News For MRK From the Last 2 Days
Nov 14, 2019 | 17:37 EST
Specialty Pharmaceuticals Analyst Chen, along with Dr. Sabari, Asst Professor at NYU School of Medicine & Lung Cancer Specialist, discuss what to expect from AstraZeneca's POSEIDON trial, the readthroughs to Bristol-Myers' 9LA and how these trials could affect Merck's Keytruda on an Analyst/Industry conference call to be held on November 18 at 11 am.
Nov 14, 2019 | 06:56 EST
AstraZeneca (AZN) and Merck (MRK) announced that the U.S. FDA has accepted a New Drug Application and granted priority review for the MEK 1/2 inhibitor selumetinib as a potential new medicine for pediatric patients aged three years and older with neurofibromatosis type 1 and symptomatic, inoperable plexiform neurofibromas. This is the first acceptance of a regulatory submission for an oral MEK 1/2 monotherapy for patients with NF1, a rare and incurable genetic condition. A Prescription Drug User Fee Act date is set for the second quarter of 2020.
Nov 12, 2019 | 09:18 EST
NewLink Genetics Corporation (NLNK) announced that Monday, November 11th, the European Commission granted a conditional marketing authorization to ERVEBO, investigational V920 Ebola Zaire vaccine, as confirmed by partner, Merck (MRK), known as MSD outside the US and Canada. With this approval, the EC will grant a centralized marketing authorization for the vaccine with unified labeling that is valid in 31 European countries. The granting of this approval by the EC follows the September 17th announcement by the FDA that it has accepted the Biologics License Application and granted priority review for the investigational Ebola vaccine. The Prescription Drug User Fee Act or target FDA action date, is set for March 14, 2020. As NewLink has previously stated, the FDA's approval of this Ebola vaccine would trigger the issuance of a priority review voucher owned by Merck and in which NewLink Genetics has a substantial economic interest. Thereafter, NewLink would have the right to monetize its share of interest in the voucher.
Nov 12, 2019 | 07:17 EST
Gossamer Bio (GOSS) announced that it has entered into a clinical collaboration agreement with Merck (MRK) to evaluate the combination of Gossamer's investigational product candidate GB1275, the oral modulator of CD11b, and Merck's anti-PD-1 therapy, Keytruda in patients with selected advanced solid tumors. Under the terms of the agreement, Gossamer will conduct a Phase 1/2 study, Keynote-A36, in advanced solid tumors, with the Phase 1 consisting of dose escalation of three GB1275 regimens including one with Keytruda. Additionally, the Phase 2 consists of expansion cohorts evaluating GB1275 in combination with Keytruda or chemotherapy. Gossamer owns worldwide commercial rights to GB1275. GB1275 is an oral modulator of CD11b, a receptor broadly expressed on immunosuppressive myeloid cells found within the tumor microenvironment, or TME. In preclinical studies, GB1275 has been shown to reduce the recruitment of these cells into the TME, while also converting the cells within the TME from an immunosuppressive to an active state. The FDA has granted GB1275 orphan drug designation for the treatment of pancreatic cancer.