BioSpace News Archive

Policy

What a Headache! Amgen and Novartis Duel Over Migraine Drug Aimovig

Amgen is suing Novartis, alleging a breach of the partnership and seeking to terminate the 2015 contract. Novartis, in response, filed a lawsuit accusing Amgen of inappropriately attempting to end the alliance.

April 5, 2019
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2 min read
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Mark Terry
Business

Recro Pharma to Lay Off 50 Following Second FDA Rejection for Non-Opioid Pain Treatment

The Pennsylvania-based company disagrees with the FDA’s analysis of its clinical data and will seek to work with the agency for approval.

April 5, 2019
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2 min read
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Alex Keown
Policy

White House Forces PatientsLikeMe to Dump Current Chinese Majority Owner and Find New Investor

Sino-American relations continue to show signs of strain after the administration of President Donald Trump ordered the Chinese majority owner of healthcare company PatientsLikeMe to sell his stake.

April 5, 2019
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2 min read
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Alex Keown
Policy

Industry and Advocacy Groups Urge FDA to Allow More Real-World Data for Rare Disease Trials

In January 2019, the U.S. Food and Drug Administration (FDA) updated a 2015 draft guidance on rare diseases.

April 5, 2019
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3 min read
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Mark Terry
FDA

FDA Approves Pfizer’s Ibrance in Men With Breast Cancer

“Men with breast cancer have limited treatment options, making access to medicines such as Ibrance critically important,” stated Bret Miller, founder of the Male Breast Cancer Coalition.

April 5, 2019
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3 min read
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Mark Terry
Policy

Independent Review Shows Memorial Sloan Kettering Leaders Repeatedly Violated Conflict of Interest Policies

A review of top officials at Memorial Sloan Kettering Cancer Center found that there were repeated violations on financial conflicts of interest. The review was conducted by law firm Debevoise & Plimpton and jointly reported by The New York Times and ProPublica.

April 5, 2019
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3 min read
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Mark Terry
Deals

BioSpace’s List of April 2019 Life Science IPOs

A summary of IPOs from companies in the biotech and pharma world since April 1, 2019.

April 5, 2019
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2 min read
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Editorial Staff
Policy

FDA Action Alert: Spotlight on Merck’s Keytruda

The FDA calendar has only one PDUFA data scheduled for the next couple weeks. On Thursday, April 11, the U.S. Food and Drug Administration (FDA) and Merck & Co. have a target action date for their supplemental Biologics License Application (sBLA) for Keytruda

April 5, 2019
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3 min read
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Mark Terry
Business

AbSci Develops Game-Changing 12-Week Cell Line Optimization Workflow and Adds Two New Members to Its Executive Team

Martina Molsbergen, Vice President, Business Development and Johan Kers, PhD, Vice President, Research.

April 5, 2019
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2 min read
Business

Elmar Schnee and Diane Parks Proposed as New Board Members of Calliditas Therapeutics

The nomination committee of Calliditas Therapeutics AB has proposed that Elmar Schnee and Diane Parks be elected as new Board members at the company’s Annual General Meeting on May 8, 2019.

April 5, 2019
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2 min read