00:49 , Aug 17, 2019 |  BioCentury  |  Emerging Company Profile

Impact casting a wide synthetic lethality net

After laying the foundation with its PARP inhibitor, Impact plans to build a comprehensive synthetic lethality pipeline across known DNA damage repair targets and new ones outside of DDR to address a wider range of...
22:35 , Aug 5, 2019 |  BC Extra  |  Clinical News

Bladder cancer data gives Tecentriq another first-line win

With more positive data in first-line bladder cancer, Roche's Tecentriq could become the leading immunotherapy agent for the indication. An interim analysis of the 1,213-patient Phase III IMvigor-130 trial showed Tecentriq atezolizumab plus chemotherapy met...
19:24 , Jul 19, 2019 |  BC Extra  |  Company News

July 19 Company Quick Takes: First biosimilars of Avastin, Herceptin launched; plus Gilenya, Celltrion-Nan Fung and Celgene

Amgen, Allergan launch pair of biosimilars  Amgen Inc. (NASDAQ:AMGN) and Allergan plc (NYSE:AGN) launched Mvasi bevacizumab-awwb and Kanjinti trastuzumab-anns in the U.S.; they are the first biosimilars of Avastin bevacizumab and Herceptin trastuzumab available in...
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...