Drugmakers Manipulate Orphan Drug Rules To Create Prized Monopolies Print E-mail
Written by Sarah Jane Tribble and Sydney Lupkin | KHN   
Tuesday, 17 January 2017 19:03

khn logo black More than 30 years ago, Congress overwhelmingly passed a landmark health bill aimed at motivating pharmaceutical companies to develop new drugs for people whose rare diseases had been ignored.

By the drugmakers' calculations, the markets for such diseases weren't big enough to bother with.

But lucrative financial incentives created by the Orphan Drug Act signed into law by President Ronald Reagan in 1983 succeeded far beyond anyone's expectations. More than 200 companies have brought almost 450 "orphan drugs" to market since the law took effect.

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Last Updated on Tuesday, 17 January 2017 19:06
'We trained for this,' say doctors who treated shooting victims Print E-mail
Written by FHI's Week in Review   
Monday, 09 January 2017 18:55

George Richards & Susan Miller Degnan reporting for the Miami Herald on 1/6/17:

It was a somber scene at Fort Lauderdale's Broward Health Medical Center following the mass shooting at Fort Lauderdale-Hollywood International Airport on Friday afternoon, as dozens of reporters and camera crews crowded the entryways to the trauma center.

Victims of the shooting were brought to the hospital soon after the attack occurred at the Terminal 2 baggage claim...

Dr. Ralph Guarneri, the trauma surgeon on duty, said five gunshot victims came into the trauma center and two were undergoing surgery. All five, Guarneri said, were in stable condition.

Read more in the current issue of Week in Review>>
For daring to study a discredited therapy, this doctor earned scorn - and a $37 million grant Print E-mail
Written by Karen Weintraub | STAT   
Tuesday, 03 January 2017 20:09

MIAMI BEACH, FL - The new heart patient asked Dr. Gervasio Lamas if he thought chelation therapy was worth a try. "Of course not!" the cardiologist replied emphatically. His Harvard training had taught him that alternative therapies were a waste of time and money, and potentially risky to boot. "I told him it was quackery."

But Lamas went home that night unsure if he had given his patient the best medical advice. He looked up research on chelation therapy, which removes heavy metals from the body, and found very little data either supporting or contradicting the procedure.

Lamas was troubled by the idea that he had offered this man a medical opinion that wasn't supported by science. And he decided to conduct a study himself. He had no idea what he was getting into.

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Last Updated on Tuesday, 03 January 2017 20:13
Sponsor Showcase Print E-mail
Written by Sponsor   
Tuesday, 10 January 2017 00:00
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Last Updated on Tuesday, 10 January 2017 20:19

GlobeNewswire: Florida Feed

GlobeNewswire: Latest search results from Industry: (Health Care) AND Language: (English) AND State/Province: (Florida)
  • IRADIMED CORPORATION Announces 2017 Annual and First Quarter Financial Guidance
    • Announces Preliminary Full Year and Fourth Quarter 2016 Revenue
    • Announces Fourth Quarter 2016 Financial Results Conference Call Date

    WINTER SPRINGS, Fla., Jan. 18, 2017 (GLOBE NEWSWIRE) -- IRADIMED CORPORATION (NASDAQ:IRMD), the only known provider of non-magnetic intravenous (IV) infusion pump systems that are designed to be safe for use during magnetic resonance imaging (MRI) procedures, today announced its financial guidance for the full year and first quarter 2017.

    For the full year 2017, the Company expects to report revenue of $23.9 million to $24.3 million, GAAP diluted earnings per share of $0.07 to $0.08 and non-GAAP diluted earnings per share of $0.14 to $0.18.

    For the first quarter 2017, the Company expects to report revenue of $5.2 million to $5.3 million, GAAP diluted earnings per share of $(0.01) to $(0.02) and non-GAAP diluted earnings per share of $0.00 to $0.01. We expect that approximately $0.3 million of our first quarter 2017 revenue will come from backlog, compared to approximately $3.2 million of our first quarter 2016 revenue that came from backlog.

    The Company also announced that it expects to report revenue of approximately $32.6 million for the full year 2016 and $6.1 million for the fourth quarter 2016. We expect that approximately $12.5 million and $1.3 million of our full year and fourth quarter 2016 revenue, respectively, came from backlog. At December 31, 2016, the Company had approximately $1.4 million of backlog remaining and expects that backlog will approximate this level throughout 2017.

    “In December, we achieved an important milestone in the Company’s plans by making the first shipments of our new MRI compatible patient vital signs monitoring system to key European distributors. Interest in our MRI compatible IV pump system remains strong, although we continue to experience difficulty in converting this interest into confirmed purchase orders. We are currently highly focused on enhancing the abilities of our domestic sales team to handle the longer and more intricate selling process the multi-department/multi-pump sale requires,” said Roger Susi, President and Chief Executive Officer of the Company.

    The Company plans to release its 2016 fourth quarter results before the market opens on February 6, 2017.

    The Company’s non-GAAP earnings per share guidance excludes stock-based compensation expense, net of tax, which the Company expects to be approximately $1.3 million and $0.3 million for the full year and first quarter 2017, respectively.

    Use of non-GAAP Financial Measures

    This release contains financial guidance that excludes stock-based compensation expense, net of tax. Because of varying available valuation methodologies, subjective assumptions and the variety of equity instruments that can impact a company’s non-cash expenses, we believe that providing non-GAAP financial measures that exclude stock-based compensation expense allow for meaningful comparisons between our operating results from period to period. This non-GAAP financial measure is an important tool for financial and operational decision making and for evaluating our operating results.  This non-GAAP financial measure should not be considered in isolation or as a substitute for a measure of the Company’s operating performance or liquidity prepared in accordance with U.S. GAAP and is not indicative of net income or cash provided by operating activities.


    IRADIMED CORPORATION is a leader in the development of MRI compatible medical devices. IRADIMED is the only known provider of non-magnetic intravenous (IV) infusion pump systems that are specifically designed to be safe for use during magnetic resonance imaging (MRI) procedures. We were the first to develop an infusion delivery system that largely eliminates many of the dangers and problems present during MRI procedures. Standard infusion pumps contain magnetic and electronic components which can create radio frequency (RF) interference and are dangerous to operate in the presence of the powerful magnet that drives an MRI system. Our patented MRidium® MRI compatible IV infusion pump system has been designed with a non-magnetic ultrasonic motor, uniquely-designed non-ferrous parts and other special features in order to safely and predictably deliver anesthesia and other IV fluids during various MRI procedures. Our pump solution provides a seamless approach that enables accurate, safe and dependable fluid delivery before, during and after an MRI scan, which is important to critically-ill patients who cannot be removed from their vital medications, and children and infants who must generally be sedated in order to remain immobile during an MRI scan.

    Our 3880 MRI compatible patient vital signs monitoring system has been designed with non-magnetic components and other special features in order to safely and accurately monitor a patient’s vital signs during various MRI procedures. The IRADIMED 3880 system operates dependably in magnetic fields up to 30,000 gauss, which means it can operate virtually anywhere in the MRI scanner room, including in very close proximity to the MRI scanner bore. The IRADIMED 3880 has a compact, lightweight design allowing it to travel with the patient from their critical care unit, to the MRI and back, resulting in increased patient safety through uninterrupted vital signs monitoring and decreasing the amount of time critically ill patients are away from critical care units. The features of the IRADIMED 3880 include: wireless ECG with dynamic gradient filtering; wireless SpO2 using Masimo® algorithms; non-magnetic respiratory CO2; non-invasive blood pressure; patient temperature, and; optional advanced multi-gas anesthetic agent unit featuring continuous Minimum Alveolar Concentration measurements. The IRADIMED 3880 MRI compatible patient vital signs monitoring system has an easy-to-use design and allows for the effective communication of patient vital signs information to clinicians.

    For more information please visit

    CONTACT: Media Contact:
    Chris Scott
    Chief Financial Officer
    (407) 677-8022
  • PetMed Express D/B/A 1-800-PETMEDS to Announce Its Third Quarter Financial Results on January 23, 2017

    DELRAY BEACH, Fla., Jan. 17, 2017 (GLOBE NEWSWIRE) -- PetMed Express, Inc. (NASDAQ:PETS) will announce its financial results for the quarter ended December 31, 2016 on Monday, January 23, 2017 at 8:00 A.M. Eastern Time, then at 8:30 A.M. Eastern Time, Menderes Akdag, the Company’s Chief Executive Officer and President, will host a conference call to review the financial results.

    To access the call, which is open to the public, please dial (888) 455-1758 (toll free) or (203) 827-7025, ten minutes prior to the scheduled start time.  Callers will be required to supply PETMEDS as the passcode, and will be placed on hold with music until the call begins.

    For those unable to participate in the live event, the call will be available for replay from 10:00 A.M. on January 23, 2017 until February 6, 2017 at 11:59 P.M.  To access the replay, call (888) 568-0521 (toll free) or (402) 998-1495, and enter passcode 5500.

    Founded in 1996, PetMed Express is America’s Largest Pet Pharmacy, delivering prescription and non-prescription pet medications and other health products for dogs and cats at competitive prices direct to the consumer through its 1-800-PetMeds toll free number and on the Internet through its website at
    This press release may contain “forward-looking” statements, as defined in the Private Securities Litigation Reform Act of 1995 or by the Securities and Exchange Commission, that involve a number of risks and uncertainties, including the Company’s ability to meet the objectives included in its business plan.  Important factors that could cause results to differ materially from those indicated by such “forward-looking” statements are set forth in Management’s Discussion and Analysis of Financial Condition and Results of Operations in the PetMed Express Annual Report on Form 10-K for the year ended March 31, 2016.  The Company’s future results may also be impacted by other risk factors listed from time to time in its SEC filings, including, but not limited to, the Company's Form 10-Q and its Annual Report on Form 10-K.

    For investment relations contact PetMed Express, Inc., Bruce S. Rosenbloom, CFO, 561-526-4444.

    CONTACT: Contact: Bruce S. Rosenbloom, CFO
    Phone: (561) 526-4444                     
    Fax: (561) 526-4433
  • Summit Chiropractic Offers Chiropractic Treatment for Victims of Car Accidents

    ORLANDO, Fla., Jan. 15, 2017 (GLOBE NEWSWIRE) -- Most auto accident victims are unaware that they need to quickly address their car accident injuries. Chiropractic appointments should be made soon after a car accident as those that experience optimal results and receive useful insurance coverage begin chiropractic rehabilitation within 14 days after a car accident. Victims of car accidents can experience symptoms and soft tissue injuries that are not immediately observable. Dizziness and migraines from whiplash are common symptoms often unaddressed and appear approximately 48 hours after an accident.  Undiagnosed and untreated injuries can lead to long-term discomfort and reduce the ability of car accident victims to perform routine activities.

    Whiplash is one of the many injuries that occur as a result of an auto accident. Whiplash often results from auto collisions which forcefully move the head past its normal range of motion. Misalignment of the spine, as well as soft tissue damage in the neck and shoulders, result. Symptoms include stiffness, neck pain and headaches. Chiropractic care can address injuries from car accidents, realign the spinal column and reduce pressure on damaged areas. Patients report less pain and an improved range of motion in the neck, shoulders, back, and hips with the use of chiropractic treatments and therapeutic massage. An individualized program of treatment at Summit Chiropractic may include myofascial release (MFR) and deep massage therapy integrated with cryotherapy and intersegmental traction.

    “Chiropractic is effective for recovery from soft tissue and spinal injuries following car accidents,” said Dr. Jamee Fike. “As an experienced chiropractor, I have seen the improvement experienced from many car accident victims after using chiropractic techniques and complementary approaches as part of an individualized program to holistically treat their injuries. Many clients appreciate how subtle manipulations help manage and reduce pain and relieve migraines that may be directly related to spinal misalignment, nerve impingement, and inflammation. Many patients want to reduce their reliance on medication and address the injury at its source. Chiropractic treatment uses the body’s innate healing ability to help patients alleviate inflammation and pain and assist in the optimal recovery of range of motion and strength. Patients often find the sessions educational and implement exercises and techniques to be used at home.”

    Dr. Jamee Fike and Dr. Daniel Warner serve residents of Waterford Lakes, Union Park, University Park, UCF, Avalon Park, and Orlando. The team at Summit Chiropractic helps patients reach their optimal health and recover from acute and chronic injuries with services including chiropractic care, massage therapy, spinal correction and rehabilitation services, migraine treatment, corrective exercises, and lifestyle advice. Their holistic approach promotes natural healing without invasive surgery.

    Call (407) 203-6745 to schedule a chiropractic exam after becoming the victim of a car accident, learn about car accident rehabilitation, or visit for details.

    CONTACT: Summit Chiropractic, (407) 203-6745

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