Onco Actu du 31 juillet 2017

	2.3 Etiologie - OGM
Most anti-GMO papers contain serious flaws [The Logic of Science] Anti-GMO studies represent a tiny portion of the literature, they are usually published in low-quality journals, they are riddled with statistical and methodological problems, several of them have been retracted (sometimes because of scientific fraud), and they are refuted by a vast body of literature.
	3.1 Tabac
FDA announces comprehensive regulatory plan to shift trajectory of tobacco-related disease, death [FDA] Agency to pursue lowering nicotine in cigarettes to non-addictive levels and create more predictability in tobacco regulation.
FDA Announces a Major Shake Up in Tobacco Regulatory Policy [FDA Law Blog] FDA’s new approach to the regulation of nicotine will have profound effects on the tobacco product industry. We will continue to monitor this bold new plan as it unfolds.
FDA announces plans to slash nicotine levels in cigarettes [STAT] The agency announced Friday a goal of lowering nicotine in traditional cigarettes to a non-addictive level, and ensuring that alternative nicotine delivery systems — read: electronic cigarettes — are properly and sensibly regulated.
Tobacco's Teflon Gets Tested [Bloomberg] For decades, it seems nothing has been able to hold back the tobacco industry -- not a steady decline in U.S. smoking rates, not rising cigarette sales taxes, not even the warning labels added to packs years ago spelling out the potentially deadly effects of smoking. That was until Friday.
Tobacco Shares Plunge After FDA Proposes Cut to Cigarette Nicotine [Bloomberg] The U.S. Food and Drug Administration will work to cut the amount of nicotine in cigarettes to nonaddictive levels, with the goal of preventing thousands of tobacco-related deaths a year. The surprise move sent shares of cigarette stocks plummeting.
	3.1.1 Tabac - e-cigs
F.D.A. Delays Rules That Would Have Limited E-Cigarettes on Market [NY Times] Dr. Gottlieb sounded notably more open to e-cigarettes than many other federal public health officials, who have opposed the devices as a gateway to nicotine addiction and eventually to the smoking of tobacco cigarettes.
	5. Traitements
IMRT: bending radiotherapy beams to spare healthy cells [Cancer Research UK] The crux of IMRT treatment is to give each part of the tumour enough radiation to kill it but to protect healthy cells at the same time. This is done by using a bit of high-tech kit in the radiotherapy machine called a multileaf collimator. The radiation beam passes through metal leaves that slide to make different shapes.
	5.10 Traitements - Essais
Research into clinical trial transparency shows huge variation in standards [Pharmafile] There was also a warning that AllTrials is able to discover which trials have been hidden and will pursue those who are withholding them adding another pressure point to encourage the release of data.
	5.12 Immunothérapies
Cancer immunotherapy drugs like Keytruda and Opdivo hold hope for some, but there’s still a way to go [The Conversation] We rightly celebrate these successes, but must face the sobering truth that only a minority of people experience these dramatic benefits. Decades of research have helped us reach this point. Now scientists and doctors from Australia and around the world are working furiously to learn more about how these immune treatments work or fail.
A humbling setback for an immune-revving cancer therapy underscores the many questions facing the field [STAT] “Fundamentally, this is still imprecision medicine,” said Dr. George Demetri, an oncologist and professor at the Dana-Farber Cancer Institute in Boston, referring to cancer immunotherapy. “We have great targets, but we still don’t know how to identify the right patients.”
Calling time on the immunotherapy gold rush [The Lancet Oncology] While heralding an enticing treatment opportunity, it is essential to bear in mind that the current generation of immunotherapies merely extends life expectancy for a small proportion of patients.
	5.12.5 Immunothérapies - Pharma
AstraZeneca drug gets breakthrough status in early lung cancer [Reuters] The Food and Drug Administration decision paves the way for a speedy regulatory review and confirms the drug's potential in earlier stage disease, despite its initial failure in the key Mystic trial, which targeted the bigger advanced cancer market.
Imfinzi granted Breakthrough Therapy Designation by US FDA for patients with locally-advanced unresectable non-small cell lung cancer [AstraZeneca] The Breakthrough Therapy Designation for Imfinzi was granted on the basis of interim results from the Phase III PACIFIC trial, a randomised, double-blinded, placebo-controlled multi-centre trial of Imfinzi (durvalumab) as sequential treatment in patients with locally-advanced, unresectable (Stage III) NSCLC who had not progressed following standard platinum-based chemotherapy concurrent with radiation therapy.
CheckMate-227: Bristol-Myers Squibb has a MYSTIC problem [EndPoints] None of this, of course, was unexpected at Bristol-Myers, which is acutely sensitive to just how important Opdivo is to its future.
	5.2 Pharma
GSK Rearranges, Once More [In the Pipeline] Now, at last, everyone’s positioned to be lean, effective, courageous, and productive – right? But you can’t get these qualities by asking for them, or by proclaiming them. They’re rare, and they’re hard.
	5.2.1 Pharma - Partenariats
Shooting for the moon: The National Cancer Institute’s Formulary [Pharmafile] The Formulary encourages companies to share their agents to initiate combination research to the mutual benefit of the owners of the drugs and, potentially, the public.
	5.2.3 Pharma - économie
Still reeling from cyberattack, Merck warns some drug supplies may be delayed [FiercePharma] Frazier said recovery will take some time, but the U.S.-based company is working nonstop to get that done.
Soon-Shiong’s NantCell in $356M deal for underperforming CytRx cancer drug [FierceBiotech] The med is an adapted form of the chemotherapy agent doxorubicin, and the biotech has put all of its eggs into this one drug basket.
Biotech billionaire Soon-Shiong picks up rights to CytRx’s troubled cancer drug [EndPoints] As the man who made a fortune off the development and sale of Abraxane, he feels he has special insights into aldoxorubicin that will help with the research to come.
Merck admits cyberattack is having an impact on research, manufacturing — we’re just not sure how big [EndPoints] "The cyber-attack led to a disruption of our worldwide operations, including research. However, we have been able to maintain our clinical trial execution plan and we continue to pursue previously outlined priorities."
Merck profit tops estimates as Keytruda sales surge [Reuters] Sales of Keytruda, which works by taking the brakes off the immune system, nearly tripled to $881 million in the second quarter, handily beating consensus estimates of $777 million, according to Barclays.
	5.3 Traitements - FDA, EMA, NICE...
EMA Lays out Plans for Companion Diagnostic Guideline [RAPS] According to EMA, drug and diagnostic developers oftentimes begin work on their products independently, and come together "only superficially towards the end" of the development phase, which the agency says is not ideal.
Concept paper on development and lifecycle of personalised medicines and companion diagnostics [EMA] There is no common definition of personalised medicine, but in the context of this guidance the term refers to the targeted use of a treatment in a patient on the basis of the individual’s characteristics and genetic makeup and the understanding of how the treatment works.
	5.4 Traitements - Economie
US Drug Prices And R&D, Take 2: A Reply To Grabowski And Manning, And To Light [Health Affairs blog] Grabowski and Manning offer no logic or data to support a bold claim that our estimates are biased upwards due to our sampling frame. Moreover, they have mischaracterized our methods.
	6. Lutte contre les cancers
Don't run biomedical science as a business [Nature] Science should abandon its assembly-line mentality and rebuild for quality, not quantity, argues Michele Pagano.
	6.11 Patients
In debt with cancer: Is your bank listening? [BBC News] Because of cases like Sam - who is one of its customers - Lloyds Banking Group has decided to offer particular support to cancer patients.
	6.5 Médecines alternatives
These People Are Making Money Off A Bogus Cancer Cure That Doctors Say Could Poison You [BuzzFeed] Apricot seeds can cure cancer — or so thousands of cancer patients believed in the 1970s, despite lots of evidence to the contrary. Now, in an era when natural remedies are no longer fringe and wellness is a multitrillion-dollar industry, this widely debunked theory has taken on a new life as a hydra-headed e-commerce ecosystem that regulators are virtually powerless to stop.
	6.7 DMP, Big Data & applis
Two Methods to De-identify Large Patient Datasets Greatly Reduced the Risk of Re-identification [AACR] To test the strength of their de-identification technique, Ursin and colleagues used screening data containing 5,693,582 records from 911,510 women in the Norwegian Cervical Cancer Screening Program. The data included patients’ dates of birth, and cervical screening dates, results, names of the labs that ran the tests, subsequent cancer diagnoses, if any, and date of death, if deceased.