BioSpace News Archive

Policy

Law Firm Proposes Effort to Make FDA’s Complete Response Letters More Complete

In the company’s FDA Law Blog, attorneys Deborah L. Livornese, JP Ellison and Josephine M. Torrente outlined problems with the FDA’s complete response letter (CRL) and what should be done about it.

October 26, 2018
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3 min read
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Mark Terry
Policy

FDA Action Alert: Merck’s Keytruda in Lung Cancer, Trevena and AcelRx Drugs for Pain

As we end October and head into November, the Food and Drug Administration (FDA) continues its work. This upcoming week has several PDUFA action dates for drug applications. Here’s a look.

October 26, 2018
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2 min read
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Mark Terry
Business

Gottlieb Says... The FDA Commissioner’s Most Recent Statements

Scott Gottlieb, commissioner of the Food and Drug Administration (FDA) is notoriously outspoken. Let’s take a look at some of Gottlieb’s more recent statements.

October 26, 2018
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4 min read
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Mark Terry
Glycotest Inc. Completes $10 Million Series A Financing with Fosun Pharma

Significant external equity investment by a prominent pharmaceutical company in a NetScientific portfolio company

October 26, 2018
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2 min read
BioCapital

Science Top Company List Ranks Innovation and Work Culture

In a survey of more than 8,000 people in the biotech and pharma industry for Science, Regeneron Pharmaceuticals, topped the list.

October 26, 2018
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3 min read
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Mark Terry
Drug Development

Lundbeck Schizophrenia Drug Fails to Differentiate Itself from Conventional Therapies, Stocks Plunge

Shares of H. Lundbeck A/S plunged more than 25 percent after the company announced Thursday that its Phase III treatment for treatment-resistant schizophrenia failed to differentiate itself against conventional therapies.

October 26, 2018
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2 min read
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Alex Keown
Business

Synergy Pharma Struggles Despite Promising Market Opportunities in 2019

After providing an update of its ongoing strategic review, New York-based Synergy Pharmaceuticals’ stock plunged more than 71 percent.

October 26, 2018
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3 min read
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Mark Terry
Drug Development

Seattle Genetics Announces Multiple Data Presentations Evaluating ADCETRIS® (Brentuximab Vedotin) in Patients with Hodgkin Lymphoma at ISHL 2018

Seattle Genetics, Inc. (Nasdaq:SGEN) today highlighted multiple presentations evaluating ADCETRIS (brentuximab vedotin) across a broad range of Hodgkin lymphoma (HL) settings at the 11th International Symposium on Hodgkin Lymphoma (ISHL) taking place in Cologne, Germany, October 27-29, 2018

October 26, 2018
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19 min read
Job Trends

Varex Imaging To Showcase Its Industrial Imaging Products At ASNT Fall 2018 Conference & Exhibit

Varex Imaging Corporation (Nasdaq: VREX) will exhibit its latest industrial Nondestructive Testing (NDT) imaging products at the Annual Meeting for the American Society for Nondestructive Testing in Houston, Texas from October 28-31, 2018.

October 26, 2018
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3 min read
Pharm Country

Zoetis to Participate in the Credit Suisse 27th Annual Healthcare Conference

Zoetis Inc. (NYSE:ZTS) will participate in the Credit Suisse 27th Annual Healthcare Conference on Tuesday, Nov. 13, 2018, in Scottsdale, Ariz. Glenn David, Executive Vice President and Chief Financial Officer, will represent the company and respond to questions from analysts.

October 26, 2018
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1 min read