockbuster. The name won’t be final until official confirmation, which comes with FDA approval. But Novartis will introduce the name for the first time this weekend in presentations at the European Society of Cardiology Heart Failure meeting in Seville, […]

A “near miss” is how San Diego-based Otonomy Inc. (OTIC) describes the results of its Phase IIb clinical trial for OTO-104 for Ménière’s disease. The company could not be reached for a statement in time for deadline. The primary endpoint of the trial was decreasing the frequency of vertigo associated with Ménière’s disease in patients […]

THOUSAND OAKS, Calif., May 22, 2015 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced the Company has commenced termination of its participation in the co-development and commercialization of brodalumab with AstraZeneca (LON:AZN, STO:AZN and NYSE: AZN).  Brodalumab, an investigational IL-17 inhibitor, is in development for patients with moderate-to-severe plaque psoriasis, psoriatic arthritis, and axial spondyloarthritis.  The decision […]

Smokers who kick the habit could be hard-wired for success, thanks to greater communication between two regions of the brain that may play a role in controlling the urge to reach for cigarettes, a U.S. study suggests. Researchers reviewed brain scans of smokers who tried to quit and found the people who succeeded had something […]

A U.S. House of Representatives committee on Thursday unanimously approved a bill to speed new drugs to the market, overcoming last-minute wrangling over how to pay for the legislation. The bill, known as the 21st Century Cures Act, requires the Food and Drug Administration to incorporate patient experience into its decision-making, streamline its review of […]