20:38 , Jul 3, 2019 |  BC Extra  |  Company News

After negative panel vote, FDA approves Karyopharm's multiple myeloma drug

FDA evidently saw enough data from an ongoing confirmatory trial to grant accelerated approval to Karyopharm's Xpovio selinexor to treat relapsed or refractory multiple myeloma. During the drug's extended review, the new data added to...
23:48 , Jun 28, 2019 |  BC Extra  |  Company News

June 28 Company Quick Takes: FDA approves Pfizer's biosimilar of Avastin; plus Aimmune, PeptiDream, Novartis and Just/Teva

Pfizer gets second FDA-approved biosimilar with Zirabev approval  FDA approved Zirabev bevacizumab-bvzr from Pfizer Inc. (NYSE:PFE) to treat metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell long cancer; recurrent glioblastoma; metastatic...
22:29 , Jun 21, 2019 |  BC Extra  |  Politics & Policy

China drafts guidelines for use of real-world data

Five months after FDA released a framework for use of real-world data in drug development, China’s Center for Drug Evaluation followed with its first guidelines for the data in May, which the country’s large population...
23:54 , Jun 19, 2019 |  BioCentury  |  Regulation

Why China’s 4 + 7 policy is good news for innovative drug developers

China’s new policy on generic drugs is likely to have knock-on benefits for drug developers aiming to bring innovative compounds to the China market. For multinationals, it will come after some pain, as they’ll see...
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...