FDA
Mylan launches generic of Valeant’s Ultram in the US
March 29, 2016Manufacturing and Production, Sales and Marketing FDA, Mylan, Valeant, abbreviate new drug application, generic, pain, tramadol, ultram
Mylan (NASDAQ, TASE: MYL) has announced the launch of its generic version of Valeant’s Ultram tablets in the US. The …
Teva announces FDA approval for asthma injection, Cinqair
March 24, 2016Research and Development, Sales and Marketing FDA, Teva, approval, asthma, cinqair
The US Food and Drug Administration has approved Cinqair (reslizumab), an injection for patients with severe asthma developed by Teva …
FDA announces strongest warnings for opioid pain medications
March 23, 2016Medical Communications, Research and Development FDA, abuse, addiction, boxed, label, misuse, opioids, public health, restrictions, safety, warnings
The US Food and Drug Administration has announced class-wide safety labelling changes for immediate release (IR) opioid pain medications. The …
FDA bans clinical trial co-ordinator who faked patient samples and stole funds
March 22, 2016Manufacturing and Production, Medical Communications FDA, HIV, clinical trials, faked, forgery, mcquerry, prison
The US Food and Drug Administration has permanently banned a clinical trial co-ordinator who was found to have falsified patient …
FDA approves new anthrax treatment
March 22, 2016Manufacturing and Production, Research and Development Antibacterial, FDA, US, anthim, anthrax, defense, inhalational
The US Food and Drug Administration (FDA) has approved Anthim (obiltoxaximab) to treat inhalational anthrax in combination with appropriate antibacterial …
FDA approves Breckenridge’s generic of Pfizer’s anti-epilepsy drug
March 18, 2016Research and Development, Sales and Marketing FDA, Neurontin, Pfizer, anti-epilepsy, approval, breckenridge, gabapentin, tris pharma
Breckenridge Pharmaceutical Inc. has announced that their generic of Pfizer’s anti-epilepsy drug Neurontin (gabapentin) has been approved by the US …
FDA approves Bayer haemophilia A drug Kovaltry
March 17, 2016Research and Development, Sales and Marketing Bayer, FDA, approval, drug, drug approval, haemophilia, haemophilia a, kovaltry, viii compound
Bayer (ETR:BAYN) has received approval from the US Food and Drug Administration (FDA) for Kovaltry (octocog alfa), an unmodified, full-length …
Genentech cancer immunotherapy gets Priority FDA Review in bladder cancer
March 15, 2016Manufacturing and Production, Research and Development FDA, Genentech, Roche, atezolizumab, bladder cancer, priority review
The US FDA has granted Roche subsidiary Genentech a Priority Review for atezolizumab in treating advanced bladder cancer, whose disease …
COMMENT: What does Amarin’s off-patent victory over the FDA mean for the industry?
March 14, 2016Medical Communications, Sales and Marketing Amarin, FDA, off label, off-label, vascepa
Last week, Pharmafile.com reported that small biopharma Amarin had settled litigation with US drugs regulator the FDA that will allow …
Novartis seeks expanded Arzerra use in US
March 11, 2016Research and Development Arzerra, CLL, FDA, Genmab, Novartis
Novartis has submitted a supplemental Biologics License Application (sBLA) to the US FDA for the use of Arzerra (ofatumumab) in …
FDA grants approval for first generic version of Viagra
March 10, 2016Manufacturing and Production, Research and Development, Sales and Marketing FDA, Pfizer, Teva, erectile dysfunction, generic, viagra
The US Food and Drug Administration (FDA) has granted approval to the first generic version of Pfizer’s blockbuster erectile dysfunction …
Amarin wins case against FDA to promote Vascepa for off-label uses
March 10, 2016Medical Communications, Research and Development, Sales and Marketing Amarin, FDA, first amendment, off label, vascepa
Amarin has announced a settlement with the US Food and Drug Administration (FDA) that resolves the dispute over the Irish-based …
Lupin completes acquisition of US-based Gavis Pharmaceuticals
March 10, 2016Research and Development, Sales and Marketing FDA, Gavis, Lupin, acquisition, generics
Indian drug manufacturer Lupin has announced the completion of its acquisition of New Jersey-based pharmaceutical firm, Gavis, in a deal …
Teva suffers EpiPen generic setback after FDA rejection
March 4, 2016Medical Communications, Research and Development FDA, Teva, analphylaxis, approval, auto injector, auto-injector, rejection
The release of Teva Pharmaceuticals generic for the anaphylaxis treatment, EpiPen (epinephrine), is now expected to be severely delayed after …
Senate confirms Dr Robert Califf to lead FDA
February 25, 2016Medical Communications Drug pricing, FDA, Robert Califf
The US Senate has confirmed Dr Robert Califf as Commissioner of the Food and Drugs Administration, in an overwhelming 89-4 …
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