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BioWorld, Clinical
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IMV’s phase II ovarian cancer data trend positive while the stock reverses

Feb. 25, 2020
By Lee Landenberger
Updated results from IMV Inc.’s ongoing phase II trial of DPX-Survivac to treat advanced recurrent ovarian cancer show the company’s lead candidate was active and well-tolerated in patients.
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NGM studios’ top-line phase II NASH premiere whets appetite for Alpine 2/3 sequel

Feb. 24, 2020
By Randy Osborne
NGM Biopharmaceuticals Inc. wowed investors with positive preliminary top-line results from the 24-week double-blind, randomized, placebo-controlled fourth cohort of an adaptive phase II study testing aldafermin in nonalcoholic steatohepatitis (NASH).
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VMAT2 carry-through brings Waterloo for Austedo TS bid by Teva

Feb. 20, 2020
By Randy Osborne
Teva Pharmaceutical Industries Ltd.’s Austedo (deutetrabenazine) lived up to the lack of expectations in pediatric Tourette syndrome (TS), missing identical primary endpoints in a pair of late-stage trials.
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Zelira’s medicinal cannabis therapy meets primary endpoints in phase I/II insomnia trial

Feb. 20, 2020
By Tamra Sami
PERTH, Australia – Medicinal cannabis company Zelira Therapeutics Ltd. reported that its ZLT-101 therapy met the primary endpoint of a statistically significant improvement in insomnia in a phase Ib/IIa study in patients diagnosed with chronic insomnia.
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Newco news

Reinvented Coimmune has a new IND and two clinical trials

Feb. 19, 2020
By Lee Landenberger
It’s been a rapid year of change for Coimmune Inc., which was incorporated only 12 months ago and now has FDA approval of an IND clearing the way for a phase IIb trial using CMN-001 to treat advanced metastatic renal cell carcinoma (mRCC).
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Coronavirus and DNA

Coronavirus waylays China trials, may delay regulatory approvals too

Feb. 18, 2020
By Elise Mak
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
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
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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Syringe and ampoules

Sanifit seeks benefit in pivotal trial for rare calcification disorder

Feb. 14, 2020
By Michael Fitzhugh
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
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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