22:33 , May 24, 2019 |  BC Extra  |  Company News

Novartis breast cancer drug marks first approval of PI3Kα inhibitor

Piqray alpelisib became the first FDA-approved PI3Kα inhibitor on Friday, as well as the first novel drug approved under the agency's Real-Time Oncology Review pilot program. FDA approved the breast cancer drug about three months...
21:58 , May 24, 2019 |  BioCentury  |  Product Development

Why quizartinib hiccup at ODAC shouldn’t derail Daiichi’s 2025 cancer drug goals

FDA's ODAC may have given the thumbs down to Daiichi’s quizartinib, but a stocked pipeline and another ongoing trial of the candidate suggest it’s more of a hiccup than a hurdle in the Japanese pharma’s...
19:06 , May 22, 2019 |  BC Extra  |  Company News

Management tracks: Gottlieb re-joining NEA; plus Seattle Genetics, Celsius and more

Former FDA Commissioner Scott Gottlieb is joining New Enterprise Associates as a special partner. Gottlieb was a venture partner at the firm from 2007 to 2017. In his new role, Gottlieb will have a “deeper...
22:42 , May 21, 2019 |  BioCentury  |  Finance

Debt and equity investor K2HV seeks 'profit and purpose' in $400M launch

Newly launched venture debt and equity investor K2 HealthVentures says it will redirect some of its returns to "underserved and underinvested" areas of the life sciences and healthcare sphere as it invests the first $400...
12:00 , May 21, 2019 |  BC Extra  |  Financial News

Sequoia leads digital therapeutics company Biofourmis' $35M round

Biofourmis raised $35 million in a series B round to develop its AI-powered digital therapeutics platform for improving patient outcomes. The platform uses AI, drug intervention, wearable sensors and a smartphone app to remotely monitor...
22:18 , May 20, 2019 |  BioCentury  |  Product Development

Making Orphan drug prices work for society

The Orphan Drug Act worked too well. It didn’t just stimulate development of therapies for rare diseases, it reoriented huge swaths of the industry to the pursuit, all attracted by the high prices and product...
00:17 , May 18, 2019 |  BioCentury  |  Politics, Policy & Law

Cutting through the noise: the handful of pricing proposals the Trump administration or Congress may enact

Scores of proposals for reducing the cost of drugs are swirling around Congress, the White House and the U.S. Department of Health and Human Services, but only a few merit attention outside the beltway. Eliminating...
19:24 , May 17, 2019 |  BioCentury  |  Product Development

Pushing China to the forefront: When a first-in-China regulatory strategy makes sense

As reforms in China shorten clinical and regulatory timelines for biotechs across the board, the country has a growing chance to become the first stop for regulatory approvals of first-in-class drugs. The decision to do...
23:10 , May 16, 2019 |  BC Extra  |  Clinical News

Roche, Bayer unveil brain tumor data for NTRK inhibitors ahead of ASCO

Efficacy data for two tissue-agnostic NTRK inhibitors from Roche and Bayer to treat primary and metastatic brain tumors were released in abstracts ahead of the American Society of Clinical Oncology meeting in Chicago. Data from...
19:41 , May 16, 2019 |  BC Extra  |  Company News

Genentech adds to autoimmune pipeline with Parvus deal

In its second deal based on its immunomodulatory platform, Parvus granted Genentech rights to develop and commercialize its Navacim nanoparticle therapeutics to treat inflammatory bowel disease (IBD), autoimmune liver diseases and celiac disease. Parvus Therapeutics...