FDA
FDA Commissioner Scott Gottlieb announces resignation
March 8, 2019Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing FDA, Scott Gottlieb, appointment, pharma
Dr Scott Gottlieb, the 23rd Commissioner of the US Food and Drug Administration (FDA), stoked surprise throughout the industry with …
Allergan’s depression drug rapastinel fails to outperform placebo at Phase 3
March 7, 2019Research and Development Allergan, FDA, depression, major depressive disorder, pharma, rapastinel
As Janssen celebrated the FDA approval of the first novel therapy for depression in three decades with Spravato, Allergan released …
FDA Commissioner Scott Gottlieb announces resignation
March 6, 2019Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing FDA, Scott Gottlieb, opioid crisis, pharma
Dr Scott Gottlieb, the 23rd Commissioner of the US Food and Drug Administration (FDA), stoked surprise throughout the industry with …
Iran ready to export medicines to Venezuela
February 25, 2019Sales and Marketing FDA, Iran, Venezuela, biotech, global, pharma
The chairman of the Iranian Food and Drug Administration (FDA) Mehdi Pirsalehi, has said that Iran is ready to export …
FDA halts Xencor’s acute myeloid leukaemia trial following two patient deaths
February 21, 2019Research and Development Cancer, FDA, Xencor, leukaemia, pharma
Cancer biopharma firm Xencor has revealed it is to place a hold on its ongoing Phase 1 trial of XmAb14045, …
Top Ten most popular articles on Pharmafile.com this week!
February 15, 2019Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing AMR, Dame Sally Davies, FDA, FMD, antibiotic resistance, esketamine, falsified medicines, top 10
News that the FDA’s advisory panel had recommended Janssen’s intranasal esketamine spray Spravato as a treatment for treatment resistant depression, …
FDA approves Novartis’ Egaten for parasitic infection fascioliasis
February 14, 2019Sales and Marketing Egaten, FDA, Novartis, fascioliasis, pharma
The FDA has taken the decision to authorise the use of Novartis’ Egaten (triclabendazole) in patients older than six years …
Janssen’s esketamine drug recommended by FDA panel for depression
February 13, 2019Research and Development, Sales and Marketing FDA, Janssen, Spravato, depression, esketamine, major depressive disorder, pharma
In a rare and welcomed development in the treatment of major depressive disorder (MDD), Janssen has announced that its esketamine …
FDA to crack down on dietary supplements
February 12, 2019Manufacturing and Production Alzheimer's, Alzheimers, Cancer, Dietary Supplements, FDA, USA, diabetes
The FDA is cracking down on those selling ‘dietary supplements’, having sent warning letters to companies who claim, without proof, …
FDA warns over breast implant cancer risk after nine deaths confirmed
February 8, 2019Medical Communications, Research and Development Cancer, FDA, breast implants, pharma
The FDA has warned against the link between breast implants and anaplastic large cell lymphoma, noting that at least nine …
Top Ten most popular articles on Pharmafile.com this week!
February 8, 2019Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing FDA, GSK, Merck, Pfizer, falsified medicines, strike, top 10
The strike in Ireland featured twice in this week’s top 10 after Pfizer employees in County Cork lost a dispute …
FDA approves first therapy for acquired thrombotic thrombocytopenic purpura: Sanofi’s Cablivi
February 7, 2019Sales and Marketing Calblivi, FDA, Sanofi, acquired thrombotic thrombocytopenic purpura, pharma
Following swiftly on the heels of the previous success with the announcement of positive Phase 3 data for Icaria in …
AstraZeneca scores accelerated approval in US and Europe for respiratory syncytial virus drug
February 5, 2019Manufacturing and Production, Research and Development, Sales and Marketing AstraZeneca, EMA, FDA, MEDI8897, pharma, respiratory syncytial virus
It’s a double victory for AstraZeneca as the company announced its F monoclonal antibody MEDI8897 has been granted accelerated review …
FDA knocks back Alkermes’ opioid-based depression therapy over lack of evidence
February 4, 2019Sales and Marketing Alkermes, FDA, major depressive disorder, pharma, rejection
Alkermes experimental opioid-based depression therapy ALKS 5461 has been rejected by the FDA, it has emerged, in the adjunctive treatment …
Mylan’s Wixela becomes first FDA-approved generic version of GSK’s Advair inhaler
January 31, 2019Sales and Marketing Advair, COPD, FDA, Wixela, asthma, generic, pharma
Mylan’s Wixela has become the first generic version of GlaxoSmithKline’s Advair Diskus (fluticasone propionate and salmeterol inhalation powder) inhaler to …
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Five Facts about cardiovascular disease
