BioSpace News Archive

FDA

Incyte’s Jakafi Snags FDA Approval for Treatment of Steroid-Refractory Acute GVHD

The approval of Jakafi marks the first approved treatment for this indication in the United States.

May 28, 2019
·
2 min read
·
Alex Keown
Drug Development

Newron Pharma Delays Schizophrenia Trials Over Safety Concerns

The agency expressed concern over the results of recently finished studies in rats and dogs that showed central nervous system events that might have implications in humans.

May 28, 2019
·
3 min read
·
Mark Terry
Drug Development

Pfizer’s Lyrica Misses the Mark in Epilepsy Clinical Trial

The patients receiving Lyrica didn’t show a statistically significant reduction in seizure frequency compared to placebo.

May 28, 2019
·
2 min read
·
Mark Terry
FDA

Novartis Wins Approval for First-of-its-Kind Breast Cancer Treatment

The approval of Piqray combined with fulvestrant is the first FDA-approved treatment for patients with a PIK3CA mutation in HR+/HER2- advanced breast cancer.

May 28, 2019
·
2 min read
·
Alex Keown
FDA

FDA Approves Allergan’s Vraylar for Treatment of Bipolar Disorder

There are approximately 11 million adults in the U.S. living with bipolar disorder, a condition that causes extreme shifts in mood, energy and activity levels.

May 28, 2019
·
2 min read
·
Alex Keown
MiniMed(TM) 670G System Real-World Data on 8 Million Patient Days Shows 71 Percent Time in Range Across All Age Groups

Medtronic plc, the global leader in medical technology, announced real-world clinical outcomes for the MiniMed 670G system, which is being used by more than 180,000 people.

May 28, 2019
·
5 min read
Pharm Country

Soligenix Announces $600,000 Subaward Supporting Evaluation of Innate Defense Regulator Platform Technology as a Medical Countermeasure for Bacterial Threat Agents - May 28, 2019

Soligenix, Inc. announced that Soligenix will be participating in a biodefense contract for the development of medical countermeasures against bacterial threat agents, with Soligenix awarded a subcontract of approximately $600,000 over 3 years.

May 28, 2019
·
8 min read
Genetown

CENTOGENE iPSC Technology Solutions to Support Disease Modeling

In a whitepaper released, CENTOGENE provided an update on its induced pluripotent stem cells program.

May 28, 2019
·
2 min read
Medtronic EVP & CVG President Mike Coyle to Speak at Jefferies 2019 Global Healthcare Conference

Medtronic plc, the global leader in medical technology, announced it will participate in the Jefferies 2019 Global Healthcare Conference on Wednesday, June 5, 2019, in New York City.

May 28, 2019
·
1 min read
Business

Juvenescence’s Latest Venture, Souvien Therapeutics, Creating Innovative Medicines Addressing Neurodegenerative Diseases

Juvenescence is pleased to announce its latest biotech company Souvien Therapeutics, creating innovative medicines to address neurodegenerative diseases by targeting the epigenetic underpinnings of neurodegeneration.

May 28, 2019
·
3 min read