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Friday, January 11, 2019

Knight in-licenses Puma Bio’s Nerlynx in Canada


Puma Biotechnology grants an exclusive license to Knight Therapeutics to commercialize breast cancer med NERLYNX (neratinib) in Canada.
Knight will be responsible for regulatory filings.
Puma will receive upfront and milestone payments of up to $7.2M, as well as double digit royalties on net sales.

Abbott announces collaboration with Malaria No More


Abbott announced that it is supporting a partnership between the government of the eastern Indian state of Odisha and Malaria No More, providing technology, expertise and funding support to advance efforts to end malaria in the state. The partnership builds on Odisha’s success in significantly driving down malaria cases and deaths in the last year. With a population of nearly 42M people, Odisha accounted for about 40% of India’s malaria burden and one-third of Southeast Asia’s malaria burden in 2016.1 In support of India’s 2015 commitment to be malaria-free by 2030, the government of Odisha has prioritized malaria control and elimination. In collaboration with Malaria No More and the government of Odisha, Abbott is supplying 1M rapid diagnostic tests and technical expertise to strengthen Odisha’s malaria detection and surveillance system. In addition, Abbott is providing $750,000 over three years to Malaria No More to back its work with the Odisha government to define and support a comprehensive state malaria elimination strategy that can be used as a model for other states to follow.
https://thefly.com/landingPageNews.php?id=2847473

NanoVibronix enters collaboration agreement with Fritz Clinic


NanoVibronix announced that it has entered into a collaboration agreement with the Fritz Clinic, which operates 7 locations in North America dedicated to wellness, longevity and preventative medicine, including comprehensive services related to opiate dependency and drug detox. Fritz Clinic intends to offer its patients NanoVibronix’s PainShield as an alternative treatment option for pain, and to aid in decreasing the dependency on opioids for pain relief.
https://thefly.com/landingPageNews.php?id=2847475

Thursday, January 10, 2019

FDA Panel to Tackle Takeda Gout Med’s Cardio Safety


The spotlight is on Takeda’s urate-lowering drug febuxostat (Uloric) and its safety this Friday when a panel of FDA advisors convenes to discuss potential regulatory action regarding cardiovascular risk of this gout medicine. Febuxostat is currently indicated for the chronic management of hyperuricemia in patients with gout.
Panel members will discuss the results from the FDA-required postmarketing safety trial called CARES. Last March, that trial found febuxostat was inexplicably linked to more cardiac deaths than was allopurinol, the mainstay in patients with gout and cardiovascular disease.
Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee panelists will discuss the potential biological mechanisms behind cardiovascular events in febuxostat use and the strength of the safety signal, weighing the benefits and risks of the drug for patients with gout.
Direction will also be given for potential regulatory activities — such as withdrawal of febuxostat from the market or limiting its use to patients who have failed allopurinol therapy.
One specialist (not on the advisory committee) was Daniel Arkfeld, MD, of the University of Southern California Keck School of Medicine in Los Angeles. He told MedPage Todaythat there are few alternatives, especially in renal patients with high creatinine in whom allopurinol is “more dangerous due to hypersensitivity reactions as well.”
A black box warning might be a good option if febuxostat were to stay, Arkfeld suggested.
FDA twice rejected the new drug application for febuxostat (in 2005 and 2006) because of concerns over cardiovascular risk. Approval in 2009 came on the condition that a postmarketing safety study be conducted and that the drug label warn of a higher rate of cardiovascular thromboembolic events with the drug.
safety communication from the agency was released in November 2017 based on a preliminary analysis of CARES. Public Citizen petitioned in June 2018 for the drug to be pulled altogether.

HealthStream (HSTM) Acquires Providigm


HealthStream (NASDAQ: HSTM), a leading provider of workforce and provider solutions for the healthcare industry, today announced that it has acquired Providigm LLC, a Denver-based company focused on quality assurance and performance improvement in healthcare, primarily serving skilled nursing facilities. HealthStream adds to its workforce development solutions with a comprehensive quality management system created by Providigm, known as “abaqis®,” which is the leading SaaS-based quality-improvement program adopted by U.S. skilled nursing facilities.
HealthStream’s commitment to improving the quality of healthcare through the development of the healthcare workforce extends throughout the continuum of care, including the 15,600+ skilled nursing facilities in the U.S. and the 1.66 million employees working in them. New federal requirements by CMS are driving the need for innovative solutions to better manage quality and performance improvement in skilled nursing facilities. HealthStream’s acquisition of Providigm expands its marketplace of powerful solutions for the healthcare workforce in this important segment of the care continuum. With substantial overlap among acute care and skilled nursing facilities’ workforce competency requirements, the acquisition of Providigm and its SaaS-based products provides a particularly relevant and timely extension of HealthStream’s market-leading workforce solutions.
In 2016, the Centers for Medicare & Medicaid Services (CMS) published revised Requirements of Participation (RoP) in Medicare and Medicaid for skilled nursing facilities, which introduced a “competency-based staffing approach.” Requirements for clinical staff assessments, demonstration of competencies, and competency-based education (among other requirements) were spread across three phases set to go into effect in November 2016, November 2017, and November 2019, respectively. The third phase requires all skilled nursing facilities to have programs in place to assess competencies, provide competency-based education, and document their effectiveness. If flagged for substandard compliance, admissions can be frozen and financial penalties levied. To date, over 2,000 skilled nursing facilities are already using Providigm’s abaqis® to achieve better outcomes and compliance with RoP.
Dr. Andrew Kramer, co-founder and chief executive officer of Providigm, has led a transformation in measuring and improving quality of care for frail elders at the bedside. His groundbreaking research at the University of Colorado, followed by Senate and House testimony, led CMS to adopt more reliable and comprehensive approaches to overseeing post-acute and long-term care.
“Helping eldercare providers deliver improved quality of care has been my passion for decades,” said Dr. Andrew Kramer, CEO, Providigm. “The link between delivering quality care and the competency development / training of those eldercare providers is unequivocal. That’s why I believe HealthStream’s acquisition of Providigm is particularly opportune—as they have the resources, knowledge, and technology to advance our solutions to the next level, helping providers achieve the best outcomes.”
Providigm’s operations will continue in its Denver office, along with the continued contributions of their approximately 45 employees. Clients of Providigm will continue to experience continuity of services and the same outstanding customer service they have grown to appreciate over the years from Providigm.
“I would like to extend a warm welcome to Providigm’s clients and employees that will be joining HealthStream,” said Robert A. Frist, Jr., chief executive officer, HealthStream. “We are excited to expand our workforce solutions to further support the continuum of care, particularly among the nation’s skilled nursing facilities. Providigm is a terrific company doing important work that is strongly aligned with our long-standing vision to improve the quality of healthcare by developing the people that deliver care.”
Terms of the Transaction: HealthStream purchased the outstanding equity of Providigm for approximately $18 million in cash, subject to a post-closing working capital adjustment. In addition, up to an additional $500,000 in cash may be paid following the closing based on the performance of Providigm during an 18-month period following closing.

Corbus Pharmaceuticals (CRBP) PT Raised to $38 at Cantor Fitzgerald


Cantor Fitzgerald analyst Elemer Piros raised the price target on Corbus Pharmaceuticals

Hormone replacement therapy tablets linked to higher blood clot risk: study


Certain types of hormone replacement therapy (HRT) could lead to increased risk of venous thromboembolism (VTE), a new study has suggested.
HRT is used to prevent a range of symptoms experienced by many women during the menopause, such as hot flushes and night sweats.
The study, by researchers from the University of Nottingham and published in the BMJ, looked at 80,396 women aged 40-79 with a primary diagnosis of VTE compared with 391,494 controls.
Overall, the increased risk of VTE from taking HRT tablets was equivalent to nine extra cases per 1,000 women per year.
The study found that tablets containing equine oestrogen had a 15% increased risk of VTE compared to oestrogen only estradiol.
Meanwhile, combined conjugated equine oestrogen carried a 17% higher risk than combined estradiol.
Compared with no exposure, conjugated equine oestrogen with medroxyprogesterone acetate had the highest risk, and estradiol with dydrogesterone had the lowest risk.
The study found that no transdermal HRT formulations, such as patches and gels, were associated with increased risk of VTE – and that this was consistent across different regimens – but that these were underused compared to the “overwhelming” preference for oral drugs.
“Our study has shown that, for oral treatments, different tablets are associated with different risks of developing blood clots, depending on the active components,” said Dr Yana Vinogradova, one of the study’s authors.
“It has also confirmed that risks of thrombosis for patients using HRT treatments other than tablets is very low.
“Our findings are particularly important information for women who require HRT treatment and are already at increased risk of developing blood clots.”
Professor Helen Stokes-Lampard, chair of the Royal College of GPs, said that the study was interesting but could not prove that the HRT tablets had caused the blood clots, and added that it was important patients didn’t panic or immediately stop taking HRT.