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Phase III STOP 301 trial of INP 104 meets primary endpoint in acute migraine.- Impel NeuroPharma

Written by | 11 Jun 2020

Impel NeuroPharma announced positive results from “STOP 301” (Safety and Tolerability of POD-DHE), the Company’s pivotal Phase III, open-label study of the safety and tolerability of INP 104… read more.

Phase III SELECT trials show Rinvoq efficacy continues to week 84 in rheumatoid arthritis.- AbbVie

Written by | 11 Jun 2020

AbbVie announced new long-term results showing that once-daily Rinvoq (upadacitinib) continued to improve signs and symptoms in patients with rheumatoid arthritis at 72 and 84 weeks in the… read more.

Fulcrum Therapeutics to evaluate losmapimod in Phase III trial as a potential treatment for COVID-19.

Written by | 11 Jun 2020

Fulcrum Therapeutics, Inc. announced plans to evaluate losmapimod as a potential treatment for patients with COVID-19 . Fulcrum has submitted an investigational new drug (IND) application to support… read more.

Stratatech/Mallinckrodt has completed its rolling submission of its BLA to the FDA for StrataGraft, for the treatment deep partial-thickness thermal burns.

Written by | 10 Jun 2020

Mallinckrodt Plc announced that Stratatech, a Mallinckrodt company, has completed its rolling submission of a Biologics License Application (BLA) to the FDA for StrataGraft, a regenerative skin tissue… read more.

Tirzepatide enters SURPASS-CVOT, the phase III cardiovascular outcomes trial,- Eli Lilly

Written by | 10 Jun 2020

The first patient dose has been delivered in SURPASS-CVOT, the phase III cardiovascular outcomes trial for tirzepatide, Eli Lilly and Company’s investigational dual GIP and GLP-1 receptor agonist…. read more.

Phase III DOLOMITES study of roxadustat versus darbepoetin alfa to treat anemia in non-dialysis-dependent adult patients with chronic kidney disease.- Astellas

Written by | 9 Jun 2020

Astellas Pharma Inc. announced results from the Phase III DOLOMITES study , evaluating the efficacy and safety of roxadustat compared with darbepoetin alfa for the treatment of anemia… read more.

Gilead Sciences files MAA for remdesivir at the EMA to treat COVID-19.

Written by | 9 Jun 2020

The European Medicines Agency (EMA) reports that Gilead Sciences has submitted its marketing application seeking conditional approval of antiviral remdesivir for the treatment of COVID-19. Since the EU… read more.

Regulatory applications for vericiguat to treat symptomatic chronic heart failure are filed in the EU and Japan.- Bayer HealthCare + Merck Inc.

Written by | 9 Jun 2020

Bayer announced the submission of two regulatory applications seeking the approval of vericiguat in the EU and Japan. Vericiguat is an investigational oral, once-daily, first-in-class soluble guanylate cyclase… read more.

CE Mark for OPTI SARS-CoV-2 RT-PCR laboratory test kit for the detection of SARS-CoV-2,.- Opti Medical Systems

Written by | 9 Jun 2020

OPTI Medical Systems, Inc., a subsidiary of IDEXX Laboratories, Inc. announced that it has received the CE mark certification in the European Union for its OPTI SARS-CoV-2 RT-PCR… read more.

ALN GO1 filed with EMA and FDA for primary hyperoxaluria type 1.- Alnylam Pharma

Written by | 8 Jun 2020

Alnylam Pharmaceuticals announced positive Phase III results from the ILLUMINATE-A study of ALN GO1 (lumasiran), an investigational RNAi therapeutic targeting hydroxyacid oxidase 1 (HAO1) – the gene encoding… read more.

Calquence showed promising clinical improvement in majority of 19 hospitalised COVID-19 patients .- AstraZeneca

Written by | 7 Jun 2020

Results published in Science Immunology showed that Calquence (acalabrutinib), a Bruton’s tyrosine kinase (BTK) inhibitor, reduced markers of inflammation and improved clinical outcomes of patients with severe COVID-19… read more.

New analyses of phase II EQUATOR clinical program support durable efficacy of filgotinib in psoriatic arthritis.- Gilead Sciences, Inc. + Galapagos NV

Written by | 7 Jun 2020

Gilead Sciences, Inc. and Galapagos NV announced new analyses from two clinical trials evaluating filgotinib, an investigational, oral, selective JAK1 inhibitor, in adults with psoriatic arthritis (PsA). The… read more.

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