The labeling logo is designed to encourage doctors and patients to report side effects, as part of a new effort to more closely monitor drug safety. The list of 100-plus products includes all new drugs and biologics approved since January 2011.
The well-armed German pricing gatekeepers have dismissed two more Big Pharma drugs. Pfizer's ($PFE) lung cancer treatment Xalkori and the Bristol-Myers Squibb ($BMY)/AstraZeneca ($AZN) diabetes drug Komboglyze both got an initial thumbs-down from the Institute for Quality and Efficiency in Health Care (IQWiG).
Computer-designed drugs have come of age. More than two decades after industry pioneer Joshua Boger set sail from Merck to start Vertex Pharmaceuticals ($VRTX) to advance structure-based drug design, the industry has seen multiple drugs discovered with the help of computers reach the finish line with FDA approvals.
Personalized medicine takes another step forward, as scientists from Pfizer and South Korea make progress developing a diagnostic test that can quickly and cheaply identify patients who can benefit from the company's lung cancer drug Xalkori (crizotinib).
Pfizer's U.S. sales reps are updating their résumés. The company's primary care sales force faces another round of job cuts, numbers as yet unspecified. The laid-off reps--to be notified Dec. 20, Dow Jones reports--will join thousands of previous patent-cliff casualties.
With the European Society of Medical Oncology meeting in Vienna, the cancer-drug studies are dropping like autumn leaves. But that's not all the cancer news today. As if to piggyback on the ESMO headlines, insurers and regulators have chipped in with their own oncology developments
With its lead drug ponatinib on track to a likely approval in the U.S. and Europe, Ariad Pharmaceuticals ($ARIA) moved center stage at ESMO 2012 over the weekend with an early-stage cancer drug that produced some impressive results among a small population of non-small cell lung cancer patients.
The companies were among several winners of positive recommendations from the EMA's Committee for Medicinal Products for Human Use (CHMP) on Friday, and their nods represent two cases where the FDA has beat its EU counterpart to the punch.
E.U. regulators have recommended Pfizer's kidney cancer drug Inlyta be approved for use in patients who don't respond to other medications.
Some of the biggest headlines coming out of the massive ASCO abstract release aren't focused on a promising experimental treatment. They're about Pfizer's recently approved treatment Xalkori.