Genomic & Biopharma News

Pfizer switches RA patients to lower dose of fast-growing Xeljanz as safety issues arise in postmarketing study
Pfizer moved rheumatoid arthritis patients to a lower Xeljanz dose after a data monitoring board highlighted safety concerns for the 10-mg arm in a postmarketing study.
Fierce Pharma, 2019-02-20 16:08:10

Medtronic launches ‘brain pacemaker’ implant for reducing epileptic seizures
By delivering controlled electrical pulses to a portion of the brain linked to memory and alertness—and which forms part of a network involved in seizures—Medtronic aims to treat medication-resistant epilepsy patients using a deep brain stimulation implant similar to a cardiac pacemaker.
Fierce Biotech, 2019-02-20 15:56:58

‘Organic’ growth and ‘pivoting’ at Bausch Health? One analyst begs to disagree
One key word that was repeated over and over on Bausch Health’s fourth-quarter earnings call was “organic,” as management tried to convince investors that it is pivoting away from some old bad habits. But one analyst wasn’t buying it.
Fierce Pharma, 2019-02-20 15:49:14

Electronic Sun Sentinel: Gene analysis lab moves to Deerfield Beach

ORB Company News, 2016-12-02 21:24:27

Turbulent times for Xencor as FDA slaps hold on AML bispecific
Last month, Xencor's partner Novartis returned the rights to a bispecific antibody it had licensed as part of a 2016 deal worth up to $2.41 billion. Now a second asset from that deal, in development for acute myeloid leukemia (AML), has hit a snag in the form of a partial clinical hold from the FDA.
Fierce Biotech, 2019-02-20 15:25:15

Pfizer, Merck, J&J well-positioned for M&A and Biogen and BioMarin are prime targets: report
M&A will help the biopharma industry deal with significant new challenges, Morningstar said in a new report, including pressure from lawmakers and payers to lower prices. As companies look for deals to boost their pipelines, oncology, neurology and rare-disease therapeutics will emerge as sought-after assets, the analysts predicted.
Fierce Pharma, 2019-02-20 15:00:04

Intuitive Surgical receives FDA clearance for its lung cancer biopsy robot
Robotic surgery giant Intuitive Surgical has received an FDA clearance for its minimally invasive lung cancer biopsy system, which features a thin, articulating catheter designed to snake its way through the airway to the periphery of the organ.
Fierce Biotech, 2019-02-20 14:50:44

Electronic Sun Sentinel: Gene analysis lab moves to Deerfield Beach

ORB Company News, 2016-12-02 21:24:27

FDA Grants Priority Review to Keytruda-Inlyta Combo for Untreated, Advanced Kidney Cancer Patients

Immuno-Oncology News, 2019-02-20 14:38:10

Teva, FTC enter expanded settlement barring certain 'pay-for-delay' deals for 10 years
Years after Teva Pharmaceutical Industries entered an FTC settlement on "pay-for-delay" deals, the parties on Tuesday expanded the agreement.
Fierce Pharma, 2019-02-20 14:29:58

Young Blood Unproven as Anti-Aging Treatment: US FDA
The agency warns that plasma treatments costing thousands of dollars, which supposedly treat the infirmities of old age, have not been proven "safe or effective."
The Scientist, 2019-02-20 14:13:13