BioSpace News Archive

Drug Development

Elevar Touts First-line Potential of Rivoceranib in Phase III Liver Cancer Trial

Late-stage data, which showed significant overall and progression-free survival benefits in unresectable hepatocellular carcinoma patients, supports Elevar’s New Drug Application filed in May 2023.

July 25, 2023
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2 min read
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Tristan Manalac
From Crisis to Cure: Unraveling the Cancer Drug Shortage and the FDA’s Role

While chemo drugs remain in shortage, Congress asks for answers from the FDA to find solutions to the supply chain disintegration.

July 25, 2023
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4 min read
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Lisa Munger
Business

Biogen to Cut 1,000 Jobs as Part of $1B Cost Savings Plan

The biotech’s “Fit for Growth” program, which includes the headcount reduction, is expected to generate a net savings of $700 million on operating expenses by 2025.

July 25, 2023
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3 min read
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Kate Goodwin
Business

ImmunoGen Inks Cancer ADC Partnership with ImmunoBiochem

The license and option deal, for an undisclosed amount, seeks to develop potentially first-in-class antibody-drug conjugate candidates against different oncology targets.

July 25, 2023
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2 min read
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Tristan Manalac
Business

Roche Decides Not to Exercise Solid Tumor Option with SQZ

Embattled SQZ Biotechnologies announced Tuesday that the Swiss biotech will not exercise its option for HPV 16 positive solid tumors under the SQZ-APC-HPV program.

July 25, 2023
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2 min read
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Connor Lynch
Business

Alvotech Expands Biosimilar Collaboration with Teva Amid Manufacturing Woes

Following two BLA rejections for its Humira biosimilar, Alvotech is expanding its partnership with Teva Pharmaceuticals, which will enable the latter to have greater involvement with quality and control.

July 25, 2023
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2 min read
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Tristan Manalac
Policy

US FDA Grants XVIVO Approval to Include DCD Hearts in IDE Clinical Trial

XVIVO Perfusion AB The US Food & Drug Administration has approved XVIVO’s Investigational Device Exemption supplement for its heart preservation clinical trial to now include Donation after Circulatory Death hearts.

July 25, 2023
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3 min read
RetinAI and Retina Consultants of America Join Forces to build the Most Comprehensive U.S.-based Real World Evidence Database in Ophthalmology

RetinAI Medical AG (“RetinAI”), a leader in clinical and imaging data management software and advanced analytics using artificial intelligence (AI)

July 25, 2023
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5 min read
Policy

FDA Clears Numares Health Cardiovascular Diagnostic Test and Core Technology Platform

The US Food and Drug Administration has cleared a Numares Health test, the AXINON® LDL-p Test System, as a new tool physicians can use to measure lipoproteins for patients at risk for cardiovascular disease.

July 25, 2023
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3 min read
NK:IO Raises £1.2M, Bringing Total Seed Funding to £5.1M, to Advance Pioneering NK Cell Therapy

NK:IO, a leader in natural killer cell biology applied to the development of exceptionally potent, off-the-shelf cell therapies targeting solid tumours, has raised £1.2M.

July 25, 2023
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3 min read