- Inventor Of Banned Drug Taken By Sharapova Insists It Protects Heart But Doesn’t Boost Performance (forbes.com)
Maria Sharapova has never met Ivars Kalvins, and it’s likely that she’s never even heard of the Latvian scientist, but the he has an offer for her…As pretty much the whole world knows by now, Sharapova announced last month that she had failed a drug test because she was found to have taken meldonium, which WADA, the World Anti-Doping Agency, banned...What isn’t as well known is that Kalvins invented meldonium, a heart drug…This is like insurance...explaining that the drug ensures that the heart gets enough oxygen, even when pushed to the limits of its capacity, as in elite-level sports...Athletes have to work very, very close to this border of the physical capacity of the human body...If they cross this border, there is no way back. Their hearts are damaged, their muscles are damaged, etc...He predicted that the WADA ban could lead to sudden deaths of athletes whose hearts aren’t able to get enough oxygen, resulting in permanent tissue damage...some scientists say that meldonium increases athletes’ endurance besides improving their recovery after exercise and protecting their hearts from stress…His (Kalvins) and WADA’s conflict over whether meldonium boosts athletic performance seems to rest on their different interpretations of "improves physical capacity." Kalvins says the drug doesn’t enable athletes to push themselves further, but it helps their hearts recover when they do so. WADA, on the other hand...determined that meldonium was being used by athletes with the intent of enhancing performance...
- In Rare Turn, Competing Health Groups Agree on Drugs, Risk (morningconsult.com)
The strange dance between the pharmaceutical industry, insurers and the Obama administration has taken a new turn. When it comes to one of the wonkiest healthcare policies out there, all three seem close to agreement. They want prescription drugs to be included in determinations about whether a certain pools of patients are riskier than others...The determinations are important because insurers who take on riskier sets of patients are eligible to receive compensation under Obamacare. Right now, those determinations are made using just medical claims. Drug companies and insurers generally agree that prescription drugs should be included in the risk adjustment models. They currently are not... Improving risk adjustment by including data on whether beneficiaries are using certain classes of medicines could better compensate plans for taking on higher risk patients and so allow these plans to focus on helping patients manage their chronic conditions in a way that avoids costly complications...The goal is to create stability on exchanges regardless of the distribution of sick people. If it works, insurers, in theory, would be more willing to participate in the market and increase competition, which in turn could incentivize them to offer benefits that help less healthy people.
- Public Safety Alert from Drug Enforcement Administration Counterfeit Hydrocodone Tablets Containing Fentanyl (dea.gov)
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.
- FTC Sues Endo, Alleges Company Paid Off Generic Drugmakers (wsj.com)
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...
- Samsung brings in the lawyers for biosimilars push (reuters.com)Samsung Bioepis files lawsuit against AbbVie on Humira patents (koreaherald.com)
Samsung Bioepis Co Ltd, which aims to become a force in the fledgling biosimilar drugs industry, has filed a lawsuit against the originator of the world's best-selling drug, to stop it blocking the launch of its own version...Samsung Group...along with...Biogen, filed suit...against AbbVie Inc, maker of rheumatoid arthritis drug Humira (adalimumab), which generated sales of $14 billion last year...patent for Humira loses its exclusivity in the United States in December 2016...AbbVie...has been filing new patents in a bid to push back sales of biosimilars...more than a dozen firms have challenged AbbVie’s strategy through patent authorities or the courts...We believe that AbbVie has been attempting to obstruct market entry of competing products by applying for a large number of overlapping patents around Humira, which could affect patient access to affordable medication...
- Drug Maker Reconsidering $20 Million North Carolina Factory (nytimes.com)
North Carolina's governor met...with gay-rights advocates bearing a letter signed by more than 100 corporate executives urging him to repeal the nation's first state law limiting the bathroom options for transgender people...Some companies are already reconsidering doing business in the country's ninth-largest state...Braeburn Pharmaceuticals said it is "reevaluating our options based on the recent, unjust legislation" whether to build a $20 million manufacturing and research facility in Durham County. The 50 new jobs paying an average of nearly $76,000 a year were announced two weeks ago....A silent majority of North Carolina businesses may well approve of North Carolina's new law...A company "is not going to say so publicly, since that could lead to angry demonstrators picketing or surrounding its headquarters or places of business...Corporations opposing the law may be expressing core corporate values, but they also need to be perceived favorably by customers, especially affluent gay ones, and to motivate highly educated, high-value employees who value diversity...
- Second case of Zika virus reported in Clark County (reviewjournal.com)Nevada gets its first case of Zika virus (reviewjournal.com)
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...
- Death with Dignity doctors thwart drugmaker’s price hike with new medication (seattletimes.com)
After a Canadian drugmaker doubled the price for the most commonly prescribed aid-in-dying drug, Washington Death-with-Dignity advocates created a cheaper new medication to help terminally ill patients who choose to end their lives under the law...They’ve come up with a new mix of medications that induces death for about $500...to ensure that cost doesn’t prevent terminally ill patients from making the choice they want under the state’s right-to-die law...The issue arose...when Valeant Pharmaceuticals...doubled the cost (secobarbital), from $1,500 to more than $3,000 — and up to $5,000...doctors in the state decided to seek an alternative to the high-priced drug...They turned to a compounding pharmacist...The result was a less-expensive mix of three medications: phenobarbital, chloral hydrate and morphine sulfate, all in powdered form to be mixed with water, alcohol, applesauce or juice...
- US, Canada issue joint ransomware alert, discourage paying cyber attackers (healthcareitnews.com)
Warning comes on the heels of recent ransomware onslaughts on hospitals, businesses and private entities...United States Department of Homeland Security and the Canadian Cyber Incident Response Center issued a joint cyber alert...in response to the recent surge in ransomware attacks...The alert offered a breakdown and description of the ransomware variants for which healthcare and other organizations should be on the lookout...both government agencies strongly recommended that organizations and individuals not pay the ransoms demanded by cyber attackers...Paying the ransom doesn't guarantee the encrypted files will be released; it only guarantees the malicious actors receive the victim’s money and in some cases, their banking information...In addition, decrypting files doesn't mean the malware infection itself has been removed...Private security experts have predicted these types of cyber attacks will intensify in the near future, as hackers increase in experience and due to the outdated security measures in place at many organizations...
- Pharmacy Times Week in Review: April 1, 2016 (pharmacytimes.com)
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.







