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19177 items
6:53 PM, Feb 16, 2018  |  BioCentury | Product Development

Necessary adjustment

Changing a pivotal trial’s primary endpoint analysis after the study is under way is usually not a good sign. So when Bristol-Myers Squibb Co. revealed top-line results from the CheckMate -227 trial in a biomarker-defined...
6:09 PM, Feb 16, 2018  |  BioCentury | Politics, Policy & Law

FDA’s bigger piggy bank

FDA plans to use a proposed record-setting funding boost to invest in projects it believes could lead to fundamental improvements in the way medical products are tested, reviewed and manufactured. The goal is to use...
4:24 PM, Feb 16, 2018  |  BioCentury | Product Development

This year’s model

Companies are answering FDA’s push for model-informed dose optimization in cancer by modeling how tumors grow and how tumor kinetics relate to outcomes. The models can support dosing decisions and help companies make faster, better...
2:59 PM, Feb 16, 2018  |  BioCentury | Finance

Earnings on deck

Earnings on deck At least six profitable biotechs and pharmas are slated to report earnings this week. (A) 12-month EPS CompanyDatePre/post mkt4Q17 EPS est4Q16 EPSExpected chgUnited Therapeutics Corp. (NASDAQ:UTHR)2/21Pre$3.89$2.4956%Anika Therapeutics Inc. (NASDAQ:ANIK)2/21Post$0.44$0.54-19%Genmab A/S (CSE:GEN)2/21PostDKK9.79DKK13.62-28%Ligand Pharmaceuticals Inc. (NASDAQ:LGND)2/21Post$1.14$1.25-9%UCB...
1:31 PM, Feb 16, 2018  |  BioCentury | Finance

Listing single

Chinese cancer company 3D Medicines Corp. is vying for a Hong Kong or NASDAQ listing this year and is restructuring as a Cayman Islands-based entity in order to tap public funds while keeping its diagnostics...
1:18 PM, Feb 16, 2018  |  BioCentury | Finance

Global access

Vivo Capital could help InnoCare Pharma Ltd. seek global development partners as the Chinese cancer and autoimmune company evaluates its first four candidates in the clinic. Vivo, a new investor, led an untranched $55 million...
12:04 PM, Feb 16, 2018  |  BioCentury | Finance

Quark gets specific

Abac Therapeutics S.A.’s targeted approach to antibiotic development led Quark Venture to join the company’s €16 million ($19.6 million) series A round, which will enable it to bring its lead program into the clinic. Pontifax...
10:26 AM, Feb 16, 2018  |  BioCentury | Emerging Company Profile

Synthetic speed

Vaxxilon AG is developing synthetic carbohydrate vaccines for bacterial infections that are designed to be quicker and less expensive to manufacture, and easier to store than traditional conjugate vaccines. “It’s an order of magnitude different...
5:22 PM, Feb 09, 2018  |  BioCentury | Finance

Foundation validation

The not-for-profit Cystic Fibrosis Foundation is putting its weight behind a new approach to treating CF through a $25 million award to Corbus Pharmaceuticals Holdings Inc. (NASDAQ:CRBP). Corbus plans to use the award to validate...
5:00 PM, Feb 09, 2018  |  BioCentury | Finance

What Woodford worries?

A trio of U.K. life science investors don’t expect the recent lackluster performance of Neil Woodford to weigh on local biotechs looking to raise money. The high profile investor’s largest fund, Woodford Equity Income Fund, saw...