Author: Peter

Pay-Per-Click advertising sites, primarily search engines, are largely unaware of the new regulations governing 503B Outsourcing Facilities. Pay-per-click advertising has been one of the main ways non-compliant compounding pharmacies have been able to sell their products and services to hospitals, physicians and patients. Outsourcing Facilities of America is working to educate PPC advertising companies on the regulatory requirements… create new policies and procedures to stop non-compliant compounding pharmacies from selling their products in violation of these regulations.

Hedge-fund manager Kyle Bass may have hit some recent speed bumps in his quest to challenge pharma patents through a U.S. Patent and Trademark Office review system. But he's not giving up… not to be deterred, refiled the two Ampyra challenges…with more documentation, and he filed two new challenges against the drug's other IP shields, too… Bass has been using the inter partes review system to wage war on patents from companies such as Celgene, Shire, Biogen and Acorda that he thinks aren't up to snuff,...Bass and his partners want "to line their own pockets at the expense of public pharmaceutical companies and their shareholders,"…

Citing the success of product launches, the ratings firm Moody's has raised the outlook for the pharmaceutical sector from "neutral" to "positive."...Projected annual EBIDTA for the global biopharma industry is 4% to 5% over the next 12 to 18 months…One of the industry's biggest areas of growth is oncology, driven largely by the emergence of immuno-oncologic drugs, such as Bristol-Myers Squibb's Opdivo and Merck's Keytruda.

Dispensing medical marijuana may soon become an issue for specialty pharmacy…first medical marijuana capsules were made available online to patients in Europe…marks the first in a long list of goals set by the company (MMJ PhytoTech Limited) and sets the tone for how the cannabidiol market is anticipated to play out.

According to the Congressional Budget Office, Inter Partes Review exemptions currently being sought by the pharmaceutical industry could cost Medicare $1.3 billion over the next decade… IPR system is used as an alternative way for generic companies to challenge patents, as opposed to using the federal court system. IPR challenges are generally decided within 15 to 18 months… IPR is a quicker process…On one side in this fight are major industry trade groups… On the other side: IPR advocates, including the health insurance industry…

Six Southern Nevada physicians have been honored by a nonprofit organization committed to improving access and delivery of medical care in the region. This year's Inspired Excellence in Health Care awards from Las Vegas HEALS (Health Education Advocacy Leadership of Southern Nevada) go to…

1. Joseph Adashek - Desert Perinatal Associates, Summerlin, Southern Hills and Valley hospitals, Angel Flight
2. Rutu Ezhuthachan – United Healthcare, Southern Nevada Immunization and Health Coalition, Immunize Nevada
3. Mitchell Forman - founding dean Touro Univerity (University) College of Osteopathic Medicine
4. Oscar Goodman Jr. - Comprehensive Cancer Centers of Nevada, Roseman University of Health Sciences
5. David Steinberg - Steinberg Diagnostic Medical Imaging, American College of Nuclear Medicine
6. Dylan Wint - Cleveland Clinic Lou Ruvo Center for Brain Health

At the beginning of the year, there was a great deal of anticipation about when the first biosimilar would be approved in the U.S…And then it happened…On March 6, the FDA has approved Novartis/Sandoz's Zarxio (filgrastim-sndz), a biosimilar of Amgen's Neupogen…And as of Thursday, September 3, Zarxio officially hit the U.S. market at a 15% discount to Neupogen… to gain clarification around several key issues concerning biosimilars, we spoke with Dr. Bert Liang, Chair of the Biosimilars Council…

1. Last month, you responded to the decision from the Federal Circuit Court of Appeals that recognized the ‘patent dance’ as optional by applauding the decision. Can you explain your reaction?
2. When would it be beneficial for a biosimilar company to provide a complete copy of its biosimilar application to the reference manufacturer upon filing?
3. You have indicated that the proposed biosimilar naming convention put forth by the FDA in which originator products and biosimilars share the same core name and have different suffixes. Please tell us why you disagree with that.
4. What type of approach to naming would work in your opinion?
5. How do you see the public hearing hosted by the FDA playing out? Who are your allies in this issue?
6. Can the U.S. look to Europe as a model for the evolving role of biosimilars?

It's no secret that pharma salespeople are barred at the doors of many doctors' offices. Those doors have been closing one by one for several years…barriers are rising at a bad time for drugmakers intent on launching new products to make up for patent-cliff losses. Just as doors are closing, there's been a renaissance in drug approvals, with the FDA blessing record numbers of meds in the past few years…pharma marketers have adopted workarounds--such as digital detailing--face-to-face meetings are still the cornerstone of new drug launches.

UNLV (University of Nevada Las Vegas) and the Cleveland Clinic Lou Ruvo Center for Brain Health have been awarded an $11.1 million federal grant to advance the understanding of Alzheimer's and Parkinson's diseases…is aimed at increasing knowledge of dementia-related and age-associated degenerative disorders…will create a Center of Biomedical Research Excellence,..part of a program that promotes the study of medicine, molecular biology and public health.

• Amendment of Nevada Administrative Code 453.510 - Schedule 1 - The proposed amendment to NAC 453.510 will add newly identified synthetic drugs to the list of controlled substances listed on Schedule 1, and provides for other matters properly related thereto.
• A REGULATION relating to pharmacy; revising provisions governing the licensure of a third-party logistics provider; and providing other matters properly relating thereto.
• A REGULATION relating to the practice of pharmacy; requiring certain entities collecting controlled substances to provide certain notification and a copy of a certain federally required form to the State Board of Pharmacy; clarifying standards for the disposal of controlled substances; and providing other matters properly relating thereto.
• A REGULATION relating to pharmacy; requiring, under certain circumstances, an outsourcing facility to obtain a license from the State Board of Pharmacy as a manufacturer; and providing other matters properly relating thereto.