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REDWOOD CITY, Calif., Nov. 28, 2016 (GLOBE NEWSWIRE) -- Relypsa, Inc., a Vifor Pharma company, today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) with important updates to the label of Veltassa® (patiromer) for oral suspension. Veltassa’s label no longer includes a Boxed Warning regarding the separation of Veltassa and other oral medications. The updated label recommends patients take Veltassa at least 3 hours before or 3 hours after other oral medications. This information is now detailed in the dosage and administration section (Section 2) and the drug interactions section (Section 7) of the label. In addition, data from the Veltassa drug-drug interaction program has been added to the Clinical Pharmacology section of the label (Section 12). “We are extremely pleased the FDA has approved these changes to Veltassa’s label, including removal of the Boxed Warning. These important updates are based on our positive data, which showed there is a low risk for drug-drug interactions with Veltassa when it is separated from other oral medications by at least 3 hours,” said John A. Orwin, president and chief executive officer of Relypsa. “We believe the 3-hour dose separation and addition of data from our drug-drug interaction program to the label can provide doctors greater flexibility in choosing Veltassa and adding it to patients’ daily treatment regimen.” About the Veltassa Drug-Drug Interaction Program Veltassa was approved by the FDA for the treatment of hyperkalemia in the United States on October 21, 2015, becoming the first medicine in more than 50 years for people with elevated blood potassium levels. The drug-drug interaction program tested 28 drugs to determine the potential for interaction with Veltassa. Fourteen drugs showed no interaction with Veltassa in in vitro drug-drug interaction tests (conducted in test tubes). Of the 14 drugs that did show an interaction in vitro, 12 were selected for further testing in Phase 1 studies in healthy volunteers to assess whether the results seen in vitro translated into an effect in people. These studies showed Veltassa did not alter the absorption of nine of the 12 drugs when co-administered. Veltassa reduced absorption of three drugs when co-administered, however, there was no interaction when Veltassa and these three drugs were taken 3 hours apart. About Hyperkalemia Approximately 3 million people in the United States with stage 3 or 4 chronic kidney disease (CKD) and/or heart failure have hyperkalemia, or elevated blood potassium levels. Hyperkalemia can cause abnormal heart rhythms and even sudden death. There are often no warning signs, meaning a person can unknowingly experience spikes in potassium levels recurrently and be at risk for these cardiac events. Some medicines that are often prescribed to people with CKD and heart failure to help delay progression of their underlying disease can cause hyperkalemia as a side effect. These include renin angiotensin aldosterone system (RAAS) inhibitors such as angiotensin receptor blockers (ARBs), aldosterone antagonists (AAs) and angiotensin-converting-enzyme (ACE) inhibitors. About Veltassa Veltassa is a potassium binder approved for the treatment of hyperkalemia. Veltassa should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action. Made in powder form consisting of smooth, spherical beads, Veltassa is mixed with water (one-third of a cup) and taken once-a-day with food. Veltassa is not absorbed and acts within the gastrointestinal tract. It binds to potassium in exchange for calcium, primarily in the colon. The potassium is then excreted from the body through the normal excretion process. Contraindications Veltassa is contraindicated in patients with a history of a hypersensitivity reaction to Veltassa or any of its components. Worsening of Gastrointestinal Motility   Use of Veltassa should be avoided in patients with severe constipation, bowel obstruction or impaction, including abnormal post-operative bowel motility disorders, because Veltassa may be ineffective and may worsen gastrointestinal conditions. Patients with a history of bowel obstruction or major gastrointestinal surgery, severe gastrointestinal disorders, or swallowing disorders were not included in clinical studies. Hypomagnesemia Veltassa binds to magnesium in the colon, which can lead to hypomagnesemia. In clinical studies, hypomagnesemia was reported as an adverse reaction in 5.3 percent of patients treated with Veltassa. Approximately 9 percent of patients in clinical trials developed hypomagnesemia with a serum magnesium value <1.4 mg/dL. Doctors should monitor serum magnesium and consider magnesium supplementation in patients who develop low serum magnesium levels. Adverse Reactions The most common adverse reactions (incidence ≥2 percent) are constipation, hypomagnesemia, diarrhea, nausea, abdominal discomfort and flatulence. Mild to moderate hypersensitivity reactions were reported in 0.3 percent of patients treated with Veltassa and included edema of the lips. About Relypsa, Inc. Relypsa, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of polymeric medicines for patients with conditions that are often overlooked and undertreated and can be addressed in the gastrointestinal tract. The Company's first medicine, Veltassa® (patiromer) for oral suspension, was developed based on Relypsa's rich legacy in polymer science. Relypsa was founded in 2007 and, in September 2016, became a Vifor Pharma company. More information is available at www.relypsa.com. About Vifor Pharma Vifor Pharma, a company of the Galenica Group, is a world leader in the discovery, development, manufacturing and marketing of pharmaceutical products for the treatment of iron deficiency. The company also offers a diversified portfolio of prescription medicines as well as over-the-counter (OTC) products. Vifor Pharma, headquartered in Zurich, Switzerland, has an increasingly global presence and a broad network of affiliates and partners around the world. For more information about Vifor Pharma, please visit www.viforpharma.com.


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.


Galenica Group today announced that Relypsa, Inc., a Vifor Pharma Company, has received approval from the US Food and Drug Administration (FDA) for a supplemental New Drug Application (sNDA) with important updates to the US label of Veltassa® (patiromer) for oral suspension. The US label for Veltassa® no longer includes a Boxed Warning regarding the separation of Veltassa® and other oral medications. The updated US label for Veltassa® recommends patients take Veltassa® at least 3 hours before or 3 hours after other oral medications. This information is now detailed in the dosage and administration section (Section 2) and the drug interactions section (Section 7) of the label. In addition, data from the Veltassa® drug-drug interaction program has been added to the Clinical Pharmacology section of the label (Section 12). The separation time between administration of Veltassa® and other oral medications has changed from at least 6 hours to at least 3 hours. With the removal of the Boxed Warning doctors can have greater flexibility in prescribing Veltassa® in combination with other oral medications. "In addition to the positive impact that this approval will have for patients, it also validates the decision of Vifor Pharma to acquire Relypsa," said Etienne Jornod, Executive Chairman of Galenica and Vifor Pharma. "With this approval, we will continue to build on the solid and consistent growth of Vifor Pharma and we will undertake the investments required to support the commercialization of Veltassa® to achieve its full potential. As a result of the Relypsa acquisition, Vifor Pharma has gained direct access to the key US market. This will enable us to maximise the potential of our compelling product portfolio and enhance our growing attraction as an international partner of choice." The investment made in Relypsa underlines Vifor Pharma's strategy to grow both organically as well as through in-licensing deals and acquisitions to further support the company's emerging global leadership in nephrology, cardio-renal and gastroenterology therapies. With the combination of the assets and products of Vifor Pharma, Vifor Fresenius Medical Care Renal Pharma (VFMCRP), Relypsa and its partners, Vifor Pharma is positioned to become a major player in the US in its core therapy areas. Mr. Jornod added: "Vifor Pharma is in a transformational phase and we are investing now to accelerate future revenue growth and to further reduce the manufacturing cost of Veltassa®." Veltassa® was approved by the FDA for the treatment of hyperkalemia in the United States on October 21, 2015, becoming the first medicine in more than 50 years for people with elevated blood potassium levels and it is patent protected until 2030. A Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for Patiromer (powder for oral suspension) was submitted in April 2016 and is currently under review with a decision expected in the second half of 2017. For further information, please contact: Galenica is a diversified Group active throughout the healthcare market which, among other activities, develops, manufactures and markets pharmaceutical products, runs pharmacies, provides logistical and database services and sets up networks. With its two Business units Vifor Pharma and Galenica Santé, the Galenica Group enjoys a leading position in all its core business activities. A large part of the Group's income is generated by international operations. Galenica is listed on the Swiss Stock Exchange (SIX Swiss Exchange, GALN, security number 1,553,646). Additional information concerning the Galenica Group can be found at www.galenica.com. Vifor Pharma, a company of the Galenica Group, is a world leader in the discovery, development, manufacturing and marketing of pharmaceutical products for the treatment of iron deficiency. The company also offers a diversified portfolio of prescription medicines as well as over-the-counter (OTC) products. Vifor Pharma, headquartered in Zurich, Switzerland, has an increasingly global presence and a broad network of affiliates and partners around the world. For more information about Vifor Pharma, please visit www.viforpharma.com. Relypsa, Inc., is a biopharmaceutical company focused on the discovery, development and commercialization of polymeric medicines for patients with conditions that are often overlooked and undertreated and can be addressed in the gastrointestinal tract. The Company's first medicine, Veltassa® (patiromer) for oral suspension, was developed based on Relypsa's rich legacy in polymer science. Relypsa was founded in 2007 and, in September 2016, became a Vifor Pharma company.  More information is available at www.relypsa.com. Veltassa® (patiromer for oral suspension) is an oral potassium binder approved in the US for the treatment of hyperkalaemia, a potentially life-threatening condition defined as abnormally elevated serum potassium. This medicine has been studied in patients with CKD, and/or heart failure, as well as patients with diabetes and hypertension. Patiromer is not absorbed and acts within the gastrointestinal tract. It binds to potassium in exchange for calcium, primarily in the colon. The potassium is then excreted from the body through the normal excretion process. Hyperkalaemia, or abnormally elevated levels of potassium in the blood, is a serious condition that can lead to life-threatening cardiac arrhythmia and even sudden death. Approximately 3 million people in the United States with stage 3 or 4 CKD and/or heart failure have hyperkalaemia. There are often no warning signs, meaning a person can unknowingly experience spikes in potassium levels recurrently and be at risk for these cardiac events. Some medicines that are often prescribed to people with CKD and heart failure to help delay progression of their underlying disease can cause hyperkalaemia as a side effect. These include renin angiotensin aldosterone system (RAAS) inhibitors such as angiotensin receptor blockers (ARBs), aldosterone antagonists (AAs) and angiotensin-converting-enzyme (ACE) inhibitors. Veltassa® Drug-Drug Interaction Program tested 28 drugs to determine the potential for interaction with Veltassa®. Fourteen drugs showed no interaction with Veltassa® in in vitro drug-drug interaction tests (conducted in test tubes). Of the 14 drugs that did show an interaction in vitro, 12 were selected for further testing in Phase 1 studies in healthy volunteers to assess whether the results seen in vitro translated into an effect in people. These studies showed Veltassa® did not alter the absorption of nine of the 12 drugs when co-administered. Veltassa® reduced absorption of three drugs when co-administered, however, there was no interaction when Veltassa® and these three drugs were taken 3 hours apart.


News Article | December 7, 2016
Site: www.eurekalert.org

GRAND RAPIDS, Mich. (Dec. 7, 2016)--A new investigational drug originally developed for type 2 diabetes is being readied for human clinical trials in search of the world's first treatment to impede the progression of Parkinson's disease following publication of research findings today in the journal Science Translational Medicine. "We hope this will be a watershed moment for millions of people living with Parkinson's disease," says Patrik Brundin, M.D., Ph.D., director of Van Andel Research Institute's Center for Neurodegenerative Science, chairman of The Cure Parkinson's Trust's Linked Clinical Trials Committee, and the study's senior author. "All of our research in Parkinson's models suggests this drug could potentially slow the disease's progression in people as well." Until now, Parkinson's treatments have focused on symptom management. If successful in human trials, MSDC-0160 would be the world's first therapy to treat the underlying disease and slow its progression--potentially improving quality of life and preventing the occurrence of falls and cognitive decline. It may also reduce or delay the need for medications that can have debilitating side effects, says Brundin. Parkinson's disease afflicts between 7-10 million people worldwide, including an estimated 1 million Americans, and these numbers are expected to increase dramatically as the average human lifespan increases. There is currently no cure, and first-line treatment has remained relatively unchanged since the introduction of levodopa in the 1960s. Tom Isaacs, a co-founder of The Cure Parkinson's Trust who has lived with Parkinson's for 22 years, says MSDC-0160 represents one of the most promising treatment the Trust's international consortium has seen to date. "Our scientific team has evaluated more than 120 potential treatments for Parkinson's disease, and MSDC-0160 offers the genuine prospect of being a breakthrough that could make a significant and permanent impact on people's lives in the near future," says Isaacs. "We are working tirelessly to move this drug into human trials as quickly as possible in our pursuit of a cure." MSDC-0160 was developed by Kalamazoo, Michigan-based Metabolic Solutions Development Company (MSDC) to treat type 2 diabetes. In 2012, Brundin recognized it as an exciting drug candidate because of its mode of action, proven safety in people, local availability and the start-up company's interest in collaborating on drug repurposing initiatives. After four years of work, the effects of the drug in the laboratory exceeded Brundin's expectations. The novelty of MSDC-0160 stems from a recently revived revelation that Parkinson's may originate, at least partially, in the body's energy metabolism. The new drug appears to regulate mitochondrial function in brain cells and restore the cells' ability to convert basic nutrients into energy. Consequently, the cells' ability to handle potentially harmful proteins is normalized, which leads to reduced inflammation and less nerve cell death. "Parkinson's disease and diabetes may have vastly different symptoms with unrelated patient outcomes; however, we're discovering they share many underlying mechanisms at the molecular level and respond similarly to a new class of insulin sensitizers like MSDC-0160," says Jerry Colca, Ph.D., co-founder, president and chief scientific officer of MSDC. While Brundin says he is eager to see MSDC-0160 launched into a clinical trial in Parkinson's disease, he's equally excited about the possibility of testing the drug in Lewy body dementia and other cognitive decline conditions, such as Alzheimer's disease. "This is an immensely promising avenue for drug discovery," says Brundin. "Whatever the outcome of the upcoming trial for Parkinson's, we now have a new road to follow in search of better treatments that cut to the root of this and other insidious diseases." The Cure Parkinson's Trust and Van Andel Research Institute are currently working with MSDC to address regulatory issues and obtain funding to organize the clinical trial, which Brundin hopes can begin sometime in 2017. Funding for the research was provided by Van Andel Research Institute, The Cure Parkinson's Trust, the Campbell Foundation, and the Spica Foundation. The paper's authors include Anamitra Ghosh, Trevor Tyson, Sonia George, Erin N. Hildebrandt, Jennifer A. Steiner, Zachary Madaj, Emily Schulz, Emily Machiela, Martha L. Escobar Galvis, Jeremy M. Van Raamsdonk and Patrik Brundin, all of Van Andel Research Institute; William G. McDonald and Jerry R. Colca, both of Metabolic Solutions Development Company; and Jeffrey H. Kordower, of Rush University Medical Center and Van Andel Research Institute. Although Parkinson's symptoms vary widely among patients, they typically progress from a constellation of vague problems, including loss of smell, constipation, poor sleep, mood fluctuations, and changing blood pressures, to the disease's hallmarks, such as tremors, affected speech and facial expressions, stooping, poor motor function, and memory loss. The gold standard treatment, levodopa, supplements the neurotransmitter dopamine, a chemical in the brain that is critical for motor function and one that decreases as the disease progresses. Though often effective early in Parkinson's progression, levodopa's effectiveness may decline and the need to endure increasingly heavy doses comes with debilitating side effects like confusion, anxiety, hallucinations, uncontrollable movements and tremors, and incontinence. MSDC-0160 is a novel mTOT modulator being developed to treat neurodegenerative diseases such as Parkinson's and Alzheimer's disease. It is a once-a-day, oral insulin sensitizer that works through a new drug target located in the inner mitochondrial membrane, called mTOT. The mTOT mechanism ties mitochondrial metabolism to aspects of the pathology associated with insulin resistance and certain neurodegenerative diseases. MSDC-0160 has been shown to safe, well-tolerated, and efficacious in a 90-day, randomized, double-blind, comparator- and placebo-controlled, multi-dose Phase 2b clinical study in 258 patients with type 2 diabetes (Clinical Pharmacology & Therapeutics (advance online publication 6 March 2013); and in a Phase 2a study conducted by researchers at Rush University Medical Center in Chicago in patients diagnosed with dementia due to Alzheimer's disease, wherein this new therapeutic agent prevented the decline in a measure of brain glucose utilization in patients with mild to moderate Alzheimer's disease (Current Alzheimer Research, 2014, 11).


News Article | October 6, 2016
Site: motherboard.vice.com

A new study suggests that cannabis might be useful in treating cervical cancer. Through in vitro, or test tube/petri dish, analysis, researchers from the biochemistry department at North-West University in Potchefstroom, South Africa found that the non-psychotropic cannabinoid, or chemical compound, CBD (cannabidiol), taken from a Cannabis sativa extract, could hold anticarcinogenic properties. They pointed out that cannabis acted on the cancerous cells through apoptosis, or a process of cell death, causing only the cancerous cells to kill themselves, and inhibiting their growth. Cervical cancer is no longer a leading cause of death as much as it used to be in the United States, thanks in large part to the widespread use of pap smears, but it's still a widespread threat. And in Sub-Saharan Africa, it kills 250,000 women every year. "This makes it the most lethal cancer amongst black women and calls for urgent therapeutic strategies," the study's authors wrote in the BMC Complementary and Alternative Medicine journal. "In this study we compare the anti-proliferative effects of crude extract of Cannabis sativa and its main compound cannabidiol on different cervical cancer cell lines." It will take much more research before cannabis can be integrated into official cervical cancer treatments in sub-Saharan Africa. But earlier studies also shows that cannabis has been useful in treating not only the symptoms of cancer and chemotherapy, but also the cancer itself. One study from the journal of Current Clinical Pharmacology found that cannabis served as a preventative agent, reducing inflammation, which researchers also said was useful in reducing the likelihood of cancer. Another study from Oncology Hematology also noted cannabis' anti-cancer effects, explaining how the plant's cannabinoids inhibited tumor growth in vitro, such as in a petri dish or test tube, and in vivo, or a living organism. A handful of other studies have also looked into cannabis as a treatment specifically for cervical cancer. Another from the University Hospital in Geneva, Switzerland, found that the cannabinoids, including the body's own endocannabinoids, offered "attractive opportunities for the development of novel potent anticancer drugs." At the same time, there could also be carcinogenic effects of cannabis smoke, especially for cancer patients. One study in France found that "increased risks of lung or colorectal cancer due to marijuana smoking were not observed, but increased risks of prostate and cervical cancers among non-tobacco smokers...were observed." With that said, often medical marijuana is ingested via capsules, tinctures, vaporizable oils, and other non-smokeable, more pharmaceutical-style forms. Should cannabis eventually become approved for cervical cancer treatment in Africa, it may be up for debate whether whole plant therapy (in which all the cannabinoids work synergistically through the "entourage effect") or specific cannabinoid therapy is best.


News Article | February 23, 2017
Site: www.eurekalert.org

A new analysis indicates that not obtaining a medication the first time it is prescribed--called initial medication non-adherence--is common among patients within the Catalan health system in Spain. In the analysis of some 1.6 million patients with 2.9 million prescriptions, the prevalence of total initial medication non-adherence was 17.6% of prescriptions. Predictors were younger age, American nationality, having a pain-related or mental disorder, and being treated by a substitute/resident general practitioner in a teaching center. "We are especially concerned about the high rates of initial medication non-adherence in chronic treatments such as insulins, statins, or antidepressants and suspect that it is also related to an increase in costs, so we are designing an intervention targeting high risk patients," said Dr. Maria Rubio-Valera, senior author of the British Journal of Clinical Pharmacology study.


News Article | November 22, 2016
Site: www.24-7pressrelease.com

RIO VISTA, CA, November 22, 2016-- Dr. Daniel Azarnoff has been included in Marquis Who's Who. As in all Marquis Who's Who biographical volumes, individuals profiled are selected on the basis of current reference value. Factors such as position, noteworthy accomplishments, visibility, and prominence in a field are all taken into account during the selection process.Dedicated to his career as a pharmaceutical executive and consultant, Dr. Azarnoff has amassed more than six decades of experience in a wide array of positions. He began his professional journey as a research fellow at the University of Kansas Medical School in 1950, beginning a long association with the institution. Dr. Azarnoff served there as an intern in 1955, a resident of the National Heart Institute research fellowship in 1956, an assistant professor of medicine in 1962, and associate professor and the director of the clinical pharmacology study unit in 1964. Then, in 1965, he transitioned to the role of associate professor of pharmacology, in 1968 he became a full professor of medicine and pharmacology and the president of the Sigma Xi Club. In 1978, Dr. Azarnoff was named a Kansas University Medical School Distinguished Professor of Medicine, and in 1982, he attained the position of clinical professor of medicine. It wasn't until 2007 that Dr. Azarnoff officially left the college. The move allowed him to focus solely on running his company, D.L. Azarnoff Associates, a pharmaceutical development consultancy that he established in 1987 and still operates to this day.Throughout his time at the University of Kansas Medical School, Dr. Azarnoff held a variety of other positions as well. He spent seven years as the senior vice president, and then the president, of Searle, a pharmaceutical research and development company, five years as the senior vice president of clinical regulatory affairs at Cellegy Pharmaceuticals, and two years as the commissioner of the National Commission on Orphan Diseases. Dr. Azarnoff also taught at Northwestern University Medical School, Washington University School of Medicine, and Stanford University Medical School. Further, he supplemented his career by participating in the creation of literature on developments in his field. He edited, "Yearbook of Drug Therapy" from 1977 to 1979, and the series, "Monographs in Clinical Pharmacology," from 1977 to 1984, as well as others.Dr. Azarnoff earned a Bachelor of Science and a Master of Science from Rutgers, The State University of New Jersey, in 1947 and 1948, respectively, and an MD from the University of Kansas Medical School in 1955. He is a member of the American Medical Association and the American Society of Pharmacology and Experimental Therapeutics. In 1977, he was elected to the National Academy of Medicine.As a testament to his success, Dr. Azarnoff was honored with inclusion in every edition of Who's Who in America published between 1986 and 2016, as well as numerous volumes of Who's Who in Finance and Business, Who's Who in Medicine and Healthcare, Who's Who in the West, Who's Who in the World, Who's Who in the Midwest, and Who's Who in Science and Engineering. He was the recipient of the Ginsburg Award in physical diagnosis from the University of Kansas Medical Center in 1953, the Ciba Award for gerontological research in 1958, Nathaniel T. Kwit Memorial Distinguished Service Award from the American College of Clinical Pharmacology in 2002, and the Oscar B. Hunter Award of the American Society of Clinical Pharmacology and Therapeutics in 1995, among others. Dr. Azarnoff was selected to be a Fulbright Scholar at the Karolinska Institute in Stockholm in 1968 and was named a Distinguished Medical Alumnus by the University of Kansas College of Health Science in 1995.About Marquis Who's Who :Since 1899, when A. N. Marquis printed the First Edition of Who's Who in America , Marquis Who's Who has chronicled the lives of the most accomplished individuals and innovators from every significant field of endeavor, including politics, business, medicine, law, education, art, religion and entertainment. Today, Who's Who in America remains an essential biographical source for thousands of researchers, journalists, librarians and executive search firms around the world. Marquis now publishes many Who's Who titles, including Who's Who in America , Who's Who in the World , Who's Who in American Law , Who's Who in Medicine and Healthcare , Who's Who in Science and Engineering , and Who's Who in Asia . Marquis publications may be visited at the official Marquis Who's Who website at www.marquiswhoswho.com


News Article | November 22, 2016
Site: www.24-7pressrelease.com

NEW YORK, NY, November 22, 2016-- Dr. Henry Pan has been included in Marquis Who's Who. As in all Marquis Who's Who biographical volumes, individuals profiled are selected on the basis of current reference value. Factors such as position, noteworthy accomplishments, visibility, and prominence in a field are all taken into account during the selection process.Dr. Pan arrived in the United States in 1969 upon completion of a Bachelor of Science degree in genetics from McGill University in Montreal, Canada, to pursue graduate studies at the University of Hawaii with the late Professor Louis Casarett, a world renowned inhalation toxicologist. Dr. Pan graduated with a Master of Science in toxicology and later a Ph.D. in molecular pharmacology from the University of Hawaii. While at the University, he was both a research and teaching assistant. Following his graduate degrees, Dr. Pan entered medical school and graduated in 1979 from the University of Hong Kong, School of Medicine. Upon graduation, Dr. Pan entered the field as a medical officer at Queen Mary Hospital from 1979 to 1981, and was a tenured assistant professor of medicine and clinical pharmacology at the University of Hong Kong from 1981 to 1985.Dr. Pan returned to the United States in 1983 as a fellow in clinical pharmacology and a visiting professor of medicine at Stanford University, School of Medicine. This marked the beginning of an impressive three decades of field work in research, administrative, directorial, and chief operating roles in executive positions. Ten years' worth of healthcare and medicinal knowledge and extensive research skills developed both in the classroom and the hospital opened the doors to a myriad of opportunities. Dr. Pan has been the vice president of clinical research and development at the Bristol Myers Squibb Company; the executive vice president of drug development and medical affairs at the DuPont Merck Pharmaceutical Company; the president and CEO of MDS Pharmaceutical Services; chief executive officer of Vennworks RTP; the executive vice president and chief medical officer of Neurocrine Biosciences Inc.; and the executive vice president and chief scientific and medical officer of Prometheus Laboratories Inc., among other positions. His current positions include the chief executive officer of Renascions Inc. and Renascions Biopharma Inc., and the chief executive of Pan Consulting Associates LLC, where he provides consulting services to North American, European, and Asian biopharmaceutical companies.Dr. Pan has been inducted as a fellow in multiple prestigious organizations: the American College of Cardiology, the American College of Clinical Pharmacology, the American Heart Association, the American Society of Angiology, the Institute of Biological and Clinical Investigation, the Academy of Medicine of New Jersey, and the Faculty of Pharmaceutical Medicine of the Royal College of Physicians in the UK. He has served on the board of 15 companies and was the chairman of the biopharmaceutical division of the Society of Chinese Bioscientists in America, one of the largest minority science organizations in the United States.For his contributions to the medical field, Dr. Pan has been included in the 47th through 50th, 52nd through 57th, 59th through 61st, 63rd, and the 67th through 70th editions of Who's Who in America; the 2nd through 6th editions of Who's Who in Medicine and Healthcare; the 1st through 6th editions of Who's Who in Science and Engineering; the 23rd through 28th editions of Who's Who in the East; the 16th through 25th editions of Who's Who in the World; and the 4th edition of Who's Who of Emerging Leaders in America.About Marquis Who's Who :Since 1899, when A. N. Marquis printed the First Edition of Who's Who in America , Marquis Who's Who has chronicled the lives of the most accomplished individuals and innovators from every significant field of endeavor, including politics, business, medicine, law, education, art, religion and entertainment. Today, Who's Who in America remains an essential biographical source for thousands of researchers, journalists, librarians and executive search firms around the world. Marquis now publishes many Who's Who titles, including Who's Who in America , Who's Who in the World , Who's Who in American Law , Who's Who in Medicine and Healthcare , Who's Who in Science and Engineering , and Who's Who in Asia . Marquis publications may be visited at the official Marquis Who's Who website at www.marquiswhoswho.com


News Article | December 12, 2016
Site: marketersmedia.com

SAN DIEGO, CA / ACCESSWIRE / December 12, 2016 / Each year, 1.7 billion citizens of developing countries need treatment for neglected diseases, according to the World Health Organization's (WHO) 2016 World Health Statistics. In a dynamic global environment, pharmaceutical companies face myriad obstacles in supplying poverty stricken communities with necessary medicines and vaccines. Shareholders often question such pursuits, as the cost-benefit matrix of developing drugs for countries with political or economic instability provides limited financial gain, at best. Dr. Najib Babul, an accomplished pharmaceutical scientist, drug developer and biotech entrepreneur, explains a new model of partnership between the public and private sectors that can successfully advance global health initiatives. Public-private partnerships have already helped address some of the world's largest public health challenges, noted Dr. Babul. Following the declaration of smallpox’s eradication in 1980, Merck, the WHO, the World Bank, the United Nations Children's Fund, the National Ministries of Health, and the Task Force for Global Health joined forces to launch a global initiative to distribute and administer treatment for river blindness. This campaign demonstrated that companies could successfully collaborate with government and non-profit partners, providing critical expertise in the areas of R&D, manufacturing, and distribution. In another example, pharmaceutical giant GlaxoSmithKline (GSK) and the PATH Malaria Vaccine Initiative collectively developed malaria candidate vaccine RTS,S (Mosquirix™), with grant monies from the Bill & Melinda Gates Foundation to PATH and support from a network of African research centers that performed the studies. Mosquirix recently received a positive scientific opinion from the European Medicines Agency for the prevention of malaria in young children in sub-Saharan Africa. The WHO has announced that the Mosquirix vaccine will first be rolled out in pilot projects in 3 countries in sub-Saharan Africa. The pilot program will assess whether the vaccine’s protective effects in Phase 3 clinical trials can be replicated in real-life settings. Effective research remains the basis and most vital component of developing promising medicines, and again, it is partnership, rather than the competitive model, which has shown most promise in accelerating solutions. For example, Dr. Babul cites the Pool for Open Innovation Against Neglected Tropical Diseases, administered by the non-governmental organization Bio Ventures for Global Health, which is embracing data sharing by partnering with companies who agree to grant access to their compound "libraries", and creating a singular, comprehensive collection of molecular entities. The initiative began with GSK's efforts to create a "Patent Pool" for new therapeutics to treat neglected tropical diseases. Pharmaceutical companies, academia and non-governmental organizations are encouraged to donate drug compounds for neglected tropical diseases. GSK has donated over 800 patents and patent applications to the collaboration. The Patent Pool is targeting sixteen diseases that the U.S FDA has identified in its neglected tropical diseases initiative. To date, approximately 150,000 compounds have been screened for efficacy against diseases including African sleeping sickness, visceral leishmaniasis and Chagas disease, potentially allowing for results to be achieved efficiently and with greater accuracy. A graduate of the University of British Columbia, the State University of New York in Buffalo and the California Institute of Advanced Management, Dr. Najib Babul is presently a drug development consultant to pharmaceutical companies and investment banks with over two decades of experience in bringing new drugs to market. Dr. Babul is the author of over 170 abstracts and manuscripts published by leading medical journals and scientific proceedings, including the Lancet, the Journal of American Medical Association (JAMA), the Journal of Clinical Pharmacology, the Journal of Clinical Oncology, Cancer, Anesthesiology, Clinical Pharmacology & Therapeutics, and Anesthesia & Analgesia. Najib Babul - Discusses the Benefits and Limitations of Opioids for Neuropathic Pain: https://www.yahoo.com/news/najib-babul-discusses-benefits-limitations-233500333.html Najib Babul - Explains Why Treatment Advances in Fibromyalgia Have Been Slow: http://sports.yahoo.com/news/najib-babul-explains-why-treatment-130500043.html SAN DIEGO, CA / ACCESSWIRE / December 12, 2016 / Each year, 1.7 billion citizens of developing countries need treatment for neglected diseases, according to the World Health Organization's (WHO) 2016 World Health Statistics. In a dynamic global environment, pharmaceutical companies face myriad obstacles in supplying poverty stricken communities with necessary medicines and vaccines. Shareholders often question such pursuits, as the cost-benefit matrix of developing drugs for countries with political or economic instability provides limited financial gain, at best. Dr. Najib Babul, an accomplished pharmaceutical scientist, drug developer and biotech entrepreneur, explains a new model of partnership between the public and private sectors that can successfully advance global health initiatives. Public-private partnerships have already helped address some of the world's largest public health challenges, noted Dr. Babul. Following the declaration of smallpox’s eradication in 1980, Merck, the WHO, the World Bank, the United Nations Children's Fund, the National Ministries of Health, and the Task Force for Global Health joined forces to launch a global initiative to distribute and administer treatment for river blindness. This campaign demonstrated that companies could successfully collaborate with government and non-profit partners, providing critical expertise in the areas of R&D, manufacturing, and distribution. In another example, pharmaceutical giant GlaxoSmithKline (GSK) and the PATH Malaria Vaccine Initiative collectively developed malaria candidate vaccine RTS,S (Mosquirix™), with grant monies from the Bill & Melinda Gates Foundation to PATH and support from a network of African research centers that performed the studies. Mosquirix recently received a positive scientific opinion from the European Medicines Agency for the prevention of malaria in young children in sub-Saharan Africa. The WHO has announced that the Mosquirix vaccine will first be rolled out in pilot projects in 3 countries in sub-Saharan Africa. The pilot program will assess whether the vaccine’s protective effects in Phase 3 clinical trials can be replicated in real-life settings. Effective research remains the basis and most vital component of developing promising medicines, and again, it is partnership, rather than the competitive model, which has shown most promise in accelerating solutions. For example, Dr. Babul cites the Pool for Open Innovation Against Neglected Tropical Diseases, administered by the non-governmental organization Bio Ventures for Global Health, which is embracing data sharing by partnering with companies who agree to grant access to their compound "libraries", and creating a singular, comprehensive collection of molecular entities. The initiative began with GSK's efforts to create a "Patent Pool" for new therapeutics to treat neglected tropical diseases. Pharmaceutical companies, academia and non-governmental organizations are encouraged to donate drug compounds for neglected tropical diseases. GSK has donated over 800 patents and patent applications to the collaboration. The Patent Pool is targeting sixteen diseases that the U.S FDA has identified in its neglected tropical diseases initiative. To date, approximately 150,000 compounds have been screened for efficacy against diseases including African sleeping sickness, visceral leishmaniasis and Chagas disease, potentially allowing for results to be achieved efficiently and with greater accuracy. A graduate of the University of British Columbia, the State University of New York in Buffalo and the California Institute of Advanced Management, Dr. Najib Babul is presently a drug development consultant to pharmaceutical companies and investment banks with over two decades of experience in bringing new drugs to market. Dr. Babul is the author of over 170 abstracts and manuscripts published by leading medical journals and scientific proceedings, including the Lancet, the Journal of American Medical Association (JAMA), the Journal of Clinical Pharmacology, the Journal of Clinical Oncology, Cancer, Anesthesiology, Clinical Pharmacology & Therapeutics, and Anesthesia & Analgesia. Najib Babul - Discusses the Benefits and Limitations of Opioids for Neuropathic Pain: https://www.yahoo.com/news/najib-babul-discusses-benefits-limitations-233500333.html Najib Babul - Explains Why Treatment Advances in Fibromyalgia Have Been Slow: http://sports.yahoo.com/news/najib-babul-explains-why-treatment-130500043.html


News Article | December 14, 2016
Site: marketersmedia.com

— According to the World Health Organization’s (WHO) 2016 World Health Statistics, 1.7 billion citizens of developing countries need treatment for neglected diseases each year. In a dynamic global environment, pharmaceutical companies face myriad obstacles in supplying poverty stricken communities with necessary medicines and vaccines. Shareholders often question such pursuits, as the cost-benefit matrix of developing drugs for countries with political or economic instability provides limited financial gain, at best. Dr. Najib Babul, an accomplished pharmaceutical scientist, drug developer and biotech entrepreneur, explains a new model of partnership between the public and private sectors that can successfully advance global health initiatives. Public-private partnerships have already helped address some of the world’s largest public health challenges, noted Dr. Babul. Following the declaration of smallpox’s eradication in 1980, Merck, the WHO, the World Bank, the United Nations Children’s Fund, the National Ministries of Health, and the Task Force for Global Health joined forces to launch a global initiative to distribute and administer treatment for river blindness. This campaign demonstrated that companies could successfully collaborate with government and non-profit partners, providing critical expertise in the areas of R&D, manufacturing, and distribution. In another example, pharmaceutical giant GlaxoSmithKline (GSK) and the PATH Malaria Vaccine Initiative collectively developed malaria candidate vaccine RTS,S (Mosquirix™), with grant monies from the Bill & Melinda Gates Foundation to PATH and support from a network of African research centers that performed the studies. Mosquirix recently received a positive scientific opinion from the European Medicines Agency for the prevention of malaria in young children in sub-Saharan Africa. The WHO has announced that the Mosquirix vaccine will first be rolled out in pilot projects in 3 countries in sub-Saharan Africa. The pilot program will assess whether the vaccine’s protective effects in Phase 3 clinical trials can be replicated in real-life settings. Effective research remains the basis and most vital component of developing promising medicines, and again, it is partnership, rather than the competitive model, which has shown most promise in accelerating solutions. For example, Dr. Babul cites the Pool for Open Innovation Against Neglected Tropical Diseases, administered by the non-governmental organization Bio Ventures for Global Health, which is embracing data sharing by partnering with companies who agree to grant access to their compound “libraries”, and creating a singular, comprehensive collection of molecular entities. The initiative began with GSK's efforts to create a “Patent Pool” for new therapeutics to treat neglected tropical diseases. Pharmaceutical companies, academia and non-governmental organizations are encouraged to donate drug compounds for neglected tropical diseases. GSK has donated over 800 patents and patent applications to the collaboration. The Patent Pool is targeting sixteen diseases that the U.S FDA has identified in its neglected tropical diseases initiative. To date, approximately 150,000 compounds have been screened for efficacy against diseases including African sleeping sickness, visceral leishmaniasis and Chagas disease, potentially allowing for results to be achieved efficiently and with greater accuracy. A graduate of the University of British Columbia, the State University of New York in Buffalo and the California Institute of Advanced Management, Dr. Najib Babul is presently a drug development consultant to pharmaceutical companies and investment banks with over two decades of experience in bringing new drugs to market. Dr. Babul is the author of over 170 abstracts and manuscripts published by leading medical journals and scientific proceedings, including the Lancet, the Journal of American Medical Association (JAMA), the Journal of Clinical Pharmacology, the Journal of Clinical Oncology, Cancer, Anesthesiology, Clinical Pharmacology & Therapeutics, and Anesthesia & Analgesia. Najib Babul - Discusses the Benefits and Limitations of Opioids for Neuropathic Pain: https://www.yahoo.com/news/najib-babul-discusses-benefits-limitations-233500333.html Najib Babul - Explains Why Treatment Advances in Fibromyalgia Have Been Slow: http://sports.yahoo.com/news/najib-babul-explains-why-treatment-130500043.html For more information, please visit http://www.NajibBabulNews.com

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