FDA
FDA approves first treatment for excessive night-time urination
March 6, 2017Manufacturing and Production FDA, Noctiva, Serenity
The FDA has approved Noctiva, administered as a nasal spray, for the treatment of people suffering from nocturnal polyuria – …
EU-US reach landmark deal on mutual recognition of manufacturing inspection
March 3, 2017Medical Communications EMA, EU, FDA, US
The European Union and the US has announced that an agreement has been made to mutually recognise inspection of drug …
FDA green lights AstraZeneca type-2 diabetes drug
February 28, 2017Manufacturing and Production, Sales and Marketing AstraZeneca, FDA
AstraZeneca has announced that its type-2 diabetes treatment Qtern (10mg dapagliflozin and 5mg saxagliptin) has received the approval of the …
Does Trump pose a threat to the FDA’s future?
February 27, 2017Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing FDA, Trump
President Trump’s first month in office made headlines across the industry just as it did in the wider media. Promises …
The March 2017 issue of Pharmafocus is now live!
February 22, 2017Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Actelion, FDA, Johnson & Johnson, MSD, Roche, Trump, crispr, immunotherapy, opdivo
The latest edition of Pharmafocus is available to read online now! From breakthroughs in antibiotic resistance R&D to gene editing …
FDA Priority Review for Pfizer investigational leukaemia drug
February 22, 2017Research and Development, Sales and Marketing EMA, FDA, Inotuzumab ozogamicin, Pfizer, priority review
Pfizer has announced that its leukaemia treatment inotuzumab ozogamicin has been accepted for Priority Review by the US Food and …
FDA rejects Amphastar’s application for NDA for intranasal overdose treatment
February 21, 2017Research and Development Amphastar, FDA
Amphastar has received a Complete Response Letter (CRL) for its New Drug Application (NDA) for an intranasal version of Naloxone, …
Zydus Cadila scores twin FDA approvals
February 17, 2017Medical Communications, Sales and Marketing FDA, Zydus Cadila
Indian pharmaceutical firm Zydus Cadila has announced that the US Food and Drug Administration (FDA) has given the go-ahead for …
FDA approves Valeant plaque psoriasis drug despite suicide concerns
February 16, 2017Sales and Marketing FDA, Siliq, Valeant, psoriasis
The US Food and Drug Administration (FDA) has announced that it has approved Valeant Pharmaceutical’s injectable psoriasis treatment Siliq (brodalumab) …
Allergan set to bolster ‘medical aesthetics’ unit with $2.5 billion Zeltiq deal
February 13, 2017Manufacturing and Production, Sales and Marketing Allergan, FDA, Zeltiq
Allergan, the owner of Botox, has expanded its stake in the ‘medical aesthetics’ business by acquiring Zeltiq Aesthetics. Zeltiq has …
FDA approves first treatment for Duchenne muscular dystrophy
February 10, 2017Medical Communications, Sales and Marketing Duchenne Muscular Dystrophy, FDA, marathon, marathon pharmaceuticals
The FDA has announced that it has approved Emflaza (deflazacort), developed by Marathon Pharmaceuticals. The treatment will arrive on the …
Italian firm warned by FDA over record-shredding and drug quality misrepresentation
February 1, 2017Manufacturing and Production, Research and Development FACTA Farmaceutici, FDA
Italian drug manufacturer FACTA Farmaceutici has been issued a warning letter by the FDA after being found shredding “critical laboratory …
Trump’s “one in, two out” regulatory order threatens FDA, Obama Cures Act
January 31, 2017Manufacturing and Production, Sales and Marketing FDA, Trump
An executive order signed by President Donald Trump on Monday has caused concern in the US pharma industry and beyond …
Indian pharma firm caught shredding documents at 1am by FDA
January 24, 2017Manufacturing and Production, Research and Development FDA, Hetero Labs, observations
Hetero Labs, an Indian pharmaceutical firm, has been observed by the FDA shredding what the FDA judged to be controlled …
Roche’s Actemra granted Priority Review by FDA
January 24, 2017Manufacturing and Production, Sales and Marketing Actemra, FDA, Roche, priority review
Roche’s drug, Actemra (also known as RoActemra in Europe), has been granted priority review designation by the FDA for the …
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