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...
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...
14:34 , Mar 14, 2019 |  BioCentury  |  Politics, Policy & Law

Love it or hate it, the myopic IPI won’t lower Medicare drug prices

The Trump administration has proposed that the U.S. pay similar prices to what companies charge in Europe, starting with drugs covered under Medicare Part B. The administration figures that pegging U.S. prices to an International...
17:28 , Mar 8, 2019 |  BC Week In Review  |  Clinical News

ImmunoGen down on Phase III ovarian cancer miss

ImmunoGen lost $2.21 (47%) to $2.51 on March 1 after reporting that mirvetuximab soravtansine missed the primary endpoint of improving progression-free survival (PFS) in the Phase III FORWARD I trial to treat FOLR1-positive, platinum-resistant ovarian...
01:10 , Mar 2, 2019 |  BioCentury  |  Product Development

Roche broadens its BD scope

Roche’s proposed acquisition of Spark Therapeutics Inc. is the pharma’s first major deal since James Sabry took over partnering, and could be a glimpse of what’s to come as the pharma broadens its horizons on...
20:29 , Mar 1, 2019 |  BC Extra  |  Clinical News

ImmunoGen down on Phase III ovarian cancer miss

ImmunoGen Inc. (NASDAQ:IMGN) lost $2.21 (47%) to $2.51 on Friday after reporting that mirvetuximab soravtansine missed the primary endpoint of improving progression-free survival (PFS) in the Phase III FORWARD I trial to treat FOLR1-positive, platinum-resistant...
21:56 , Feb 22, 2019 |  BioCentury  |  Politics, Policy & Law

Azar’s IPI: socialist or capitalist?

The Trump administration’s plan for an international reference pricing scheme for Medicare Part B drugs has provoked vituperative opposition from BIO, PhRMA and their allies who have branded it as an attempt to impose socialism....
00:41 , Feb 9, 2019 |  BioCentury  |  Product Development

Genentech takes the wheel

Roche has good cause to call on Genentech to prevent it from losing its long-standing dominance in cancer. While the pharma is late to the party in immuno-oncology, its former biotech unit is behind at...
18:55 , Feb 7, 2019 |  BC Week In Review  |  Clinical News

CHMP recommendations include Ajovy, Vizimpro, Humira biosimilars

EMA's CHMP recommended a basket of approvals and label extensions on Feb. 1, including Ajovy fremanezumab, Vizimpro dacomitinib and two Humira biosimilars. CHMP also backed an expanded label for Forxiga dapagliflozin to include Type I...
00:59 , Feb 7, 2019 |  BioCentury  |  Finance

Chinese Innovation: Threat or Opportunity?

Mounting techno-protectionism in response to China’s innovation drive seems destined to sap U.S. scientific leadership and entrepreneurial vigor, driving talent and capital to Europe and Asia. Biotech offers a compelling alternative to the current trend,...