FDA rejects alogliptin, but Takeda ‘remains confident’ (Weekend Rounds)

Life science current events this week include FDA rejects diabetes drug alogliptin, St. Jude and Abbott’s deal foreshadow future partnerships, and Blue Cross Blue Shield’s data spinoff grows.

A review of life science current events reported by MedCity News this week:

FDA rejects diabetes drug alogliptin; Takeda gives few CRL details. “We will immediately request a meeting with the FDA to determine the appropriate next steps and are committed to addressing outstanding issues,” Thomas Harris, vice president, regulatory affairs, Takeda Global Research & Development Center said in a statement. “We remain confident in the benefit that alogliptin will bring to patients with type 2 diabetes in the U.S., if approved.” (See also: Takeda, Furiex await FDA approval decision on diabetes drug Nesina.)

New St. Jude Medical and Abbott deal may be the model of the future. St. Jude Medical and Abbott announced Monday that they are expanding a marketing relationship, and striking a new distribution partnership such that they can present a bundled package of cardiovascular products to hospital customers. A medical device marketing expert said that because the two companies have complementary products the partnership brings a potential competitive advantage. That’s because hospitals are reducing the access of medical device sales force to physicians who tend to go for the newest, and thereby the most expensive technology, said Gunter Wessels, a consultant with Total Innovations Group Inc.

Health insurer Blue Cross Blue Shield’s data analysis spinoff looking to grow. Last year, health insurer Blue Cross Blue Shield Association spun off its data intelligence entity, known as Blue Health Intelligence. This year, the separate company is looking to raise $13.1 million.

FDA cites orthopedic medical device company over violations. Among the infractions by Extremity Medical cited in the warning letter dated Feb. 24 were two cases in which the company failed to submit a product experience report to the U.S. regulator after it became aware that a device it markets may have caused or contributed to a death or serious injury.

What Dennis Gillings told me about Quintiles during a chance encounter. We exchanged pleasantries and then I asked the Quintiles CEO what he thought about a recently announced move by a competing CRO. He laughed. So I followed up by asking him how Quintiles was doing. “Oh, we’re dead in the water, I’m afraid,” he deadpanned.