BioSpace News Archive

Pharm Country

New Freedoms Could Catapult J&J Pipeline Following Split

A week after announcing its intention to spin off its consumer health division, J&J revealed ambitious plans for its pharmaceutical business.

November 19, 2021
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4 min read
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Heather McKenzie
FDA

FDA Says COVID-19 Vaccine Boosters for All 18 Plus

The U.S. Food and Drug Administration approved COVID-19 vaccine booster shots for all Americans ages 18 and over Friday morning.

November 19, 2021
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2 min read
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Heather McKenzie
FDA

BioMarin Scores a First Day After Filing Trade Secrets Lawsuit

BioMarin Pharmaceutical scored a first on Friday and provided an option for patients with a rare disease for which there is little recourse.

November 19, 2021
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4 min read
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Alex Keown
Drug Development

New Hope for Oral Flu Vaccine as Prime Season Descends

Scientists from Stanford University investigated the effectiveness of an oral tablet flu vaccine called VXA-A1.1 by Vaxart, which uses cellular correlates of protection.

November 19, 2021
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2 min read
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Vanessa Doctor, RN
Drug Development

New Mavacamten PDUFA Date Will Allow Further Risk Mitigation Review

The extension will give the FDA sufficient time to look into the drug for the treatment of patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM).

November 19, 2021
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2 min read
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Vanessa Doctor, RN
Drug Development

COVID-19 Update: Major Global Spikes and AstraZeneca’s Antiviral Continues to Excite

While COVID-19 appears to be battling back in cold-weather states in the U.S. and parts of Europe, researchers continue to study vaccine efficacy and new approaches to dosing. Here’s a look.

November 19, 2021
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4 min read
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Mark Terry
Policy

Professor Under Fire for Undisclosed Chinese Military Ties

A Chinese professor at the University of Copenhagen in Denmark is under scrutiny over undisclosed ties to the Chinese military.

November 19, 2021
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2 min read
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Alex Keown
BioCapital

Clinical Catch-Up: November 15-19

With the last full week before the Thanksgiving week in the U.S., companies had a fair amount of clinical trial news. Here’s a look.

November 19, 2021
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8 min read
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Mark Terry
FDA

FDA Action Alert: Takeda, Aadi and Fennec

The U.S. Food and Drug Administration has a few PDUFA dates for the Thanksgiving Holiday week. Here’s a look.

November 19, 2021
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3 min read
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Mark Terry
Drug Development

Scientists Urge Tighter Phase II Trial Criteria in Oncology

A recent study has highlighted the need for more stringent Phase II trial protocols on the basis that over 80% of candidate oncology treatments that go into Phase III failed to achieve OS goals.

November 19, 2021
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2 min read
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Vanessa Doctor, RN