- September 14 Pharmacy Week in Review: FDA Ensuring Compounding Quality, New Drug Therapy for Treating Asthma (pharmacytimes.com)
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.
- How Scott Gottlieb is upending FDA communication, one tweet at a time (biopharmadive.com)
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....
- NHS announces new Genomic Medicine Service (healthcareitnews.com)
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...
- Nevada seeks emergency order to block disclosure of physician in planned Dozier execution (thenevadaindependent.com)
Nevada officials have filed an emergency request with the state Supreme Court seeking to block a lower court’s decision to release the identity of the attending physician scheduled to oversee the delayed execution of Scott Raymond Dozier...In an emergency motion...the attorney general’s office, representing the Nevada Department of Corrections, is seeking to block a...decision by District Court Judge Elizabeth Gonzalez. The judge said the state must reveal the name of the physician set to oversee Dozier’s execution to attorneys representing one of the drug manufacturers whose product will be used in the execution...Although Gonzalez’s order would limit disclosure of the physician’s identity to the attorneys for drug manufacturer Alvogen, the state wrote in its emergency request that the attending physician would only oversee the execution “to the extent their anonymity is protected from disclosure” and that even a limited disclosure of individuals involved in the execution wasn’t relevant and would limit the state’s ability to carry out the execution...“The drug manufacturers should not be permitted to go on a fishing expedition for information that can be used to harass individuals who assist the State in carrying out lawful executions,” attorneys with the state wrote in the filing. “The intended effect is to scare people away from assisting the State. This tactic is well-documented and, unfortunately, has been effective in stopping executions.”
- Why Big Pharma Cheers Rahm Emanuel’s Exit As Chicago’s Mayor (forbes.com)
Rahm Emanuel’s surprise decision to not run again for Mayor of Chicago next year for a third term may be good news for the pharmaceutical industry, which has become a high-profile target during his tenure...Emanuel was unafraid to put U.S. pharmaceutical companies and their marketing practices in his sights despite Chicago and its suburbs being home to major drug makers that are also big employers like Abbott Laboratories and its spin off Abbvie as well as Baxter International. Other drug makers and startups call Chicago home including Horizon Pharma...Emanuel led the charge for Chicago to introduce an ordinance requiring licenses for drug sales representatives . This summer, Chicago confirmed more than 1,500 licenses, which cost $750 annually, were issued after the first year of the ordinance. Marketing without a license could result in a $1,000 fine...
- The search for new drugs is coming to your house (fastcompany.com)
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...
- This Week in Managed Care: September 7, 2018 (ajmc.com)
Laura Joszt, Managing Editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network
- EU officials clash with Chinese firm on drug factory inspection (reuters.com)
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.
- Novartis Targets Production Streamlining as U.S. Prices Decline (bloomberg.com)
...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,”...
- September 7 Pharmacy Week in Review: Role of Pharmacy Technicians in Iowa Expands, Immunotherapy Shrinks Melanoma Metastases (pharmacytimes.com)
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.