01:58 , Jun 29, 2019 |  BioCentury  |  Finance

Biotech backs down in 2Q19

In a reversal from 1Q19, biotech stocks across all market cap tiers fell in the second quarter, leading to a total loss of $22.3 billion. However, the year-to-date change in market cap remains well in...
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...
22:02 , Jun 28, 2019 |  BioCentury  |  Product Development

How small companies can leverage big changes in rare diseases

Small companies bring to the table a range of advantages over large ones when it comes to rare diseases, according to Ovid CEO Jeremy Levin. But he’s learned the hard way that it doesn’t help...
23:49 , Jun 7, 2019 |  BioCentury  |  Politics, Policy & Law

Levitating Levin: new chair’s ambitious plans to elevate BIO

Jeremy Levin has been talking for years about ways to elevate biopharma business practices and public policy to bypass obstacles that hold back biomedical innovation. As BIO’s new chair, he has a chance to try...
21:19 , May 17, 2019 |  BioCentury  |  Emerging Company Profile

89bio: standing out in the NASH crowd

89bio thinks it can differentiate itself from companies targeting NASH as an inflammatory and fibrotic disease by attacking it as a metabolic disorder and addressing its root cause with an FGF analog that could be...
21:57 , May 16, 2019 |  BC Extra  |  Company News

Gilead defends Truvada pricing during House hearing

Chairman and CEO Daniel O'Day defended Gilead's pricing of HIV PrEP drug Truvada at a congressional hearing Thursday. Democrats led by House Oversight and Reform Committee Chair Elijah Cummings (D-Md.) pressed O'Day on the price...
00:31 , May 15, 2019 |  BioCentury  |  Finance

Sofinnova Investments-led syndicate forms CV play CinCor with $50M, Roche castoff

Picking up one of Roche’s few remaining clinical cardiometabolism assets, Sofinnova Investments has joined Sofinnova Partners, 5AM Ventures and CinRx to launch CinCor with a $50 million series A and exclusive, worldwide rights to the...
18:21 , May 3, 2019 |  BC Week In Review  |  Company News

Express Scripts excludes rare disease drugs Onpattro, Ingrezza

Express Scripts excluded from its 2019 preferred formulary two rare disease therapy, Alnylam's amyloidosis drug Onpattro patisiran and Neurocrine's tardive dyskinesia drug Ingrezza valbenazine. Each are one of two approved drugs in their respective indications....
21:28 , May 2, 2019 |  BC Extra  |  Company News

May 2 Company Quick Takes: Agios, Celgene/Presage, Purdue, Amgen/Syapse

Label expansion in AML for Agios’ Tibsovo  FDA approved an sNDA for Tibsovo ivosidenib from Agios Pharmaceuticals Inc. (NASDAQ:AGIO) as monotherapy for adults with newly diagnosed acute myelogenous leukemia (AML) with a susceptible isocitrate dehydrogenase...
22:52 , Apr 26, 2019 |  BC Extra  |  Company News

European regulatory roundup: CHMP opinions and a Portola approval

EMA's CHMP recommended a basket of approvals, including Dovato dolutegravir/lamivudine, Libtayo cemiplimab and two orphan therapies. Also Friday, the European Commission granted conditional approval to Ondexxya andexanet alfa from Portola Pharmaceuticals Inc. (NASDAQ:PTLA) to reverse...