Tag Archives: Merck Research Laboratories

Business, Finance, Occupation & Industry

Merck Announces FDA Acceptance of New Drug Application for an Investigational Tablet Formulation of

Leave a comment

By Business Wirevia The Motley Fool

Filed under:

Merck Announces FDA Acceptance of New Drug Application for an Investigational Tablet Formulation of the Antifungal NOXAFIL ® (posaconazole)

WHITEHOUSE STATION N.J.–(BUSINESS WIRE)– Merck (NYS: MRK) , known as MSD outside the United States and Canada, today announced that its New Drug Application for an investigational, tablet formulation of the company’s antifungal agent, NOXAFIL® (posaconazole), has been accepted for review by the U.S. Food and Drug Administration (FDA).

Merck currently markets NOXAFIL Oral Suspension for prophylaxis of invasive Aspergillus and Candida infections in patients 13 years of age and older who are at high risk of developing these infections due to being severely immunocompromised, such as patients who have received hematopoietic stem cell transplants and have graft-versus-host disease, or patients with cancers of the blood who are experiencing prolonged low white blood cell counts (neutropenia) as a result of chemotherapy.

“Invasive fungal infections are a significant cause of illness and death among severely immunocompromised patients,” said Robin Isaacs, M.D., vice president, infectious disease clinical research, Merck Research Laboratories. “This filing for a tablet formulation of NOXAFIL is an example of Merck’s ongoing commitment to developing new therapy options for patients in the hospital setting.”

Merck is seeking FDA approval of NOXAFIL tablets for once-daily administration (following a twice-a-day loading dose on the first day of therapy). The company has filed a marketing authorization application for NOXAFIL tablets with the European Medicines Agency (EMA) and plans to seek regulatory approval for the tablet formulation in other countries around the world.

Selected safety information about NOXAFIL (posaconazole) Oral Suspension

NOXAFIL is contraindicated in persons with known hypersensitivity to posaconazole, any component of NOXAFIL, or other azole antifungal agents.

NOXAFIL is contraindicated with sirolimus. Concomitant administration of NOXAFIL with sirolimus increases the sirolimus blood concentrations by approximately 9-fold and can result in sirolimus toxicity.

NOXAFIL is contraindicated with the CYP3A4 substrates that prolong the QT interval. Concomitant administration of NOXAFIL with the CYP3A4 substrates pimozide and quinidine may result in increased plasma concentrations of these drugs, leading to QTc prolongation and rare occurrences of torsades de pointes.

NOXAFIL is contraindicated with HMG-CoA reductase inhibitors that are primarily metabolized through CYP3A4 (e.g., atorvastatin, lovastatin, and simvastatin) as increased plasma concentration of these drugs can lead to rhabdomyolysis.

NOXAFIL is contraindicated with ergot alkaloids. NOXAFIL may …read more

Source: FULL ARTICLE at DailyFinance

Business, Finance, Occupation & Industry

Merck to Present New Data on VICTRELIS® (boceprevir) and Investigational Compounds MK-5172 and Vanip

Leave a comment

By Business Wirevia The Motley Fool

Filed under:

Merck to Present New Data on VICTRELIS ® (boceprevir) and Investigational Compounds MK-5172 and Vaniprevir for Chronic Hepatitis C Virus at The International Liver Congress TM / 2013 EASL Annual Meeting

WHITEHOUSE STATION, N.J.–(BUSINESS WIRE)– Merck (NYS: MRK) , known as MSD outside of the United States and Canada, announced today that two analyses of VICTRELIS (boceprevir) and data from Phase II studies of two of Merck’s investigational medicines for chronic hepatitis C virus (HCV) genotype 1, MK-5172 and vaniprevir (MK-7009), will be presented at the 2013 International Liver Congress (EASL) Annual Meeting. The meeting will take place in Amsterdam from April 24-28, 2013.

Key Presentations About VICTRELIS 200 mg Capsules

  • Safety And Efficacy Of Boceprevir/Peginterferon/Ribavirin (Boc/P/R) Combination Therapy For Chronic HCV G1 Patients With Compensated Cirrhosis: A Meta-Analysis Of Five Phase III Clinical Trials, J.M. Vierling et al. Late Breaker. Thursday, April 25, 9:00- 18:00. RAI Convention Centre.
  • Virologic Response Rates Are Similar In Previously Untreated And Previously Treated And Relapsed Patients Receiving Boceprevir Triple Therapy: A Retrospective Analysis. Bacon, B. et al. Poster 791. Friday, April 26, 12:30-14:00. RAI Convention Centre.

Key Investigational Compound Presentations

  • High Sustained Viral Response at 12- and 24-week follow-up of MK-5172 with Pegylated Interferon alfa-2b and Ribavirin (PR) in HCV Genotype 1 Treatment-naïve Non-cirrhotic Patients. Manns, M. et al. Oral Presentation: Friday, April 26, 16:00-18:00, RAI Convention Centre.
  • MK-5172 In Combination With Peg-Interferon And Ribavirin Elicits Limited Resistance While Demonstrating Robust Efficacy In Treatment Naïve Genotype 1 Chronic HCV-Infected Patients. Howe, A. et al. Poster 1197. Saturday, April 27, 12:30-13:30. RAI Convention Centre.
  • Sustained Viral Response And Safety Of MK-7009 In Cirrhotic Treatment-Experienced Patients With Genotype 1 HCV Infection Who Have Failed Previous Pegylated Interferon And Ribavirin Treatment. Rodriguez-Torres, M. et al. Oral Presentation. Saturday, April 27, 8:30-10:30. RAI Convention Centre.

“We are pleased to present new data on VICTRELIS that will help inform health care professionals as they consider the use of VICTRELIS in appropriate patients,” said Eliav Barr, M.D., vice president, Infectious Diseases, Project Leadership and Management, Merck Research Laboratories. …read more

Source: FULL ARTICLE at DailyFinance

Business, Finance, Occupation & Industry

Amarantus BioScience Appoints Adam J. Simon, Ph.D., to Board of Advisors

Leave a comment

By Business Wirevia The Motley Fool

Filed under:

Amarantus BioScience Appoints Adam J. Simon, Ph.D., to Board of Advisors

SUNNYVALE, Calif.–(BUSINESS WIRE)– Amarantus BioScience, Inc. (OTCQB: AMBS), a biotechnology company discovering and developing treatments and diagnostics for diseases associated with neurodegeneration and apoptosis, has appointed Adam J. Simon, Ph.D., to its Board of Advisors. Dr. Simon is a world expert in the field of Alzheimer’s disease biomarkers and has significant expertise in the development of in-vitro diagnostics.

“Dr. Simon will play an important role in the development of our LymPro diagnostic blood test for Alzheimer’s disease,” said Gerald E. Commissiong, President and Chief Executive Officer of Amarantus BioScience. “He is a recognized leader in the discovery of Alzheimer’s biomarkers, and has advised both major pharmaceutical companies and early stage research companies on their clinical programs and regulatory submissions. Dr. Simon is also an entrepreneur in his own right, and understands the specific challenges and opportunities we face here at Amarantus.”

Dr. Simon is the founder and president of AJ Simon Enterprises, LLC, a consulting firm serving pharmaceutical and biotechnology clients, including Bristol Myers Squibb. He is also the founder and chief executive officer of Cerora, Inc., a healthcare information technology company focused on developing medical devices and services to assess brain health, including Traumatic Brain Injury. Earlier in his career he spent more than 13 years at Merck Research Laboratories, where he served as a Senior Research Fellow in Integrative Systems Neuroscience and Biomarkers and in Alzheimer’s disease research. He has also been a visiting scientist at Princeton University.

Dr. Simon received Bachelor’s degrees in Physics and Mathematics from the University of Rochester. He received a Doctorate in Physics from the University of Chicago. He holds four patents related to medical research, and has published more than 60 articles in scientific and medical journals.

About Amarantus BioScience

Amarantus BioScience, Inc. is a development-stage biotechnology company founded in January 2008. The Company has a focus on developing certain biologics surrounding the intellectual property and proprietary technologies it owns to treat and/or diagnose Parkinson’s disease, Traumatic Brain Injury, Ischemic Heart Disease and other human diseases. The Company owns the intellectual property rights to a therapeutic protein known as Mesencephalic-Astrocyte-derived Neurotrophic Factor (“MANF“) and is developing MANF-based products as treatments for brain disorders. The Company also is a Founding Member of the Coalition for Concussion Treatment (#C4CT), a movement initiated in collaboration with Brewer Sports International seeking to raise awareness of new treatments in development for concussions and nervous-system …read more
Source: FULL ARTICLE at DailyFinance

Business, Finance, Occupation & Industry

Merck Announces FDA Acceptance of Biologics License Application for Investigational Grass Pollen All

Leave a comment

By Business Wirevia The Motley Fool

Filed under:

Merck Announces FDA Acceptance of Biologics License Application for Investigational Grass Pollen Allergy Immunotherapy Tablet

WHITEHOUSE STATION, N.J.–(BUSINESS WIRE)– Merck (NYS: MRK) , known as MSD outside the United States and Canada, today announced that the Biologics License Application (BLA) for its investigational Timothy grass pollen (Phleum pratense) allergy immunotherapy tablet (AIT) has been accepted for review by the U.S. Food and Drug Administration (FDA). In March, the company also submitted a BLA to the FDA for its investigational ragweed pollen (Ambrosia artemisiifolia) AIT.

The BLA for Merck’s grass pollen AIT is supported by Phase III trials that evaluated the safety and efficacy of the investigational product, including a long-term, multi-season trial.

“We are pleased to have achieved this important milestone in the development of our investigational grass pollen AIT, which, if approved, would represent a potential new option for allergy specialists to offer appropriate allergic rhinitis patients,” said Jeffrey A. Chodakewitz, M.D., senior vice president, Global Scientific Strategy, franchise head, Infectious Diseases and interim franchise head, Respiratory & Immunology, Merck Research Laboratories.

Merck’s grass pollen (Phleum pratense) AIT is an investigational sublingual dissolvable tablet designed to help treat the underlying cause of allergic rhinitis by generating an immune response to help protect against targeted allergens. Merck has partnered with ALK-Abello to develop its grass pollen (Phleum pratense) AIT in North America.

About Merck

Today’s Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.

Forward-Looking Statement

This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products …read more
Source: FULL ARTICLE at DailyFinance