BioSpace News Archive

FDA

FDA Panel Backs Pfizer’s Maternal RSV Vaccine Despite Safety Concerns

An advisory committee of outside experts voted unanimously Thursday that Pfizer’s vaccine was effective in preventing severe disease, but some had questions regarding its safety.

May 18, 2023
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3 min read
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Tristan Manalac
Policy

Opinion: Sarepta Enters Uncharted Territory with Adcomm Approval

The extensive discussion between the FDA’s advisory committee, company representatives and other interested parties could serve as a cautionary tale to developers of future gene therapies.

May 18, 2023
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3 min read
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Jia Jie Chen
Business

AstraZeneca Deepens Gene Editing Capabilities with Revvity Partnership

Under a non-exclusive agreement, AstraZeneca is licensing biotech Revvity’s base editing technology to help create cell therapies for the treatment of cancer and immune-mediated diseases.

May 18, 2023
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2 min read
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Tristan Manalac
Policy

SCOTUS Rules Against Amgen in PCSK9 Patent Dispute with Sanofi, Regeneron

The U.S. Supreme Court unanimously ruled Amgen’s cholesterol drug Repatha patents invalid, ending a protracted legal battle with competitors Sanofi and Regeneron.

May 18, 2023
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2 min read
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Lisa Munger
Policy

New FDA Guidance Aims to Increase Number of Children in Clinical Trials

According to the FDA, the majority of therapies prescribed for children were not tested in pediatric populations. The new guidance aims to change that.

May 18, 2023
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2 min read
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Rosemary Scott
Drug Development

Biopharma Targets the Untapped Potential of the Human Healthspan

More than $5 billion poured into the longevity space in 2022, and experts say the science is now primed to make a real difference in extending human healthspan.

May 18, 2023
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6 min read
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Heather McKenzie
Policy

US Appeals Court Panel Questions FDA Due Diligence on Abortion Pill

A three-judge panel is reviewing the legal challenge to the FDA’s approval of mifepristone. Any action by the court may result in further appeals, and possibly another Supreme Court decision.

May 18, 2023
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3 min read
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Lisa Munger
Asieris Deepens Strategic Partnership with UroViu to Further Develop Integrated Diagnosis and Treatment Platform for Bladder Cancer

Asieris Pharmaceuticals, a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases, announced a strategic collaboration with UroViu Corporation.

May 18, 2023
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3 min read
Syngenta Group Moves Forward With Its IPO Plans

Syngenta Group has withdrawn its STAR Market IPO application and will immediately apply for a public listing on the main board at the Shanghai Stock Exchange.

May 18, 2023
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3 min read
Pharm Country

GenScript Expands Peptide and Oligonucleotide Production Facility in China

GenScript’s new life-science building in Zhenjiang, Jiangsu, China spans 91,310 sq. ft. and is ISO 9001 certified; highly automated clean-room facilities offer fast-turnaround, high-purity oligonucleotide and peptide synthesis service for R&D and preclinical applications.

May 18, 2023
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3 min read