BioSpace News Archive

Policy

FDA, CDC Decide Benefits of J&J Vaccine Outweigh the Risks

On Friday April 23, the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) lifted the restrictions on the Johnson & Johnson COVID-19 vaccine.

April 26, 2021
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3 min read
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Mark Terry
Deals

Biotech SPACs Can Expect a Good Runway as Investors Focus on Quality

Special Purpose Acquisition Companies (SPACs) are here to stay, offering one more way for companies to access public markets. But doing so isn’t a quick snap of the fingers.

April 26, 2021
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5 min read
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Gail Dutton
Policy

Death, Disability Among Side Effects of Chinese COVID-19 Vaccines, Leaked Documents Reveal

Leaked documents from provincial and municipal governments in China reveal a slew of previously unreported severe adverse events related to COVID-19 vaccines made and administered in China.

April 26, 2021
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4 min read
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Gail Dutton
Drug Development

Sanofi Partners With Moderna to Answer Global Demand for COVID-19 Vaccines

Sanofi will use its manufacturing capabilities to support the development of 200 million doses of the Moderna COVID-19 vaccine beginning in September.

April 26, 2021
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2 min read
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Alex Keown
Axsome Therapeutics AXS-05 Priority Review by FDA Could Speed Up Help for MDD Patients

In keeping with Axsome’s mission of providing a solution for central nervous system (CNS) disorders that are difficult to treat, AXS-05 was developed to help patients exhibiting treatment-resistant depression (TRD) and major depressive disorder (MDD).

April 26, 2021
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2 min read
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Ava Barnes
Drug Development

AstraZeneca and Sanofi Announce Big Breakthrough With RSV Vaccine

AstraZeneca and Sanofi announced that their MELODY Phase III trial of nirsevimab hit the primary endpoint in medically attended lower respiratory tract infections (LRTI) caused by RSV in healthy late preterm and term infants.

April 26, 2021
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4 min read
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Mark Terry
Drug Development

FDA Officially Lifts Hold on UniQure’s Promising Hemophilia B Therapy

There is hope for uniQure’s HOPE-B trial after all. Shares of uniQure NV are climbing this morning after the company announced the clinical hold on its hemophilia B gene therapy has been lifted by the U.S. Food and Drug Administration.

April 26, 2021
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2 min read
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Alex Keown
Lack of Funding Drives Biotech to Suspend Drug-Resistant Antibiotic Pipeline

Five-year-old X-Biotix announced it is throwing in the towel on its antibacterial research efforts and changing gears for its corporate strategy.

April 26, 2021
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2 min read
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Kate Goodwin
Policy

Ocugen-Bharat Biotech Vaccine Shows Efficacy Against B.1.617 Variant

A new study published online has provided some hope for the citizens in India, with researchers suggesting that the Covaxin vaccine, developed by Bharat Biotech and Pennsylvania-based Ocugen, could neutralize the SARS-CoV-2 variant leading the second wave in the country.

April 26, 2021
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3 min read
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Brandon May
Relay Medical Retains Emerging Markets Consulting LLC for Investor Relations Advisory Services

EMC specializes in helping small and mid-sized public companies establish brand awareness and increase market share to its customer base while improving visibility to the institutional and retail investment community.

April 26, 2021
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3 min read