BioSpace News Archive

Drug Development

Orphazyme Drug Misses Both Endpoints in Rare Muscle-Wasting Disease Trial

Orphazyme announced its Phase II/III clinical trial of arimoclomal for inclusion body myositis (IBM) failed to hit both its primary and secondary endpoints.

March 29, 2021
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2 min read
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Mark Terry
FDA

After Many Delays, BMS and bluebird Win Approval for Multiple Myeloma CAR-T, Abecma

The FDA-approved ide-cel, which will be marketed under the brand name Abecma is going to be the second therapy for myeloma. Here’s everything you need to know.

March 29, 2021
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3 min read
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Alex Keown
Policy

WHO Report on COVID-19 Origin Focuses on Spread from Wild Animals

The report listed four scenarios in order of likelihood, with the top being from bats through another animal.

March 29, 2021
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4 min read
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Mark Terry
Drug Development

Zero to Hero – Tainted Company Bounces Back with Successful COVID-19 Drug

Humanigen, the biotech briefly run by “Pharma Bro” Martin Shkreli under the name KaloBios up until his arrest, is back in the game with an antibody that is keeping COVID-19 patients off of ventilators and improving survival.

March 29, 2021
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2 min read
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Kate Goodwin
Business

Caribou Biosciences is Armoring Cells to Fight Disease Through CRISPR

The company’s overarching aim is to edit and equip cells with molecular tools, through CRISPR, to eliminate certain cancers.

March 29, 2021
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6 min read
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Maggie Chen
Policy

French Court Fines Servier for Damages Caused by Weight-Loss Drug Mediator

Servier was found guilty of manslaughter and deceptive marketing practice for its Mediator drug for weight loss. The Paris-based company was fined $3.12 million.

March 29, 2021
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2 min read
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Alex Keown
uniQure Investigation Clears Hemophilia B Gene Therapy of Causing Liver Cancer

An investigation was conducted by an independent laboratory and reviewed by leading external experts in the field.

March 29, 2021
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2 min read
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Mark Terry
Drug Development

NeuroRx Reports Positive RLF-100 Data for Critically Ill COVID-19 Patients

A new readout from a Phase IIb/III trial showed intravenous RLF-100 (aviptadil) met the primary endpoint of improving survival and recovery at 60 days post-treatment for respiratory failure in critically ill patients with COVID-19.

March 29, 2021
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2 min read
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Mark Zipkin
Drug Development

ImmunityBio Announces 12-Month Overall Survival Probability of 83% in NCI-Led Phase 1 Study of Multi-Targeted hAd5 Immunotherapy Vaccine in Patients with Advanced Metastatic Prostate Cancer

ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, today announced the publication of Phase I data in The Journal of ImmunoTherapy of Cancer (JITC).

March 29, 2021
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7 min read
Bio NC

Remarque Systems Launches Application That Speeds Study Start-Up, and Enhances Team Collaboration and Sponsor Communications

Industry-wide, spreadsheets have long been the go-to method for tracking clinical trial start-up, but now a new purpose-built solution is available that has been created expressly to improve efficiency and quality in a clinical trial’s study start-up across the entire clinical development process.

March 29, 2021
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3 min read