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...
07:00 , Apr 15, 2013 |  BC Week In Review  |  Company News

Third Wave sales and marketing update

Third Wave began selling its Cleavase Enzyme Technology Toolbox to the worldwide research market. Cleavase uses a group of structure-specific cleaving agents to sequence and detect nucleic acid. The product also can measure gene expression...
01:32 , Jun 9, 2012 |  BC Extra  |  Politics & Policy

EU's IMI details new research projects

The EU's Innovative Medicines Initiative announced details on its third wave of research projects that were launched in January with a total budget of EUR 215 million ($266.9 million) across five years. The projects include...
07:00 , Apr 6, 2009 |  BC Week In Review  |  Company News

Exact Sciences management update

Exact Sciences Corp. (NASDAQ:EXAS), Marlborough, Mass.   Business: Diagnostic, Cancer   Hired: Kevin Conroy as president, CEO and a director, formerly president and CEO of Third Wave Technologies Inc. (now part of Hologic Inc. );...
07:00 , Mar 23, 2009 |  BC Week In Review  |  Clinical News

16/18 genotyping HPV test regulatory update

FDA approved a PMA from Hologic for its Cervista HPV 16/18 test as an adjunct with the Cervista HPV HR test to detect HPV types 16 and 18 infection in women ages 30 and older...
07:00 , Mar 23, 2009 |  BC Week In Review  |  Clinical News

14-type high-risk HPV test regulatory update

FDA approved a PMA from Hologic for its Cervista HPV HR test to detect 14 high-risk types of human papillomavirus (HPV) infection in women ages 30 and older and to screen patients whose Pap smears...
08:00 , Nov 24, 2008 |  BC Week In Review  |  Clinical News

14-type high-risk HPV test diagnostic data

A U.S. study in >4,000 women showed that Cervista HPV detected 100% of grade 3 cervical intraepithelial neoplasia (CIN3), with a negative predictive value of 100%. The test had a 92.8% sensitivity for CIN2/3, with...
08:00 , Nov 24, 2008 |  BC Week In Review  |  Clinical News

16/18 genotyping HPV test diagnostic data

Data from a study showed that the Cervista 16/18 test had a negative predictive value of 99.5% for grade 3 cervical intraepithelial neoplasia (CIN3) and 97.7% for CIN2/3. Data were presented at the European Research...
07:00 , Jul 28, 2008 |  BC Week In Review  |  Company News

Hologic, Third Wave deal

Hologic completed its second tender offer for Third Wave, acquiring about 3 million additional shares for a total of about 48 million shares (95.8%). The remaining shares will be converted into the right to receive...
07:00 , Jul 21, 2008 |  BC Week In Review  |  Company News

Hologic, Third Wave deal

Hologic completed its previously announced tender offer for Third Wave, acquiring about 45 million shares (92.1%) at $11.25. Hologic started a subsequent tender offer for the remaining shares at the same price, which will expire...