Author: Peter

European medicines regulators have issued a notice that an ingredient for a generic brain cancer drug made in China does not meet manufacturing standards, after inspectors were refused entry to a factory run by Jiangsu Yew Pharmaceutical Co. Ltd...is the latest example of regulatory problems with bulk pharmaceutical substances manufactured in China...Jiangsu Yew refused to allow a site inspection by Hungarian officials, acting on behalf of Europe’s drug regulatory system. The rebuttal led the EU authorities to determine that its supplies of temozolomide, used to treat brain tumors, did not comply with good manufacturing standards...The company’s export director Henry Yang told Reuters via email that the inspection was refused because Jiangsu Yew only made an intermediate product, rather than an active pharmaceutical ingredient, so an audit was not required.

Virtual trials could address some of the problems that come with developing new drugs, but a host of challenges remain before they can become routine...Last October, AOBiome Therapeutics...announced the results of a 12-week clinical trial of an experimental acne drug. In the randomized double-blind and placebo-controlled trial, a topical spray containing a beneficial bacteria was shown to be safe and effective in reducing the severity and number of acne lesions, the company said...The drug must successfully go through another round of testing–what’s called a Phase III trial–before AOBiome can apply to the Food and Drug Administration for marketing approval...Volunteers for the completed trial were recruited through social media and internet advertisements, and more than 8,000 people were screened online to see if they were eligible. The resulting 372 participants received the drug or a placebo in the mail and used company-issued iPhones to take selfies of their acne, a phone app to send the photos to physician-investigators for evaluation, and video conferencing to communicate with study staff...That’s markedly different from a typical drug trial...AOBiome’s acne drug trial, there were no in-person screening interviews, and no doctor visits. The trial was entirely what people in the trade call “virtual.”...Whether virtual clinical trials are the way forward is a matter of some debate, and industry analysts say a host of challenges remain before virtual trials–which currently represent a tiny fraction of the more than 100,000 registered clinical research studies in the United States–become the norm. These include overcoming a conservative corporate culture, ensuring that the technology is easy for patients to use, managing and analyzing the enormous amount of data that round-the-clock sensors generate, and proving the data’s reliability and validity to regulators...

Agency said the goal is to provide access to genetic testing to drive personalized treatments and enable interventions for the whole country...National Health Service...announced a new national Genomic Medicine Service...The new service...will provide 'equitable access' to genetic and genomic testing, including whole genome sequencing, and drive personalized treatments and interventions for the country’s entire population, building on the 100,000 Genomes Project, delivered to ‘common national standards, specifications and protocols’...The U.S. also has a similar undertaking, the National Institutes of Health’s All of Us program, which aims to enroll 100,000 participants to share their data for research purposes. Both it and the NHS program comes as hospitals and technology vendors are increasingly building next-gen tools for precision medicine and genomics based on machine learning, SMART on FHIR and EHR integration to meet the demand for consumerism in healthcare...

A doctor has been disciplined by Nevada state pharmacy regulators after he was accused of improperly looking up prescription records of the dead gunman in last October's mass shooting in Las Vegas...Attorney E. Brent Bryson said Thursday that Dr. Ivan Goldsmith has to pay $26,000 in fines and attorney fees but keeps his license to prescribe medicines if he completes a year of probation...Goldsmith was accused of improperly looking up gunman Stephen Paddock's patient profile and disclosing to the Las Vegas Review-Journal that Paddock had been prescribed diazepam, an anti-anxiety drug better known as Valium.

The Latest on a court hearings on a pharmaceutical companies lawsuit to stop Nevada from using their drugs for a lethal injection...Nevada's top doctor isn't licensed to practice medicine in the United States...Ihsan Azzam testified in Las Vegas...that he has a master's degree and worked for several years in environmental public health and epidemiology before being named chief state medical officer last May...Azzam says he practiced for several years as an obstetrics and gynecology physician in Africa before moving to the United States in the 1990s...That qualifies Azzam for the job under Nevada state law...Azzam testified that while he has no background in anesthesia or pain management, he says the doses of three drugs proposed for an inmate's lethal injection would be enough to kill a mammoth.

...Novartis AG wants to increase its operating margins by making production and other processes more efficient as it positions for possible further declines in U.S. drug prices...Joerg Reinhardt (chairman) told the newspaper NZZ am Sonntag that his company is taking steps to increase its operating profit margin towards 35 percent in no more than five years, from 32 percent, and is closely watching developments in the U.S...“Many of our 68 plants aren’t being fully utilized. We’re trying to achieve an optimization globally,”...“In other areas too, we need to operate simply and more efficiently, and that includes centralized services as part of our Business Services organization.”...More broadly, “we are preparing for the fact that in the medium term there will be changes in the U.S. pricing system that will affect the entire pharma sector,”...

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

Just two weeks after the Senate confirmed Scott Gottlieb as the next Food and Drug Administration commissioner, he returned to face Congress...The event was slated to be a dry appropriations subcommittee hearing on the FDA budget — but Gottlieb had other things in mind...The former health official in George W. Bush's administration shifted topic to his plans to address abuse of the REMS system, in which pharmas are accused of slow-walking providing samples needed by generic companies to develop cheaper copies. He also previewed a proposal to list off-patent drugs with no generic competition...Now, more than a year into Gottlieb's tenure, the race to keep up with the FDA leader has only quickened...On his well-known Twitter account, he's averaged more than 14 tweets each day in 2018, or roughly 400 per month counting retweets and replies, one Twitter analysis service reported. He set a personal record in July with 554 total tweets...Stakeholders both inside and outside the agency have given Gottlieb credit for both transparency and effort...Among current FDA scientists, a recent survey found Gottlieb a positive force in an administration rated poorly by most federal scientists. His eagerness to publicly stand by his agency's work could be part of explaining the rank-and-file support he's received....

Maryland...charged Insys Therapeutics Inc with deceptively marketing a powerful opioid pain killer so that it was prescribed inappropriately beyond its intended use with cancer patients...Maryland Attorney General Brian Frosh announced that he had filed administrative charges...which he said provided thousands of dollars in inducements to doctors to promote prescribing its medication Subsys to their patients...The state alleged that over 90 percent of the prescriptions for Subsys in Maryland ultimately were for patients who should never have received the product, an under-the-tongue spray that contains fentanyl, an opioid 100 times stronger than morphine...“The allegations against Insys describe a calculated scheme employing doctors, pharmacist, and sales reps to increase profits and market share at the expense of the health and well-being of vulnerable patients,” Frosh said in a statement.

Nicole Grassano, PTNN, Pharmacy Week in Review, this weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.