BioSpace News Archive

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
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

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
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

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
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
Business

Kapruvia® (difelikefalin) recommended by England’s NICE for the treatment of adults with moderate-to-severe CKD-associated pruritus

Vifor Fresenius Medical Care Renal Pharma today announced that England’s National Institute for Health and Care Excellence (NICE) has recommended Kapruvia ® for the treatment of moderate-to-severe CKD-associated pruritus in adult patients on haemodialysis.

May 18, 2023
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4 min read
Pharm Country

Kapruvia® (difelikefalin) recommended by England’s NICE for the treatment of adults with moderate-to-severe CKD-associated pruritus

Vifor Fresenius Medical Care Renal Pharma and Cara Therapeutics, Inc. announced that England’s National Institute for Health and Care Excellence has recommended Kapruvia® for the treatment of moderate-to-severe CKD-associated pruritus in adult patients on haemodialysis.

May 18, 2023
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5 min read
Biotech Beach

ImaginAb Advances Two Solid Tumor Radiopharmaceutical Therapy (RPT) Candidates Towards Clinical Development

ImaginAb, Inc. announced lead selection and progression to IND-enabling studies of IAB56, a minibody designed to target the αvβ6 integrin for use as Lu-177 radiopharmaceutical therapy in solid tumors.

May 18, 2023
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2 min read