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BioMarin plans regulatory submissions in Q3 2020 at FDA and EMA for vosoritide to treat children with achondroplasia.

Written by | 7 Apr 2020

BioMarin Pharmaceutical Inc. announced that based on recent meetings with health authorities in the US and Europe, the Company plans to submit marketing applications to the FDA and… read more.

Phase III FALCON study of bardoxolone in patients with autosomal dominant polycystic kidney disease is paused.- Reata Pharma

Written by | 6 Apr 2020

Reata Pharmaceuticals, Inc. provided an update on the impact of the COVID-19 pandemic on its clinical programs, drug supply chain, and business operations The Company announced measures it… read more.

Reata Pharmaceuticals closes CATALYST study of bardoxolone methyl for connective tissue disease-associated pulmonary arterial hypertension .

Written by | 6 Apr 2020

Reata Pharmaceuticals, Inc. provided an update on the impact of the COVID-19 pandemic on its clinical programs , drug supply chain, and business operations. The Company announced measures… read more.

The COVID-19 pandemic will not have a significant impact on completion of the Phase III CARDINAL trial of bardoxolone for CKD caused by Alport syndrome.- Reata Pharma

Written by | 6 Apr 2020

Reata Pharmaceuticals, Inc. provided an update on the impact of the COVID-19 pandemic on its clinical programs , drug supply chain, and business operations. The Company announced measures… read more.

Case study in Wuhan, China shows positive effect of Actemra as a treatment for COVID-19 and is published in Blood Advances.- Roche

Written by | 5 Apr 2020

A case study of a patient in Wuhan, China, suggests that the immunosuppressant Actemra (tocilizumab) from Roche may be an effective COVID-19 treatment for very ill patients who… read more.

FDA approves Reblozyl to treat anemia associated with lower-risk myelodysplastic syndromes. BMS + Acceleron

Written by | 5 Apr 2020

Bristol Myers Squibb and Acceleron Pharma Inc. announced the FDA has approved Reblozyl (luspatercept-aamt), the first and only erythroid maturation agent (EMA), for the treatment of anemia failing… read more.

FDA grants emergency use authorization for new COVID-19 diagnostic for use in U.S- BD + BioGX Inc.

Written by | 4 Apr 2020

-BD (Becton, Dickinson and Company) , a leading global medical technology company, and BioGX Inc., a molecular diagnostics company, announced that the FDA has granted Emergency Use Authorization… read more.

Vanda Pharma initiates ODYSSEY VLY-686-3501 trial of tradipitant in hospitalized patients with COVID-19.

Written by | 4 Apr 2020

Vanda Pharmaceuticals Inc. announced the initiation of clinical study, ODYSSEY VLY-686-3501, in hospitalized patients with COVID-19. The novel SARS-CoV-2 coronavirus is associated with a lower respiratory tract inflammation… read more.

Novan announced after FDA meeting the decision to conduct one additional phase III trial for SB 206 as a treatment for molluscum contagiosum.

Written by | 4 Apr 2020

Novan, Inc. announced that the Company has conducted its Type C meeting with the FDA regarding SB 206 for the treatment of molluscum. The purpose of the meeting… read more.

Phase III SYNAPSE study of Nucala meets endpoints in chronic rhinosinusitis with nasal polyps.- GlaxoSmithKline

Written by | 4 Apr 2020

GlaxoSmithKline announced positive results from the pivotal phase III SYNAPSE study of Nucala (mepolizumab) in patients suffering from chronic rhinosinusitis with nasal polyps (CRSwNP). This is the first… read more.

FDA grants emergency use authorization for new COVID-19 diagnostic for use in U.S- BD + BioGX Inc.

Written by | 4 Apr 2020

-BD (Becton, Dickinson and Company) , a leading global medical technology company, and BioGX Inc., a molecular diagnostics company, announced that the FDA has granted Emergency Use Authorization… read more.

Novartis initiates clinical study of Jakavi in severe COVID-19 patients and establishes international compassionate use program. – Novartis + Incyte Corpn.

Written by | 3 Apr 2020

Novartis announced plans to initiate a Phase III clinical trial in collaboration with Incyte to evaluate the use of Jakavi (ruxolitinib) for treatment of a type of severe… read more.

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