FDA
FDA awards Roche priority review in HER2-positive breast cancer
October 2, 2017Sales and Marketing Cancer, FDA, Herceptin, Perjeta, Roche, breast cancer, pharma, pharmaceutical
Roche has revealed that its monoclonal antibody Perjeta (pertuzumab) has been awarded priority review by the FDA as an adjuvant …
Top Ten most popular articles on Pharmafile.com this week
September 29, 2017Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Allergan, EMA, FDA, HIV, J&J, JJ, Kevzara, Mylan, NICE, Sanofi, nash, top ten
It’s Friday, and it’s time for another round up of the most popular articles on pharmafile.com over the last seven …
Makers of immediate-release opioids must fund training on their use, FDA says
September 29, 2017Medical Communications FDA, OxyContin, opioids, pharma, pharmaceuticals, vicodin
As part of its ongoing response to the opioid crisis in the US which is claiming the lives of over …
FDA pointedly rejects Intellipharma’s opioid painkiller
September 26, 2017Manufacturing and Production, Sales and Marketing FDA, Intellipharma, biotech, drugs, pharma, pharmaceutical
The FDA has been very public in its stance that it will look to gain the upper hand in bringing …
Pangea X: the largest coordinated operation against counterfeit drugs
September 26, 2017Manufacturing and Production, Sales and Marketing Europol, FDA, biotech, drugs, interpol, pharma, pharmaceutical
Operation Pangea X represents an anniversary, of sorts – as it stands as the 10th year of operations by Interpol …
FDA approves first-ever biosimilar for cancer treatment
September 15, 2017Medical Communications, Sales and Marketing Amgen, Cancer, FDA, Mvasi, avastin, biosimilar
The FDA has announced the news that it has awarded approval to the first-ever biosimilar for the treatment of cancer …
FDA halts trial after first CAR T-associated patient death
September 6, 2017Research and Development CAR T, CAR-T, Cancer, FDA, cellectis, leukaemia, patient death, pharma, pharmaceutical
French clinical-stage biopharma firm Cellectis has received an order from the FDA to halt its study of CAR T therapy …
Novo Nordisk settles lawsuit over illegal marketing practices for $58.7 million
September 6, 2017Research and Development, Sales and Marketing FDA, Novo Nordisk, US, US Justice Department, Victoza, diabetes, pharma, pharmaceutical
Novo Nordisk has resolved a probe by the US Justice Department which accused the Danish drugmaker of illegal marketing activities …
Teva scores expanded indication for Austedo in tardive dyskinesia
August 31, 2017Sales and Marketing FDA, Teva, medicine, pharma, pharmaceuticals
Following the FDA’s approval of Teva’s Austedo (deutetrabenazine) in the treatment of chorea associated with Huntington’s disease in April this …
FDA approves first treatment for the ‘silent killer’
August 30, 2017Research and Development, Sales and Marketing Chagas disease, FDA, biotech, drugs, pharma, pharmaceutical
The FDA has announced that it has granted an accelerated approval for the use of benznidazole in children between the ages …
FDA fast-tracks recreational drug MDMA for treatment of PTSD
August 30, 2017Research and Development, Sales and Marketing FDA, MDMA, PTSD, life sciences, pharma, pharmaceuticals
In another leap forward for the promising treatment, the FDA has announced that it has granted Breakthrough Therapy Designation to …
‘Trade secret information’ to be shared between EMA and FDA
August 25, 2017Manufacturing and Production, Medical Communications EMA, FDA, biotech, drugs, pharma, pharmaceutical
As part of the on-going harmonisation of manufacturing standards across the Atlantic, the EMA and FDA have announced that they …
FDA approves Ironwood’s combination gout treatment
August 22, 2017Manufacturing and Production, Sales and Marketing Duzallo, FDA, Ironwood Pharmaceuticals, gout, life sciences, pharma, pharmaceuticals
Ironwood Pharmaceuticals has announced that the FDA has approved its drug Duzallo for the treatment of hyperuricemia associated with gout …
Pfizer’s leukaemia drug gets opposing regulatory decisions on either side of the Atlantic
August 18, 2017Medical Communications, Sales and Marketing Besponsa, Cancer, FDA, NICE, Pfizer, leukaemia, pharma, pharmaceutical
Pfizer has received a bittersweet bout of news as it emerges that its drug Besponsa (inotuzumab ozogamicin) has received approval …
FDA recalls liquid pharma products after bacterial contamination detected
August 17, 2017Medical Communications, Sales and Marketing FDA, life sciences, pharma, pharmaceutical
The FDA has announced that it has been forced to recall a range of liquid pharmaceutical and dietary supplement products …
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