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Farxiga phase III DAPA-CKD trial will be stopped early after overwhelming efficacy in patients with chronic kidney disease.-AstraZeneca

Written by | 31 Mar 2020

The Dapagliflozin And Prevention of Adverse outcomes in Chronic Kidney Disease (DAPA-CKD) Phase III trial for Farxiga (dapagliflozin) in patients with chronic kidney disease (CKD) will be stopped… read more.

FDA approves Imfinzi as first line treatment for extensive stage small cell lung cancer.- AstraZeneca

Written by | 31 Mar 2020

Imfinzi (durvalumab) from AstraZeneca has been approved in the US as a 1st-line treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC) in combination with standard-of-care… read more.

CHMP recommends extending indication of Ruconest to children with Hereditary Angioedema.- Pharming

Written by | 31 Mar 2020

Pharming has announced the Committee for Medicinal Products for Human Use (CHMP), an advisory committee of the European Medicine Agency (EMA), has adopted a positive opinion recommending an… read more.

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.

CHMP recommends Cosentyx for the treatment of adult patients with active non-radiographic axial spondyloarthritis. -Novartis

Written by | 29 Mar 2020

Novartis, announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Cosentyx (secukinumab) for the treatment… read more.

China’s National Medical Products Administration has accepted an application for the approval of denosumab copy biological HLX 14.- Shanghai Henlius Biotech

Written by | 29 Mar 2020

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), has accepted an application for the approval of denosumab copy biological HLX 14. China-based… read more.

CHMP recommends Zolgensma for the treatment of patients with 5q spinal muscular atrophy . – Novartis

Written by | 29 Mar 2020

AveXis, a Novartis company, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending conditional… read more.

CHMP recommends Zeposia to treat adult patients with relapsing remitting multiple sclerosis.- BMS

Written by | 29 Mar 2020

Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion for Zeposia (ozanimod) for… read more.

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.

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