BioSpace News Archive

Drug Development

FDA Action Alert: Regeneron, BioMarin, Eton and Amneal

Regeneron envisions new dosing for Eylea’s label and it’s the moment of truth for BioMarin’s gene therapy for hemophilia A. For that and more, see inside.

June 23, 2023
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4 min read
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Tristan Manalac
Policy

States Back FTC in Lawsuit Seeking to Block Amgen-Horizon Deal

Citing anti-trust issues, six states—California, Illinois, Minnesota, New York, Washington and Wisconsin—are joining the FTC’s legal challenge to Amgen’s nearly $27.8 billion buyout of Horizon.

June 23, 2023
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2 min read
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Tristan Manalac
Policy

Intercept Cuts All NASH Investments, One-Third of Staff After Second FDA Rejection

A day after the FDA denied Intercept’s application for its non-alcoholic steatohepatitis treatment, the pharma announced it has axed all NASH investments and one-third of its staff.

June 23, 2023
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3 min read
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Tristan Manalac
Deals

Apogee Files for IPO with Promising Preclinical Immuno Asset

Banking on its lead antibody APG777 for atopic dermatitis, Apogee Therapeutics is filing an initial public offering for an as-yet-undisclosed value.

June 23, 2023
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2 min read
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Tristan Manalac
Drug Development

Roivant Reports Positive Results in Phase II Ulcerative Colitis Trial

Results of a Phase IIb trial of the company’s anti-TL1A antibody showed more than a third of ulcerative colitis patients entered remission while receiving the experimental treatment.

June 23, 2023
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2 min read
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David Adam
Policy

Opinion: Cracking the Code—Solving the Economic Puzzle of Leqembi

CMS has stated that it will cover new Alzheimer’s drugs if the therapies are fully approved. But significant financial questions remain.

June 23, 2023
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5 min read
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Maggie Urquiza
Life-Threatening Consequences Loom as Cancer Drug Shortages Grip the US

Experts and analysts warn that the short supply of more than a dozen cancer drugs has reached a crisis level, causing significant anxiety and impacting patient care.

June 23, 2023
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5 min read
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Lisa Munger
Business

RevolKa Ltd.: Announcement of Milestone Achievement in the Collaborative Research with Sumitomo Pharma Co., Ltd.

RevolKa Ltd., a venture-backed biotech company providing a game-changing protein engineering technology platform is pleased to announce the successful completion of the collaborative drug discovery project with Sumitomo Pharma Co., Ltd. for rare diseases within the contractually agreed time frame.

June 23, 2023
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3 min read
RELIEF THERAPEUTICS Holding SA Announces Closing of CHF 5 Million Private Placement

RELIEF THERAPEUTICS Holding SA, a biopharmaceutical company committed to delivering innovative treatment options with the potential for transformative outcomes to benefit those suffering from select specialty and rare diseases, announced the closing of the previously announced private placement.

June 23, 2023
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4 min read
Relief Therapeutics and World Orphan Drug Alliance Announce an Exclusive, Long-Term, Distribution Agreement to Introduce PKU GOLIKE(R) in the Middle East

RELIEF THERAPEUTICS Holding SA and the World Orphan Drug Alliance announced an exclusive, long-term distribution agreement between Relief Therapeutics’ subsidiary APR Applied Pharma Research SA and WODA’s member company Vector Pharma FZCO to introduce PKU GOLIKE Plus®3-16 in the Middle East.

June 23, 2023
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8 min read