Eight months after Johnson & Johnson committed to a $1.1 billion deal package to partner on Genmab's cancer antibody daratumumab, the FDA has blessed the Phase I/II program with its new "breakthrough" designation.
Hangzhou, China-based Ascletis aims to develop the candidate, called TMC310911, as an affordable and superior treatment for HIV patients in China, company CEO Jinzi Wu told FierceBiotech in an interview.
The German biotech Evotec and Johnson & Johnson have the inside track on drug development based on a Harvard lab's discovery of a hormone that spurs replication of insulin-producing beta cells. The finding opens the door to a novel mechanism for treating diabetes, yet researchers caution that the impressive data in mice have some time to go before they are replicated in humans.
Pfizer has big expectations for its oral rheumatoid arthritis treatment Xeljanz--about $3 billion worth. But those expectations were struck a serious blow when European Medicines Agency regulators Thursday turned it down for approval.
With a new late-stage study being prepped for the Alzheimer's drug solanezumab, Eli Lilly found itself in a London courtroom this week defending itself against a patent claim by Johnson & Johnson, one of its chief rivals in the risky game of Alzheimer's drug development.
Last month, Johnson & Johnson voluntarily recalled three models of its market-leading LifeScan glucose meters, and now the FDA has slapped a Class I label on the stateside effort, warning that use of the device could lead to serious injury or death.
While the success rate in developing new disease treatments remains alarmingly low, a cadre of R&D executives from some of the world's biggest drug developers insisted at BIO that they've zeroed in on a number of ways to boost the chance a promising drug will actually reach patients.
In its first-quarter earnings confab, J&J made good on CEO Alex Gorsky's pledge to get the company's troubled OTC manufacturing plants in shape and return the consumer health business to a growing top line.
Johnson & Johnson, Abbott, St. Jude Medical and Quest Diagnostics are already experiencing new declines in demand for non-emergency medical devices and diagnostic tests. And that reality will likely spread to their competitors, Reuters reports. Blame the gradual ramp-up of the Affordable Care Act, which is likely to broaden the trend through much of the med tech industry in the months ahead.
Johnson & Johnson has sold 82 million Elan shares for $11.25 per share as part of Elan's $1 billion stock buyback plan, providing J&J's Janssen unit an after-tax gain of $213 million. The "Dutch Auction" price for Elan's buyback has implication for Royalty Pharma's ongoing efforts to acquire the Ireland-based biotech for up to $7.3 billion.