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27 Feb 2018, 9:12 am by Tom Lamb
We point out that there was no similar "Dear Doctor" letter sent in the US by Novartis Pharmaceuticals Corporation in 2013, nor was any similar Tasigna drug label change made by Novartis in the US back then. [read post]
7 Feb 2018, 8:39 am by Clay Hodges
What’s more alarming, the drug’s manufacturer, Novartis Pharmaceuticals Corporation, may have known about those risks and failed to disclose them to you. [read post]
17 Jan 2018, 1:37 pm
Novartis Pharmaceuticals Corporation, S233898).La prescription "off-label" d'un produit pharmaceutique est admise. [read post]
17 Jan 2018, 1:29 pm
Novartis Pharmaceuticals Corporation, S233898).Quand elles statuent en diversité, les cours fédérales veilleront à appliquer le droit des états dans sa teneur objective, sans chercher à créer de nouvelles théories juridiques. [read post]
17 Jan 2018, 1:25 pm
Novartis Pharmaceuticals Corporation, S233898).Le devoir de diligence est une des conditions centrales de l'obligation de réparer un dommage en responsabilité civile. [read post]
17 Jan 2018, 1:16 pm
Novartis Pharmaceuticals Corporation, S233898).Prévisibilité du dommage en responsabilité civile et contractuelle (droit californien) :Face à la question de savoir si un défendeur répond envers un lésé, le droit californien accorde une importance essentielle à la notion de prévisibilité. [read post]
14 Jan 2018, 6:34 am
Novartis Pharmaceuticals Corporation, S233898).Exigences en matière d'étiquetages et notices, ici de médicaments et de dispositifs médicaux Le droit des états, ici californien, protège substantiellement les consommateurs de médicaments des dangers posés par des étiquetages et des notices faux, trompeurs ou inadéquats. [read post]
14 Jan 2018, 4:00 am
Novartis Pharmaceuticals Corporation, S233898).Le producteur d'un carburant vendu en gros n'est redevable d'aucun devoir d'aviser des risques envers le consommateur final, lorsque le producteur a donné un avis adéquat au distributeur, auquel revient les tâches de conditionner et d'écouler le produit. [read post]
13 Jan 2018, 8:00 pm
Novartis Pharmaceuticals Corporation, S233898).Responsabilité civile et contractuelle (droit californien), déclaration inexacte ("misrepresentation") :En droit californien, une action en dommages-intérêts fondée sur une déclaration inexacte peut être déposée contre d'autres défendeurs que le seul fabricant du produit. [read post]
21 Nov 2017, 2:40 pm by Tom Lamb
We recommend that the FDA and [Novartis Pharmaceuticals Corporation] the manufacturer [of Entresto] more clearly communicate the full risk of hypotension, including appropriate steps for monitoring patients, and examine whether a more gradual escalation of dose to the recommended level would reduce the risk. [read post]
30 Oct 2017, 3:46 pm by Baum Hedlund
(formerly Questcor Pharmaceuticals Inc.) of California; Mallinckrodt PLC of Ireland; and United BioSource Corporation (UBC) of Delaware. [read post]
26 Jul 2017, 7:24 pm by FDABlog HPM
It was just earlier this month that FDA’s Oncologic Drugs Advisory Committee recommended that FDA approve the first gene therapy product: Novartis Pharmaceuticals Corporation’s BLA 125646 for Tisagenlecleucel for the treatment of pediatric and young adult patients 3 to 25 years of age with relapsed/refractory (r/r) B-cell acute lymphoblastic leukemia. [read post]
16 Sep 2016, 4:07 am by John Collins
In the Actavis case, the applicants similarly argued that Orion’s agreement to supply finished product, or active pharmaceutical ingredients, to Novartis meant that the arrangement did not constitute an exclusive licence. [read post]
13 Jul 2016, 8:52 pm by FDABlog HPM
We recently got our hands on a Memorandum prepared by FDA’s Office of Generic Drugs concerning the Agency’s December 3, 2015 approval of Sun Pharma Global FZE’s (“Sun’s”) ANDA 078340 for generic versions of Novartis Pharmaceuticals Corporation’s GLEEVEC (imatinib mesylate) Tablets, 100 mg and 400 mg, that we though was worth sharing with folks. [read post]
30 Jun 2016, 5:38 pm by Fenwick & West Blogs
CN, EP US20110281284 NOVEL LIVER CANCER MARKER HYOGO COLLEGE OF MEDICINE OTSUKA PHARMACEUTICAL CO CN, EP US20100317001 METHOD OF USING TUMOUR RNA INTEGRITY TO MEASURE RESPONSE TO CHEMOTHERAPY IN CANCER PATIENTS LAURENTIAN UNIVERSITY EP, JP US20110306049 METHOD FOR DETECTING GYNECOLOGIC CANCER LSIP CN, EP US20110117551 DETECTION AND PROGNOSIS OF LUNG CANCER MDXHEALTH EP US20120004129 BIOMARKERS FOR INHIBITORS WITH ANTI-ANGIOGENIC ACTIVITY MERCK PATENT GMBH CN, EP US20090181393 METHODS FOR… [read post]
28 Jun 2016, 3:39 pm by FDABlog HPM
  There’s also the short-lived lawsuit Novartis Pharmaceuticals Corporation filed back in 2010 after FDA mistakenly approved ANDA 078278 for a generic version of FAMVIR (famciclovir) Tablets (see our previous post here). [read post]
2 Jun 2016, 5:23 am by Mary Jane Wilmoth
.; Medical Capital Corporation; Medical Provider Funding Corporation VI; Sidney M. [read post]