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Santhera provides update on the ongoing regulatory review of Puldysa by the CHMP in Duchenne Muscular Dystrophy.

Written by | 29 May 2020

Santhera Pharmaceuticals announces that the CHMP has granted a requested extension of the clock-stop in the regulatory procedure for its conditional marketing authorization (CMA) application for Puldysa (idebenone)… read more.

Santhera provides update on the ongoing regulatory review of Puldysa by the CHMP in Duchenne Muscular Dystrophy.

Written by | 29 May 2020

Santhera Pharmaceuticals announces that the CHMP has granted a requested extension of the clock-stop in the regulatory procedure for its conditional marketing authorization (CMA) application for Puldysa (idebenone)… read more.

Remdesivir granted early access in the UK by MHRA for COVID-19 treatment.- Gilead Sciences

Written by | 29 May 2020

Remdesivir has been granted a special early access status in the UK, which will allow patients hospitalized with COVID-19 to receive the antiviral treatment.The public assessment report issued… read more.

Genentech/Roche + Gilead Sciences initiate Phase III trial of Actemra + remdesivir in hospitalized patients with severe COVID-19 pneumonia.

Written by | 29 May 2020

Genentech, a member of the Roche Group announced the initiation of a global Phase III, randomized, double-blind, multicenter study (REMDACTA) to evaluate the safety and efficacy of Actemra… read more.

Santhera provides update on the ongoing regulatory review of Puldysa by the CHMP in Duchenne Muscular Dystrophy.

Written by | 29 May 2020

Santhera Pharmaceuticals announces that the CHMP has granted a requested extension of the clock-stop in the regulatory procedure for its conditional marketing authorization (CMA) application for Puldysa (idebenone)… read more.

Phase III Archway study of Lucentis Port Delivery System meets primary endpoint in age-related macular degeneration.- Genentech/Roche

Written by | 28 May 2020

Genentech/Roche announced positive topline results from the Phase III Archway study, evaluating Lucentis Port Delivery System (ranibizumab or PDS) in people living with neovascular or “wet” age-related macular… read more.

FDA approves Opdivo + Yervoy combined with limited chemotherapy as first-line treatment of metastatic or recurrent non-small cell lung cancer.- BMS

Written by | 28 May 2020

Bristol Myers Squibb announced that Opdivo (nivolumab) 360 mg plus Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) given with two cycles of platinum-doublet chemotherapy was approved by… read more.

Hansa Biopharma submits responses to outstanding questions from EMA for imlifidase application in kidney transplantation.

Written by | 28 May 2020

Hansa Biopharma, the leader in immunomodulatory enzyme technology for rare IgG mediated diseases, announced that the ongoing EMA review of imlifidase for a potential marketing authorization in Europe… read more.

Aurinia Pharmaceuticals Inc.has completed the rolling submission to the FDA for voclosporin as a potential treatment for lupus nephritis.

Written by | 28 May 2020

Aurinia Pharmaceuticals Inc.has announced the completion of the rolling submission of a New Drug Application (“NDA”) to the FDA for voclosporin as a potential treatment for lupus nephritis… read more.

Novartis announces at EAN new data for ofatumumab demonstrating robust efficacy and safety in the treatment of relapsing forms of multiple sclerosis (RMS).

Written by | 28 May 2020

Novartis announced that new ofatumumab data from the Phase III ASCLEPIOS trials and the Phase II APLIOS trial were presented virtually at the 6th Congress of the European… read more.

Boehringer Ingelheim + Lilly to collaborate with Duke Clinical Research Institute on a pragmatic trial,EMPACT-MI, examining Jardiance’s effects following an acute myocardial infarction.

Written by | 27 May 2020

Boehringer Ingelheim and Eli Lilly and Company announced an academic research collaboration with the Duke Clinical Research Institute (DCRI) on a new trial, EMPACT-MI (EMPAgliflozin for the prevention… read more.

WHO pausing the hydroxycholoroquine arm of its global COVID-19 drug trials.

Written by | 27 May 2020

The World Health Organization (WHO) is pausing the hydroxycholoroquine arm of its global COVID-19 drug trials after a review found the malaria therapy was associated with raised death… read more.

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