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South Korean authorities aren’t letting Novartis off the hook easily in an ongoing bribery controversy. After a separate agency fined the drugmaker nearly $50 million over kickback payments in April, antitrust authorities in the country have just issued a new fine and complaint against the Swiss drug giant...South Korea’s Fair Trade Commission fined Novartis 500 million won ($445,000) and filed a new complaint over payments the company offered doctors between March 2011 and August 2016, according to the Korea Times...The developments come shortly after the country’s Ministry of Health & Welfare fined Novartis 55 billion Korean won—approximately $50 million—and suspended reimbursement of Exelon and Zometa for three months, alleging the company’s employees provided approximately $2.3 million in unlawful kickbacks…

...the U.S. Food and Drug Administration requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market. After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks. This is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse...The FDA’s decision is based on a review of all available postmarketing data, which demonstrated a significant shift in the route of abuse of Opana ER from nasal to injection following the product’s reformulation. Injection abuse of reformulated Opana ER has been associated with a serious outbreak of HIV and hepatitis C, as well as cases of a serious blood disorder (thrombotic microangiopathy). This decision follows a March 2017 FDA advisory committee meeting where a group of independent experts voted 18-8 that the benefits of reformulated Opana ER no longer outweigh its risks...

In the works for years, a new medical school is finally going to become a reality at the University of Nevada, Las Vegas…The Nevada Legislature gave final approval Monday night to a bill that includes $25 million in state money to build the UNLV School of Medicine…It's been a priority for Gov. Brian Sandoval, who announced earlier Monday he'd received $25 million in matching funds from an anonymous private donor to launch construction…The deal was contingent on the matching funds. Sandoval believes it's the single largest philanthropic contribution in state history…The Senate passed Senate Bill 553 unanimously. Nine Republicans opposed it in the Assembly, where it passed 33-9…Lawmakers also gave final approval to a capital improvements package that includes $43 million for a new engineering building at the University of Nevada, Reno. Sandoval says he'll sign both bills.

The state of Ohio...sued five major drug manufacturers, accusing them of misrepresenting the risks of prescription opioid painkillers that have fueled a sky-rocketing drug addiction epidemic...The suit, filed by Attorney General Mike DeWine, comes as a growing number of state and local governments are suing drugmakers and distributors, seeking to hold them accountable for a deadly and costly opioid crisis...The five companies Ohio sued were Purdue Pharma LP, Johnson & Johnson's Janssen Pharmaceuticals Inc unit, a unit of Endo International Plc, Teva Pharmaceutical Industries Ltd's Cephalon unit and Allergan Plc...The suit...seeks to halt deceptive practices, a declaration the companies acted illegally and unspecified damages to the state and consumers...

The National Association of Chain Drug Stores this week shared with the House Ways and Means Committee the important role pharmacy plays in the nation’s healthcare system in an effort to encourage passage of legislation giving pharmacists provider status under Medicare Part B...The Pharmacy and Medically Underserved Areas Enhancement Act has been introduced in both the House and Senate, and NACDS’ statement looked to drum up support by outlining the work pharmacists do for patients, particularly in medically underserved areas..."We urge you to increase access to much-needed services for underserved Medicare beneficiaries by supporting H.R. 592/S. 109, the Pharmacy and Medically Underserved Areas Enhancement Act, which will allow Medicare Part B to utilize pharmacists to their full capability by providing those underserved beneficiaries with services, subject to state scope of practice laws, not currently reaching them," NACDS said...

Nicole Crisano, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

Gov. Brian Sandoval...vetoed a bill that would have required drug manufacturers to notify the state in advance of planned price increases for diabetes-related drugs, among other provisions...Sandoval said that while Senate Bill 265 had well-intentioned provisions related to access to affordable health care, the measure also contained potentially detrimental consequences for Nevadans, “not the least of which is the possibility that access to critical care will become more expensive, more restricted, and less equitable.”...“SB 265 fails to account for market dynamics that are inextricably linked to health care delivery and access to prescription drugs,” Sandoval said. “This failure cannot be overlooked, and it could cause more harm than good for Nevada’s families.”...Sandoval also said there was insufficient evidence to support the notion that the measure would lead to lower drug costs…

Christopher Topoleski, Director of Federal Legislative Affairs for ASHP, talks about the ongoing legislative actions aimed at addressing rising medication costs in the drug industry.

Laura Joszt, assistant managing editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network

Kaléo Pharma's price hikes on the lifesaving overdose med Evzio haven’t only angered lawmakers. A leading pharmacy benefit manager, Express Scripts, is going after the tiny drugmaker for unpaid rebates triggered by the exponential price increases...Express Scripts sued...claiming Kaléo owes it $14.5 million in unpaid rebates. The company’s coverage contract with Kaléo includes two types of rebates, a "formulary rebate" designed to secure coverage and a "price protection rebate" to limit exposure to dramatic price hikes….Kaléo faced Congressional heat earlier this year, when more than 30 senators wrote to the drugmaker seeking information about the drastic price hikes. According to the lawsuit, Kaléo took Evzio’s price from $718 per unit in September 2014 to $4,687 by November 2015...The senators wrote that they were "deeply concerned" about the price hikes that came amid an opioid-abuse epidemic...