BioSpace News Archive

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
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
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

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
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
BioForest

Hepcludex® (Bulevirtide) Demonstrates Sustained Efficacy and Safety Profile in People With Chronic Hepatitis Delta Virus at 96 Weeks

Gilead Sciences, Inc. announced Week 96 results from the pivotal MYR301 Phase 3 clinical trial evaluating the first-in-class entry inhibitor Hepcludex® for the treatment of adults with chronic hepatitis delta infection.

June 23, 2023
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8 min read
Drug Development

Akero Therapeutics Presents Analyses of Phase 2b HARMONY Study at the 2023 International Liver Congress Reinforcing and Characterizing EFX-Related Improvements in Liver Histopathology

Akero Therapeutics, Inc. announced two presentations of secondary and post-hoc analyses of the Phase 2b HARMONY study of efruxifermin in patients with pre-cirrhotic nonalcoholic steatohepatitis, fibrosis stage 2 or 3.

June 23, 2023
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7 min read
Business

Acasti Pharma Reports Fiscal Year 2023 Operational Results

Acasti Pharma Inc. (“Acasti” or the “Company”) (Nasdaq: ACST) today announced financial and operational results for the fiscal year ended March 31, 2023.

June 23, 2023
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10 min read