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Centrexion Therapeutics announcing six-month data with its drug, CNTX-4975, for the treatment of moderate to severe knee osteoarthritis pain. The results are from a Phase 2b trial...and Centrexion is pretty excited by what has been seen so far:..The new data show large and statistically significant pain relief...a single 1 mg injection...resulted in large levels of pain reduction compared to baseline and statistical separation from placebo...These data represent the largest reductions seen in knee osteoarthritis reported for any drug treatment, marketed or in development…the active component is capsaicin...CNTX-4975 is "based on Centrexion’s proprietary STRATI technology (Synthetic TRans cApsaicin ultra-pure Injection), a highly potent, ultrapure, synthetic form of trans-capsaicin."...In certain ways, CNTX-4975 is reminiscent of the EpiPen. The active component of the latter is epinephrine, which, like capsaicin, is a drug that’s been known for decades. It’s the injector device, however, and not the drug, that drives Mylan’s proprietary position–and price–for the EpiPen. Similarly, the STRATI technology is what protects CNTX-4975 competitively, as anyone can easily access trans-capsaicin. In addition, epinephrine and trans-capsaicin are cheap drugs. These aren’t complex biologic molecules...The major cost will be for the STRATI technology...it is possible that Centrexion and its investors are going to demand premium pricing for the unprecedented pain relief...How will payers react?

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

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

A group of prominent cancer doctors is planning a novel assault on high drug costs, using clinical trials to show that many oncology medications could be taken at lower doses or for shorter periods without hurting their effectiveness...they point to their pilot study involving a widely prescribed drug for advanced prostate cancer. Cutting the standard dose of Zytiga by three-quarters was as effective as taking the full amount…Szmulewitz (University of Chicago oncologist) and others now want to run full trials to see whether the doses of other oral oncology drugs can be ratcheted back because of the “food effect,” which can alter how a medication is absorbed. They also plan to explore whether the duration of some prescriptions can be shortened and whether some cheaper non-cancer drugs can be substituted for expensive cancer ones. They recently created a nonprofit organization, the Value in Cancer Care consortium, to organize their work...

An eye for an eye, a tooth for a tooth — a life for a lab book?...In the past few months, China has announced two new crackdowns on research misconduct — one of which could lead to executions for scientists who doctor their data...Scientists have been sounding alarms for years about the integrity of research in China. One recent survey estimated that 40 percent of biomedical papers by Chinese scholars were tainted by misconduct. Funding bodies there have in the past announced efforts to crack down on fraud, including clawing back money from scientists who cheat on their grants...Chinese...Ministry of Science and Technology proclaimed a "no tolerance" policy for research misconduct — although it’s not clear what that might look like...the mass retractions "seriously harmed the international reputation of our country’s scientific research and the dignity of Chinese scientists at large."...courts approved a new policy calling for stiff prison sentences for researchers who fabricate data in studies that lead to drug approvals. If the misconduct ends up harming people, then the punishment on the table even includes the death penalty...

The upcoming serialization requirements in the European Union and the United States have presented pharmaceutical companies with the challenge of balancing data integrity with performance when designing the appropriate information architecture...The pharma sector is currently undergoing the process of introducing new systems and processes for serialization...Companies offering networks for the storing and sharing of vast amounts of serialization data are challenged with creating a shareable world that is also scalable. For pharmaceutical companies, serialization will require a paradigm shift in IT architecture to deal with the combination of the vast amount of data stored within network databases and the operational processes associated with the upcoming requirements...In an industry as highly regulated and safety critical as the pharmaceutical sector, the integrity of the real world must meet the volume and performance of the virtual world. Cloud networks for serialization must offer security, together with speed and scalability especially with the introduction of new drug traceability requirements across the globe...

The stars of the blockbuster "Despicable Me" movie franchise, the popular pill-shaped yellow Minions, have pitched everything from Amazon to Twinkies. This week, their evil overlord Gru is taking a starring role in an advertising campaign for 23andMe...Borrowing from the main plot point of the upcoming release of "Despicable Me 3," a 60-second commercial titled "Genetically Me" features the supervillain finding family through the results of his DNA analysis. In the film, Gru...discovers that he has a brother...through a stranger...23andMe teamed up with the $1 billion franchise for its first movie partnership in order to raise awareness about the brand and DNA testing...Personal genetics is a new and growing category. As a brand, we're tasked with not only building our brand and selling our product, but also building the category and explaining to people what it is, what they can get from it…

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

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

Researchers at the National Institutes of Health's National Center for Advancing Translational Sciences and the University of Nevada, Reno School of Medicine have demonstrated that a drug originally targeted unsuccessfully to treat cancer may have new life as a potential treatment for Duchenne muscular dystrophy...The candidate drug, SU9516, represents a different kind of approach for treating DMD, a degenerative muscle disease that usually begins in childhood and has no known cure...NCATS Chemical Genomics Center Acting Branch Chief Juan Marugan, Ph.D., and UNR Med Professor of Pharmacology Dean Burkin, Ph.D., led a team that screened more than 350,000 compounds to find SU9516, which had been previously developed as a treatment for leukemia. The research demonstrated that this compound improved muscle function in both laboratory and animal DMD models. The results, published recently in Molecular Therapy, may provide a promising approach against the disorder and other muscle-wasting conditions...Our findings open the door to develop new drug treatments for DMD...