Although the FDA is supposed to intervene when safety concerns arise with an existing pharmaceutical or over-the-counter product, they do not have the authority to require companies to stop marketing unsafe products. This loophole allows companies to refuse FDA’s calls to remove their pharmaceuticals from the market because they are unsafe. Rep. Rose DeLauro (D-CT) introduced the “Recall Unsafe Drugs Act” that will give the FDA mandatory recall authority over drugs and homeopathic products. (Regulatory Focus)
Tune in to the new BBC documentary that revisits the infamous “Elephant Man” drug trial that left participants fighting for their lives
The British Broadcasting System (BBC) has created a documentary, “The Drug Trial: Emergency at the Hospital” which revisits the events that resulted in the harmful effects of the infamous “Elephant Man” trial, which will air on February 21. In March 2006, eight young men, healthy volunteers in London signed up for a Phase 1 trial which was designed to manipulate the immune system with the hope that it would revolutionize cancer treatment. The trial resulted in the young men fighting for their lives. A subsequent government investigation resulted in 21 recommendations to improve the safety of first-in-man trials. (Daily Mail.com)
Shares of Intercept Pharma soar after change in protocol
Shares of Intercept Pharmaceuticals (ICPT) jumped after the drug maker announced it was changing an ongoing late-stage clinical trial for a drug that treats liver disease. Patient enrollment in the study has been too slow, so Intercept has changed protocols, drastically cutting the number of patients to be enrolled and lowering the bar for clinical success. Intercept said the changes were based on discussions with the FDA. (Barrons)
Former FDA commissioner: 5 takeaways on drug approval standards and safety
Dr. Robert Califf, the former commissioner of the Food and Drug Administration (FDA), shared his thoughts about keeping Americans safe- and making sure drugs actually work- after a year of overseeing the federal agency. Califf is concerned about plans to speed up drug approvals and dramatically reduce regulations at the agency, as advocated by President Donald Trump. (Modern Healthcare)
Should approval for 18 cancer drugs be withdrawn?
The U.S. Food and Drug Administration (FDA) has increasingly used the accelerated pathway to bring potentially lifesaving drugs to market faster. Once granted, accelerated drug approvals are subject to withdrawal if a postmarketing study fails to confirm clinical benefit. The authors examined 18 cancer drugs that received accelerated FDA approval, but were found in postmarketing confirmatory trials to have no overall survival (OS) benefit. The FDA should withdraw approval for cancer drugs that are proven to have no clinical benefit. (The JAMA Network)
Can We Match NASA’s Apollo 11 Success? Checking in on Biden’s Cancer Moonshot 2020 Initiative
by Madison Arenchild, freelancer for Clinical Research Currents “..we have examined where we are strong and where we are not, where we may succeed and where we may not. Now it is time to take longer strides–time for a great new American enterprise–time for this nation to take a clearly Read more
CEO of The One Health Company promotes new approach to clinical trials at World Economic Forum
Christina Lopes, the CEO and cofounder of The One Health Company, explained at the World Economic Forum in Davos that her company seeks to use pet dogs and cats suffering from the kinds of conditions that pharmaceutical companies are developing treatments for in humans (such as bone cancer, lymphoma) for animal trials as part of drug development. The rationale is that the canine genome more closely resembles humans than the mouse genome. And pharma companies can use the data for R&D.
Sanofi to launch 20+ new drugs in Japan by 2020
Japan is likely to see more than 20 new drugs from French pharma major Sanofi (Euronext: SAN) by 2020, said the newly-appointed Sanofi Japan chief executive Jacques Nathan at a press meeting held in Tokyo earlier this month.
Among these new drugs, which include existing drugs for new indications, “a significant amount will be biologics,” said Mr Nathan, reports Wang Fangqing, The Pharma Letter’s correspondent. (thepharmaletter.com)
Ilumina spinout Grail is seeking to raise $1.7 billion for large-scale clinical trial: sources
Grail, a spinout company of the DNA-sequencing giant Illumina, has a very bold mission: to develop a blood-based screening test for cancer. The company is now seeking to raise $1.7 billion, say three sources familiar with the matter, to fund a large-scale clinical trial in the United Kingdom involving 500,000 people.
The underlying science is nothing new…But it’s never been applied to early-stage cancer detection, a far more challenging prospect. Grail is convinced it can do it through an ultra-deep sequencing approach. (fast company.com)
Sick dogs could be key to unlocking mysteries of immunotherapy
Novel cancer drugs that harness an individual’s own immune system to fight cancer are showing incredible promise in some patients, but researchers don’t fully understand why these immunotherapies work for some people and not others. Animal models that imitate the human immune system will help in the study of the effects of these drugs. The National Cancer Institute at NIH said it will start a new large-scale program in 2017 to study experimental immunotherapies in dogs with cancer. (MIT Technology Review)
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