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Sanofi receives positive CHMP opinion for Sarclisa for the treatment of relapsed and refractory multiple myeloma.

Written by | 29 Mar 2020

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Sarclisa (isatuximab). The CHMP recommends Sarclisa in combination with pomalidomide… read more.

Data from two Phase III trials in adult and pediatric patients for MM 36 showed statistically significant improvements in atopic dermatitis.- Medimetriks Pharmaceuticals

Written by | 28 Mar 2020

Medimetriks Pharmaceuticals announced that its partner, Otsuka Pharmaceuticals Co. Ltd., achieved positive results in two Phase III Japanese clinical trials in adult and pediatric patients for MM 36… read more.

Synairgen plc initiates Phase II trial of SNG 001 to treat COVID-19 patients .

Written by | 28 Mar 2020

Synairgen plc , the respiratory drug discovery and development company,announces that it has received expedited approvals from the Medicines and Healthcare products Regulatory Agency (MHRA) and Health Research… read more.

Interim analysis in phase III OVAL study of VB 111 shows positive outcome in ovarian cancer.- VBL Therapeutics

Written by | 28 Mar 2020

VBL Therapeutics announced an encouraging outcome of the planned interim analysis in the phase III OVAL study, a double-blind controlled potential-registration study in patients with platinum-resistant ovarian cancer… read more.

EU gives CE mark approval to SARS-CoV-2 test for Coronavirus.- Thermo Fisher

Written by | 28 Mar 2020

Thermo Fisher Scientific Inc announced that it has received the CE mark in the European Union for its diagnostic test to detect nucleic acid from SARS-CoV-2, the virus… read more.

FDA approves Zeposia to treat relapsing forms of multiple sclerosis ,including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.-BMS

Written by | 28 Mar 2020

Bristol-Myers Squibb Company announced that the FDA approved Zeposia (ozanimod) 0.92 mg for the treatment of adults with relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome,… read more.

New England Journal of Medicine publishes results from pivotal phase III BELIEVE trial of Reblozyl in adult patients With beta thalassemia- BMS

Written by | 28 Mar 2020

Bristol-Myers Squibb Company and Acceleron Pharma Inc. announced that the New England Journal of Medicine (NEJM) has published results from BELIEVE, the pivotal Phase III study evaluating the… read more.

Tepmetko is approved in Japan for the treatment of patients with unresectable, advanced or recurrent non-small cell lung cancer with MET exon 14 (METex14) skipping alterations.- Merck KGaA

Written by | 27 Mar 2020

Merck KGaA announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Tepmetko (tepotinib) for the treatment of patients with unresectable, advanced or recurrent non-small… read more.

FDA accepts for filing NDA for JZP 258 for the treatment of cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy.-Jazz Pharma

Written by | 27 Mar 2020

Jazz Pharmaceuticals plc announced that the FDA accepted for filing with Priority Review the company’s New Drug Application (NDA) seeking marketing approval for JZP 258, an investigational medicine… read more.

NanoFlu, seasonal influenza vaccine , achieves all primary endpoints in phase III clinical trial.-Novavax Inc.

Written by | 27 Mar 2020

Novavax, Inc. announced positive top-line results of its pivotal Phase III clinical trial of NanoFlu , its recombinant quadrivalent seasonal influenza vaccine candidate with its proprietary Matrix-M adjuvant,… read more.

Phase IV trial data with Rayaldee shows efficacy in chronic kidney disease.- OPKO Health

Written by | 27 Mar 2020

OPKO Health reported interim results from an ongoing Phase IV clinical trial comparing Rayaldee with three common treatment regimens for secondary hyperparathyroidism (SHPT) in adult patients with stage… read more.

The Lancet publishes papers from two studies of TAK 003 dengue vaccine candidate.- Takeda

Written by | 26 Mar 2020

Takeda Pharmaceutical Company Limited announced that The Lancet published two papers related to Takeda’s dengue vaccine candidate (TAK 003), reporting on results from the 18-month analysis of the… read more.

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