Author: Peter

Fentanyl...has been linked to multiple overdoses and deaths throughout the Sacramento region since last week.  The overdoses are occurring at an alarming rate and are the basis for this public safety alert.  Fentanyl is an odorless substance considered to be 25 to 50 times more potent than heroin and 50 to 100 times more potent than morphine...according to the Sacramento County Department of Health and Human Services there have been 36 opioid-related overdoses and nine deaths that have been reported...Public Health and Law Enforcement officials believe that the pills containing Fentanyl were likely sold on the street under the guise of being legitimate hydrocodone.  Additionally, the pills are marked to mimic the authentic hydrocodone product. However, the Sacramento County Department of Health and Human Services reports that test results show that some of the tested pills did not contain hydrocodone, but rather fentanyl.

The Federal Trade Commission said...it sued drugmaker Endo International PLC, alleging the company violated federal antitrust laws by paying hundreds of millions of dollars to delay generic competition against two of its biggest drugs...The suit...is the latest by the FTC to target alleged "pay-for-delay" agreements. In these deals, generic-drug companies typically agree to drop patent challenges against brand-name drugs and to refrain from launching cheaper knockoffs before a certain date in exchange for payments from the manufacturer of the brand-name drugs...The FTC contends such agreements cost consumers and taxpayers $3.5 billion annually by keeping drug prices higher than they would be otherwise...Suits like the one filed against Endo are relatively rare...These are very resource-intensive cases, and we don’t have the resources to bring that many cases," Markus Meier, FTC acting director for the bureau of competition...

Michael Cawley, BS, PharmD, RRT, CPFT, FCCM, professor of clinical pharmacy at the University of the Sciences, discusses how new technology is changing the inhaler manufacturing industry.

Valeant Pharmaceuticals International Inc's directors and key officers have received a cease-trade order by the securities regulator in the Canadian province of Quebec, on the company's request, Valeant said...In a separate statement, the Autorité Des Marches Financiers said the order against trading shares takes effect Thursday and is in place for 15 days...The delay in Valeant filing its annual report poses a risk of debt default, Valeant said March 15, generating new scrutiny of the much-criticized company. Defaulting on debt could prompt lenders to demand faster repayment and place restrictions on Valeant's ability to borrow...The cease-trade order technically applies only to Quebec, but the practical effect of such orders in Canada, which does not have a national securities regulator, is to stop trading across the country...Valeant is not under active investigation by AMF, but has been under "verification"...

Clark County health officials confirmed the second case of Zika virus disease statewide and in Southern Nevada on Monday, less than a week after the first case was reported...A woman who recently visited Brazil contracted the disease and became sick March 18, Southern Nevada Health District medical epidemiologist Tony Fredrick said...We do expect that we will report more positive cases in the future. However, it is important for the public to continue to understand that to date these cases have all been acquired outside of the United States...The health district has sent 22 total samples for testing, with 10 returned so far. Of those 10, two have been positive...

After a decade in which drug makers regularly paid huge fines for various fraudulent practices, there was a noticeable drop over the past two years, according to a new analysis by Public Citizen...Pharmaceutical companies paid approximately $2.8 billion to settle federal and state civil and criminal charges in 2014 and 2015, compared with $9.9 billion during 2012 and 2013. The most recent payments also amounted to the lowest two-year total since 2004 and 2005...Among the worst offenders in recent years were Johnson & Johnson, Pfizer, Novartis, and GlaxoSmithKline, although the report noted that nearly every large drug maker has paid fines to resolve some kind of infraction over the past two decades...A spokesman for the Pharmaceutical Research and Manufacturers of America...We are disappointed at the report’s misleading conclusions...Among its many methodological flaws, the report aggregates all settlements involving the pharmaceutical industry, with little regard as to whether the companies actually broke the law. Civil settlements rarely resolve the question of guilt. Yet the report glosses over its own finding that 88 percent of the settlements reported were civil, not criminal...

GlaxoSmithKline is to adopt a graduated approach to patenting its medicines, depending on the wealth of different countries, in order to make drugs more affordable in the developing world...Britain's biggest drugmaker said...it would not file patents in low-income states, leaving the way clear for generic companies to make cheap copies of its drugs without fear of being sued...For lower middle-income countries, GSK will seek patents but it aims to strike license deals that allow supplies of generic versions of its medicines for 10 years. These licenses are expected to earn GSK a "small" sales royalty...The company will continue to seek full patent protection in high- and upper middle-income countries, as well as members of the Group of 20 major economies...It is the latest move by the pharmaceuticals industry to address criticism that many new drugs are simply too expensive for....people in Africa, Asia and Latin America...

Mike Glaicar, Business Development: Pharmacy Times...(PTNN) This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

A new app may help streamline medication needs for travelers...International travel is increasingly more common, but many travelers are often ill prepared for dealing with health issues while abroad...French pharmacist...developed a new app to help...travelers with essential medication information...The "Convert Drugs Premium" app allows users to find information in 11 different languages for therapeutically equivalent medications in 220 countries...Convert Drugs Premium promises that health care professionals who use it will "be able to quickly help visitors from other countries find the medications they need, or help advise domestic patients about the products they will and will not be able to find in the country they plan to travel in."

Aveo Pharmaceuticals agreed to pay $4 million to settle charges that it misled investors about efforts to obtain regulatory approval for its flagship drug, a kidney cancer treatment called Tivozanib, the US Securities and Exchange Commission said today...the agency is still pursuing a case against three former executives...The biotech allegedly concealed concerns that the Food and Drug Administration had about the medicine in public statements to investors. In particular...failed to disclose that FDA staff had recommended...that the company should run a second clinical trial to address issues concerning patient death rates that were seen during an earlier clinical trial...A spokesman for Aveo..."we hope to have this matter behind us and to be able to pursue our new strategy without being distracted by these claims" The new strategy...includes running a second Phase III study for the...drug...