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Phase III trial of tislelizumab + pemetrexed for first-line NSCLC met the primary endpoint of progression-free survival at interim analysis,- BeiGene

Written by | 15 Apr 2020

BeiGene, Ltd. a commercial-stage biotechnology company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, announced that the Phase III trial evaluating… read more.

FDA approves Koselugo to treat paediatric patients two years of age and older with neurofibromatosis type 1 (NF1). – AstraZeneca + Merck Inc.

Written by | 14 Apr 2020

AstraZeneca and Merck Inc.announced that the FDA has approved the kinase inhibitor Koselugo (selumetinib) for the treatment of paediatric patients two years of age and older with neurofibromatosis… read more.

Studies MTI-105 and MTI-106 of oral serlopitant did not meet their respective primary endpoint of reduction of pruritus.-Menlo Therapeutics

Written by | 13 Apr 2020

Menlo Therapeutics Inc. announced top line results from two Phase III clinical trials evaluating the safety and efficacy of once daily oral serlopitant for the treatment of pruritus… read more.

Data on 53 patients treated with remdesivir through the compassionate use program is published in New England Journal of Medicine.- Gilead Sciences

Written by | 12 Apr 2020

Gilead Sciences, Inc. announced results from a cohort analysis of 53 patients hospitalized with severe complications of COVID-19 who were treated with the investigational antiviral remdesivir on an… read more.

Immunomedics announces phase III ASCENT study of sacituzumab govitecan to treat metastatic triple-negative breast cancer to be stopped for compelling efficacy.

Written by | 12 Apr 2020

Immunomedics, Inc. has announced that its Phase III confirmatory ASCENT study will be halted due to compelling evidence of efficacy. This decision was based on the unanimous recommendation… read more.

Keytruda filed at FDA to treat patients with unresectable or metastatic solid tumors with tissue tumor mutational burden-high.- Merck Inc.

Written by | 12 Apr 2020

-Merck Inc., has announced that the FDA has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) for Keytruda, Merck’s anti-PD-1 therapy. The application… read more.

Adial Pharmaceuticals provides update on Phase III ONWARD trial of AD 04 to treat Alcohol Use Disorder.

Written by | 10 Apr 2020

Adial Pharmaceuticals, Inc. provided an update on its landmark ONWARD Phase III pivotal trial of its lead drug candidate, AD 04 in genetically identified subjects for the treatment… read more.

FDA extends PDUFA date for review of risdiplam to treat spinal muscular atrophy.- Genetech/Roche

Written by | 9 Apr 2020

Genentech, a member of the Roche Group announced that the FDA has extended the Prescription Drug User Fee Act (PDUFA) date for its review of the New Drug… read more.

FDA and EMA filings for Opdivo + Yervoy with limited chemotherapy are accepted in first-line lung cancer.

Written by | 9 Apr 2020

-Bristol Myers Squibb announced that the FDA has accepted its supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) plus Yervoy (ipilimumab), administered concomitantly with a limited course of… read more.

FDA approves Braftovi + cetuximab for the treatment of BRAFV600E-mutant metastatic colorectal cancer (CRC) after prior therapy.- Pfizer

Written by | 9 Apr 2020

Pfizer Inc.announced that the FDA has approved Braftovi (encorafenib) in combination with cetuximab (marketed as Erbitux) for the treatment of adult patients with metastatic colorectal cancer (CRC) with… read more.

Alnylam completes rolling submission of NDA to the FDA and submits MAA to the European Medicines Agency for lumasiran for the treatment of primary hyperoxaluria Type 1.

Written by | 8 Apr 2020

Alnylam Pharmaceuticals, Inc. announced the completion of the rolling submission of a New Drug Application (NDA) to the FDA for lumasiran, an investigational RNAi therapeutic targeting glycolate oxidase… read more.

Stratatech/Mallinckrodt initiates a rolling submission to the FDA of StrataGraft ,a regenerative skin tissue therapy, for the treatment of burns.

Written by | 7 Apr 2020

Mallinckrodt Plc has announced that Stratatech, a Mallinckrodt company, has initiated the rolling submission of a Biologics License Application (BLA) to the FDA seeking approval to market StrataGraft,… read more.

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