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TXT High Court Mixed on Changing Federal Circuitís Role in Patent Appeals [252 Words] [ Price : $8.95]
The U.S. Supreme Court expresses mixed reactions to whether the Federal Circuit Court of Appeals should continue to be given leeway to overturn certain facts determined in lower court decisions related to drug patent claim construction.
TXT Spectrum Wants Fusilev Approval Date, Exclusivity Extended [333 Words] [ Price : $8.95]
Spectrum asks FDA to extend the approval date and orphan drug expiration date for its Fusilev to account for the delay in launch caused by the lack of agency approval for the drugís proprietary name.
TXT Advisors Asked About Cosentyx Efficacy, Safety [304 Words] [ Price : $8.95]
FDA medical reviewers tell the Dermatologic and Ophthalmic Drugs Advisory Committee that Novartisí data show a favorable benefit-risk assessment for its Cosentyx in treating adults with plaque psoriasis.
TXT Comments Sought on Consumer Tobacco Panel [105 Words] [ Price : $8.95]
Federal Register Notice: FDA seeks comments on establishing a probability-based panel of tobacco users.
TXT FDA Sends Collection of Info on Device Tracking to OMB [48 Words] [ Price : $8.95]
Federal Register Notice: FDA submits a proposed collection of information on medical device tracking to the Office of Management and Budget.
TXT FDA Panel Votes to Retain Chantix Boxed Warning [288 Words] [ Price : $8.95]
A joint FDA advisory committee votes to recommend retaining a boxed warning on Pfizerís smoking cessation drug Chantix (varenicline) about serious neuropsychiatric events.
TXT County Health System Wants Clozapine REMS Changed [350 Words] [ Price : $8.95]
Michiganís Genesee County Health System asks FDA to revise the clozapine REMS so the drug can be used in African-American patients with schizophrenia and benign ethnic neutropenia whose blood counts fall below the current REMS limits.
TXT Court Says Branded Drug Design Defects Preempted [219 Words] [ Price : $8.95]
An Ohio federal judge says that Johnson & Johnson could not comply with a Georgia law requirement to change the composition of its Ortho Evra and a federal law requirement that it could not make changes.
TXT Orphan Drug Status for OctreoPharm Tumor Drug [122 Words] [ Price : $8.95]
FDA grants OctreoPharm Sciences an orphan drug designation for its new radiotracer OPS202, indicated for managing neuroendocrine tumors.
TXT FDA Refuse-to-File Letter for Insysí Dronabinol [114 Words] [ Price : $8.95]
FDA issues Insys Therapeutics a Refuse-to-File letter for its proprietary dronabinol oral solution because it provided an inadequate pediatric study plan in its NDA submission.
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