FDA
US shutdown starts to bite – UPDATED
October 2, 2013Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing CDC, FDA, Medicare, Obama, Obamacare
Twenty-four hours into the US government’s shutdown, the impact on pharma of the freezing of federal government activity remains hard …
Perjeta becomes first approved drug for early breast cancer
October 1, 2013Sales and Marketing FDA, Herceptin, Perjeta, Roche
Roche’s Perjeta has become the first preoperative breast cancer drug to be authorised by the FDA after it was granted …
The future of data disclosure in Europe
September 30, 2013Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing EMA, FDA, GSK, transparency
The debate of clinical trial transparency has at times appeared a peculiarly British issue, but plans are afoot in Europe …
MSD’s sugammadex knocked back by FDA – again
September 25, 2013Research and Development, Sales and Marketing FDA, MSD, Merck, Sugammedex
FDA: we won’t regulate most apps
September 24, 2013Medical Communications, Sales and Marketing FDA, apps, iphone
FDA spends big on social media outlook
September 20, 2013Medical Communications, Sales and Marketing FDA, Facebook, PMCPA, Psoriasis 360, Twitter
FDA approves first generic Xeloda
September 17, 2013Sales and Marketing FDA, Roche, Teva, Xeolda, breast cancer, colorectal cancer
Sanofi withdraws lixisenatide US application
September 12, 2013Sales and Marketing FDA, Lixisenatide, Sanofi, diabetes, elixa
In a blow to its diabetes pipeline, Sanofi has withdrawn a new drug application (NDA) for lixisenatide in the US …
Regulators produce QbD report
August 28, 2013Manufacturing and Production, Sales and Marketing EMA, FDA, QbD
European and US regulators have published the first fruits of their collaboration on assessing measures to ensure drugs are manufactured …
FDA warns Fresenius Kabi over plant problems
August 27, 2013Manufacturing and Production FDA, Fresenius, kabi, recall
German drugmaker Fresenius has been sent another warning letter by the US Food and Drug Administration, this time for a …
Doctor questions FDA’s diet drug approvals
August 23, 2013Research and Development, Sales and Marketing BMJ, Belviq, EMA, FDA, Vivus, diet pills, obesity
HIV pill Tivicay gains FDA approval
August 14, 2013Sales and Marketing FDA, GSK, Tivicay, ViiV
ViiV and partner GlaxoSmithKline’s new HIV drug Tivicay has been shown the FDA’s green light for distribution in the US. …
FDA project will examine abuse-resistant formulations
August 13, 2013Manufacturing and Production API, CDC, FDA
The FDA is seeking tenders for a research project to examine how effective tamper-resistant formulations of opioid analgesics really are …
