BioSpace News Archive

FDA

Qiagen Wins Nod to Roll Out Its Diagnostic Test in Lung Cancer

The approval extends the labeling claim to include detection of EGFR mutations L681Q, G719X and S768I to aid the identification of NSCLC patients for whom GILOTRIF is indicated.

January 18, 2018
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1 min read
Policy

Statement From FDA Commissioner Scott Gottlieb, M.D., on New Policy Steps for Strengthening Public Warning and Notification of Recalls

Americans depend on the U.S. Food and Drug Administration to help ensure that the products they buy are safe.

January 18, 2018
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4 min read
Business

Dow R. Wilson to Join Agilent’s Board of Directors

Agilent Technologies Inc. today announced that Dow R. Wilson, CEO of Varian Medical Systems, has been elected to its board of directors, effective March 20, 2018.

January 18, 2018
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2 min read
Biotech Beach

Ligand Establishes Program to Develop Captisol-Enabled, Next-Generation Contrast Agents for Diagnostic Imaging

The program will leverage Ligand’s patented Captisol technology, as well as data and intellectual property obtained through its acquisition of Verrow Pharmaceuticals.

January 18, 2018
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7 min read
Business

Zimmer Biomet Holdings Announces Audio Webcast and Conference Call of Fourth Quarter and Full-Year 2017 Results

A news release detailing the quarterly and full-year results will be made available at 7 a.m. Eastern Time the morning of the conference call.

January 18, 2018
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1 min read
Policy

Medizone Determines Regulatory Pathway for the AsepticSure System, a Revolutionary Disinfection Technology, Following Meeting With U.S. FDA

The company has reached decisions regarding the regulatory pathway for approval of the system and the additional information that must be generated to support a marketing application.

January 18, 2018
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3 min read
Laminate Medical Technologies Announces Enrollment of First Patients in Pivotal Trial of the VasQ Device

The first surgeries were performed by Dr. Jason Burgess and Dr. Paul Orland at the Carolinas Medical Center-Mercy, Charlotte, North Carolina.

January 18, 2018
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3 min read
Policy

Amerigen’s Petition Leads to U.S. Zytiga Patent Invalidation

Amerigen was represented during the hearings on IPR2016-00286 by William Hare of McNeely Hare & War LLP.

January 18, 2018
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1 min read
Pharm Country

PAVmed Announces Firm Commitment Public Offering of Common Stock

PAVmed also expects to grant to the underwriters a 45-day option to purchase additional shares of common stock to cover overallotments, if any.

January 18, 2018
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4 min read
Business

Heptares Co-Founder Resigns as VP and CSO of Parent Company Sosei

Dr. Marshall will leave Sosei at the end of February 2018.

January 18, 2018
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4 min read