BioSpace News Archive

FDA

Iveric Gets FDA Approval in Geographic Atrophy After Being Acquired by Astellas

Friday, Iveric Bio scored a regulatory win for its geographic atrophy eye injection Izervay, just three months after the New Jersey biotech was bought by Astellas Pharma for $5.9 billion.

August 7, 2023
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2 min read
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Tristan Manalac
Policy

EU Pulls Authorization of Novartis’ Sickle Cell Disease Drug

The Phase III STAND trial found no significant therapeutic benefit to Novartis’ Adakveo, pushing the European Commission to revoke its conditional authorization of the SCD treatment.

August 7, 2023
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2 min read
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Tristan Manalac
Business

Nektar Files Lawsuit Against Lilly as Drug Development Split Escalates

In a lawsuit filed Monday, Nektar Therapeutics accused Eli Lilly of scheming to ensure rezpegaldesleukin would not succeed after acquiring a competing medicine.

August 7, 2023
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4 min read
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Tristan Manalac and Heather McKenzie
FDA

Sage Hints at Difficult Decisions After Zuranolone’s Rejection in MDD

The FDA approved Sage and Biogen’s zuranolone Friday as the first oral medication for postpartum depression but declined to approve the application in major depressive disorder.

August 7, 2023
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3 min read
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Heather McKenzie
Drug Development

Bavarian Nordic Touts Second Round of Positive Phase III Chikungunya Vaccine Data

The Danish company’s vaccine candidate met all co-primary endpoints in a late-stage study in adults and adolescents just months after publishing trial data for elderly patients, as it seeks to challenge Valneva.

August 7, 2023
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2 min read
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Connor Lynch
Pharm Country

New Study in JNCCN Highlights Rapid Adoption of Clinical Research Results into Chemotherapy Prescribing Patterns

New research in the August 2023 issue of JNCCN—Journal of the National Comprehensive Cancer Network evaluates how an important analysis on local-regionally advanced colon cancer adjuvant chemotherapy impacted prescribing patterns.

August 7, 2023
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6 min read
Business

Bolt Biotherapeutics Reports Second Quarter 2023 Financial Results and Provides Business Update

Bolt Biotherapeutics, Inc. (Nasdaq: BOLT), a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer, today reported financial results for the second quarter ended June 30, 2023 and provided an update on the continued advancement of its clinical programs.

August 7, 2023
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12 min read
Business

ACELYRIN, INC. to Present Second Quarter 2023 Financial Results and Corporate Update on August 14, 2023

ACELYRIN, INC. announced it will host a conference call on Monday, August 14, 2023 at 4:30 p.m. ET to discuss its second quarter 2023 financial results and provide a corporate update.

August 7, 2023
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2 min read
Business

Zevra Therapeutics Appoints Thomas Anderson to Board of Directors and Announces Retirement of Matthew R. Plooster

Zevra Therapeutics, a rare disease company melding science, data, and patient need to create transformational therapies for diseases with limited or no treatment options, proudly welcomes Tom Anderson, a highly accomplished biopharma veteran, to its Board of Directors.

August 7, 2023
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5 min read
Business

Merus Announces Financial Results for the Second Quarter 2023 and Provides Business Update

Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®), today announced financial results for the second quarter and provided a business update.

August 7, 2023
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21 min read