BioSpace News Archive

FDA

Merck’s Big Week: HIV Approval and Landmark 3-Country Approval for Keytruda

Merck had the unusual case of having its checkpoint inhibitor Keytruda (pembrolizumab) approved simultaneously in three countries for advanced endometrial carcinoma.

September 20, 2019
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3 min read
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Mark Terry
Drug Development

Clinical Catch-Up: September 16-20

Last week was an unusually busy week for clinical trial news, with numerous companies presenting results at conferences. Here’s a look at the top stories.

September 20, 2019
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11 min read
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Mark Terry
Drug Development

New Data Shows Long-Term Benefits of Zolgensma in SMA Patients

While the approval of AveXis’ gene therapy for spinal muscular atrophy has been tainted by the revelation of early data manipulation, the Novartis subsidiary presented some long-term data at a conference that backs up the treatment’s efficacy.

September 20, 2019
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3 min read
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Alex Keown
Rheumatoid Arthritis Drug May Help Repair Heart After Heart Attacks

Researchers at Vanderbilt University recently studied the inflammation phase after heart attacks and identified a protein, cadherin-11, that is significantly involved in the inflammation in cardiac fibrosis.

September 20, 2019
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3 min read
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Mark Terry
Business

Allogene Partnering with Stanford to Develop Better CAR-T Therapies

South San Francisco-based Allogene Therapeutics inked a research collaboration deal with Stanford University to work on a novel nucleic acid delivery system for CAR-T therapy.

September 20, 2019
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2 min read
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Mark Terry
Drug Development

Novo’s Tresiba Misses Comparison Mark to Sanofi’s Toujeo

While the Danish drugmaker’s Tresiba (insulin degludec) didn’t fare as well as hoped in the head-to-head trial, Novo Nordisk was quick to point out that Tresiba showed an overall lower risk of hypoglycemia compared to Toujeo.

September 20, 2019
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2 min read
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Alex Keown
Should You Work with a Coach to Enhance Your Life Sciences Career?

Just what is a career coach? These practitioners have been compared to personal trainers for your life, your champion, cheerleader, advocate, partner and sounding board.

September 20, 2019
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4 min read
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Katharine Hansen, PhD
Innovent Provides Update on Two Studies of IBI301 (Rituximab Biosimilar) in the Treatment of CD20-positive Lymphoma at Annual Meeting of CSCO

Innovent Biologics, Inc. (Innovent) (HKEX: 01801), announced today that the data for two studies of IBI301, a rituximab biosimilar co-developed with Eli Lilly and Company, was presented at the 22nd Annual Meeting of Chinese Society of Clinical Oncology (CSCO).

September 20, 2019
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7 min read
BioMidwest

Rush University Medical Center Ranked # 1 for Highest Quality Care

Rush tops list of major academic medical centers in 2019 Vizient Quality and Accountability Study

September 20, 2019
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3 min read
CHMP Issues Positive Opinion to Expand Trulicity® (dulaglutide) Label to Include Results from REWIND Cardiovascular Outcomes Trial

Eli Lilly and Company (NYSE: LLY) announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending an update to the Trulicity® (dulaglutide) label and indication statement

September 20, 2019
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9 min read