BioSpace News Archive

Policy

Fractyl Secures FDA Approval for Weight Maintenance Study After Discontinuation of GLP-1s

Fresh from its IPO, Fractyl Health got an Investigational Device Exemption from the FDA, clearing a pivotal study of its Revita system to help maintain weight loss following the discontinuation of GLP-1 drugs.

April 1, 2024
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2 min read
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Tyler Patchen
Policy

Lack of Medicare Coverage for GLP-1 Drugs Tied to Lower Prescription Rates: Study

Despite strong demand for weight-loss drugs, the lack of Medicare coverage is potentially interfering with prescription and dispensing rates of anti-obesity medications for elderly adults, according to a new study.

April 1, 2024
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2 min read
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Tristan Manalac
Policy

Biogen and Eisai Fall Behind on Leqembi’s Subcutaneous BLA for Alzheimer’s

The filing of a Biologics License Application for a subcutaneous version of Biogen and Eisai’s Leqembi (lecanemab) has been delayed due to procedural reasons, the companies announced Monday.

April 1, 2024
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2 min read
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Tristan Manalac
Policy

Chinese ADC Investment Boom in Question With China-U.S. R&D Relations in Flux

Alongside the abrupt departure of Chinese biotech WuXi from BIO, Congress is rattling sabers over perceived national security implications of the U.S.’s R&D relationship with the country.

April 1, 2024
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4 min read
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Neil Versel
Drug Development

BMS Pulls Ahead of Amgen, Aces Confirmatory Phase III NSCLC Trial for Krazati

Bristol Myers Squibb’s $4.8 billion acquisition of Mirati pays off with strong data from the KRYSTAL-12 study of Krazati, showing that the KRAS inhibitor significantly improves progression-free survival.

April 1, 2024
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2 min read
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Tristan Manalac
FDA

AstraZeneca Gets FDA Approval in Boost to Rare Disease Franchise

AstraZeneca has secured the FDA’s green light for Voydeya, a first-in-class, oral, Factor D inhibitor developed as an add-on to its standard-of-care Ultomiris or Soliris for certain patients with paroxysmal nocturnal haemoglobinuria.

April 1, 2024
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2 min read
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Nick Paul Taylor
Drug Delivery

Poor Customer Data Management Costs Pharma Companies Money: Report

While some companies look to AI models to stop revenue leakage in business operations, experts say more fundamental issues must first be addressed.

April 1, 2024
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5 min read
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Patience Asanga
CryoEM: Evolution and Best Practices

Helix Biostructures offers a full gene-to-structure suite of cryo-EM services that focuses on both quality and fast turnaround/throughput.

April 1, 2024
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4 min read
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Helix Biostructures
Microbix Announces Annual and Special Meeting Voting Results - April 01, 2024

Microbix Biosystems Inc., a life sciences innovator and exporter, announces the voting results from the Annual and Special Meeting of Shareholders of the Company which was held on March 27, 2024.

April 1, 2024
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4 min read
Bio NC

Shattuck Labs Announces Participation in Upcoming 23rd Annual Needham Virtual Healthcare Conference

Shattuck Labs, Inc. (Shattuck) (NASDAQ: STTK) today announced that company management will participate in the 23rd Annual Needham Virtual Healthcare Conference being held virtually from April 8-11, 2024.

April 1, 2024
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1 min read