BioSpace News Archive

Drug Development

Novartis Launches Phase III Study of Hydroxychloroquine in COVID-19 Patients

Swiss pharma giant Novartis will launch a Phase III trial assessing hydroxychloroquine for the treatment of COVID-19. The trial will be conducted across the United States.

April 20, 2020
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2 min read
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Alex Keown
FDA

FDA Approves Incyte’s Pemazyre for Rare Bile Duct Cancer

The U.S. Food and Drug Administration (FDA) approved Incyte’s Pemazyre (pemigatinib) for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement.

April 20, 2020
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3 min read
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Mark Terry
Business

FDA and Immunology Experts Call for Flexible Trial Design for Pandemic Vaccines

Traditional vaccine development and regulatory policies are changing in response to the current pandemic. Some of those approaches may become more common, expanding into other, non-pandemic-related areas in the future.

April 20, 2020
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5 min read
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Gail Dutton
Policy

Biopharma Update on the Novel Coronavirus: April 20

Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 20, 2020.

April 20, 2020
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4 min read
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BioSpace Editorial Staff
Business

Cyberattacks on Health Care Groups Increase During COVID-19 Pandemic

GlobalData released a report that showed the global healthcare sector has been subjected to an array of cyberattacks as it deals with the COVID-19 pandemic.

April 20, 2020
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2 min read
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Alex Keown
Drug Development

Idorsia Moves Forward with Experimental Insomnia Drug After Positive Phase III Trial

“The excellent results seen in this Phase III study of 3-month duration suggest that daridorexant can fulfill this significant need for patients with insomnia,” said Dr. Thomas Roth, PhD, Director of the Sleep Disorder and Research Center at Henry Ford Hospital.

April 20, 2020
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3 min read
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Krystle Vermes
FDA

Seattle Genetics’ Tukysa Earns FDA Approval for HER2+ Breast Cancer

Tukysa came out of Project Orbis, a multinational partnership between the FDA, the Australian Therapeutic Goods Administration, Health Canada, Health Sciences Authority and Swissmedic.

April 20, 2020
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3 min read
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Mark Terry
Drug Development

BMS and Exelixis Eye Potential Approval of RCC Combination Drug Following Positive Phase III Results

This morning, the two companies announced the positive topline results from the pivotal Phase III CheckMate -9ER study in previously untreated patients with renal cell carcinoma.

April 20, 2020
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2 min read
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Alex Keown
Insight Report: HIV and AIDS Research and Treatments

BioSpace takes an in-depth look at the human immunodeficiency virus including research, drugs in the pipeline and treatments. Check out the free downloadable report.

April 20, 2020
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4 min read
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Chelsea Weidman Burke, M.S.
FDA

GenoSensor Granted FDA Emergency Use Authorization for High Throughput COVID-19 RT-PCR Diagnostic for Use in U.S.

GenoSensor Corporation has received FDA Emergency Use Authorization for the GS™ COVID-19 RT-PCR KIT.

April 20, 2020
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5 min read