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BioMarin provides highlights of 4 Years of clinical data from ongoing phase 1/II study of valoctocogene roxaparvovec gene therapy for severe hemophilia A.

Written by | 1 Jun 2020

BioMarin Pharmaceutical Inc. announced an update to its previously reported results of an open-label Phase 1/II study of valoctocogene roxaparvovec, an investigational gene therapy treatment for adults with… read more.

Phase III ASPEN trial of Brukinsa in Waldenström’s macroglobulinemia shows positive follow-up data.- BeiGene

Written by | 31 May 2020

BeiGene announced follow-up data from the Phase III ASPEN trial comparing BRUKINSA (zanubrutinib) to ibrutinib for the treatment of Waldenström’s macroglobulinemia. Data presented from the Phase III ASPEN… read more.

CHMP recommends Zercepac for treating breast or gastric cancer.- Accord Healthcare

Written by | 31 May 2020

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Zercepac (trastuzumab), from Accord… read more.

CHMP recommends approval of Hepcludex for chronic hepatitis delta virus.- Myr

Written by | 31 May 2020

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for Hepcludex (bulevirtide), from MYR GmbH, intended… read more.

CHMP recommends approval of Rozlytrek in NTRK fusion-positive solid tumours.- Roche

Written by | 31 May 2020

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product Rozlytrek (entrectinib), from… read more.

CHMP recommends approval of Rozlytrek for ROS1-positive advanced non-small cell lung cancer.- Roche

Written by | 31 May 2020

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product Rozlytrek (entrectinib), from… read more.

CHMP recommends approval of Xenleta for community-acquired pneumonia.- Nabriva Therapeutics

Written by | 31 May 2020

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Xenleta (lefamulin), from Nabriva… read more.

CHMP recommends approval of Lynparza for metastatic adenocarcinoma of the pancreas.- AstraZeneca

Written by | 31 May 2020

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Lynparza… read more.

FDA approves Cyramza + erlotinib for first-line treatment of metastatic NSCLC with EGFR exon 19 deletions or exon 21 (L858R) mutations.- Eli Lilly

Written by | 31 May 2020

Eli Lilly and Company announced that the FDA has approved Cyramza (ramucirumab injection, 10 mg/mL solution), in combination with erlotinib, for the first-line treatment of people with metastatic… read more.

CHMP recommends approval of Zabdeno + Mvabea for Ebola.- Janssen-Cilag International

Written by | 31 May 2020

The EMA’s CHMP has recommended granting a marketing authorisation in the European Union for a new Ebola vaccine Zabdeno (formerly Ad26.ZEBOV) + Mvabea (formerly MVA-BN-Filo), from Janssen-Cilag International,… read more.

Minerva Neurosciences announces results from phase III trial of roluperidone (MIN-101) for treatment of negative symptoms in schizophrenia.

Written by | 30 May 2020

Minerva Neurosciences, Inc., a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, announced that the Phase III trial of roluperidone to… read more.

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.

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