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BioWorld - Sunday, February 8, 2026
Home » Topics » Regulatory » IND

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Edesa’s COVID-19 IND sparks the stock

July 30, 2020
By Lee Landenberger
By filing an IND with the FDA to initiate a phase II/III study of EB-05, a monoclonal antibody, Edesa Biotech Inc. joined the handful of companies developing COVID-19 treatments that inhibit Toll-like receptor 4 (TLR4) signaling. The Toronto-based company’s stock (NASDAQ:EDSA) responded by rocketing 81.38% upward Thursday to close at $9.45, after trading as high as $19.10.
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Health professional pointing stethoscope at Clinical Trial words, icons

Luoxin’s PIK3α inhibitor receives trial nod in China after Novartis’ alpelisib

May 19, 2020
By Elise Mak
BEIJING – Shandong, China-based Luoxin Pharmaceuticals Group Stock Co. Ltd. said its PIK3α inhibitor, LX-086, has been approved by China’s National Medical Products Administration (NMPA) to enter clinical trials for advanced solid tumors.
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Health professional pointing stethoscope at Clinical Trial words, icons

Luoxin’s PIK3α inhibitor receives trial nod in China after Novartis’ alpelisib

May 13, 2020
By Elise Mak
BEIJING – Shandong, China-based Luoxin Pharmaceuticals Group Stock Co. Ltd. said its PIK3α inhibitor, LX-086, has been approved by China’s National Medical Products Administration (NMPA) to enter clinical trials for advanced solid tumors, two weeks after Novartis AG’s alpelisib, which aims at the same target, was also granted IND clearance in China.
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Will to Prevail in FTD-GRN Proclaimed, phase I/II gene therapy start near

April 22, 2020
By Randy Osborne
The acceptance by the FDA of Prevail Therapeutics Inc.’s IND for the one-time, fast-tracked gene therapy PR-006 provided hope for 50,000 to 60,000 people in the U.S beset by frontotemporal dementia with the GRN mutation (FTD-GRN), and the New York-based company is moving ahead with a phase I/II experiment called Proclaim.
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Lungs wireframe illustration

Mallinckrodt to submit IND to FDA for inhaled nitric oxide to treat COVID-19 respiratory distress

March 13, 2020
By Stacy Lawrence
Mallinckrodt plc is engaging with the U.S. FDA, NIH and the Biomedical Advanced Research and Development Authority to address the potential use of its INOmax (nitric oxide) inhaled gas to treat COVID-19-associated lung complications. INOmax is marketed in the U.S. by the Staines-upon-Thames, U.K.-based company to treat full- and near-term neonates with hypoxic respiratory failure associated with pulmonary hypertension.
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China confirms drug reforms to spur innovation, ensure drug quality, ease restrictions

Sep. 10, 2019
By Elise Mak
BEIJING – China has finally written all its drug-related reforms into law, as it passed the amendment of its drug administration law in late August, the amendment to take effect on Dec. 1. Those moves carry one goal: to bring more and better drugs into the Chinese market as quickly as possible.
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Drug pricing: Are we paying for efficacy or innovation?

Feb. 12, 2014
By Jennifer Boggs
What if we paid professional athletes only when they won? What if spectators got their tickets refunded whenever the home team lost? That might make that $1,300 Super Bowl ticket a little easier to purchase. And, hey, perhaps that might assuage some of the crushing disappointment for Denver fans still bemoaning the Broncos’ embarrassing defeat. (Though, on second thought, maybe not. Broncos’ fans are pretty passionate and hard core.) But along those same lines, what if we paid for therapeutics only when they worked? That would keep the cost of health care from further spiraling out of control, right? That...
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