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Enhertu significantly improved tumour response rate and overall survival in HER2-positive metastatic gastric cancer in Phase II DESTINY-Gastric01 trial .- AstraZeneca + Daiichi Sankyo.

Written by | 30 May 2020

Detailed results from the positive, registrational, randomised controlled Phase II DESTINY-Gastric01 trial showed AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo)’s Enhertu (trastuzumab deruxtecan) demonstrated a statistically significant… read more.

FDA approves Zilxi for rosacea.- Menlo Therapeutics

Written by | 30 May 2020

Menlo Therapeutics announced that the FDA has approved Zilxi (minocycline) topical foam, 1.5%, for the treatment of inflammatory lesions of rosacea in adults. Zilxi, developed as FMX103 by… read more.

Piqray + fulvestrant receives positive CHMP opinion to treat HR+/HER2- advanced breast cancer with a PIK3CA mutation.- Novartis

Written by | 30 May 2020

Novartis has announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending approval of Piqray (alpelisib) in… read more.

Phase III HERO study of TAK 385 for prostate cancer published in New England Journal of Medicine.- Myovant Sciences

Written by | 30 May 2020

Myovant Sciences announced additional results from its Phase III HERO study of once-daily, oral TAK 385 (relugolix) (120 mg) in men with advanced prostate cancer in an oral… 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.

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.

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