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Health Canada approves first COVID-19 serological test for use in the country to detect COVID-19 antibodies. DiaSorin

Written by | 14 May 2020

Health Canada says it has authorized the first COVID-19 serological test for use in the country to detect antibodies specific to the virus. DiaSorin, an Italian multinational biotechnology… read more.

NIH clinical trial testing antiviral remdesivir plus anti-inflammatory baricitinib for COVID-19 begins.

Written by | 13 May 2020

A randomized, controlled clinical trial evaluating the safety and efficacy of a treatment regimen of the investigational antiviral remdesivir plus the anti-inflammatory drug baricitinib for coronavirus disease 2019… read more.

Sarclisa + carfilzomib + dexamethasone phase III IKEMA trial meets primary endpoint early in patients with relapsed multiple myeloma.- Sanofi

Written by | 13 May 2020

The Phase III IKEMA clinical trial evaluating Sarclisa (isatuximab) added to carfilzomib and dexamethasone met the primary endpoint at its first planned interim analysis, demonstrating significantly prolonged progression-free… read more.

Phase III EXPLORER-HCM trial of MYK 461 meets all endpoints in hypertrophic cardiomyopathy.- MyoKardia

Written by | 13 May 2020

MyoKardia announced positive topline data from the company’s Phase III pivotal EXPLORER-HCM clinical trial of MYK 461 (mavacamten) for the treatment of patients with symptomatic, obstructive hypertrophic cardiomyopathy… read more.

FDA gives emergency use authorisation for SARS-CoV-2 IgG test for COVID-19 diagnostics.- Abbott

Written by | 12 May 2020

Abbott announced that the FDA issued Emergency Use Authorization (EUA) for the company’s SARS-CoV-2 IgG lab-based serology blood test on the Alinity i system. Abbott plans to ship… read more.

Phase III BRIDGE trial of PRX 102 met main objectives for safety and efficacy in Fabry disease.- Protalix BioTherapeutics

Written by | 12 May 2020

Protalix BioTherapeutics announced positive topline results from its Phase III BRIDGE clinical trial of PRX 102 (pegunigalsidase alfa), the Company’s plant cell-expressed recombinant, PEGylated, cross-linked alpha-galactosidase-A product candidate… read more.

Results from interim analysis of RESOLVE-IT phase III trial of elafibranor in adults with NASH and fibrosis. Genfit

Written by | 12 May 2020

Genfit announced results from an interim analysis of the RESOLVE-IT Phase III trial evaluating once-daily, 120mg of elafibranor in adults with non-alcoholic steatohepatitis (NASH). The trial did not… read more.

FDA grants emergency use authorization to the Zero Contact COVID-19 test kit as a saliva-based diagnostic for at home use to detect COVID-19.- Vitagene

Written by | 11 May 2020

Vitagene has announced the availability of 50,000 FDA authorized at home Zero-Contact or Saliva-based COVID-19 test kits for use during the current public emergency to detect COVID-19. Vitagene… read more.

FDA grants emergency use authorisation for Sofia 2 SARS Antigen Test for COVID-19 detection.- Quidel Corp

Written by | 11 May 2020

Quidel Corporation announced that it has received Emergency Use Authorization (EUA) from the FDA to market its Sofia 2 SARS Antigen rapid point-of-care test to be used with… read more.

Higher investigational doses of Trulicity meaningfully reduced A1C and body weight in people with type 2 diabetes.- Eli Lilly

Written by | 10 May 2020

New 36-week data showed higher investigational doses of Trulicity (3 mg and 4.5 mg) were well-tolerated and led to A1C reductions up to 1.9 percent and weight reductions… read more.

Phase III clinical data of Fexuprazan shows efficacy in gastroesophageal reflux disease.- Daewoong Pharma

Written by | 9 May 2020

Daewoong Pharmaceutical unveiled for the first time the phase III clinical data of Fexuprazan, a novel gastroesophageal reflux disease agent at Digestive Disease Week (DDW) 2020. The phase… read more.

FDA approves Keytruda for use at an additional recommended dose of 400 mg every six weeks for all approved adult indications.-Merck Inc.

Written by | 9 May 2020

Merck announced that the FDA has approved an additional recommended dosage of 400 mg every six weeks (Q6W) for Keytruda, Merck’s anti-PD-1 therapy, across all adult indications, including… read more.

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