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Celltrion reaches milestone on COVID-19 super antibody

March 24, 2020

HONG KONG - Korean biopharma Celltrion Inc. said it’s halfway through the process of creating a super antibody to reign in the COVID-19 novel coronavirus that has claimed almost 13,000 lives globally.

Junshi pushes COVID-19 neutralizing antibodies to clinic; IPO on STAR next

March 24, 2020

By Elise Mak

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BEIJING – Shanghai Junshi Biosciences Ltd. is developing neutralizing antibodies as a potential treatment for COVID-19, and the program will move on to clinical trials soon. Meanwhile, the biotech is set to launch a pre-revenue IPO on Shanghai’s STAR market.

'MIST' tachycardia endpoint sends Milestone shares to record low

March 24, 2020

By Michael Fitzhugh

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Despite earlier signs it might meet the primary endpoint of a phase III trial testing its ability to terminate supraventricular tachycardia (SVT) episodes in patients with paroxysmal supraventricular tachycardia (PSVT), a short-acting calcium channel blocker tested by Milestone Pharmaceuticals Inc. failed to do so.

'It's really not going to scale'

Companies face challenges with increasing clinical trial data sources

March 24, 2020

By Brian Orelli

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A survey of 149 companies by Tufts Center for the Study of Drug Development found more than two-thirds of clinical trial sponsors were using or piloting at least four different data sources in their clinical trials.

Clinical testing and the new virtual reality in time of COVID-19

March 24, 2020

By Lee Landenberger

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It took less than a week from the publication of Science 37’s whitepaper on March 12 encouraging virtual clinical trials to the FDA’s decision to endorse the idea, tailored to address the COVID-19 pandemic.

Clinical testing and the new virtual reality in time of COVID-19

March 24, 2020

By Lee Landenberger

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King of the road? Monarch partly pulled over but hope Stoked in DS

March 23, 2020

By Randy Osborne

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Stoke Therapeutics Inc. is marching ahead in the second half of this year with its phase I/IIa study with STK-001 in Dravet syndrome (DS), one of the more abysmal forms of epilepsy, although the FDA has temporarily hobbled part B of the test, pending preclinical data that will more fully characterize the safety profile of the antisense oligonucleotide (ASO).

Policy advocates propose measures for clinical disruptions in China

March 20, 2020

By Elise Mak and Cornelia Zou

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BEIJING – China was the first country to face serious disruptions in clinical trials caused by COVID-19, and policy advocates in the country moved quickly to identify lessons for future outbreaks and address the concerns of a biotech industry in dismay.

Go toward the light: Soligenix CTCL therapy no FLASH in the pan

March 19, 2020

By Randy Osborne

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Princeton, N.J.-based Soligenix Inc.’s quick response testing SGX-301 (synthetic hypericin) – with results shown after just six weeks of treatment – puts the company in strong position against cutaneous T-cell lymphoma (CTCL) as it readies for a “robust” discussion with the FDA.

EU boosts funding for COVID-19 epidemic, encourages clinical trial cooperation

March 19, 2020

By Nuala Moran

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LONDON – As the epicenter of the COVID-19 epidemic shifted to Europe and the number of deaths in Italy exceeded the toll in China, the EU stepped up efforts to mount a coordinated response, with a big boost for collaborative R&D funding and a call for clinical research to be pooled in multicenter, multi-arm randomized controlled trials.

South Korea approves first four COVID-19 test kits under urgent-use license
BioWorld
HONG KONG – South Korea’s Ministry of Food and Drug Safety (MFDS) recently granted the first urgent-use licenses to four COVID-19 novel coronavirus diagnostic...
Two South Korean COVID-19 kits look overseas, seek FDA approval
BioWorld MedTech
HONG KONG – As the number of COVID-19 confirmed cases and deaths continue to rise globally, South Korea’s focus on testing has attracted international attention....
Noninvasive ventilation options explored for COVID-19, as FDA eases with guidance
BioWorld MedTech
Like so many other ventilator providers in recent days, Resmed Inc. has committed to ramping up production. It aims to triple its ventilator output and multiply...
FDA says yes to NO: Bellerophon Therapeutics wins expanded access approval for inhaled nitric oxide system
BioWorld
DUBLIN—Can high-dose inhaled nitric oxide (NO) make a meaningful contribution to patients with COVID-19 infection? The FDA was sufficiently persuaded by the data...
Antiviral favipiravir effective against COVID-19, China says
BioWorld
Randomized trials of the broad-spectrum antiviral favipiravir, marketed as an anti-influenza treatment by Fujifilm Holdings Corp., have shown "obvious efficacy"...

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