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BioWorld - Thursday, May 19, 2022
Home » Topics » Clinical

Clinical
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Coronavirus and DNA

Coronavirus waylays China trials, may delay regulatory approvals too

Feb. 18, 2020
By Elise Mak
No Comments
BEIJING – Multiple China-based clinical trials have been put on hold as the country concentrates on its fight against COVID-19. To curb the spread of the novel coronavirus that has infected over 72,000 people and killed nearly 2,000, China has imposed travel and transport restrictions, making trips difficult or even impossible for patients and physicians.
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Lungs wireframe illustration

Bellerophon shares blast off with new Inopulse data

Feb. 18, 2020
By Michael Fitzhugh
No Comments
Shares of Bellerophon Therapeutics Inc. (NASDAQ:BLPH), rescued from potential delisting by a recent reverse stock split, shot 168.4% higher to $9.20 on Feb. 18 as new top-line data from a small phase II study showed its inhaled nitric oxide delivery system, Inopulse, delivered significant improvements in blood flow for people with pulmonary hypertension (PH) associated with pulmonary fibrosis (PF).
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Doctor examining patient's hand
Newco news

Zhittya gains approval for phase I Parkinson’s trial in Mexico

Feb. 14, 2020
By Lee Landenberger
No Comments
Privately held Zhittya Genesis Medicine Inc. received approval from Mexico’s Comisión Federal para la Protección contra Riesgos Sanitarios (Cofepris) to begin a phase I trial at the Zambrano Hospital in Monterrey for patients with Parkinson’s disease.
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Woman giving birth

Alydia Health wraps up enrollment in pivotal study of device postpartum hemorrhage

Feb. 14, 2020
By Liz Hollis
No Comments
Alydia Health Inc., of Menlo Park, Calif., has completed enrollment in the pivotal PEARLE investigational device exemption (IDE) study, which is assessing the safety and effectiveness of the Jada system to rapidly control and treat abnormal postpartum uterine bleeding and postpartum hemorrhage.
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Syringe and ampoules

Sanifit seeks benefit in pivotal trial for rare calcification disorder

Feb. 14, 2020
By Michael Fitzhugh
No Comments
Spain's Sanifit Laboratoris SL, a company developing treatments for calcification disorders, has dosed the first patient in a phase III trial of its lead asset, SNF-472, for the treatment of the rare and sometimes deadly disease calciphylaxis, a calcium accumulation disorder.
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Hoth touts preliminary data on lupus skin disease candidate

Feb. 12, 2020
By Michael Fitzhugh
No Comments
New York-based Hoth Therapeutics Inc. said preliminary preclinical data on a topical nanoparticle formulation of the endocannabinoid anandamide it licensed from Zylö Therapeutics Inc. represents "a positive step toward underlining the transformative potential" of the early stage therapy for the skin disease cutaneous lupus erythematous.
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Logicbio shares sink as FDA hold delays plans to launch phase I/II trial

Feb. 11, 2020
By Michael Fitzhugh
No Comments
Pediatric gene editing specialist Logicbio Therapeutics Inc. has revealed an FDA clinical hold on a planned phase I/II trial of its lead candidate, LB-001, an investigational therapy for rare inherited metabolic disorder methylmalonic acidemia (MMA).
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Pan-Cancer illustration showing molecular clock in cells

Pan-Cancer Project looks closer, sees more

Feb. 11, 2020
By Nuala Moran
No Comments
LONDON – The genomes of 38 different tumor types and the 47 million mutations that fostered their growth are revealed in unprecedented detail in 23 studies published in Nature and other journals on Feb. 6, 2020.
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Roche, Lilly drugs fail to slow decline in early onset AD

Feb. 10, 2020
By Michael Fitzhugh
No Comments
A high-profile test of two experimental medicines in people with autosomal dominant Alzheimer’s disease (ADAD), a rare inherited form of the disease, found that neither drug significantly slowed rates of cognitive decline vs. placebo, the primary endpoint.
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Anxious balance: Biohaven’s troriluzole misses its primary endpoint while rimegepant could be a blockbuster

Feb. 10, 2020
By Lee Landenberger
No Comments
Top-line results from Biohaven Pharmaceutical Holding Co.’s phase III trial of troriluzole against placebo in treating generalized anxiety disorder (GAD) failed to hit its primary endpoint, prompting the company CEO to say the poor results support halting development plans for the glutamate modulator as a monotherapy in GAD.
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