BioSpace News Archive

FDA

Two More Cancer Drug Candidates Hit the Fast Track

Two experimental cancer drugs, one for ovarian cancer and one for a form of breast cancer, received Fast Track designation from the U.S. FDA, which will speed up the regulatory process for these medications.

August 16, 2021
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3 min read
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Alex Keown
FDA

Merck’s VHL Drug Becomes First-Ever HIF-2α Inhibitor Approved in U.S.

Merck’s Welireg won FDA approval for adult patients with von Hippel-Lindau disease who require therapy for associated RCC, central nervous system, and hemangioblastomas.

August 16, 2021
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2 min read
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Alex Keown
Drug Development

Rocket Relaunches Gene Therapy Program as FDA Lifts Clinical Hold

Patient enrollment in the Phase I study will resume, the company announced this morning.

August 16, 2021
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2 min read
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Alex Keown
Drug Development

Researchers Discover On/Off Switch for Inflammatory Pain

In a preclinical study published in PNAS, scientists from Feinstein Institutes for Medical Research presented a new approach to treating diseases that involve inflammation and pain, like arthritis.

August 16, 2021
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2 min read
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Vanessa Doctor, RN
Drug Development

Hoping to Change the Game, Bharat’s Intranasal Vaccine Moves Forward

By administering a vaccine directly into the nasal cavity, the mucus membranes of the nose and throat would provide better protection than the intramuscular alone.

August 16, 2021
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2 min read
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Kate Goodwin
Business

Codiak BioSciences Un-Strands Assets with Extracellular Vesicles

Codiak has two engineered exosome programs in Phase I, each showing different types of engineering possibilities to deliver targeted payloads that pharmaceutical companies haven’t managed to push all the way through the clinic.

August 16, 2021
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6 min read
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Mark Zipkin
FDA

FDA Gives Nod to Pfizer’s Tick-Borne Encephalitis Vaccine

This approval makes TICOVAC the only FDA-backed vaccine in the U.S. to protect people of all ages against the virus when visiting or living in TBE endemic regions.

August 16, 2021
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2 min read
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Brandon May
Drug Development

Study: Innovent’s Sintilimab and Chemo Combo Improves Survival in Advanced Gastric Cancer

An interim analysis of a Phase III study shows that a combination of Innovent’s sintilimab with chemotherapy significantly improves overall survival compared with placebo in the first-line management of patients with advanced gastric cancer.

August 16, 2021
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2 min read
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Brandon May
Business

Vivek Ramaswamy Comes Out Pushing His Book Attacking Woke Culture and Corporations

Vivek Ramaswamy is launching a book that represents the social injustice in society. Read the article to get some information about the book and its author.

August 16, 2021
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2 min read
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Mark Terry
3 Simple Ways to Succeed in a Hybrid Work Environment

If you are in a hybrid work environment, you might be finding it difficult to work between office and home. Here are a few tips to help optimize your work.

August 16, 2021
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2 min read
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Ellen Bombela