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1. Biologie
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CRISPR studies muddy results of older gene research [Nature]
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The
literature suggested that the gene MELK was ideal: there was ample
evidence that it is important in cancer-cell proliferation, and clinical
trials are under way to test drugs that inhibit the MELK protein. But
disabling the gene using CRISPR–Cas9 yielded no effect. “That threw a
monkey wrench into our experiments,” says Sheltzer. “It brought
everything to a halt.”
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3.1 Tabac
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FDA Warns Pfizer Clinical Investigator Over Chantix Study [RAPS]
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Following
an inspection at the clinical site between 15 August 2016 and 14
September 2016, FDA says in the letter that Indianapolis-based Cassandra
Curtis, MD, failed to adhere to the investigational plan’s protocol
requiring certain subjects to be excluded and other requirements on the
use of certain medications.
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4.1 Dép., diag. & prono. - Prostate
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4.13 Dép., diag. & prono. - Peau
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5. Traitements
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Taking Shortcuts In Drug Testing Can Put Patients At Risk [NPR]
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The
solution to speeding breakthroughs in medicine is not to take shortcuts
in evidence generation, but to leverage emerging methods and networks
that can potentially generate robust clinical evidence faster, cheaper
and better. In a digital age, we can push for better evidence without
sacrificing much time.
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5.12 Immunothérapies
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Cancer immunotherapy: more reason for concern? [HealthNewsReview]
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During
the honeymoon period there was no shortage of press releases,
headlines, and advocates more than ready to endorse immunotherapy with
those highly clickable 7 words (cure, breakthrough, miracle, etc.) … but
now that the scrutiny phase has kicked in … the enthusiasm for
explaining negative outcomes, caveats, and limitations seems to wane at
exactly the time when we need more information presented with more care.
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5.12.2 Immunothérapies - CAR-T
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5.12.5 Immunothérapies - Pharma
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5.3 Traitements - FDA, EMA, NICE...
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Trump nominee to lead FDA questioned on ties to pharmacy industry [Reuters]
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Gottlieb,
who held a financial interest in the vape shop Kure, said some
e-cigarettes may have the potential to wean smokers off combustible
cigarettes and be less harmful. "An e-cigarette or vaping product might
be a good smoking cessation tool while a chocolate chip-flavored
e-cigarette might not be," he said.
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Gottlieb At the FDA [In the Pipeline]
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From
the outside, it looks like FDA approval must be the rate-limiting step
for drug approval, but it isn’t. The mental picture of a giant dammed-up
lake of wonderful therapies, held back by a huge concrete bureaucracy
that allows only a mocking trickle to get through at any one time – is
wrong.
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5.9.3 AACR - mélanome
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5.9.4 AACR - poumon
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Immunomedics says IMMU-132 hits targets in small cell lung cancer [FierceBiotech]
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The
small trial of IMMU-132—also known as sacituzumab govitecan—involved 53
patients with advanced metastatic SCLC who had already been heavily
treated with conventional chemotherapy but whose disease was still
progressing. All told, out of 49 evaluable patients there were 7 partial
responses and 21 people in whom the disease stabilized, according to
the AACR abstract.
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5.9.5 AACR - CAR-T
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5.9.6 AACR - prostate
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5.9.7 AACR - divers
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6.10.1 Politiques (USA)
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6.12 Ethique
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6.6 Publications
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