Five years after the FDA formally rejected J&J's Yondelis (trabectedin) for ovarian cancer, and three years after an aborted effort to get it back on track, the pharma giant has finally made its way back to the agency for another try at an approval--this time as a treatment for soft tissue sarcoma.
Johnson & Johnson is following in the footsteps of pioneers like Novartis, Celgene and GlaxoSmithKline, inking a discovery-stage development deal--but turning to the little-known Transposagen Biopharmaceuticals to make its entry.
Boston Scientific and Johnson & Johnson are gearing up for a courtroom showdown, as the companies prepare for a multibillion-dollar trial over a breach-of-contract suit related to a failed bidding war for devicemaker Guidant.
Johnson & Johnson's Ethicon unit scored a victory in its ongoing vaginal mesh litigation as a federal judge in Texas tossed out 76 liability lawsuits related to the company's pelvic mesh devices.
The only FDA-approved, wearable cancer treatment device may expand its reach. A Phase III trial of Optune (NovoTTF-100A System) from Novocure was halted early due to statistically significant efficacy for the device in combination with chemotherapy to treat newly diagnosed glioblastoma patients.
Days after finally getting the FDA's go-ahead to resume the stop-and-start development of its lead candidate, Geron has signed a deal to cut Johnson & Johnson in on the process, putting the biotech in line for as much as $935 million if all goes according to plan.
China's registration review process for imported medical devices and in vitro diagnostics has been shortened under new China FDA importation regulations that took effect last month, and companies that fail to follow the guidelines will not get a second chance, meaning any mistakes could prove fatal to a product's chances in China.
A couple of years ago, Dendreon sold off a manufacturing plant to Novartis for $40 million-plus to raise some quick cash. Now, someone can pick up its two remaining manufacturing facilities, a logistics center and headquarters in Seattle and its one-time promising drug, Provenge, for as little as $275 million.
Ironically, Johnson & Johnson is suing Boston Scientific for preventing it from acquiring ill-fated stent maker Guidant, thereby sparing the plaintiff from the $6 billion-plus in write-offs that Boston Scientific has incurred in the years following its 2006 acquisition.
Bribery and pricing investigations aren't scaring Johnson & Johnson away from China. CEO Alex Gorsky tells The Wall Street Journal that his company is expanding full speed ahead in the fast-growing emerging market--and is actively looking at deals there to boost pharma sales.