Onco Actu du 3 janvier 2020

	3.1.1 PRÉVENTION - TABAC - E-CIGS
Vape Shops Saved for Now: Dodged One Bullet, But Now Must Dodge Another One [The Rest of The Story] The decision of the FDA not to ban all flavored e-cigarettes is a huge victory for public health. By allowing vape shops to continue selling flavored vape liquids, the FDA is preventing hundreds of thousands of ex-smokers from being forced to return to smoking.
With Partial Flavor Ban, Trump Splits the Difference on Vaping [NY Times] An initiative to reduce the use of e-cigarettes by teenagers led to compromise. Sales of most flavored pods popular with youth will be forbidden, but flavored liquid nicotine for open tank devices will be exempt.
Trump administration restricts some e-cigarette flavors [Reuters] Gary Reedy, chief executive of the American Cancer Society, called it “a hollowed-out policy that will allow the tobacco industry to continue to attract kids to a lifetime of nicotine addiction.”
Vaping industry offers academic scholarships to high school kids [Reuters] Searching online, researchers found 21 vaping-related entities - including manufacturers, distributors and review websites - offering a total of 40 scholarships to high school and college students in the U.S., according to the report in the journal Tobacco Control.
FDA finalizes enforcement policy on unauthorized flavored cartridge-based e-cigarettes that appeal to children, including fruit and mint [FDA] Companies that do not cease manufacture, distribution and sale of unauthorized flavored cartridge-based e-cigarettes (other than tobacco or menthol) within 30 days risk FDA enforcement actions.
	3.3 PRÉVENTION - VACCINS
This Italian scientist has become a celebrity by fighting vaccine skeptics [Science] Burioni realized he didn't have time to make the usual arguments about statistics and scientific uncertainty, so he kept his message simple: "The Earth is round, gasoline is flammable, and vaccines are safe and effective," he said. "All the rest are dangerous lies."
	4.3 DÉP., DIAG. & PRONO. - INDUSTRIELS
Illumina & PacBio Throw In The Towel [Omics! Omics!] PacBio also needs to take a hard look at all the applications it is used for and assess which are likely to yield serious growth and also which are most vulnerable to being upended by competition. For example, Iso-Seq mRNA sequencing has been quite popular and generating publications -- but it also is at huge risk of being taken over by Oxford Nanopore, as it is an application in which base perfect accuracy may be very secondary.
Illumina, Pacific Biosciences Abandon $1.2B Acquisition Deal [Genome Web] In after hours trading on the Nasdaq, shares of both PacBio and Illumina were flat.
After Antitrust Challenges, Illumina and PacBio Throw in Towel on Merger [Xconomy] Regulators—including the UK’s antitrust group and the Federal Trade Commission—asserted that bringing PacBio within the Illumina fold would hamper innovation and deter competitors by allowing the already dominant company to extend its lead.
Illumina and Pacific Biosciences Announce Termination of Merger Agreement [BusinessWire] Considering the lengthy regulatory approval process the transaction has already been subject to and continued uncertainty of the ultimate outcome, the parties decided that terminating the agreement is in the best interest of their respective shareholders and employees.
	4.5 DÉP., DIAG. & PRONO. - COLORECTAL
Circulating Tumor DNA Methylation Profiles May Aid in Colorectal Cancer Early Diagnosis, Prognosis [Genome Web] The researchers also constructed a prognostic prediction model, dubbed "cp-score," that combines cell-free methylation analysis with clinical and demographic features, such as tumor stage and site and patient age and gender.
Machine learning accurate at colorectal cancer diagnosis, may also predict survival [UPI] According to Luo, their technology works by screening for methylation markers, which are DNA modifications that are frequently found in tumors. To test the approach, they created a diagnostic model based on nine methylation markers associated with colorectal cancer, which they identified by studying plasma samples from 801 people with colorectal cancer, as well as 1,021 healthy controls.
	4.9 DÉP., DIAG. & PRONO. - SEIN
AI shows promise for breast cancer screening [Nature] Could artificial intelligence improve the accuracy of screening for breast cancer? A comparison of the diagnostic performance of expert physicians and computers suggests so, but the clinical implications are as yet uncertain.
Artificial intelligence could help breast screening save more lives [Cancer Research UK] We’ve partnered with Google Health on research to develop artificial intelligence that not only has the potential to change the way we detect breast cancer but could also save the NHS time and money.
	5.1 TRAITEMENTS - PRÉ-CLINIQUE
How a transporter protein could be a new target for colorectal cancer [Fierce Biotech] The protein is called Importin-11. Its coding gene, IPO11, belongs to the Importin-beta family, which mediates trafficking between the cell nucleus and cytoplasm for different cellular functions. In Importin-11’s case, it transports beta-catenin into the nucleus of colon cancer cells, where it can lead to cell growth.
	5.10 TRAITEMENTS - ESSAIS
Half the amount of chemo prevents testicular cancer from coming back, new trial shows [Institute of Cancer Research] “This new trial is already changing clinical practice on a global scale, and is set to improve patients’ quality of life as well as reducing the cost of testicular cancer treatment.
	5.12.6 IMMUNOTHÉRAPIES - AMM
Milestone for Biopharmaceuticals in China [Boehringer Ingelheim] Through its collaboration with BeiGene, Ltd. and the provision of manufacturing services for their monoclonal antibody tislelizumab, Boehringer Ingelheim Biopharmaceuticals China is the first company to successfully apply the adopted Marketing Authorization Holder (MAH) system within the revised Chinese Drug Administration Law (DAL).
BeiGene scores first China OK with PD-1 — to be manufactured by Boehringer Ingelheim [EndPoints] The approval for BeiGene’s tislelizumab just before 2019 ended is also marking a new historic event: the first time a foreign partner will be producing the marketed drug under a reformed contract manufacturing regulatory system.
	5.12.8 IMMUNOTHÉRAPIES - ECONOMIE
Despite secret discount, Roche's Tecentriq hits NICE roadblock in small-cell lung cancer [Fierce Pharma] Analysts predicted the go-ahead could land the company blockbuster sales, but if Roche wants to max out its potential around the world, it’ll need to change minds at NICE. It has until Jan. 28 to appeal the gatekeeper’s recommendation and negotiate a price NICE finds acceptable.
Tough times for Tecentriq as NICE once again slaps down Roche's immunotherapy — slight benefit not worth price [EndPoints] The National Institute for Health and Care Excellence’s latest filing is for extensive-stage small cell lung cancer patients. The regulator determined that although Tecentriq appeared to improve patient survival and quality of life in clinical trials, that data was uncertain and based on patients who were dissimilar to the average NHS patient.
	5.3 TRAITEMENTS - FDA, EMA, NICE...
Additional evidence needed to assess histology-independent cancer drugs says paper co-authored by NICE staff [Nice] These mutations are often rare, so the clinical evidence on the effectiveness of histology-independent cancer drugs in treating these tumours is based on immature data and on studies with extremely small sample sizes. This will make it very challenging to assess whether the drug will provide value for money to health systems such as the NHS.
	5.3.4 TRAITEMENTS - AMM (FDA, EMA,...)
FDA Grants Accelerated Approval to Enfortumab Vedotin-ejfv for Metastatic Urothelial Cancer [ESMO] It is the first Nectin-4-directed antibody-drug conjugate to receive FDA approval.
	5.4 TRAITEMENTS - ECONOMIE
Pfizer, BMS, Gilead, AbbVie and others hike prices on hundreds of meds to ring in 2020 [Fierce Pharma] It may be a new year, but an old tradition is playing out in the pharma world—the price-hiking tradition, that is.
New year, new (higher) drug prices [EndPoints] Bristol-Myers, which swallowed Celgene in a $74 billion deal last year, also increased the prices of 10 drugs on Wednesday, including a 1.5% hike on its immunotherapies Opdivo and Yervoy.
	6.10 POLITIQUES
U.K. looks to shake up trial, medicines regulation amid Brexit [Fierce Biotech] This will create a “streamlined, internationally competitive” process for approving new drugs and devices, the government said, and would focus on “removing unnecessary bureaucracy” for what it deems low-risk clinical trials.