BioSpace News Archive

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FDA

Rigel Website Shows Erroneous Information that Tavalisse Has Been Approved by the FDA

Shares of Rigel Pharmaceuticals shot up about 40 percent during Thursday trading due primarily to an error on the company’s website that claimed its drug candidate Tavalisse had gained approval from the U.S. Food and Drug Administration (FDA).

April 13, 2018

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2 min read

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Alex Keown

Vibrant vector illustration is showing a teacher and adult students in the middle of the process of facilitating learning. On the bottom part of the illustration there are students and teacher; above them there are different speech bubbles randomly filled with different elements/icons related with education, learning and teaching. Those elements are: light bulb for new knowledge and ideas; gears and wheels for thinking and processing; question mark for questioning; magnifying glass for looking the right solution or to look closer to the problem; brain for thinking and intelligence; speech bubbles for communication ect. Illustration is nicely layered.

Research Roundup: Some of the Top Research Stories of the Week

There is almost always exciting research going on every day. Here are just a few that caught BioSpace’s attention this week.

April 13, 2018

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4 min read

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Mark Terry

Business

Terns Pharmaceuticals Taps 2 Scientific Advisors as it Eyes the Clinic for its New NASH Programs

Less than one week after licensing three non-alcoholic steatohepatitis (NASH) programs from Eli Lilly, startup company Terns Pharmaceuticals has strengthened its leadership team with the appointment of two scientific advisors.

April 13, 2018

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2 min read

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Alex Keown

Macro photo of tooth wheel mechanism with REGULATION, LAW, RULE, AUTHORITY, GUIDELINE and STANDARD words imprinted on metal surface

Policy

FDA Provides New Guidance for Next-Generation Sequencing Test

The U.S. Food and Drug Administration (FDA) finalized two separate guidances for next-generation sequencing technologies.

April 13, 2018

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3 min read

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Alex Keown

Business

Mylan Rumored to be in Discussions to Buy Merck KGaA’s Consumer Health Business, but Mylan Denies It

Mylan is reportedly in top-level talks with Germany’s Merck KGaA to buy its consumer health business. However, Mylan has denied it.

April 13, 2018

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3 min read

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Mark Terry

Policy

Suit Alleges Drug Impurity, Price Fixing as Mallinckrodt Shares Tumble

Amid news of a whistleblower lawsuit, Mallinckrodt Pharmaceuticals (MNK:NYSE) shares dropped 9.51% yesterday.

April 13, 2018

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2 min read

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Don McCormick

Diagnosis of Muscular Dystrophy closeup. Medical book guide for doctor neurologist with heading text of neurological disease Muscular Dystrophy surrounded neurological hammer and stethoscope

Drug Development

In First Trial of New Gene Therapy Program, Pfizer Doses First Duchenne Muscular Dystrophy Patient

Pfizer Inc. has dosed its first patient in a Phase Ib clinical trial of PF-06939926 for Duchenne muscular dystrophy (DMD). At the moment, the only approved drug is Sarepta Therapeutics’ Exondys 51 (eteplirsen).

April 13, 2018

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2 min read

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Mark Terry

Manhattan, New York USA - July 9, 2011: Pfizer letter sign on the building's Headquarters. Pfizer's is the largest pharmaceutical company in the world.

Deals

Pfizer Boss Ian Read Claims They Won’t Buy Bristol-Myers Squibb or Make Any Other Big Deals

There has been speculation for several years whether Pfizer Inc. would consider buying Bristol-Myers Squibb. That appears to have been laid to rest by comments made by Pfizer’s chief executive officer, Ian Read.

April 13, 2018

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2 min read

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Mark Terry

Business

Endo to Announce First-Quarter 2018 Financial Results

Endo International plc will announce its first-quarter 2018 financial results on May 8, 2018 and members of its senior management team will host a conference call and webcast before the U.S. financial markets open at 7:30 a.m. ET.

April 13, 2018

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1 min read

Tolero Pharmaceuticals to Present Preclinical Data Supporting Apoptosis-Inducing Activity of Alvocidib in Acute Myeloid Leukemia

Findings show that alvocidib potentiates the activity of apoptosis-inducing agents cytarabine and daunorubicin (7+3) in non-clinical models

April 13, 2018

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5 min read