BioCentury | Feb 26, 2020
Product Development

U.S. testing of coronavirus vaccine, therapeutic begin

NIH is kicking off the first U.S. clinical trials for COVID-19 with an adaptive trial of remdesivir, an antiviral therapeutic, and a Phase I trial of Moderna’s vaccine candidate. Separately Tuesday, FDA Commissioner Stephen Hahn...
BioCentury | Jun 3, 2019
Product Development

There are opportunities to eradicate opioid misuse: Investors and innovators should seize them

Eradicating opioid misuse and addiction will take an integrated, holistic approach involving prevention, treatment, and recovery. Crucially, it will also take the help of investors and innovators in biotechnology who understand the challenges and opportunities...
BC Innovations | Dec 22, 2017
Product R&D

Dengvaxia’s warning

The fallout of Sanofi’s dengue vaccine debacle has researchers scrambling to rationalize whether competitor products will fall afoul of the same effects, and whether other, related fields should change course. The early upshot is that...
BioCentury | Sep 30, 2017
Product Development

Running interference

Editor’s Note: An earlier version of this story was published in BioCentury on Sept. 25. It has been updated to include reporting about safety and efficacy data that was not included in the original. The...
BioCentury | Jun 23, 2017
Product Development

Sequential insights

After showing it can detect both occult and late-stage cancers, Grail Inc. is now ready to tackle developing its first cancer screening assay. The company has begun clinical studies that will help it build and...
BioCentury | Apr 15, 2017
Product Development

Outside factors

This year could see the first regulatory submission from a coming wave of new therapies for hemophilia prophylaxis that do not simply replace missing clotting factors, which has been the standard for care for decades....
BioCentury | Dec 10, 2016
Product Development

Rules of the road

Investigators and companies have long been devising strategies to mitigate or preempt toxicities from CAR T cell therapies without compromising efficacy. Now, data presented at the American Society of Hematology meeting suggest strategies to prevent...
BioCentury | Oct 19, 2015

Preferring PCSK9s

While the Institute for Clinical and Economic Review refines its value assessment of PCSK9 inhibitors, Express Scripts Holding Co. has already made its coverage decision for the new lipid lowering agents, and Prime Therapeutics LLC...
BC Week In Review | Jul 28, 2014
Clinical News

Orencia abatacept: Phase IIIb data

The double-blind, international Phase IIIb AVERT trial in 351 patients with early RA showed that first-line treatment with once-weekly 125 mg subcutaneous Orencia plus methotrexate for 12 months met the co-primary endpoints of a greater...
BioCentury | Oct 14, 2013
Product Development

Doubling up on diabetes

Poxel S.A. hopes imeglimin will become physicians' go-to oral therapy to combine with metformin in diabetes. Clinical data show it improves the activity of two affected organs, may be safer than targeted oral antidiabetics and...
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