21:35 , Mar 18, 2019 |  BC Extra  |  Company News

Biohaven spends $105M for faster review of oral CGRP inhibitor

Biohaven bought a $105 million Priority Review voucher from GW Pharmaceuticals to expedite the entry of its oral migraine therapy into the CGRP inhibitor market. It plans to use the voucher on an NDA for...
21:01 , Mar 15, 2019 |  BC Extra  |  Company News

ICER suggests Novartis' MS therapy siponimod won't be cost-effective

ICER said the price of multiple sclerosis therapy Mayzent siponimod from Novartis would have to reach a monthly net price of $995 to meet its standard cost-effectiveness threshold of $150,000 per QALY. That price would...
22:35 , Mar 14, 2019 |  BC Extra  |  Company News

Management tracks: Sandoz CEO steps down, C4T hires NIBR's Crystal as CMO

Richard Francis said he will step down as CEO of Sandoz , the biosimilars and generics unit of Novartis AG (NYSE:NVS; SIX:NOVN), effective March 31. Francis said Thursday, "As we announced earlier this year, Sandoz...
22:24 , Mar 14, 2019 |  BC Extra  |  Company News

Germany strikes outcomes-based deal with Novartis for Kymriah

CAR T therapy Kymriah tisagenlecleucel will be available in Germany under an outcomes-based payment model, the country's first such agreement for a gene or CAR T cell therapy. Novartis AG (NYSE:NVS; SIX:NOVN) and German health...
13:06 , Mar 13, 2019 |  BC Innovations  |  Distillery Therapeutics

ACVR2B as target for heart failure

DISEASE CATEGORY: Cardiovascular INDICATION: Heart failure Patient sample and mouse studies suggest inhibiting ACVR2B could help treat heart failure. In 50 adults with severe aortic stenosis and heart failure, high plasma levels of activin A,...
21:38 , Mar 12, 2019 |  BC Extra  |  Company News

Oxford BioMedica, Microsoft join on digital tools to optimize lentiviral production

In the latest example of how digital computing is increasingly interfacing with biomanufacturing to optimize yields and purity, Oxford BioMedica on Tuesday entered a two-year R&D collaboration with Microsoft to identify the optimal conditions for...
01:35 , Mar 9, 2019 |  BioCentury  |  Regulation

Gottlieb’s exit interview

FDA Commissioner Scott Gottlieb sat down with BioCentury after announcing his resignation to discuss his approach to promoting medical product innovation, the importance of strategic communications, and how a reorganization will bring FDA drug reviews...
01:56 , Mar 8, 2019 |  BC Innovations  |  Targets & Mechanisms

Oral insulin innovation

While clinical data suggest an oral insulin product may finally be within reach, the technology struggles to compete with injectables on price and efficacy. A handful of academics and companies are pushing preclinical innovation in...
00:27 , Mar 8, 2019 |  BC Innovations  |  Targets & Mechanisms

Flipping the switch in immuno-oncology

Tumor myeloid cells are emerging as prime candidates for filling a hole in the immuno-oncology tool box, offering targets that can simultaneously release the brakes and rev up the gas in the immune system. As...
22:34 , Mar 7, 2019 |  BC Extra  |  Preclinical News

Beyond cancer: CAR T cells treat lupus in mice

University of Tennessee researchers have shown that CD19-targeted CAR T cells could help treat lupus, suggesting the approach could be applied to diseases beyond cancer. Systemic lupus erythematosus (SLE) is an autoimmune disease characterized by...