Roche’s PD-L1 Companion Dx Approved
The FDA marked a first with its approval of Roche’s companion diagnostic Ventana PD-L1.
The assay is a companion diagnostic to Roche’s FDA approved immunotherapy treatment Tecentriq, used for metastatic urothelial cancer, a common type of bladder cancer.
Tecentriq is the first FDA-approved PD-L1 inhibitor and the latest of three in the broader class of PD-1/PD-L1 targeted biologics approved by the FDA.
The companion in-vitro diagnostic is not required for use of Tecentriq but is a method of evaluation for clinicians to evaluate PD-L1 status, respectively guiding immunotherapy options.
Biofrontera’s Drug-Device Combo Cleared
The FDA has approved Biofrontera’s drug-device topical Ameluz and BF-RhodoLED for treatment of mild to moderate actinic keratosis on the face and scalp, the German startup announced Wednesday.
The combination uses photodynamic therapy to target lesions caused by prolonged exposure to UV rays.
Ameluz was granted marketing authorization by the EMA in December 2011 for the same indication, and the device was approved in the EU in November 2012.
FDA Lifts Custom Ultrasonics’ Recall
The FDA has lifted a recall affecting Custom Ultrasonics’ automated endoscope reprocessors while the company carries out corrective actions, the company announced Monday.
The FDA ordered Custom Ultrasonics to recall its AERs last November, following a slew of infection outbreaks related to duodenoscopes, according to a company statement.
Moving forward, the company is working with the agency to correct its procedures and protocols. The lift does not apply to duodenoscopes.
J&J Gets in the 3D Printing Game
Johnson and Johnson is taking a step toward 3D printing technologies by inking a deal with HP to create customized medical devices.
Both companies have begun merging their scientific, clinical, material science and technological knowledge to develop on-demand customizable products in orthopedics, eye health and consumer products.
Using advances in data mining and software, 3D printing could enable patient-specific products, therapies and solutions that deliver better outcomes, better economics and improved global accessibility, J&J said.
Medtronic to Pick Up Smith & Nephew’s Business
Medtronic has entered into an agreement to acquire Smith & Nephew’s gynecology business for an estimated $350 million, the device giant announced Wednesday.
The acquisition will expand Medtronic’s collection of minimally invasive surgical offerings and enhance its existing GYN business.