Tag Archives: MSD

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

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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

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

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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

UnitedHealth's Big Day Energizes the Dow

By Dan Carroll, The Motley Fool

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You want gains? The Dow Jones Industrial Average has gains — enough to put a smile on many a blue-chip investor’s face this Tuesday.

The index has hit a new intraday record high in its latest surge, and as of 2:15 p.m. EDT the Dow has advanced 95 points, or 0.6%. Health care stocks are leading the way, with most of the index in the green despite one computer maker’s huge losses. Who’s on the move? Let’s get caught up on the stocks you need to know about.

A day of healthy gains for UnitedHealth
Few people are having a better Tuesday than UnitedHealth Group investors. The big insurer has pulled down gains of 4.9% after the Centers for Medicare and Medicaid Services announced on Monday a reimbursement rate hike of 3.3% for Medicare Advantage payments to insurers in 2014. Previously, the program had been planned to slash government reimbursement to insurers by 2.2%. The rate increase is a major win for the entire insurance industry.

With UnitedHealth having increased its Medicare membership last year, the announcement is a big long-term for the company and its stock despite the uncertainty still surrounding the launch of Obamacare.

The rest of the health care sector is not quite hitting that high note, but big pharma’s Pfizer and Merck still rank among the top of the Dow as this sector rolls higher. Shares of the companies have climbed more than 1% each so far. Even though both of them — Merck in particular — are still dealing with revenue declines related to patent expirations of top-selling drugs, both stocks have rewarded shareholders substantially so far this year.

Merck recently locked horns with Indian pharmaceutical firm Glenmark Pharmaceuticals in a legal battle over patent infringement. Merck’s Indian division, MSD, accused Glenmark of violating its Indian patent of blockbuster diabetes drugs Januvia and Janumet. Glenmark admitted to launching a generic version of the drug, which could hit Merck’s revenue growth in the second-largest nation in the world. Around 65 million Indians suffer from type 2 diabetes, making for a tempting market for Merck to tap into as it looks to grow in emerging economies.

On the other side of the Dow, even as the index surges, beleaguered tech stock Hewlett-Packard has found a way to frustrate investors. The stock has exploded this year, pulling in gains of more than 55% after last year’s calamitous fall, but today’s downgrade from Goldman Sachs won’t help it sustain that momentum.

Goldman downgraded HP from “neutral” to “sell” and lowered its projections of the company’s revenue and EPS over the next few years. Additionally, the bank mentioned that HP‘s struggling hardware segments will likely continue to flounder. The fall of the PC market certainly hasn’t helped HP‘s fate, and while investors have seen plenty of green since the start of 2013, the company still faces a long road back to respectability. Even the most optimistic believer …read more
Source: FULL ARTICLE at DailyFinance

Merck to Hold First-Quarter 2013 Sales and Earnings Conference Call on May 1

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Merck to Hold First-Quarter 2013 Sales and Earnings Conference Call on May 1

WHITEHOUSE STATION, N.J.–(BUSINESS WIRE)– Merck (NYS: MRK) , known as MSD outside the United States and Canada, will hold its first-quarter 2013 sales and earnings conference call with institutional investors and analysts at 8:00 a.m. EDT on Wednesday, May 1. During the call, Kenneth C. Frazier, chairman and chief executive officer; Peter N. Kellogg, executive vice president and chief financial officer; and Adam H. Schechter, president, Global Human Health, will provide an overview of Merck’s financial performance for the quarter.

Investors, journalists and the general public may access a live audio webcast of the call on Merck’s website at http://www.merck.com/investors/events-and-presentations/home.html. Software needed to listen to the webcast is available on Merck’s website and should be downloaded prior to the beginning of the webcast. A replay of the webcast will be available at approximately 11:00 a.m. EDT on May 1 and will remain on the website for 12 months. The quarter’s sales and earnings news release and supplemental financial disclosures also will be available in the Newsroom and Investor sections of the company’s website at www.merck.com.

Institutional investors and analysts can participate in the call by dialing (706) 758-9927 or (877) 381-5782 and using ID code number 22104203.

Members of the media are invited to monitor the call by dialing (706) 758-9928 or (800) 399-7917 and using ID code number 22104203. Journalists who wish to ask questions are requested to contact a member of Merck’s Media Relations team at the conclusion of the call.

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.comand 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 …read more
Source: FULL ARTICLE at DailyFinance

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

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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

Merck and Luminex Corporation Enter Agreement to Develop Companion Diagnostic to Support Investigati

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Merck and Luminex Corporation Enter Agreement to Develop Companion Diagnostic to Support Investigational BACE inhibitor Clinical Development Program for Alzheimer’s Disease

Collaboration to Support Patient Selection for the Clinical Development of MK-8931, Merck’s Lead Investigational Medicine for Alzheimer’s Disease

WHITEHOUSE STATION, N.J. & AUSTIN, Texas–(BUSINESS WIRE)– Merck (NYS: MRK) , known as MSD outside the United States and Canada, and Luminex Corporation (NAS: LMNX) have signed a collaboration and license agreement to develop a companion diagnostic device that will be evaluated to help screen patients for recruitment into Merck’s clinical development program for MK-8931, a novel oral beta amyloid precursor protein site cleaving enzyme (BACE) inhibitor and Merck’s lead investigational candidate for Alzheimer’s disease (AD). Financial terms were not disclosed.

“Evaluation of biomarkers that may provide an indicator of disease onset and enable earlier diagnosis is an important goal toward facilitating early intervention and potentially improving the treatment of Alzheimer’s disease,” said Darryle D. Schoepp, Ph.D., senior vice president, head of Neuroscience and Ophthalmology at Merck Research Laboratories. “We look forward to working with Luminex to advance our ongoing clinical development program for MK-8931.”

Luminex will be responsible for development, regulatory submission and commercialization of the candidate companion diagnostic device, which will employ Luminex’s xMAP® Technology to measure concentrations of two candidate biomarkers (Aβ42 and t-tau) in cerebrospinal fluid (CSF) samples from patients with mild cognitive impairment (MCI). The candidate device will be evaluated as a means to identify subjects with MCI who have a higher risk of developing AD to support patient selection for Merck’s therapeutic BACE inhibitor clinical program.

“This collaboration has the potential to deliver a novel companion diagnostic to identify patients at increased risk of developing Alzheimer’s disease,” added Patrick J. Balthrop, president and CEO of Luminex. “We are pleased to leverage our technologies and development capabilities and look forward to expanding our activity into the companion diagnostic segment of personalized medicine.”

The accumulation of beta amyloid in the brain is a key pathological characteristic related to AD. Recent clinical evidence supports the hypothesis that the measurement of the investigational biomarkers Aβ42 and t-tau in CSF may be useful in identifying patients at greater risk of developing AD. Currently, AD is diagnosed by clinical examination (i.e., medical history; physical, neurological, psychiatric and neuropsychological exams; and Magnetic Resonance Imaging [MRI] or Computed Tomography [CT] scan). An AD diagnosis can only be …read more
Source: FULL ARTICLE at DailyFinance

Video: Russel Sutton's nine-cylinder radial engine LIVES!

By Zach Bowman

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Russell Sutton Radial Engine

Russell Sutton has proven once again that patience can trump all adversity. If you recall, the man has spent nearly five years constructing a nine-cylinder radial engine from a smattering of Honda single-cylinder XR600 thumpers. The last time we saw this beast, it ran briefly before succumbing to mechanical failure due to some lackluster cylinder sleeves. Now Sutton has resleeved each of the nine cylinders and has his creation running like a song with a little help from an MSD rev limiter.

The big beastie idles at around 600 rpm, and our favorite mad engine builder has rigged up a clever disc-brake load generator to give the radial something to work against. Pushing against the load, the radial evens out into a delicious thrum. Sutton is currently working on a three-blade prop for his design as he works toward building what will be the world’s coolest air boat. Check out the lengthy video for yourself below. The fun gets started around the four-minute mark.

Continue reading Russel Sutton’s nine-cylinder radial engine LIVES!

Russel Sutton’s nine-cylinder radial engine LIVES! originally appeared on Autoblog on Wed, 30 Jan 2013 17:00:00 EST. Please see our terms for use of feeds.

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Source: FULL ARTICLE at Autoblog