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European Medicines Agencys CHMP Recommends Mercks KEYTRUDA (pembrolizumab) for the First-Line Treatment of Patients with Metastatic Non-Small Cell Lung Cancer (NSCLC) Whose Tumors Have High PD-L1 Expression with No EGFR or ALK Positive Tumor...
2016-12-16 13:26:00| Merck.com - Product News
Dateline City: KENILWORTH, N.J. Opinion Based on Findings from KEYNOTE-024 Trial, Which Showed Superior Overall Survival and Progression Free Survival with KEYTRUDA Compared to Chemotherapy First Anti-PD-1 Therapy to Receive a CHMP Positive Opinion for Previously Untreated Patients with Metastatic NSCLC KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of KEYTRUDA (pembrolizumab), the companys anti-PD-1 therapy, for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) in adults whose tumors have high PD-L1 expression (tumor proportion score [TPS] of 50 percent or more) with no EGFR or ALK positive tu Language: English Contact: MerckMedia:Pamela Eisele, 267-305-3558Courtney Ronaldo, 908-236-1108orInvestors:Teri Loxam, 908-740-1986Amy Klug, 908-740-1898 Ticker Slug: Ticker: MRK Exchange: NYSE @Merck read more
Merck Receives CHMP Positive Opinion for KEYTRUDA (pembrolizumab) for the Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)
2016-06-27 12:00:00| Merck.com - Corporate News
Dateline City: KENILWORTH, N.J. Opinion Based on Data from KEYNOTE-010, Which Showed Superior Overall Survival Compared to Chemotherapy in Previously-Treated Patients Whose Tumors Express PD-L1 KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of KEYTRUDA (pembrolizumab), the companys anti-PD-1 therapy, for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults whose tumors express PD-L1 and who have received at least one prior chemotherapy regimen. Language: English Contact: MerckMedia:Pamela Eisele, 267-305-3558Courtney Ronaldo, 908-236-1108orInvestor:Teri Loxam, 908-740-1986Justin Holko, 908-740-1879 Ticker Slug: Ticker: MRK Exchange: NYSE read more
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Merck Receives Positive CHMP Opinion for ZEPATIER (elbasvir and grazoprevir) in the European Union
2016-05-27 13:46:00| Merck.com - Corporate News
Dateline City: KENILWORTH, N.J. KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of ZEPATIER (elbasvir and grazoprevir), an investigational, once-daily, fixed-dose combination tablet for the treatment of chronic hepatitis C virus (HCV) in adult patients. The CHMP positive opinion will be reviewed by the European Commission. Language: English Contact: MerckMedia:Pam Eisele, 267-305-3558orSarra Herzog, 908-740-1871orInvestors:Teri Loxam, 908-740-1986orAmy Klug, 908-740-1898 Ticker Slug: Ticker: MRK Exchange: NYSE read more
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GSK receives European and CHMP approval for stem cell gene therapy
2016-04-02 23:10:57| Biotech - Topix.net
GlaxoSmithKline has been given encouraging support for a stem cell gene therapy that uses an individual patient's own cells to treat a very rare immunodeficiency disorder in children. The Committee for Medicinal Products for Human Use of the European Medicines Agency , in conjunction with the Committee for Advanced Therapies , has issued a positive opinion recommending marketing authorisation for Strimvelis, GSK's brand name for the medicine to treat the ADA-SCID disorder.
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Enanta Pharmaceuticals Announces CHMP Positive Opinion For AbbVie's VIEKIRAX + EXVIERA Without Ribavirin For The Treatment Of Chronic Hepatitis C In Genotype 1b Patients With Compensated Cirrhosis
2016-03-02 03:39:36| drugdiscoveryonline Home Page
Enanta Pharmaceuticals, Inc., a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, announced recently that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion for the use of VIEKIRAX (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA (dasabuvir tablets) without ribavirin (RBV) in chronic hepatitis C virus (HCV) infected genotype 1b (GT1b) patients with compensated cirrhosis (Child-PughA)
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