Merck & Company (MRK) 61.18 $MRK
Membrane Technology Market in Pharmaceutical, Biopharma and Life Sciences by Transparency Market Research
PRWeb - Fri Sep 05, 1:01PM CDT
The constantly growing global marketplace offers continually enhancing products, while maintaining cost-reduction is paramount. Hence, the sanitary line of membrane separation systems and technologies plays a vital role in multifarious industries including industrial biotechnology and pharmaceutical industries. Brief Introduction Membrane processes are commonly used in industrial applications as they easily replace distillation and evaporation at improved economics. Membrane separation technologies such as ultrafiltration, reverse osmosis, and microfiltration are often used to purify and concentrate both small and large molecules in a given application. Membrane technology has experienced significant development in the last couple of decades. And to this day, the market continues to grow stronger due to certain factors such as environmental regulations, challenges related to water supply and sanitation, advancement of material science and process technologies, and exploration of new applications - all of which are rapidly increasing in emerging regions. Browse Full Report Membrane Technology Market Report: http://www.transparencymarketresearch.com/mem...arket.html The Need of Membrane Systems The constantly growing populations across the world and diminishing fresh water sources due to environmental degradation and drought sources that have caused shortages of water have led the world into a huge demand for usable and clean water. Seemingly, such aspects have given rise to advances in membrane filtration and separation technologies from biotechnology development to purification of water supply. According to the global statistics, the past three decades has shown a rise in the desalination systems that have specifically emerged as effective solutions for changing contaminated water or other liquids into potable or usable products for domestic and commercial use. Worldwide experts estimate that technical advancements in membrane technology coupled with improvements in the membrane-based reverse osmosis RO systems have resulted in an 80% cost-reduction for desalinated water, and hence the need and growth of such systems is increasing year-on-year basis. Membrane Technology in Pharmaceuticals Applications Most of the times there are different membrane technologies leveraged in the field of pharmaceutical Research & Development. Some of them include phosphatidylcholine-immobilized artificial membrane used in vitro pharmacodynamic study for drug absorption profiling and hollow fiber membrane. Also, there is structural and screening characterization of reactive metabolites that helps to reduce attrition rates in drug development. This has increasingly become a fundamental part of the ADMET-guided lead optimization process in drug discovery. The need for detecting reactive metabolites is highly required in the pharmaceutical industry. Moreover, its use is also seen in the biomedical industry where synthetic polymer membranes are used in a wide range of applications including blood oxygenators, hemodialysis, and controlled release of therapeutics. Get report sample PDF copy from here: http://www.transparencymarketresearch.com/sam...ep_id=1848 Global Market Growth of the Membrane Technology Market Due to increasing research and development, and advancements in production in biopharmaceutical, life sciences, and pharmaceutical sectors, the membrane technology market is witnessing remarkable growth across different verticals. The global membrane technology market is estimated at USD 6,461.3 million in 2013 and is further expected to grow at a CAGR of 9.1% in the forecast period of 2014 to 2019, and reach an estimated value of USD 10,886 million in 2019. The major players in this global market are GE Healthcare and 3M Healthcare, along with some other players that include Sartorius, Merck Millipore, Koch Membrane System, Novasep, and more. Additionally, some of the major countries active in the advancements of membrane technology market are seen in regions such as North America, Asia Pacific, Europe, and Rest of the World (RoW).
Dow Today: Merck (MRK) Higher
at The Street - Fri Sep 05, 12:00PM CDT
The Dow component leading the way higher looks to be Merck (NYSE:MRK), which is sporting an 80-cent gain (+1.3%) bringing the stock to $60.88.
Merck (MRK) Breaks Through Resistance at $60.75
Comtex SmarTrend(R) - Fri Sep 05, 11:41AM CDT
Shares of Merck (NYSE:MRK) have bullishly opened above the pivot of $60.33 today and have reached the first resistance level of $60.75. Analysts will be watching for a cross of the next upside pivot targets of $61.41 and $62.49.
Merck's Anti-PD-1 Drug Keytruda First to be Launched in US - Analyst Blog
Zacks Equity Research - Zacks Investment Research - Fri Sep 05, 10:20AM CDT
The FDA approved Merck & Co.'s (MRK) advanced melanoma treatment, Keytruda.
Stock Market News for September 05, 2014 - Market News
Zacks Equity Research - Zacks Investment Research - Fri Sep 05, 9:10AM CDT
Benchmarks reversed early gains and settled in the red zone on Thursday due to a late sell-off in energy shares
Merck wins accelerated approval from the US FDA for KEYTRUDA for unresectable or metastatic melanoma
M2 - Fri Sep 05, 8:10AM CDT
Healthcare company Merck (NYSE:MRK) said on Thursday that it has received approval from the US Food and Drug Administration (FDA) for KEYTRUDA (pembrolizumab) at a dose of 2 mg/kg every three weeks for the treatment of patients with unresectable or metastatic melanoma and disease progression.
Research and Markets: Global Hepatitis B Vaccines Market 2014-2018 - GlaxoSmithKline, Merck & Sanofi Pasteur Dominate the Market
Business Wire - Fri Sep 05, 8:00AM CDT
Research and Markets (http://www.researchandmarkets.com/research/6bmnvq/global_hepatitis) has announced the addition of the "Global Hepatitis B Vaccines Market 2014-2018" report to their offering.
Upcoming Presentations, Technical Update, Study Results, and Marketing Authorization Application - Research Reports on Novartis, InterMune, Johnson & Johnson, Amgen and Merck
PR Newswire - Fri Sep 05, 8:00AM CDT
Today, Analysts Review released its research reports regarding Novartis AG (NYSE: NVS), InterMune Inc. (NASDAQ: ITMN), Johnson & Johnson (NYSE: JNJ), Amgen Inc. (NASDAQ: AMGN) and Merck & Co., Inc. (NYSE: MRK). Private wealth members receive these notes ahead of publication. To reserve complementary membership, limited openings are available at: http://www.analystsreview.com/6244-100free.
Global Hepatitis B Vaccines Market 2014-2018 - GlaxoSmithKline, Merck & Sanofi Pasteur Dominate the Market
M2 - Fri Sep 05, 6:36AM CDT
Research and Markets (http://www.researchandmarkets.com/research/wkk2vm/global_hepatitis) has announced the addition of the "Global Hepatitis B Vaccines Market 2014-2018" report to their offering. The Global Hepatitis B Vaccines market to grow at a CAGR of 4.00 percent over the period 2013-2018. This report covers the present scenario and the growth prospects of the Global Hepatitis B Vaccines market for the period 2014-2018. To calculate the market size, the report considers revenue generated through the sales of various vaccines intended for active immunization against different serogroups of hepatitis B virus. In terms of composition, the Global Hepatitis B Vaccines market can be segmented into the following: Mono Vaccines and Combination Vaccines. One of the key emerging trends in this market is the increasing focus on combination vaccines. These vaccines confer protection against multiple causative agents and thereby decrease the costs incurred in packaging and administering individual vaccines. According to the report, recommendation of hepatitis B vaccines while traveling is one of the major drivers in the market. Various government bodies have mandated the immunization of travelers visiting hepatitis B-prone areas with prophylactic vaccines for the prevention of the spread of infection and reduction in the chance of epidemic outbreaks. Further, the report states that inadequate coverage of the vaccine is one of the major challenges in the market. Lack of awareness is a major factor limiting the uptake of vaccines, resulting in low coverage rates. Key Questions Answered in this Report What will the market size be in 2018 and what will the growth rate be? What are the key market trends? What is driving this market? What are the challenges to market growth? Who are the key vendors in this market space? What are the market opportunities and threats faced by the key vendors? What are the strengths and weaknesses of the key vendors? Key Vendors - GlaxoSmithKline - Merck - Sanofi Pasteur Other Prominent Vendors - Dynavax Technologies - Janssen Pharmaceuticals - LG Life Sciences - Kaketsuken - Shenzhen Kangtai Biological Products For more information visit http://www.researchandmarkets.com/research/wk..._hepatitis
Bionomics Receives $7.5M 2014 R&D Tax Incentive
GlobeNewswire - Fri Sep 05, 6:30AM CDT
Bionomics Limited (ASX:BNO) (ADR:BMICY) has received an Australian R&D Tax Incentive payment of $7.5 million following its FY2014 tax return. The incentive refund amount is as recorded in the FY2014 financial report lodged with the ASX on 19 August 2014.
Novartis Offers Healthy Gains at a Bargain Stock Price
at The Street - Fri Sep 05, 5:30AM CDT
The company has a potential life-saving catalyst in its portfolio, too.
US Cancer Vaccine Pipeline Analysis
M2 - Fri Sep 05, 3:19AM CDT
Cancer vaccines are a viable option for treating many types of cancers which in the present day do not have effective treatments. With the approval of the expensive prostate cancer vaccine, Provenge by Dendreon, the field of cancer vaccines has received an unprecedented boost. Consequently, many companies are expected to enter this emerging and highly profitable field of preventing, treating, and potentially curing cancer. Merck's Gardasil, a Prophylactic cancer vaccine, along with GSK's Cervarix are some of the first vaccines to have gained attention globally with their blockbuster status.
Merck & Co., Inc. Wins First Stage of the PD-1 Race
Brian Orelli, The Motley Fool - Motley Fool - Thu Sep 04, 9:55PM CDT
Source: Merck. Merck has won the race to get the first immunotherapy drug that blocks the PD-1 pathway on the U.S. market. Today, the FDA approved pembrolizumab, which will go by the brand name Keytruda, for patients with advanced or...
FDA OKs Merck drug, 1st in new cancer drug class
By LINDA A. JOHNSON - AP - Thu Sep 04, 4:41PM CDT
TRENTON, N.J. (AP) — Merck & Co. on Thursday won the first U.S. approval for a new kind of cancer drug with big advantages over chemotherapy and other older cancer treatments.
FDA Approves Pembrolizumab for Advanced Melanoma
PR Newswire - Thu Sep 04, 4:07PM CDT
Today the FDA approved Keytruda (pembrolizumab), a new treatment for advanced melanoma, the deadliest form of skin cancer. Melanoma patients have been waiting anxiously for this day, given the promising data that early studies have shown. In clinical trials, 24 percent of patients taking pembrolizumab had their tumors shrink. Most of these patients continued to respond past the 8.5 month study cut off. This is particularly significant because these studies were conducted in patients who had already failed to respond to other approved therapies. The approval of pembrolizumab is a tremendous step forward for the melanoma patient community, as this is the most promising and positive patient response to a melanoma treatment to date.
Merck PD-1 Inhibitor Approved For Skin Cancer
at Investor's Business Daily - Thu Sep 04, 3:33PM CDT
Merck's (MRK) pembrolizumab won FDA approval for melanoma Thursday afternoon, making it the first drug in the much-anticipated PD-1 inhibitor class to hit the U.S. market. Pembrolizumab, now branded Keytruda, was approved before the normal three...
Merck Receives Accelerated Approval of KEYTRUDA® (pembrolizumab), the First FDA-Approved Anti-PD-1 Therapy
PR Newswire - Thu Sep 04, 2:46PM CDT
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA® (pembrolizumab) at a dose of 2 mg/kg every three weeks for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. This indication is approved under accelerated approval based on tumor response rate and durability of response. An improvement in survival or disease-related symptoms has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
How Will Merck (MRK) Stock React To FDA Approval Of Melanoma Immunotherapy?
at The Street - Thu Sep 04, 2:40PM CDT
Merck (MRK) won FDA approval to bring to market the first in a new line of cancer fighting treatments that use patients' own immune systems against the disease.
MRA Applauds Latest Melanoma Drug Approval as "Major Breakthrough"
Business Wire - Thu Sep 04, 2:31PM CDT
The Melanoma Research Alliance (MRA) today welcomed as a major breakthrough the news that the U.S. Food & Drug Administration (FDA) has granted approval to Merck's new immunotherapy drug, Keytruda (pembrolizumab), for treating metastatic melanoma. It is the first anti-PD-1 drug, aimed at re-energizing a patient's protective immune response to cancer, to have earned FDA approval in the U.S.
Merck Receives Accelerated Approval of KEYTRUDA(R) (pembrolizumab), the First FDA-Approved Anti-PD-1 Therapy
Business Wire - Thu Sep 04, 2:15PM CDT
Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA(R) (pembrolizumab) at a dose of 2 mg/kg every three weeks for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. This indication is approved under accelerated approval based on tumor response rate and durability of response. An improvement in survival or disease-related symptoms has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Membrane Technology Market in Pharmaceutical, Biopharma and Life Sciences by Transparency Market Research
PRWeb - Fri Sep 05, 1:01PM CDT
The constantly growing global marketplace offers continually enhancing products, while maintaining cost-reduction is paramount. Hence, the sanitary line of membrane separation systems and technologies plays a vital role in multifarious industries including industrial biotechnology and pharmaceutical industries. Brief Introduction Membrane processes are commonly used in industrial applications as they easily replace distillation and evaporation at improved economics. Membrane separation technologies such as ultrafiltration, reverse osmosis, and microfiltration are often used to purify and concentrate both small and large molecules in a given application. Membrane technology has experienced significant development in the last couple of decades. And to this day, the market continues to grow stronger due to certain factors such as environmental regulations, challenges related to water supply and sanitation, advancement of material science and process technologies, and exploration of new applications - all of which are rapidly increasing in emerging regions. Browse Full Report Membrane Technology Market Report: http://www.transparencymarketresearch.com/mem...arket.html The Need of Membrane Systems The constantly growing populations across the world and diminishing fresh water sources due to environmental degradation and drought sources that have caused shortages of water have led the world into a huge demand for usable and clean water. Seemingly, such aspects have given rise to advances in membrane filtration and separation technologies from biotechnology development to purification of water supply. According to the global statistics, the past three decades has shown a rise in the desalination systems that have specifically emerged as effective solutions for changing contaminated water or other liquids into potable or usable products for domestic and commercial use. Worldwide experts estimate that technical advancements in membrane technology coupled with improvements in the membrane-based reverse osmosis RO systems have resulted in an 80% cost-reduction for desalinated water, and hence the need and growth of such systems is increasing year-on-year basis. Membrane Technology in Pharmaceuticals Applications Most of the times there are different membrane technologies leveraged in the field of pharmaceutical Research & Development. Some of them include phosphatidylcholine-immobilized artificial membrane used in vitro pharmacodynamic study for drug absorption profiling and hollow fiber membrane. Also, there is structural and screening characterization of reactive metabolites that helps to reduce attrition rates in drug development. This has increasingly become a fundamental part of the ADMET-guided lead optimization process in drug discovery. The need for detecting reactive metabolites is highly required in the pharmaceutical industry. Moreover, its use is also seen in the biomedical industry where synthetic polymer membranes are used in a wide range of applications including blood oxygenators, hemodialysis, and controlled release of therapeutics. Get report sample PDF copy from here: http://www.transparencymarketresearch.com/sam...ep_id=1848 Global Market Growth of the Membrane Technology Market Due to increasing research and development, and advancements in production in biopharmaceutical, life sciences, and pharmaceutical sectors, the membrane technology market is witnessing remarkable growth across different verticals. The global membrane technology market is estimated at USD 6,461.3 million in 2013 and is further expected to grow at a CAGR of 9.1% in the forecast period of 2014 to 2019, and reach an estimated value of USD 10,886 million in 2019. The major players in this global market are GE Healthcare and 3M Healthcare, along with some other players that include Sartorius, Merck Millipore, Koch Membrane System, Novasep, and more. Additionally, some of the major countries active in the advancements of membrane technology market are seen in regions such as North America, Asia Pacific, Europe, and Rest of the World (RoW).
Dow Today: Merck (MRK) Higher
at The Street - Fri Sep 05, 12:00PM CDT
The Dow component leading the way higher looks to be Merck (NYSE:MRK), which is sporting an 80-cent gain (+1.3%) bringing the stock to $60.88.
Merck (MRK) Breaks Through Resistance at $60.75
Comtex SmarTrend(R) - Fri Sep 05, 11:41AM CDT
Shares of Merck (NYSE:MRK) have bullishly opened above the pivot of $60.33 today and have reached the first resistance level of $60.75. Analysts will be watching for a cross of the next upside pivot targets of $61.41 and $62.49.
Merck's Anti-PD-1 Drug Keytruda First to be Launched in US - Analyst Blog
Zacks Equity Research - Zacks Investment Research - Fri Sep 05, 10:20AM CDT
The FDA approved Merck & Co.'s (MRK) advanced melanoma treatment, Keytruda.
Stock Market News for September 05, 2014 - Market News
Zacks Equity Research - Zacks Investment Research - Fri Sep 05, 9:10AM CDT
Benchmarks reversed early gains and settled in the red zone on Thursday due to a late sell-off in energy shares
Merck wins accelerated approval from the US FDA for KEYTRUDA for unresectable or metastatic melanoma
M2 - Fri Sep 05, 8:10AM CDT
Healthcare company Merck (NYSE:MRK) said on Thursday that it has received approval from the US Food and Drug Administration (FDA) for KEYTRUDA (pembrolizumab) at a dose of 2 mg/kg every three weeks for the treatment of patients with unresectable or metastatic melanoma and disease progression.
Research and Markets: Global Hepatitis B Vaccines Market 2014-2018 - GlaxoSmithKline, Merck & Sanofi Pasteur Dominate the Market
Business Wire - Fri Sep 05, 8:00AM CDT
Research and Markets (http://www.researchandmarkets.com/research/6bmnvq/global_hepatitis) has announced the addition of the "Global Hepatitis B Vaccines Market 2014-2018" report to their offering.
Upcoming Presentations, Technical Update, Study Results, and Marketing Authorization Application - Research Reports on Novartis, InterMune, Johnson & Johnson, Amgen and Merck
PR Newswire - Fri Sep 05, 8:00AM CDT
Today, Analysts Review released its research reports regarding Novartis AG (NYSE: NVS), InterMune Inc. (NASDAQ: ITMN), Johnson & Johnson (NYSE: JNJ), Amgen Inc. (NASDAQ: AMGN) and Merck & Co., Inc. (NYSE: MRK). Private wealth members receive these notes ahead of publication. To reserve complementary membership, limited openings are available at: http://www.analystsreview.com/6244-100free.
Global Hepatitis B Vaccines Market 2014-2018 - GlaxoSmithKline, Merck & Sanofi Pasteur Dominate the Market
M2 - Fri Sep 05, 6:36AM CDT
Research and Markets (http://www.researchandmarkets.com/research/wkk2vm/global_hepatitis) has announced the addition of the "Global Hepatitis B Vaccines Market 2014-2018" report to their offering. The Global Hepatitis B Vaccines market to grow at a CAGR of 4.00 percent over the period 2013-2018. This report covers the present scenario and the growth prospects of the Global Hepatitis B Vaccines market for the period 2014-2018. To calculate the market size, the report considers revenue generated through the sales of various vaccines intended for active immunization against different serogroups of hepatitis B virus. In terms of composition, the Global Hepatitis B Vaccines market can be segmented into the following: Mono Vaccines and Combination Vaccines. One of the key emerging trends in this market is the increasing focus on combination vaccines. These vaccines confer protection against multiple causative agents and thereby decrease the costs incurred in packaging and administering individual vaccines. According to the report, recommendation of hepatitis B vaccines while traveling is one of the major drivers in the market. Various government bodies have mandated the immunization of travelers visiting hepatitis B-prone areas with prophylactic vaccines for the prevention of the spread of infection and reduction in the chance of epidemic outbreaks. Further, the report states that inadequate coverage of the vaccine is one of the major challenges in the market. Lack of awareness is a major factor limiting the uptake of vaccines, resulting in low coverage rates. Key Questions Answered in this Report What will the market size be in 2018 and what will the growth rate be? What are the key market trends? What is driving this market? What are the challenges to market growth? Who are the key vendors in this market space? What are the market opportunities and threats faced by the key vendors? What are the strengths and weaknesses of the key vendors? Key Vendors - GlaxoSmithKline - Merck - Sanofi Pasteur Other Prominent Vendors - Dynavax Technologies - Janssen Pharmaceuticals - LG Life Sciences - Kaketsuken - Shenzhen Kangtai Biological Products For more information visit http://www.researchandmarkets.com/research/wk..._hepatitis
Bionomics Receives $7.5M 2014 R&D Tax Incentive
GlobeNewswire - Fri Sep 05, 6:30AM CDT
Bionomics Limited (ASX:BNO) (ADR:BMICY) has received an Australian R&D Tax Incentive payment of $7.5 million following its FY2014 tax return. The incentive refund amount is as recorded in the FY2014 financial report lodged with the ASX on 19 August 2014.
Novartis Offers Healthy Gains at a Bargain Stock Price
at The Street - Fri Sep 05, 5:30AM CDT
The company has a potential life-saving catalyst in its portfolio, too.
US Cancer Vaccine Pipeline Analysis
M2 - Fri Sep 05, 3:19AM CDT
Cancer vaccines are a viable option for treating many types of cancers which in the present day do not have effective treatments. With the approval of the expensive prostate cancer vaccine, Provenge by Dendreon, the field of cancer vaccines has received an unprecedented boost. Consequently, many companies are expected to enter this emerging and highly profitable field of preventing, treating, and potentially curing cancer. Merck's Gardasil, a Prophylactic cancer vaccine, along with GSK's Cervarix are some of the first vaccines to have gained attention globally with their blockbuster status.
Merck & Co., Inc. Wins First Stage of the PD-1 Race
Brian Orelli, The Motley Fool - Motley Fool - Thu Sep 04, 9:55PM CDT
Source: Merck. Merck has won the race to get the first immunotherapy drug that blocks the PD-1 pathway on the U.S. market. Today, the FDA approved pembrolizumab, which will go by the brand name Keytruda, for patients with advanced or...
FDA OKs Merck drug, 1st in new cancer drug class
By LINDA A. JOHNSON - AP - Thu Sep 04, 4:41PM CDT
TRENTON, N.J. (AP) — Merck & Co. on Thursday won the first U.S. approval for a new kind of cancer drug with big advantages over chemotherapy and other older cancer treatments.
FDA Approves Pembrolizumab for Advanced Melanoma
PR Newswire - Thu Sep 04, 4:07PM CDT
Today the FDA approved Keytruda (pembrolizumab), a new treatment for advanced melanoma, the deadliest form of skin cancer. Melanoma patients have been waiting anxiously for this day, given the promising data that early studies have shown. In clinical trials, 24 percent of patients taking pembrolizumab had their tumors shrink. Most of these patients continued to respond past the 8.5 month study cut off. This is particularly significant because these studies were conducted in patients who had already failed to respond to other approved therapies. The approval of pembrolizumab is a tremendous step forward for the melanoma patient community, as this is the most promising and positive patient response to a melanoma treatment to date.
Merck PD-1 Inhibitor Approved For Skin Cancer
at Investor's Business Daily - Thu Sep 04, 3:33PM CDT
Merck's (MRK) pembrolizumab won FDA approval for melanoma Thursday afternoon, making it the first drug in the much-anticipated PD-1 inhibitor class to hit the U.S. market. Pembrolizumab, now branded Keytruda, was approved before the normal three...
Merck Receives Accelerated Approval of KEYTRUDA® (pembrolizumab), the First FDA-Approved Anti-PD-1 Therapy
PR Newswire - Thu Sep 04, 2:46PM CDT
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA® (pembrolizumab) at a dose of 2 mg/kg every three weeks for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. This indication is approved under accelerated approval based on tumor response rate and durability of response. An improvement in survival or disease-related symptoms has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
How Will Merck (MRK) Stock React To FDA Approval Of Melanoma Immunotherapy?
at The Street - Thu Sep 04, 2:40PM CDT
Merck (MRK) won FDA approval to bring to market the first in a new line of cancer fighting treatments that use patients' own immune systems against the disease.
MRA Applauds Latest Melanoma Drug Approval as "Major Breakthrough"
Business Wire - Thu Sep 04, 2:31PM CDT
The Melanoma Research Alliance (MRA) today welcomed as a major breakthrough the news that the U.S. Food & Drug Administration (FDA) has granted approval to Merck's new immunotherapy drug, Keytruda (pembrolizumab), for treating metastatic melanoma. It is the first anti-PD-1 drug, aimed at re-energizing a patient's protective immune response to cancer, to have earned FDA approval in the U.S.
Merck Receives Accelerated Approval of KEYTRUDA(R) (pembrolizumab), the First FDA-Approved Anti-PD-1 Therapy
Business Wire - Thu Sep 04, 2:15PM CDT
Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA(R) (pembrolizumab) at a dose of 2 mg/kg every three weeks for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. This indication is approved under accelerated approval based on tumor response rate and durability of response. An improvement in survival or disease-related symptoms has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
