ello, everyone, and how are you this morning? We are doing just fine, thank you, courtesy of a warm and shiny sun enveloping the calm and quiet Pharmalot campus. Our short person has departed for the local schoolhouse and the official mascots are comfortably snoozing in various corners. All of which means we can focus on the matters at hand — foraging for items of interest and quaffing cups of stimulation. No doubt, you may relate to this routine. In any event, here is the latest batch of tidbits to get you going. Have a wonderful day and hope you conquer the world …
The Food and Drug Administration says it is re-examining the safety of a Parkinson’s medicine that was approved despite concerns that not enough was known about its risks, CNN reports. Last week, FDA Commissioner Scott Gottlieb told members of Congress that he would “take another look” at Nuplazid, which is the only drug approved to treat hallucinations and delusions associated with Parkinson’s psychosis. Nuplazid has been cited as a “suspect” medicine in hundreds of deaths voluntarily reported by caregivers, doctors, and other medical professionals since it hit the market. Shares in Acadia Pharmaceuticals (ACAD), which sells the drug, plummeted 23 percent on the news.
A U.S. appeals court affirmed a ruling that Merck (MRK) dishonestly obtained patent rights and was not entitled to collect a $200 million infringement verdict it won against Gilead Sciences (GILD), Reuters says. The court upheld a June 2016 ruling that two Merck patents, which cover methods of treating hepatitis C, were unenforceable because of a pattern of misconduct by the company, including lying under oath by an in-house lawyer. A federal court jury in 2016 awarded Merck $200 million after finding two Gilead drugs infringed two of its patents, but a judge threw out the verdict later that year.
Following an internal investigation, the McKesson (MCK) board absolved senior management of any failures to oversee the distribution of opioid painkillers, but the findings were dismissed by the International Brotherhood of Teamsters, which has accused the wholesaler of exacerbating the opioid crisis and late last year pushed the board to conduct the probe, STAT tells us. The Teamsters maintained the investigation was inconsequential because the board failed to identify executives responsible for instances in which the company did not adequately track opioid shipments.
A top Trump administration official pushed back on state efforts to legalize marijuana, calling it a dangerous drug, MedPage Today says. Dr. Elinore McCance-Katz — who oversees the Substance Abuse and Mental Health Services Administration — raised concerns over increased use, particularly among children, teens, and pregnant women. “For too many years, we have simply heard a message from an industry that makes billions of dollars about how safe this drug is,” she said. “I’m here to tell you this is not a safe drug.”
U.S. and European pharmaceutical industry lobbies in Japan expressed deep concerns over a Ministry of Finance proposal to apply stringent cost-effectiveness assessments in pricing and reimbursement decisions, according to Pharma Japan. Meanwhile, Hiroyuki Sakamaki, a professor at Tokyo University of Science, maintained it is “scientifically difficult” to adjust prices for drugs based on their cost effectiveness measured by incremental cost-effectiveness ratio values, because they are derived from a precarious patchwork of random data.
The Koch-backed group Americans for Prosperity is pouring hundreds of thousands of dollars into a renewed push for federal “right to try” legislation that aims to give terminally ill patients a new way to access experimental therapies, STAT reports. The six-figure ad campaign will include both targeted digital ads and a new national television ad that pulls seemingly supportive sound bites from Senate Majority Leader Chuck Schumer (D-N.Y.) as well as longtime proponent Sen. Ron Johnson (R-Wis.) and President Trump. The latter will air on both broadcast and cable channels.
Three directors are stepping down from the Teva Pharmaceutical (TEVA) board and only one new director is being nominated to replace them, Reuters writes. The drug maker is in the midst of an overhaul to deal with the $35 billion of debt it amassed after buying the Actavis generic drug business from Allergan for $40.5 billion in 2016. Analysts and investors have criticized the management and board of directors for overpaying. Teva has since replaced most of its management and announced major job cuts. It has also reduced both the average tenure and age of its directors.
With less than a year to go before the European Medicines Agency must leave its London headquarters because of Brexit, the agency is facing an unexpected rent increase that could cut into its budget for approving new medicines and overseeing clinical trials, Nature explains. The multimillion-dollar rent increase, which is spread over two decades, was revealed in EMA board-meeting minutes that were released this month — along with other problems hampering the agency move to Amsterdam.
The FDA Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 15-5 that a post-marketing cardiovascular outcome trial showed that Celebrex from Pfizer (PFE) had comparable safety to non-steroidal anti-inflammatory drugs, such as naproxen and ibuprofen, BioCentury writes. After Merck withdrew Vioxx, a drug similar to Celebrex, an FDA panel opined that there appeared to be a class effect for cardiovascular risk among this class of drugs, but there was less agreement regarding non-selective NSAIDs.
Novartis (NVS) has launched a new app that enables patients taking part in ophthalmic clinical trials to self-report data, which could potentially speed up the development of new therapies, PharmaTimes informs us. Known as FocalView, the app will be tested in a prospective, non-interventional study to evaluate efficacy and use in assessing visual function. Researchers will look at its ease of use, level of enrollment, and the ability to obtain important documentation for future clinical trial research. The app will also be validated against traditional visual testing within conventional clinical settings.
Sanofi (SNY) has finally launched its Dupixent atopic dermatitis therapy in South Korea, but there are questions about how many people will be able to afford for the medicine, the Korea Biomedical Review suggests. A company official says Sanofi is “actively” submitting papers for reimbursement to lower the cost of the therapy for patients in need. But while noting that Korean data differs from what was submitted in the U.K., “the environment and circumstances are very similar.” Concerns over cost effectiveness have created roadblocks to coverage in the U.K. and the U.S.
A code that was introduced in India more than three years ago to control unethical marketing practices has failed to clear government hurdles, The Times of India informs us. Even the Indian Pharmaceutical Alliance, which represents the top 20 Indian drug makers, has supported the mandatory regulation. But the Uniform Code of Pharmaceutical Marketing Practices draft prepared by the Department of Pharmaceuticals was rejected by the law ministry and no final decision has been made.