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..Department of Health and Human Services is making it easier for patients with shoulder injury related to vaccine administration to be compensated for their pain….In order to capture the broader array of potential injuries,… the Secretary (Sylvia Mathews Burwell) proposes to add SIRVA for all tetanus toxoid-containing vaccines that are administered intramuscularly through percutaneous injection into the upper arm.. more individuals receiving immunizations may be contributing to…rise in patient claims. SIRVA is the first condition compensated by the government that relates to vaccine technique instead of the substance within the vaccine…

..Indian TB drugmaker has been hit with a WHO (World health Organization) Notice of Concern but an independent audit carried out by its customer Svizera Europe disputes the GMP (Good Manufacturing Practices) violations raised…The facility is run by Svizera Labs Private Limited…and manufactures a number of anti-tuberculosis drugs… firm failed to provide adequate controls to stop the contamination of products,..observing uneven floor, crumbling walls, and black mould inside a drain which also held stagnant water… Quality manager at…Svizera Europe is disputing the WHO’s findings.

Biologic therapy targets genetic defects found in various cancers… FDA granted Orphan Drug Designation to MTG-201 (MTG Biotherapeutics Inc.) for the treatment malignant mesothelioma…drug targets the Dickkopf-3 genetic defect found in various cancers…There is a…need for new treatment options for…mesothelioma…one of the most aggressive and poorly treated cancers. MTG-201 represents a…novel approach to treating this cancer by selectively inducing apoptosis and inducing an immunologic response against the cancer..

• 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.

Food and Drug Administration is working to develop regulatory systems for diagnostics using next generation sequencing technologies…will cover "analytic performance evaluation standards" and "challenges in clinical validation of NGS tests."...We aim to ensure that these tests provide accurate, reproducible, and meaningful results relevant to a person's medical condition while continuing to foster innovation so that people who have access to the best available results generated by the most cutting-edge medical technologies."

..when it comes to HIPAA compliance…the day of reckoning is coming for more covered entities..and now for business associates…OCR (Office for Civil Rights) is inching closer to conducting more HIPAA audits..including audits of business associates…next round of HIPAA audits brewing, and covered entities started receiving questionnaires…seeking...to identify business associates…The relentless move of health data to the cloud, and the exponential growth of an ecosystem of business associates providing a vast array of services to covered entities mean that the potential exposure of protected health information to breaches.. is enormous.

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…

UK cancer care is in the spotlight again following publication of two reports this week highlighting underfunded and overstretched diagnostic services, leaving patients waiting longer for their diagnosis and thus delaying treatment…It recently emerged that the ’62-day wait’ target…has been breached for six consecutive quarters, indicating that services are buckling under growing pressure… the reports… conclude that insufficient funding, workforces shortages and a lack of imaging equipment, with much of that in use out of date, is weighing heavily on diagnostic services throughout the country.

The price of…health plans sold through Maryland’s insurance exchange will jump, on average, by about one quarter next year, fueling questions about whether coverage under the Affordable Care Act will remain affordable in the state…26 percent average increase in monthly premiums are for CareFirst plans, which cover three-fourths of the state residents who have bought insurance under the federal health-care law. The price jump,…is among rate changes that the state’s insurance regulators have approved for plans sold to individual families and small businesses.

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,"…