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BioWorld - Sunday, February 15, 2026
Home » Topics » Regulatory » NDA

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Hanmi seeks domestic approval for Korea’s first neutropenia biologic

May 12, 2020
By Gina Lee
HONG KONG – South Korea’s Hanmi Pharmaceutical Co. Ltd. has filed a new drug approval application for Rolontis (eflapegrastim) with the country’s Ministry of Food and Drug Safety (MDFS).
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Hanmi seeks domestic approval for Korea’s first neutropenia biologic

May 11, 2020
By Gina Lee
HONG KONG – South Korea’s Hanmi Pharmaceutical Co. Ltd. has filed a new drug approval application for Rolontis (eflapegrastim) with the country’s Ministry of Food and Drug Safety (MDFS).
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Wall Street hails Chimerix viral load; COVID-19, smallpox bids forge onward

April 29, 2020
By Randy Osborne
A pair of good-news items from Chimerix Inc. pushed the Durham, N.C.-based company’s stock (NASDAQ:CMRX) to $2.15, closing up 64 cents, or 42%, higher as backers reacted to near-term NDA plans for smallpox countermeasure brincidofovir (BCV) and the start of a phase II/III trial with dociparstat sodium (DSTAT) in COVID-19 patients with acute lung injury (ALI).
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Too bad for Tookad: FDA adcom votes against Steba’s prostate cancer treatment

Feb. 26, 2020
By Lee Landenberger
Citing what it called poor study design and execution coupled with a lack of follow-up data, the FDA’s Oncologic Drugs Advisory Committee voted 13-2 against recommending approval of Steba Biotech SA’s NDA for Tookad (padeliporfin dipotassium) for injection in men with localized early stage prostate cancer.
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Going all the way, NMDA work sped up as chances weighed for big players

July 12, 2019
By Randy Osborne
Word from the FDA to Axsome Therapeutics Inc. about the effort with oral N-methyl-D-aspartate (NMDA) receptor antagonist AXS-05 in depression – and the company's accelerated push with the compound – had Wall Street watching the NMDA space with even more interest than usual.
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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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Patient Experience Still Undervalued in Regulating Drugs

Oct. 28, 2013
By Marie Powers
As I write this, I’m sitting in the University of British Columbia/Vancouver General Hospital (UBC/VGH) Eye Care Centre, where my husband, Chuck, is completing post-tests at the conclusion of a six-month study on prosopagnosia, otherwise known as face blindness. The condition isn’t treatable with drugs – not yet, at least – but it’s nonetheless disabling, prompting researchers at several centers in North America and Europe to work collaboratively and seek to help patients carry on with their lives. Clinical studies of prosopagnosia have, so far, informed researchers more about the causes and structural manifestations of the disease than about potential...
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What Drug Problem?

May 17, 2012
By Michael Harris
Pop quiz . . . which market is valued higher, illegal drugs or prescription drugs? Although drug lords and cartels are not apt to file annual reports, the United Nations estimates that 5 percent of the global population now takes illegal drugs that account for an approximate $430 billion black market industry that, fortunately, still trails the $800-plus billion prescription drug market. Of course, government keeps both markets in check for the sake of public safety. It seizes illegal drugs and takes the criminal kingpins to trial in the illegal market, thereby devaluing the illicit drug revenue stream. In the...
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Medical Progress Is Real

Nov. 6, 2011
By Anette Breindl
SAN FRANCISCO ‑ I’m enough of a geek that I actually enjoy the details, devil and all, and so I love covering scientific conferences. At the same time, they can be daunting. So much scientific progress is incremental. A case in point: This year’s conference handbook for the annual meeting of the American Association for the Study of Liver Diseases (AASLD) comes to over 1,500 pages, most of them describing minor advances. As I sat in a San Francisco café Saturday morning, simultaneously soaking up the atmosphere and sifting through some of those abstracts in preparation for the weekend, though,...
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Race To Nowhere

May 19, 2011
By Anette Breindl
Racial profiling – long in the realm of bad law enforcement – was criticized as bad medicine, too, in a recent paper by scientists from the Mount Sinai School of Medicine. The reason? As the authors put it, “cosmopolitan cities now include many individuals whose genetic heritage is drawn from multiple continental origins.” In other words, there’s no such thing as racial purity. In their paper, which was published in PLoS ONE and which you can find here (http://ow.ly/4YxK6) the team genotyped nearly 1,000 participants of Biobank, a program that collects DNA and plasma samples to aid in genomic and...
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