BioSpace News Archive

Policy

FDA Doubles Down on Use of Real-World Data for Regulatory Decisions

The U.S. Food and Drug Administration (FDA) released a new 2019 strategic Framework for how it plans to advance the use of so-called real-world data (RWD) to improve regulatory decisions. The agency has indicated that this is a strategic priority.

December 7, 2018
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3 min read
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Mark Terry
Deals

Mallinckrodt Plans to Spin off Its Generics Business

Shares of Mallinckrodt PLC are down nearly 2 percent in morning trading after the company announced it will spin off a new company that includes its specialty generics business to shareholders by the second half of 2019.

December 7, 2018
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3 min read
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Alex Keown
Biotech Bay

GLASSDOOR ANNOUNCES WINNERS OF ITS EMPLOYEES’ CHOICE AWARDS RECOGNIZING THE BEST PLACES TO WORK IN 2019

Glassdoor, one of the world’s largest job and recruiting sites, has announced the winners of its 11th annual Employees’ Choice Awards, honoring the Best Places to Work in 2019 across North America and parts of Europe

December 7, 2018
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6 min read
BioMidwest

AbbVie Continues Charitable Giving, Donates $50 Million to St. Jude

Christmas came a little early for St. Jude Children’s Research Hospital in the form of a $50 million contribution from pharma giant AbbVie – the largest single contribution made to the famed hospital.

December 7, 2018
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3 min read
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Alex Keown
Business

BioSpace Movers and Shakers for Dec. 10

Biotech and pharma companies strengthen their leadership teams with these appointments. Who made power moves in the industry this past week?

December 7, 2018
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4 min read
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Alex Keown
Help Us to Better Serve You!

At BioSpace, we’re continually searching for better ways to serve our community, but we need your help to do so.

December 7, 2018
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1 min read
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The BioSpace Team
Business

OnDosis and Recipharm partner to advance a novel treatment regimen for ADHD

OnDosis, and global contract development and manufacturing organisation (CDMO), Recipharm, have entered into an agreement for the formulation development of an ADHD treatment for the US market.

December 7, 2018
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3 min read
Gene-editing a significant leap forward in biomedical research but needs strong legal framework for ethical usage, says GlobalData

Following the recent claims by He Jiankui, a scientist and professor of Biology at the Southern University of Science and Technology in Shenzhen, Guangdong, China, that he has successfully created the world’s first gene-edited babies,

December 7, 2018
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1 min read
Drug Development

ADC Therapeutics Presents Updated Data from Clinical Trials of Novel Antibody Drug Conjugates

ADCT-402 (loncastuximab tesirine) continues to demonstrate acceptable safety profile and anti-tumor activity in patients with relapsed or refractory diffuse large B-cell lymphoma; data from 183-patient study supports continued evaluation in ongoing pivotal Phase II trial

December 7, 2018
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8 min read
Policy

Axovant Announces Feedback From FDA Meeting Regarding AXO-Lenti-PD for Parkinson’s Disease and Progress in Ongoing SUNRISE-PD Phase 2 Clinical Trial

Meeting with FDA confirmed that studies previously conducted using first generation ProSavin® may be considered part of a single development program with AXO-Lenti-PD

December 7, 2018
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7 min read