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CONNECT-FX study of Zygel fails to meet endpoints in Fragile X syndrome.- Zynerba Pharma

Written by | 1 Jul 2020

Zynerba Pharmaceuticals announced top line results from the 14-week pivotal CONNECT-FX study of Zygel (cannabidiol) which assessed its efficacy and safety as a treatment in for behavioral symptoms… read more.

Two phase I studies of INO 4800 report safety in COVID-19.- Inovio

Written by | 1 Jul 2020

Inovio has announced positive interim clinical data of INO 4800 vaccine candidate against novel coronavirus (SARS-CoV-2), from the first two Phase I clinical trial cohorts. In addition, INO… read more.

Ibsrela filed with FDA for hyperphosphatemia in adult patients with chronic kidney disease on dialysis.- Ardelyx

Written by | 1 Jul 2020

Ardelyx announced the submission of a New Drug Application (NDA) for Ibsrela (tenapanor) to the FDA for the control of serum phosphorus (hyperphosphatemia) in adult patients with chronic… read more.

EU approves Daurismo for acute myeloid leukemia.- Pfizer

Written by | 1 Jul 2020

Pfizer announced that the European Commission approved Daurismo (glasdegib), a Hedgehog pathway inhibitor, in combination with low-dose cytarabine (LDAC), a type of chemotherapy, for the treatment of newly… read more.

UK approves phase II/III study evaluating Yeliva in patients hospitalized with severe SARS-CoV-2 infection.- RedHill Biopharma

Written by | 30 Jun 2020

RedHill Biopharma Ltd. announced that the UK Medicines & Healthcare products Regulatory Agency (MHRA) has approved the Company’s Clinical Trial Authorization application to commence a Phase II/III study… read more.

RAUORA phase III trial of cytisinicline shows non-inferiority to Chantix in smoking cessation.- Achieve Life Sciences

Written by | 30 Jun 2020

Achieve Life Sciences announced the successful topline results from the New Zealand RAUORA Phase III non-inferiority clinical trial comparing cytisinicline to Chantix (varenicline) in Maori (indigenous New Zealanders)… read more.

In phase III SURE 1 trial sulopenem meets endpoint for uncomplicated urinary tract infections.- Iterum Therapeutics

Written by | 30 Jun 2020

Iterum Therapeutics announced topline results from its phase III SURE 1 clinical trial of sulopenem for the treatment of Uncomplicated Urinary Tract Infections (uUTI). Sulopenem is a novel… read more.

Phase III RHAPSODY trial of rilonacept meets endpoints in pericarditis.- Kiniksa Pharma

Written by | 30 Jun 2020

Kiniksa Pharmaceuticals announced that the Phase III RHAPSODY trial showed that rilonacept achieved its primary and all major secondary efficacy endpoints in patients with recurrent pericarditis. Results show… read more.

CPP 1X/sul filed with FDA and MAA for treatment of adults with familial adenomatous polyposis.- Cancer Prevention Pharma

Written by | 30 Jun 2020

Cancer Prevention Pharmaceuticals has submitted a New Drug Application (NDA) to the FDA seeking accelerated approval for CPP 1X/sul for treatment of adults with familial adenomatous polyposis (FAP)…. read more.

Complete Response Letter for HTX 011 as a treatment for postoperative pain.- Heron Therapeutics.

Written by | 30 Jun 2020

Heron Therapeutics, Inc. announced that it received a Complete Response Letter (CRL) from the FDA on June 26, 2020 regarding its New Drug Application (NDA) for HTX 011… read more.

Complete Response Letter for obeticholic acid for the treatment of fibrosis due to nonalcoholic steatohepatitis (NASH).- Intercept Pharmaceuticals

Written by | 30 Jun 2020

Intercept Pharmaceuticals, Inc. announced that the FDA has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for obeticholic acid (OCA) for the treatment of… read more.

EU approves Ultomiris for patients with atypical hemolytic uremic syndrome.- Alexion Pharma

Written by | 30 Jun 2020

Alexion Pharmaceuticals announced that the European Commission has approved Ultomiris (ravulizumab)—the first and only long-acting C5 complement inhibitor administered every eight weeks*—for the treatment of adults and children… read more.

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