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News Article | November 21, 2016
Site: www.prweb.com

Dr. Zein Obagi, premier dermatologist of Beverly Hills, CA has joined the prestigious Haute Beauty network. The Haute Beauty Network, affiliated with luxury lifestyle publication Haute Living, is proud to recognize Dr. Zein Obagi as a prominent dermatologist and the network’s newest partner. Dr. Zein Obagi is a board certified dermatologist; Diplomate of the American Academy of Dermatology; a member of the American Medical Association; the American Academy of Cosmetic Surgery; the American Society of Dermatologic Surgery; the International Society of Dermatology; the Society of Investigative Dermatology and the American Academy of Aesthetic and Restorative Surgery. Dr. Obagi will share his skill and expert opinion with the Haute Beauty and Haute Living subscribers, educating readers on his industry and providing exciting and relevant news, tips, trends and insight relating to his specialties. Dr. Obagi earned his medical degree at the Damascus Medical School and completed his internship at the Deaconess Hospital in Detroit. He did his residency in pathology at the William Beaumont Hospital in Royal Oak, Michigan and then did a one-year residency in obstetrics at Henry Ford Hospital in Detroit. He served as a Naval Medical Officer, Resident in Dermatology and Staff Dermatologist for the United States Navy. The most remarkable thing about Dr. Obagi is that he accomplishes things others thought were impossible. Some of his qualifications as a force of change include: The concept of “skin health” was unheard of when Dr. Obagi began to change the paradigms of skin care in the 1980’s. He changed traditional philosophy from superficial skin treatments to modalities that addressed problems at the cellular level putting him at the forefront of the anti-aging revolution. Some conditions, such as melasma, are unresponsive to conventional treatments. Dr. Obagi gained national attention by successfully treating cases that seemed impossible. Some skin conditions occur more often in Asian, African American or Latino skin, and are more difficult to treat. Dr. Obagi was the first doctor to develop treatment protocols for different ethnicities. Dr. Obagi developed physician-dispensed skincare products; for more than 20 years Obagi Nu-Derm® was considered the most effective topical products for treating acne, skin aging, sun damage and hyperpigmentation. Dr. Obagi one-upped his own Obagi® Nu-Derm® formulations when he introduced ZO® Skin Health and ZO® Medical products, which feature new ingredients and more effective formulations. This new treatment philosophy raises the standard for the treatment and maintenance of healthy skin. He created the Blue Peel®, a medium-depth peel that dramatically reduces wrinkles, improves skin tone and texture, reduces pore size and tightens skin. Even today, the procedure is unsurpassed in medical aesthetics. He wrote “The Art of Skin Health Restoration and Rejuvenation: The Science of Clinical Practice”—the definitive medical textbook on skin health. For more than 30 years Dr. Obagi has challenged himself, his staff, his products and his patients to achieve the best possible skin health. That’s why he goes beyond the laboratory and the classroom and continues to practice at his clinics. For him, that is what is most gratifying—living proof that the best philosophies, the best products and the best procedures deliver the best patient results.


News Article | February 22, 2017
Site: www.prweb.com

NDA Partners Chairman Carl Peck, MD, announced today that Dr. Daniel Spyker, PhD, MD former Acting Deputy Director in the FDA CDRH Division of Cardiovascular, Respiratory, and Neurological Devices and Medical Officer in CDER’s Pilot Drug Evaluation Staff has joined the company as an Expert Consultant. In Dr. Spyker’s accomplished career, he held positions as Senior Director of Drug Safety and Pharmacovigilance at Alexza Pharmaceuticals; Director, Pharmacokinetics and Pharmacodynamic Sciences, Genentech, where he established the clinical pharmacology unit; and Senior Medical Director, Clinical Risk Assessment and Coordination Department at Purdue Pharma. Dr. Spyker was a member of the Internal Medicine faculty in the Division of Clinical Pharmacology at the University of Virginia for 10 years, where he fostered and nurtured the Blue Ridge Poison Center. He was also founder and CEO of a software company specializing in poison center data collection and Bayesian pharmacokinetic applications. “Dr. Daniel Spkyer’s knowledge and expertise of cardiovascular, respiratory, and neurological devices at FDA and in the Industry, in addition to his expertise in quantitative clinical pharmacology and toxicology, make him an excellent addition to NDA Partners. He will bring great value to our medical device clients and we are very pleased to welcome him,” said Dr. Feigal, who heads NDA Partners’ Medical Device Practice. Dr. Spyker earned his PhD from the University of Minnesota in Electrical Engineering and Mathematics, his MD from the University of Virginia, and MS from Purdue University. He is board certified in Internal Medicine, a diplomate of the American Board of Medical Toxicology, and diplomate of the American Board of Clinical Pharmacology. About NDA Partners NDA Partners is a strategy consulting firm specializing in expert product development and regulatory advice to the medical products industry and associated service industries such as law firms, investment funds and government research agencies. The highly experienced Principals and Premier Experts of NDA Partners include three former FDA Center Directors; the former Chairman of the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK; an international team of more than 100 former pharmaceutical industry and regulatory agency senior executives; and an extensive roster of highly proficient experts in specialized areas including nonclinical development, toxicology, pharmacokinetics, CMC, medical device design control and quality systems, clinical development, regulatory submissions, and development program management. Services include product development and regulatory strategy, expert consulting, high-impact project teams, and virtual product development teams.


NEW YORK, Dec. 13, 2016 (GLOBE NEWSWIRE) -- Tyme Technologies, Inc. (“Tyme” or “the Company”) (OTCQB:TYMI), a clinical-stage pharmaceutical company focused on developing highly targeted cancer therapeutics for a broad range of oncology indications, today announced the launch of a Pancreatic Research Program with the Mayo Clinic led by Dr. Martin Fernandez-Zapico. Dr. Martin E. Fernandez-Zapico, Associate Professor of Medicine and Pharmacology at the Mayo Clinic, is an international expert in the field of pancreatic cancer, a disease predicted to be the second leading cause of cancer in 2030. Dr. Fernandez-Zapico's programs are affiliated with the Mayo Clinic Cancer Center, Department of Oncology, Division of Gastroenterology and Hepatology, and the Center for Cell Signaling in Gastroenterology. His research is supported by the National Institutes of Health (NIH), the NIH-funded Mayo Clinic Pancreatic Cancer Specialized Program of Research Excellence (SPORE), the NIH-funded Mayo Clinic Center for Cell Signaling in Gastroenterology, and the Leukemia and Lymphoma Foundation. His work has been seminal for the understanding of mechanisms driving this malignancy and serves as a foundation for multiple National Cancer Institute sponsored clinical trials. "Tyme is extremely pleased to be working with Dr. Fernandez-Zapico of the Mayo Clinic in an effort to potentially discover the future cure of pancreatic cancer.  I believe the pancreatic research experiments planned by Dr. Fernandez-Zapico, using our proprietary discoveries and supported by Tyme, could lead to significant progress in battling this devastating form of cancer.  We look forward to continuing our clinical development program in pancreatic and other cancers, based on collaborations with Mayo and other leading institutions," said Dr. Del Priore, Chief Medical Officer of Tyme. Our research and development efforts are based on patented technologies and our patent pending proprietary platform technology, for which we retain global IP and commercial rights.  Our lead program is SM-88, a proprietary combination drug product.  We believe SM-88 is a first-in-class oncology therapy that increases the power of the body’s innate defenses to utilize oxidative stress to kill cancer cells.  SM-88 is designed to penetrate only living cancer cells without toxic effects and without involving healthy body tissue.  We believe that SM-88’s therapeutic potential is based on its ability to increase the availability of free radicals and promote their entry into cancer cells by stripping the cancer cells of their normal barriers to these toxic electrons.  SM-88 is a combination of a proprietary novel molecule with three currently-marketed drugs that are generally considered safe for their already approved indications, which are in areas other than cancer treatment. In addition to historical information, this press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, Section 27A of the U.S. Securities Act of 1933, and Section 21E of the U.S. Securities Exchange Act of 1934.  Such forward-looking statements may include projections regarding Tyme’s future performance, and readers can identify forward-looking statements by sentences or passages involving the use of terms such as "anticipates," "believes," “designed,” "could," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "would" and similar expressions intended to identify forward-looking statements.  The forward-looking statements contained in this press release are based on management's current expectations, which are subject to uncertainty, risks and changes in circumstances that are difficult to predict and many of which are outside of Tyme’s control.  Forward-looking statements within this press release include, without limitation, statements regarding our drug development strategies, the therapeutic mechanisms of our drug candidates and our completed and planned clinical trials.  These statements involve known and unknown risks, uncertainties and other factors which may cause the Company's actual results, performance or achievements to be materially different from any historical results and future results, performances or achievements expressed or implied by the forward-looking statements.  These risks and uncertainties include, but are not limited to, the factors described in the section captioned "Risk Factors" of Tyme's Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission on March 30, 2016 (available at www.sec.gov).


NEW YORK, Dec. 13, 2016 (GLOBE NEWSWIRE) -- Tyme Technologies, Inc. (“Tyme” or “the Company”) (OTCQB:TYMI), a clinical-stage pharmaceutical company focused on developing highly targeted cancer therapeutics for a broad range of oncology indications, today announced the launch of a Pancreatic Research Program with the Mayo Clinic led by Dr. Martin Fernandez-Zapico. Dr. Martin E. Fernandez-Zapico, Associate Professor of Medicine and Pharmacology at the Mayo Clinic, is an international expert in the field of pancreatic cancer, a disease predicted to be the second leading cause of cancer in 2030. Dr. Fernandez-Zapico's programs are affiliated with the Mayo Clinic Cancer Center, Department of Oncology, Division of Gastroenterology and Hepatology, and the Center for Cell Signaling in Gastroenterology. His research is supported by the National Institutes of Health (NIH), the NIH-funded Mayo Clinic Pancreatic Cancer Specialized Program of Research Excellence (SPORE), the NIH-funded Mayo Clinic Center for Cell Signaling in Gastroenterology, and the Leukemia and Lymphoma Foundation. His work has been seminal for the understanding of mechanisms driving this malignancy and serves as a foundation for multiple National Cancer Institute sponsored clinical trials. "Tyme is extremely pleased to be working with Dr. Fernandez-Zapico of the Mayo Clinic in an effort to potentially discover the future cure of pancreatic cancer.  I believe the pancreatic research experiments planned by Dr. Fernandez-Zapico, using our proprietary discoveries and supported by Tyme, could lead to significant progress in battling this devastating form of cancer.  We look forward to continuing our clinical development program in pancreatic and other cancers, based on collaborations with Mayo and other leading institutions," said Dr. Del Priore, Chief Medical Officer of Tyme. Our research and development efforts are based on patented technologies and our patent pending proprietary platform technology, for which we retain global IP and commercial rights.  Our lead program is SM-88, a proprietary combination drug product.  We believe SM-88 is a first-in-class oncology therapy that increases the power of the body’s innate defenses to utilize oxidative stress to kill cancer cells.  SM-88 is designed to penetrate only living cancer cells without toxic effects and without involving healthy body tissue.  We believe that SM-88’s therapeutic potential is based on its ability to increase the availability of free radicals and promote their entry into cancer cells by stripping the cancer cells of their normal barriers to these toxic electrons.  SM-88 is a combination of a proprietary novel molecule with three currently-marketed drugs that are generally considered safe for their already approved indications, which are in areas other than cancer treatment. In addition to historical information, this press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, Section 27A of the U.S. Securities Act of 1933, and Section 21E of the U.S. Securities Exchange Act of 1934.  Such forward-looking statements may include projections regarding Tyme’s future performance, and readers can identify forward-looking statements by sentences or passages involving the use of terms such as "anticipates," "believes," “designed,” "could," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "would" and similar expressions intended to identify forward-looking statements.  The forward-looking statements contained in this press release are based on management's current expectations, which are subject to uncertainty, risks and changes in circumstances that are difficult to predict and many of which are outside of Tyme’s control.  Forward-looking statements within this press release include, without limitation, statements regarding our drug development strategies, the therapeutic mechanisms of our drug candidates and our completed and planned clinical trials.  These statements involve known and unknown risks, uncertainties and other factors which may cause the Company's actual results, performance or achievements to be materially different from any historical results and future results, performances or achievements expressed or implied by the forward-looking statements.  These risks and uncertainties include, but are not limited to, the factors described in the section captioned "Risk Factors" of Tyme's Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission on March 30, 2016 (available at www.sec.gov).


News Article | November 9, 2016
Site: marketersmedia.com

— Alpine Eyecare Center has opened and is now accepting new patients. The standalone facility at 2449 Pine Street is fully equipped with the latest in diagnostic testing and the only one of its kind in Boulder. Alpine Eyecare Center founder and owner Dr. Chuck Beatty provides a full range of eye care services in a comfortable, welcoming environment. With over 18 years of experience across a range of clinical situations, Dr. Beatty is a Fellow of the American Academy of Optometry and a former active duty Air Force Medical Officer. Patients can enjoy on-site parking at the convenient central Boulder location, along with a generous schedule of opening hours. All are invited to visit the Alpine Eyecare Center website to make an appointment with the Boulder Eye Doctor and to learn more about the clinic and its services. "We're happy to announce that Alpine Eyecare Center is now open and serving people throughout the area," Dr. Beatty said, "We're committed to making sure all our patients get the eye care that will benefit them the most, making every experience as comfortable and pleasant as possible. From comprehensive ocular health assessments to helping our patients find the perfect pair of frames, we're proud to provide a full range of primary eye care and related services. We truly love this community and helping the people who make it so special." After earning his Doctorate in Optometry in 1999, Alpine Eyecare Center founder Dr. Chuck Beatty served for twelve years as a Medical Officer in the U.S. Air Force, feeling driven to help after the events of September 11, 2001. Where many optometrists are shuttled early on into narrow niches that limit the breadth of their learning and experience, Dr. Beatty's service exposed him to a wide range of ocular health challenges from triaging trauma in the field to advanced aerospace optometry. By opening Alpine Eyecare Center, Dr. Beatty aims to provide people throughout the Boulder area with a full range of primary eye care services that serve their individual needs. From spotting and diagnosing medical issues before they become more serious to being the lowest-priced Boulder Contact Lenses supplier, Alpine Eyecare Center can provide everything locals need for clear vision and improved ocular health. The Alpine Eyecare Center website has information about the clinic's full range of services. It notes Dr. Beatty's background and approach to ocular health and various eye care topics. Visitors to the website can find directions to the office, view its operating hours, order contact lenses, and make an appointment with the Boulder Optometrist. About Alpine Eyecare Center: Locally owned and operated by Dr. Chuck Beatty, Alpine Eyecare Center makes use of the latest technology and techniques to provide a full range of primary eye care services in a comfortable, welcoming setting. For more information, please visit http://www.alpineeyecarecenter.com/


News Article | December 12, 2016
Site: www.prweb.com

Gateway Foundation, Illinois leading non-profit provider of addiction treatment services today announced the appointment of Roueen Rafeyan M.D. as Chief Medical Officer (CMO). This position is integral to supporting the company’s strategic growth and fulfilling its mission to provide state of the art care to individuals and families. Dr. Rafeyan brings over 20 years of specialized experience to Gateway, having served as a medical director for psychiatric and substance use programs at leading Illinois healthcare institutions including Rush, Michael Reese, Resurrection and Presence Behavioral Health. As CMO, Dr. Rafeyan is responsible for continuously advancing Gateway’s wide array of services including Medication Assisted Treatment. He works closely with Gateway’s team of experienced physicians and clinicians to deliver comprehensive high quality addictions, psychiatric and medical services and treatment as needed for each individual. Dr. Rafeyan’s treatment philosophy includes providing a comprehensive assessment of medical and psychiatric comorbidities to render better outcomes, and a core belief that the disease of addiction goes beyond the individual and affects the entire family. Professional support and education of the family is as important as treating the individual. “We are excited to be the first Illinois rehabilitation facility to introduce the addition of a Chief Medical Officer to our team,” stated Dr. Thomas Britton, Gateway’s CEO. “Dr. Rafeyan is exactly the type of leader that can help us continue to make a real difference in the lives of those we treat.” In addition to Dr. Rafeyan’s extensive medical experience, he is also a diplomat of the American Board of Psychiatry and Neurology as well as the American Society of Addiction Medicine. He is currently on the faculty of Northwestern University and an active member of the American Medical Association, the American Psychiatry Association, the Illinois Psychiatric Society and Illinois State Medical Society. Since 1968 our goal has been straightforward: to help clients get their life back on track and achieve a life of sobriety, free from drug use and symptoms of mental illness, that is productive, socially responsible, and healthy. Gateway Foundation is the largest nonprofit treatment provider in the country that specializes in the treatment of substance use disorders, providing treatment for men, women, adolescents, and clients diagnosed with co-occurring mental health disorders. Gateway’s Community Division has treatment centers located throughout Illinois, including Carbondale, Chicago, Lake County, Fox Valley, Springfield, and the St. Louis Metro East area. These centers offer residential and outpatient treatment services for adults, teens, and adolescents accessed through insurance, state funding, and self-pay. Gateway’s professional clinicians help thousands of individuals successfully complete treatment by developing a personalized plan that treats the underlying causes of substance abuse—not just addiction to drugs or alcohol. Learn more about insurance coverage, treatment options, or Gateway's confidential consultation at RecoverGateway.org or call 877-505-HOPE (4673). Reporters and Editors, for more information, please call Leslie Colman, Marketing Director, at 630-776-5725.


News Article | November 21, 2016
Site: www.eurekalert.org

Researchers have found a strong association between El Niño-Southern Oscillation conditions in the Pacific to observed weather and dengue epidemics in Sri Lanka. According to a study published in the International Journal of Environmental Research and Public Health, el Niño activity -- measured in sea surface temperature in the pacific -- impacts rainfall and temperatures in Sri Lanka and thus contributes to exacerbated dengue epidemics six months later. "Dengue is the major public health burden in Sri Lanka and the Kalutara district is one of the most affected areas. So understanding how reoccurring weather patterns drive dengue is vital in controlling and preventing the disease spread," says Joacim Rocklöv, researcher at the Unit for Epidemiology and Global Health at Umeå University in Sweden and co-author of the article. "These new findings allow disease early warning systems to provide warnings for upcoming epidemics with much longer lead time than before," says Prasad Liyanage, doctoral student at Umeå University and Medical Officer for dengue control in Kalutara district at the Sri Lankan Ministry of Health. In the study, researchers used the Oceanic Niño Index, which is a measure indicating el Niño activity by sea surface temperature in the Pacific Ocean, along with local weather and epidemiological data to quantify data associations in 10 healthcare divisions of Kalutara in southwestern Sri Lanka. Weekly weather variables and data on dengue notifications, gathered by Prasad Liyanage for the Ministry of Health between 2009 and 2013, were analysed to estimate locally specific and overall relationships between weather and dengue. The results showed an increasing relative risk of dengue with increasing rainfall starting at above 50 mm per week. The strongest association between rainfall and dengue was found around 6 to 10 weeks following rainfalls of more than 300 mm per week, which amounts to very wet conditions and floods. With increasing temperatures of 30 degrees Celsius or higher, the overall relative risk of dengue increased steadily starting from a lag of 4 weeks. "Looking at weather and dengue incidents over longer periods, we found a similar strong link between how increased rainfall and warmer temperatures resulting from the reoccurring el Niño phenomenon are associated with elevated risks of dengue epidemics. In the longer perspective, our data further confirms this association and suggests that dengue fever thrives whenever el Niño visits our island," says Prasad Liyanage. According to the researchers, the findings can be used to improve predictive surveillance models with lead times of up to six months. This would give health officials longer time to increase preparedness and mount control effort responses prior to the epidemics. Today, such control efforts usually have limited effects as they start when signs of an epidemic can be seen within the hospital and primary care surveillance system. The research was funded through the DengueTools FP7 project run by Umeå University in collaboration with the Ministry of Health in Sri Lanka.


KENILWORTH, N.J.--(BUSINESS WIRE)--Many adults with diabetes are unaware of their increased risk for certain serious illnesses, including pneumococcal pneumonia/pneumococcal disease, flu and hepatitis B. This is according to a recent national, online consumer awareness survey sponsored by Merck (NYSE:MRK), known as MSD outside the United States and Canada, and the American Diabetes Association, and conducted by Harris Poll. In the survey of 1,003 U.S. adults ages 18 years and older diagnosed with diabetes, respondents were twice as likely to recognize the potential for adults with diabetes to develop kidney disease (72%) and heart disease (67%), than serious infectious diseases such as pneumococcal disease, including pneumonia, meningitis, or an infection of the blood (36%), compared to adults without diabetes. While published data1 show that adults with diabetes are approximately three times more likely to develop pneumococcal disease compared to healthy adults of the same age, only about 1 in 3 survey respondents (35%) believed they were at least somewhat personally likely to get pneumococcal pneumonia/pneumococcal disease. In addition, less than half of those surveyed (43%) responded that they had discussed the risk factors for pneumococcal pneumonia/pneumococcal disease with their doctor. “ These data illustrate that patients with diabetes are not fully aware of their risk of other serious illnesses, and that there is a critical communication gap between patients and their health care providers about the risks for serious illness, including pneumococcal pneumonia or pneumococcal disease, flu and hepatitis B for adults with diabetes. Because people with diabetes have increased risks for these diseases and more complicated medical courses when they contract them, health care providers should seek to initiate discussions with patients to bridge the information gap, as recommended in our Standards of Care,” said American Diabetes Association Immediate Past Chief Scientific & Medical Officer Robert E. Ratner, M.D. In the 2016 Standards of Medical Care in Diabetes, the American Diabetes Association states: “ Ongoing patient self-management education and support are critical to preventing acute complications, and reducing the risk of long-term complications.” The Standards of Care also recognize and emphasize the importance of patient-centered engagement and communication to the foundation of diabetes care. Indeed, thirty-five percent of the survey respondents strongly/somewhat agreed with the statement: “ I wish I knew more about pneumococcal pneumonia or pneumococcal disease,” and eighty-five percent believed that pneumococcal pneumonia/pneumococcal disease is a very/somewhat serious health condition for adults with diabetes. “ This lack of awareness is significant—based on the survey, we know that adults with diabetes wish they knew more about certain diseases for which they are at risk, including pneumococcal pneumonia or pneumococcal disease,” said Mel Kohn, M.D., MPH, medical director, Merck. In March of 2015, Merck and the American Diabetes Association announced a collaboration aiming to educate adults with diabetes about their increased risk for certain serious illnesses, including pneumococcal pneumonia, flu and hepatitis B, encouraging people with type 1 or type 2 diabetes to talk with their HCP about these diseases. As part of the collaboration, an educational resource is available on the Association’s Diabetes Forecast website to help guide adults with diabetes to have informed conversations with their health care team: www.DiabetesForecast.org/knowyourrisk. Nearly 30 million people in the United States are living with diabetes, and 90-95 percent have type 2 diabetes. About 1.4 million Americans are diagnosed with diabetes every year. 2,3 Pneumococcus refers to the bacterium that is the most common cause of lung infection known as pneumococcal pneumonia. The bacteria can infect the upper respiratory tract, and can spread to the lungs, blood or brain. Symptoms of pneumococcal pneumonia can include sudden onset of illness characterized by shaking chills, fever, shortness of breath or rapid breathing, chest pain that is worsened by breathing deeply and a productive cough. This survey was conducted online by Harris Poll on behalf of Merck and the ADA from April 12-26, 2016 among 1,003 U.S. adults age 18 and older who have been diagnosed with type 1 or type 2 diabetes; not employed by a federal, state, county, or local government agency/facility; do not personally work/have a household member who works in a competing industry; and are not currently involved in a medical clinical trial. Data were not weighted and are only representative of those who completed the survey. For over a century, Merck has been a global health care 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 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 health care through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook, YouTube and LinkedIn. More than 29 million Americans have diabetes, and every 23 seconds another person is diagnosed with diabetes. The American Diabetes Association (Association) is the global authority on diabetes and since 1940 has been committed to its mission to prevent and cure diabetes and to improve the lives of all people affected by diabetes. To tackle this global public health crisis, the Association drives discovery in research to treat, manage and prevent all types of diabetes, as well as to search for cures; raises voice to the urgency of the diabetes epidemic; and provides support and advocacy for people living with diabetes, those at risk of developing diabetes and the health care professionals who serve them. For more information, please call the American Diabetes Association at 1-800-DIABETESS (1-800-342-2383) or visit diabetes.org. Information from both of these sources is available in English and Spanish. Find us on Facebook (American Diabetes Association), Twitter (@AmDiabetesAssn) and Instagram (@AmDiabetesAssn) Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2015 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).


News Article | February 20, 2017
Site: www.prweb.com

Love, longing, class consciousness, insanity, and death by nicotine poisoning are focal points in Dr. Richard Burack’s debut novel “Lydie of Peruwelz.” Lydie Fougnies is a young, attractive, and educated woman who falls in love with a man from a family of wealthy aristocrats. After the matriarch rejects her for not being from high society, Lydie suffers a severe mental breakdown and acts irrationally. She meets a crude count and begins grooming him to become a refined individual. What Lydie does not know is that this man is a psychopathic felon who lusts for her and plans to steal her family’s fortune. Subsequent events lead to a murder and trial. “The book is based on the murder and famous jury trial that engrossed all of Western Europe in the spring of 1851,” said Dr. Burack. “A Belgian historian from the area arranged for me to have a duplicate copy of a transcript containing every word spoken during the trial.” “Lydie of Peruwelz” is a fictionalized account of historical events that warns of dangers of class-consciousness and psychopathic behavior. It also recognizes the power of love. “Lydie of Peruwelz” By Richard Burack, Sr., MD ISBN: 978-1-49174-378-2 (softcover); 978-1-49174-380-5 (hardcover); 978-1-49174-379-9 (eBook) Available on Amazon, Barnes & Noble, and iUniverse About the author Richard Burack earned a BA from the University of Wisconsin and a MD from Wake Forest University School of Medicine. He served as a Medical Officer in the U.S. Coast Guard in the Pacific Theater during the Korean War. Dr. Burack was appointed to the faculty at Harvard Medical School in 1960, and later practiced internal medicine before embarking on a career as a medical director for two U.S. non-pharmaceutical corporations. In 1967, Dr. Burack published “The Handbook of Prescription Drugs,” alerting doctors and the public to the availability of less costly generic medications. He lives in New Hampshire with his wife, Mary. They have five children and ten grandchildren.


News Article | December 27, 2016
Site: marketersmedia.com

Ongoing growth in revenue both domestically and internationally; Successful European sales meetings highlight strong demand abroad; Continued progress with FDA CHESTER, NY / ACCESSWIRE / December 27, 2016 / Repro Med Systems, Inc. dba RMS Medical Products (OTCQX: REPR) today announced its financial results for the third quarter of the fiscal year ending February 28, 2017. For the quarter ended November 30, 2016, net revenues were $3,193,113, an increase of 1.5% compared with $3,144,954 in the same quarter last year. This also represents an increase of 1.4% versus the last quarter. For the nine months ended November 30, 2016, net revenues were $9,331,208, an increase of 4.4% compared with $8,941,676 for the same period last year, driven by increased sales of our infusion products to existing customers, as well as the addition of new customers. Excluding non-recurring clinical trial work in 2015, core revenue is up 6.5% for the most recent nine months. For the three months ended November 30, 2016, gross profit was $2,063,943 compared with $2,109,279 for the same period last year. This decrease in the quarter was mostly driven by the increases in sales rebates related to a specific customer contract renewal compared to the same period last year, as well as an increase in salary and related costs associated with increased staffing in our quality department to facilitate compliance with our quality management system. RMS continues benefiting from lean manufacturing initiatives, which have increased capacity and decreased direct assembly labor costs, as well as the effects of a moratorium on the medical device tax. For the nine months ended November 30, 2016, our gross profit margin increased to 63.8%, up from 63.0% for the same period last year. Gross profit for the nine months ended November 30, 2016 was $5,955,346 compared with $5,633,868 for the comparable period last year. RMS continues to incur professional fees related to regulatory and litigation and has made significant investment over the last nine months in its sales, regulatory, quality, and operations management, including hiring a Chief Medical Officer, to help launch RMS to the next level of growth. As a result, the Company reported for this quarter ended November 30, a net loss of $104,275, compared to net income of $167,552 in the same period last year. For the nine months ended November 30, 2016, net loss was $420,204 compared with net income of $438,126 for the same period last year. Excluding consulting and professional fees related to regulatory and litigation (summarized in the attached tables), net income for the quarter ended November 30, 2016 would have been $281,197 compared with $352,694 for the same period last year. For the nine months ended November 30, 2016, net income would have been $573,245 compared with $780,926 last year. Non-GAAP EBITDA for the quarter would have been $509,310 compared to $603,658 for last year and for the nine months would have been $1,095,662 compared with $1,387,308 for the same period last year. Andy Sealfon, RMS CEO and President, commented, "We are pleased to see some of our efforts internationally starting to come through with orders." Addressing the FDA Warning Letter, Mr. Sealfon noted: "We continue to work closely with the FDA in order to resolve the FDA Warning Letter. We have been and will continue to be proactive in working with the agency in order to resolve all issues that have been or may be raised by the agency as soon as possible." In the upcoming months, RMS plans to be participating in a number of distributor sales meetings, giving the Company the opportunity to speak with its customers and align corporate goals for 2017. In addition, RMS launched its redesigned website enhanced with search engine optimization and other analytics. As patients, providers, and distributors look to the web for better resources regarding product information, best practices and continuous improvement, we plan to make developments continuously to the site to further enhance the visitor experience and interaction with the RMS brand. The Company manufactures medical products used for infusions and suctioning. The Infusion product portfolio currently includes the FREEDOM60® and our latest FreedomEdge® Syringe Infusion Pumps, RMS Precision Flow Rate Tubing™ and RMS HIgH-Flo™ Subcutaneous Safety Needle Sets. These devices are used for infusions administered in professional healthcare settings as well as at home. The Company's RES-Q-VAC® line of medical suctioning products is used by emergency medical service providers in addition to a variety of other healthcare providers. The Company's website may be visited at www.rmsmedicalproducts.com. This press release includes "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In addition to statements which explicitly describe such risks and uncertainties, readers are urged to consider statements labeled with the terms "believes", "belief," "expects," "intends," "anticipates," "will," or "plans" to be uncertain and forward-looking. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company's reports and registration statements filed with the Securities and Exchange Commission. This press release includes non-GAAP financial measures that are not in accordance with, nor an alternate to, generally accepted accounting principles and may be different from non-GAAP measures used by other companies. In addition, these non-GAAP measures are not based on any comprehensive set of accounting rules or principles. Non-GAAP financial measures should not be considered a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP. They are limited in value because they exclude charges that have a material effect on our reported results and, therefore, should not be relied upon as the sole financial measures to evaluate our financial results. The non-GAAP financial measures are meant to supplement, and to be viewed in conjunction with, GAAP financial results. A reconciliation of our non-GAAP measures is included in an attachment to this press release. For more information please call: For the Three Months Ended For the Nine Months Ended 1. Includes consulting and professional fees related to regulatory and litigation. Ongoing growth in revenue both domestically and internationally; Successful European sales meetings highlight strong demand abroad; Continued progress with FDA CHESTER, NY / ACCESSWIRE / December 27, 2016 / Repro Med Systems, Inc. dba RMS Medical Products (OTCQX: REPR) today announced its financial results for the third quarter of the fiscal year ending February 28, 2017. For the quarter ended November 30, 2016, net revenues were $3,193,113, an increase of 1.5% compared with $3,144,954 in the same quarter last year. This also represents an increase of 1.4% versus the last quarter. For the nine months ended November 30, 2016, net revenues were $9,331,208, an increase of 4.4% compared with $8,941,676 for the same period last year, driven by increased sales of our infusion products to existing customers, as well as the addition of new customers. Excluding non-recurring clinical trial work in 2015, core revenue is up 6.5% for the most recent nine months. For the three months ended November 30, 2016, gross profit was $2,063,943 compared with $2,109,279 for the same period last year. This decrease in the quarter was mostly driven by the increases in sales rebates related to a specific customer contract renewal compared to the same period last year, as well as an increase in salary and related costs associated with increased staffing in our quality department to facilitate compliance with our quality management system. RMS continues benefiting from lean manufacturing initiatives, which have increased capacity and decreased direct assembly labor costs, as well as the effects of a moratorium on the medical device tax. For the nine months ended November 30, 2016, our gross profit margin increased to 63.8%, up from 63.0% for the same period last year. Gross profit for the nine months ended November 30, 2016 was $5,955,346 compared with $5,633,868 for the comparable period last year. RMS continues to incur professional fees related to regulatory and litigation and has made significant investment over the last nine months in its sales, regulatory, quality, and operations management, including hiring a Chief Medical Officer, to help launch RMS to the next level of growth. As a result, the Company reported for this quarter ended November 30, a net loss of $104,275, compared to net income of $167,552 in the same period last year. For the nine months ended November 30, 2016, net loss was $420,204 compared with net income of $438,126 for the same period last year. Excluding consulting and professional fees related to regulatory and litigation (summarized in the attached tables), net income for the quarter ended November 30, 2016 would have been $281,197 compared with $352,694 for the same period last year. For the nine months ended November 30, 2016, net income would have been $573,245 compared with $780,926 last year. Non-GAAP EBITDA for the quarter would have been $509,310 compared to $603,658 for last year and for the nine months would have been $1,095,662 compared with $1,387,308 for the same period last year. Andy Sealfon, RMS CEO and President, commented, "We are pleased to see some of our efforts internationally starting to come through with orders." Addressing the FDA Warning Letter, Mr. Sealfon noted: "We continue to work closely with the FDA in order to resolve the FDA Warning Letter. We have been and will continue to be proactive in working with the agency in order to resolve all issues that have been or may be raised by the agency as soon as possible." In the upcoming months, RMS plans to be participating in a number of distributor sales meetings, giving the Company the opportunity to speak with its customers and align corporate goals for 2017. In addition, RMS launched its redesigned website enhanced with search engine optimization and other analytics. As patients, providers, and distributors look to the web for better resources regarding product information, best practices and continuous improvement, we plan to make developments continuously to the site to further enhance the visitor experience and interaction with the RMS brand. The Company manufactures medical products used for infusions and suctioning. The Infusion product portfolio currently includes the FREEDOM60® and our latest FreedomEdge® Syringe Infusion Pumps, RMS Precision Flow Rate Tubing™ and RMS HIgH-Flo™ Subcutaneous Safety Needle Sets. These devices are used for infusions administered in professional healthcare settings as well as at home. The Company's RES-Q-VAC® line of medical suctioning products is used by emergency medical service providers in addition to a variety of other healthcare providers. The Company's website may be visited at www.rmsmedicalproducts.com. This press release includes "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In addition to statements which explicitly describe such risks and uncertainties, readers are urged to consider statements labeled with the terms "believes", "belief," "expects," "intends," "anticipates," "will," or "plans" to be uncertain and forward-looking. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company's reports and registration statements filed with the Securities and Exchange Commission. This press release includes non-GAAP financial measures that are not in accordance with, nor an alternate to, generally accepted accounting principles and may be different from non-GAAP measures used by other companies. In addition, these non-GAAP measures are not based on any comprehensive set of accounting rules or principles. Non-GAAP financial measures should not be considered a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP. They are limited in value because they exclude charges that have a material effect on our reported results and, therefore, should not be relied upon as the sole financial measures to evaluate our financial results. The non-GAAP financial measures are meant to supplement, and to be viewed in conjunction with, GAAP financial results. A reconciliation of our non-GAAP measures is included in an attachment to this press release. For more information please call: For the Three Months Ended For the Nine Months Ended 1. Includes consulting and professional fees related to regulatory and litigation.

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