19:20 , Apr 19, 2019 |  BioCentury  |  Politics, Policy & Law

Thin U.S. biosimilars market fuels proposals to regulate biologics prices

Frustration over the failure of biosimilars to slash the costs of decades-old biologics has prompted a group of policy analysts to suggest abandoning attempts to copy biologics. Because the sole purpose of biosimilars is to...
18:52 , Apr 17, 2019 |  BC Extra  |  Politics & Policy

Cummings defends drug price information request

House Energy & Commerce Committee Chairman Elijah Cummings (D-Md.) Wednesday denounced Jim Jordan (R-Ohio) for attempting to thwart the committee’s investigation into prescription drug prices. Cummings was responding to a letter Jordan sent on April...
20:54 , Apr 15, 2019 |  BC Extra  |  Clinical News

Invokana reduces composite endpoint by 30% in Type II diabetics with CKD

After years of failures in the CKD space, two agents have now shown efficacy in the indication. The latest is Invokana canagliflozin from Janssen, which said Sunday that Invokana is the only drug in nearly...
21:00 , Apr 12, 2019 |  BC Extra  |  Company News

J&J's Balversa gets accelerated approval for bladder cancer

FDA granted Janssen's Balversa erdafitinib accelerated approval to treat bladder cancer, making it the first FGFR kinase inhibitor to gain U.S. approval. Balversa is indicated to treat adults with locally advanced or metastatic urothelial carcinoma...
13:38 , Apr 12, 2019 |  BioCentury  |  Politics, Policy & Law

Compassionate use of gene therapies raises ethical, commercial quandaries

No matter how quickly gene therapies are developed, there will always be a gap between the news that a product may radically alter the course of a disease and the drug’s approval. Like other investigational...
22:41 , Apr 11, 2019 |  BC Extra  |  Company News

Medidata launches AI venture

Medidata launched Acorn AI to develop products that integrate clinical trial data with translational and real world information that could help life science companies and academic institutions identify responders in patient populations and improve trial...
22:48 , Apr 9, 2019 |  BC Extra  |  Company News

J&J opening Washington JLABS incubator next year

Johnson & Johnson Innovation LLC partnered with Children's National Health System on Tuesday to launch a JLABS incubator in Washington in 2020. The 32,000-square foot JLABS @ Washington, DC facility will have an emphasis on...
20:38 , Apr 9, 2019 |  BC Extra  |  Company News

Management tracks: Cyclerion, Alkermes, Alder

A week after completing its spinout from Ironwood, Cyclerion has hired Andreas Busch as chief innovation officer. Busch was EVP, head of R&D and CSO at Shire plc and previously served as EVP, head of...
17:03 , Apr 8, 2019 |  BC Extra  |  Politics & Policy

Reps. Jordan, Meadows accuse Cummings of 'partisan' drug pricing investigation

Two House Republicans have accused Rep. Elijah Cummings (D-Md.) of leading a partisan investigation into drug pricing, and implied he could leak biopharmas' sensitive, proprietary information. In letters sent to 12 biopharmas, Reps. Jim Jordan...
00:16 , Apr 6, 2019 |  BioCentury  |  Finance

Room to rally in 2Q

Strong small and mid-cap performance coupled with robust M&A has brought the sector back from 4Q18 correction territory, and chances are good for the momentum to continue given the ample capital ready to be recycled...