The industry analysts at Thomson Reuters put their heads together to tap the biggest new blockbusters in the making this year and surprised no one by capping the list with Gilead's Sovaldi.
A group of FDA advisers voted resoundingly in favor of MannKind's inhaled insulin, lending momentum to the long-delayed drug as it makes its third run at an approval.
For most biotechs, the huge cost of a late-stage diabetes drug program is enough to shut down any discussion about pushing through alone to an approval. Intarcia, though, says it now has the money needed to do just that for new technology billed as a prospective game-changer for one of the world's most prevalent diseases.
After two FDA rejections, MannKind has returned with more data on its long-delayed inhaled diabetes drug, but regulators see Afrezza as anything but a slam-dunk case, raising questions over the treatment's safety and efficacy before a scheduled review.
European officials gave a green light to GlaxoSmithKline's once-weekly diabetes drug Eperzan (albiglutide). The GLP-1 drug is awaiting FDA approval, with a decision expected next month.
With its PDUFA date for the once-weekly diabetes drug albiglutide looming at the FDA next month, GlaxoSmithKline announced today that the European Commission has OK'd the GLP-1 drug for marketing.
Last year's stinging FDA rejection for Novo Nordisk's Tresiba wiped billions off the drugmaker's market cap, but, despite getting bogged down with new safety studies, the company believes it can still get its long-acting insulin on the market before its rivals can settle in.
The latest trial over Actos' bladder-cancer risks is set to begin. With thousands of other Actos cases pending against Takeda, the case already was destined to be closely watched. And now, one of the plaintiff's lawyers says he's planning to seek the largest verdict in Nevada history.
Johnson & Johnson and AstraZeneca will just have to duke it out for share of the market for SGLT2 treatments for diabetes. A potential third competitor from Eli Lilly and Boehringer Ingelheim, empagliflozin, failed to win FDA approval, thanks to problems at a Boehringer manufacturing plant.
The FDA has rejected one of Eli Lilly's top drug prospects partnered with Boehringer Ingelheim, saying that its SGLT2 drug empagliflozin could not be approved for marketing before Boehringer fixed "deficiencies" at one of its manufacturing facilities.