Category: Recruitment News

Hormonal Contraceptives Linked to an Increased Risk of Rare Brain Cancer

Clinical News, OMG, Recruitment News, Social Awareness

Long-term use of contraceptive pills may double the risk of developing brain cancer, according to a new study.

Scientists say that taking hormonal contraception, particularly progesterone-only methods, for five years more than doubles the chance of developing glioma, a rare type of brain cancer which affects roughly five in 100,000 people.

Researchers used health data from Denmark to compare 317 women diagnosed with glioma and 2,126 who were free of the disease. The scientists evaluated females, aged 15 to 49 years old. According to the Danish study, women who had used an oral contraceptive or hormone-releasing intra-uterine device were 50 percent more likely to develop brain cancer than those who had not.

The difference in risk almost doubled for women who had used contraceptives for five years or more compared with women from the general population with no history of brain tumor, with a 90 percent increase. When taken for five years or more, progestin-only contraceptives increased the risk almost threefold, with a 2.4 times higher risk than the control group. In terms of type of brain cancer, the risk was greatest for glioblastoma multiforme, the most aggressive type of primary brain cancer.

 

Lead researcher, Dr. David Gaist from Odense University Hospital and University of Southern Denmark noted that it is important to keep the increase in risk in context. Only five out of 100,000 Danish women between the ages of 15 and 49 develop glioma each year, and this number includes women who take contraceptives.

The progesterone hormone is known to increase proliferation of high-grade glioma cells called astrocytomas in the laboratory. Additionally, it is thought to raise levels of growth factors, natural substances that stimulate cell growth. However, the scientists said that it was impossible to come to a conclusion regarding how progesterone-containing contraceptives may influence brain cancer development.

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Raptor Acquires Cystic Fibrosis Drug in $418 Million Deal

Clinical News, Recruitment News, Research

Quinsair received marketing authorization by the European Commission and Health Canada in March 2015 and June 2015, respectively. Quinsair, a twice-a-day treatment, contains levofloxacin, a proven antimicrobial active against a wide range of gram negative and gram positive bacteria. Raptor plans to launch Quinsair in Europe and Canada in the first half of 2016, and to discuss the path to potential approval in the same indication in the U.S with the FDA in 2016.

In addition to cystic fibrosis, Quinsair has development potential in two additional orphan diseases with significant unmet need, bronchiectasis (BE) and nontuberculous mycobacteria (NTM) lung infections, for which there are currently few therapeutic options. BE is characterized by abnormal dilatation and destruction of lung bronchi and bronchioles due to chronic recurring infection and long-term inflammation which leads to frequent hospitalizations. NTM are a group of microbes that cause severe and recurrent lung infections, often in individuals who are immune-compromised or who have structural lung disease, such as bronchiectasis. Raptor is evaluating Quinsair’s potential in these therapeutic indications and intends to initiate clinical programs in 2016 in at least one of the indications.

“The Quinsair acquisition is transformational for Raptor and delivers on our strategic focus to develop and commercialize therapies that bring significant relief to patients and families living with life-threatening diseases,” stated Julie Anne Smith, President and CEO of Raptor. “This acquisition expands our portfolio and leverages both our commercial and development expertise in rare diseases. By acquiring Quinsair prior to its launch, we will be able to exclusively shape its commercial strategy and potential in cystic fibrosis and other rare diseases.”

“Quinsair is an important new addition to the options that we can offer adult European and Canadian CF patients today,” stated Patrick Flume, M.D., Professor of Medicine and Pediatrics at the Medical University of South Carolina. “Since it is a new class of inhaled antibiotics, Quinsair’s availability is an important step in addressing an unmet need for the CF community. I’m especially excited about the possibilities to broaden the availability of a drug like this for patients with non-CF bronchiectasis and pulmonary nontuberculous mycobacterial infections, for whom there are limited treatment options.”

Under the terms of the agreement, Raptor will pay $68.4 million upfront, with up to $34.2 million of the closing consideration payable in Raptor common stock at Raptor’s election plus contingent payments of up to $350 million associated with development, regulatory and commercial milestones, a portion of which is payable in Raptor common stock at Raptor’s election, and a single-digit royalty on future global net sales. In addition, Raptor will have single-digit contingent obligations to two additional parties involved in Quinsair’s development. Raptor is acquiring exclusive global rights and assets to develop, manufacture and commercialize Quinsair. The transaction is expected to close in the third quarter of 2015, subject to customary closing conditions including expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Act.

“We are extremely excited to be entering into this agreement with Raptor. We strongly believe Raptor has the global presence and experience in successfully developing and launching orphan products to help realize Quinsair’s full commercial potential and bring this drug to the patients that need it the most,” stated Daniel Burgess, Chief Executive Officer of Tripex Pharmaceuticals.

With this acquisition, Raptor is reiterating its 2015 revenue guidance of $80 to $90 million and also maintaining its 2015 guidance for non-GAAP operating expenses, which exclude cost of goods and non-cash expenses, such as stock-based compensation and amortization of transaction-related intangible assets, of between $115 to $125 million.

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Ten Breakthrough Drugs will Cost the US Nearly $50 Billion Over Ten Years

Medication, OMG, Recruitment News, Research, Tips

There has been heavy debate over the high cost of prescription drugs, and an analysis by Avalere Health estimates that the federal government will spend nearly $50 billion over the next decade on ten breakthrough drugs.

The US Food and Drug Administration’s (FDA) new Breakthrough Therapy program is designed to expedite drug review periods for drugs that treat serious or life-threatening diseases where no drugs exist or that are considered more effective than treatments currently available. Drugs designated as breakthrough therapies include Gilead Sciences’ hepatitis C drug Sovaldi and Bristol-Myers Squibb’s lung and skin cancer drug Opdivo, drugs with high price tags.

The report was commissioned by America’s Health Insurance Plans (AHIP) and offers a first look at estimated state and federal spending on breakthrough drugs for certain cancers and chronic conditions. According to AHIP, these ten drugs represent a small subset of the more than 5,400 drugs in the pipeline.

The high price tags for these breakthrough drugs lead to significant increases in health care spending. Last year, spending on prescription drugs increased by 13 percent from 2013, the largest percentage in over a decade. In 2014, prescription drug spend reached a record-breaking $374 billion. Nearly half of this spending increase was a result of breakthrough therapies and specialty drugs.

Among these ten breakthrough drugs over the next decade, Medicare would absorb the largest expense at $31.3 billion. This will be followed by Medicaid with an estimated spending of $15.8 billion and another $2.1 billion in spending resulting from subsidies provided through Exchange plans under the Affordable Care Act (ACA). The report notes that total US spending may exceed these numbers when accounting for spending by other government agencies, such as Veterans Affairs and Defense, costs to private sector payers, patient out-of-pocket costs, and the significant spending increases associated with off-label use.

These new, innovative drugs offer significant promise for patients with serious health conditions, however the price that comes with these drugs often make treating large patient populations unsustainable.

Often times, breakthrough therapies have a period of market exclusivity, which can last for several years. Because of the lack of competition, drugmakers may significantly markup the price of the drug, making it unaffordable for patients and private payers.

 

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Remove Artificial Trans-Fat from Processed Foods

Clinical News, Industry News, Recruitment News, Social Awareness

Based on a thorough review of the scientific evidence, the U.S. Food and Drug Administration today finalized its determination that partially hydrogenated oils (PHOs), the primary dietary source of artificial trans fat in processed foods, are not “generally recognized as safe” or GRAS for use in human food. Food manufacturers will have three years to remove PHOs from products.

“The FDA’s action on this major source of artificial trans fat demonstrates the agency’s commitment to the heart health of all Americans,” said FDA’s Acting Commissioner Stephen Ostroff, M.D. “This action is expected to reduce coronary heart disease and prevent thousands of fatal heart attacks every year.”

This determination will significantly reduce the use of PHOs, the major source of artificial trans fats, in the food supply. In 2013, the FDA made a tentative determination that PHOs could no longer be considered GRAS and is finalizing that determination after considering public comments.

Since 2006, manufacturers have been required to include trans fat content information on the Nutrition Facts label of foods. Between 2003 and 2012, the FDA estimates that consumer trans fat consumption decreased about 78 percent and that the labeling rule and industry reformulation of foods were key factors in informing healthier consumer choices and reducing trans fat in foods. While transfat intake has significantly decreased, the current intake remains a public health concern. The Institute of Medicine recommends that consumption of trans fat be as low as possible while consuming a nutritionally-adequate diet.

“Studies show that diet and nutrition play a key role in preventing chronic health problems, such as cardiovascular disease and today’s action goes hand in hand with other FDA initiatives to improve the health of Americans, including updating the nutrition facts label,” said Susan Mayne, Ph.D., director of the FDA’s Center for Food Safety and Applied Nutrition. “This determination is based on extensive research into the effects of PHOs, as well as input from all stakeholders received during the public comment period.”

The FDA has set a compliance period of three years. This will allow companies to either reformulate products without PHOs and/or petition the FDA to permit specific uses of PHOs. Following the compliance period, no PHOs can be added to human food unless they are otherwise approved by the FDA.

The FDA encourages consumers seeking to reduce trans fat intake to check a food’s ingredient list for partially hydrogenated oils to determine whether or not a product contains PHOs. Currently, foods are allowed to be labeled as having “0” grams trans fat if they contain less than 0.5 grams of trans fat per serving, including PHOs, the primary dietary source of artificial trans fat in processed foods.

Many companies have already been working to remove PHOs from processed foods and the FDA anticipates that many may eliminate them ahead of the three-year compliance date.

 

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Fecal incontinence device for women

Medication, Recruitment News, Research, Social Awareness

Fecal incontinence is the inability to control bowel movements and is a common problem, especially among older adults. The most common cause of FI is damage to the muscles around the anus (anal sphincters). Vaginal childbirth can damage the anal sphincters or their nerves, which is why FI impacts women about twice as often as men.

“Current treatment options for fecal incontinence include drugs, dietary changes, exercise, and surgery,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health. “The Eclipse System provides an additional treatment option for women who suffer from this condition.”

The Eclipse System is intended to treat FI in women 18 to 75 years old who have had four or more FI episodes in a two-week period. The device includes an inflatable balloon, which is placed in the vagina. Upon inflation, the balloon exerts pressure through the vaginal wall onto the rectal area, thereby reducing the number of FI episodes. The device is initially fitted and inflated by a clinician (with the use of a pump) and after proper fitting, the patient can inflate and deflate the device at home as needed. The device should be removed periodically for cleaning.

The FDA reviewed data for the Eclipse System through the de novo classification process, a regulatory pathway for some low-to-moderate risk medical devices that are not substantially equivalent to a legally marketed device.

The FDA granted the de novo request based on non-clinical testing as well as a clinical trial of 61 women with FI treated with the device. The trial showed that after one month almost 80 percent of women in the study experienced a 50 percent decrease in the number of FI episodes while using the device, as compared to baseline.

Adverse events associated with the device included pelvic cramping and discomfort; pelvic pain; vaginal abrasion, redness, or discharge; and urinary incontinence. All device-related adverse events were mild or moderate, and none required any significant intervention (i.e., no surgeries were needed).

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New grants to boost the development of products for patients with rare diseases

Industry News, Recruitment News, Research, Social Awareness

The U.S. Food and Drug Administration today announced it has awarded 18 new research grants totaling more than $19 million to boost the development of products for patients with rare diseases, which affect the lives of nearly 30 million Americans. These new grants were awarded to principal investigators in ten states, with research spanning clinical sites domestically and internationally.

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Tips for Medical Job Search

Recruitment News, Tips

In terms of the medical job search, the employment picture for healthcare professionals presents the classic “good news/bad news” scenario. The good news? Healthcare is one of the hottest industries in the United States. The U.S. Bureau of Labor Statistics forecasts faster-than-average job growth through 2020 in disciplines ranging from physician and surgeon to medical assistants, to physical therapists and many more. The biggest gainer? Home health aides – projected to rise an amazing 70 percent as the Baby Boom generation continues into its senior years.

The bad news? The best jobs are not going to just fall into your lap. While demand is high, so is the competition as students, career-changers and others become attracted to healthcare positions. As in any employment field, you’re going to be selling yourself in a buyer’s market.

So can you navigate the choppy waters of a job search with your sanity intact? It’s not always going to be a breeze, but you can create a work-life balance that helps you stay motivated and inspired while you build your career.

Here’s what you can do…

  • Volunteer. Talk about a win-win: volunteering benefits your community and your outlook. In fact, a study of older Americans released by the Corporation for National and Community Service tied volunteering to enhanced longevity, higher functional ability and lower rates of depression. You’ll boost your confidence and self-esteem by helping others – and if you can tie your volunteerism into your healthcare specialty, you stand to make some meaningful contacts in the community as well.
  • Shadow. Job shadowing – a staple for high school students seeking career information – can help you as an adult jobseeker, too. If you are a student or recent graduate, you may inquire at local healthcare organizations about shadowing opportunities. Not only will you get a first-hand look at the work environment, you will meet others in your field who may help you network yourself.
  • Build your network. A job hunt is not the time to act shy. Tell everyone you know about your plans, goals and efforts. The “six degrees of separation” theory is a valid one. Your golf buddy may not be in the healthcare field, but his sister may be. Your chiropractor may know an associate who is opening a new practice and is hiring. That friend-of-a-friend on Facebook may be a medical transcriptionist who works for a team of physicians.
  • Go the “informational interview” route. Not every interview need be that make-or-break meeting tied to employment. The informational interview removes a lot of the stress and still gets you in front of key decision makers. The interest you show, and the questions you ask, will mark you as a thoughtful and committed individual – someone the company may well consider for future job opportunities.
  • Get a coach. If you have some disposable income, you may find a career coach to be a sound investment. A coach specializing in the medical job search fields can help you pinpoint the job best for you, fine-tune your networking skills, craft a winning resume, prepare for an interview, and more. Prepare for success Your medical job search may take days, weeks, even months — that’s just the nature of the job market. But you have chosen a thriving industry to enter. With the right blend of determination and inspiration, you will find your path.
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Patient Access Network Foundation : New Online Portal

Industry News, Recruitment News, Social Awareness
PAN_foundation_logo

The Patient Access Network Foundation is known for their prolific work in facilitating access to medical treatments for patients with chronic or life-threatening illness. In a survey of people enrolled for assistance with Patient Access Network, most said that PAN assistance helped them in several ways : » Read more

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