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GlaxoSmithKline is conducting an internal investigation into allegations that its subsidiary in Yemen hired government employees to influence purchasing decisions and boost sales of its medicines...more than a half-dozen Glaxo employees allegedly have also held various paid positions...at the government health ministry. The allegations are similar to those made two years ago concerning its operations in Iraq..."GSK has received allegations about staff conduct in Yemen and is investigating them thoroughly,"...The drug maker is currently being investigated by the US Department of Justice and the US Securities and Exchange Commission for potential violations of the Foreign Corrupt Practices Act. The UK’s Serious Fraud Office is also investigating Glaxo for possible criminal violations of the Bribery Act...

A federal appeals court reversed a previous dismissal of a class-action lawsuit against Pfizer, ruling the case was wrongfully dismissed...The verdict, from the 2nd U.S. Circuit Court of Appeals...sends the shareholder lawsuit back to the district court judge who originally heard the case...The lawsuit alleges Pfizer mislead shareholders about the safety of the company's Celebrex and Bextra pain-relieving drugs. A group of Pfizer investors initiated the suit in 2004, claiming the company concealed cardiovascular risks associated with Celebrex and Bextra, two COX-2 inhibitors approved as anti-inflammatories. In the mid-2000's, evidence mounted showing that COX-2 inhibitors significantly increased the risk of certain CVD events...In dismissing the case, the federal appeals court also ruled U.S. District Judge Laura Taylor Swain erred in refusing to allow expert testimony from a former Univeristy of Chicago Law School dean, Daniel Fischel, about potential damages to shareholders.

The Centers for Medicare and Medicaid Services has been letting patients grade their hospital experiences, and those "patient experience scores" may give some insight into a hospital’s health outcomes...Some people have been concerned that patient experience isn’t the most important factor to measure...Medicare has been putting a lot of data out for a long time, but the broad consensus has been it’s very hard for consumers to use this info...CMS responded by giving out star ratings that consumers can understand easily...The five-star rating system is based on patients’ answers to 27 questions about a recent hospital stay...If you use the star rating you’re more likely to end up at a high quality hospital...But I wouldn’t use only the star rating to choose a hospital...

...Office of the Actuary in the Centers for Medicare & Medicaid Services certified that the Diabetes Prevention Program reduces net Medicare spending and improves patient care...the Diabetes Prevention Program...enrolled Medicare beneficiaries at high risk of diabetes. The goal was to decrease the risk of developing serious diabetes-related illnesses...Over a 15-month period, Medicare estimated that participants in the program each saved $2,650...This program has been shown to reduce health care costs and help prevent diabetes, and is one that Medicare, employers and private insurers can use to help 86 million Americans live healthier...We are now working to determine the best strategies for incorporating the Diabetes Prevention Program into Medicare...

A total of 202 people have been detained in connection with a scandal over an illegal black market vaccine ring, the Chinese government said...as it vowed to improve supervision of the market...The case, involving millions of illegal trades of vaccines through a black market drugs ring, has ignited public ire and underscored regulatory weaknesses in the world's second largest pharmaceuticals market...The State Council...said in a report 202 people had now been detained, with 357 health and regulatory officials receiving administrative punishments...The supervision and regulatory system would be tightened, the State Council said, with better record keeping for the production, storing and transport of vaccines and tougher punishments for lawbreakers...The scandal has stirred angry debate, casting a shadow over government ambitions to bolster the domestic drug industry and underlining the challenge it faces to regulate a widespread and fragmented medicine supply chain.

Centers for Medicare and Medicare Services is reportedly proposing to ban Theranos founder Elizabeth Holmes from owning or operating a laboratory for two years, along with revoking the license of Theranos' Newark, CA lab...Theranos had ten calendar days from receiving the notice to explain to CMS why the sanctions should not be imposed on Holmes and the company...The proposed sanctions stem from a number of key deficiencies CMS found in inspections last fall. Theranos had sent in a correction plan for the deficiencies but the regulator found it to be not credible.

Athletes who tested positive for meldonium before March 1 could have bans overturned less than four months before the Rio de Janeiro Olympics after WADA said it was unable to establish how quickly the drug...cleared the human body...The World Anti-Doping Agency's notice to national anti-doping bodies is expected to have a major impact on many of the 172 athletes who have tested positive for the performance-boosting drug since January...They include five-times grand slam tennis champion Maria Sharapova, who was among 40 Russian athletes to test positive for the drug after it was added to WADA's list of banned substances in January...In these circumstances, WADA considers that there may be grounds for no fault or negligence on the part of the athlete...adding that the presence of less than one microgram of meldonium in the samples was acceptable...The fact that WADA felt compelled to issue this unusual statement now is proof of how poorly they handled issues relating to meldonium...The Russian Sports Ministry supports and welcomes the decision made by WADA because it has shown a willingness to understand the situation, rather than stick to the rulebook...WADA has demonstrated impartiality and being objective in the fight against doping...

Co-Host Blair Green Thielemier, PharmD returns to the Pharmacy Podcast with a dynamic interview with Medication Therapy Management Pharmacist Nicole Rosenke about the Pharmapreneur Academy and building an MTM Business. (podcast 31:49 min)

Federal authorities have announced that they are reviewing the possibility of loosening the classification of marijuana, and if this happens, it could have a far-reaching impact on how the substance is used in medical settings...Marijuana is currently classified as a Schedule I drug, meaning it is listed alongside heroin and LSD as among the "most dangerous drugs" and has "no currently accepted medical use and a high potential for abuse."...The Drug Enforcement Administration announced last week that it is reviewing the possibility of reclassifying it as a Schedule II drug, which would put it in the same category as Ritalin, Adderal and oxycodone...There are thousands of people who are using medical marijuana for a whole host of medical conditions...where the efficacy has yet to be thoroughly studied...By changing the classification of the drug...researchers and doctors could find out how effective marijuana is in other conditions...We could move toward a more evidence-based use of medical marijuana... For too long schedule I status for marijuana has been a barrier for necessary research...

Biosimilar development in the U.S. appears to be gathering momentum, following the approval of Celltrion and Pfizer’s Remicade copy by the Food and Drug Administration in early April...The drug, marketed as Inflectra, is only the second biosimilar to clear regulatory review in the U.S., after Sandoz’s Zarxio in March 2015. But there are a number of other biosims entering late-stage development or with applications filed at the FDA... And with several blockbuster biologics nearing patent expiry, competition is likely to increase...Biosimilars promise to increase competition and lower prices across a number of other blockbuster biologics. They also represent new avenues of growth for companies seeking to enter previously protected markets...There is still a long way to go before biosimilars have anywhere near the market impact of generic drugs in the U.S...Biosimilars are still very much in early stages domestically...biosimilars look set to present a number of important opportunities and challenges to the U.S. biopharma landscape...