FDA
MSD’s Keytruda snatches up first approval in small cell lung cancer
June 19, 2019Research and Development, Sales and Marketing Cancer, FDA, MSD, US, keytruda, lung cancer, pharma
MSD has revealed that its anti-PD-1 immunotherapy Keytruda (pembrolizumab) has been awarded marketing authorisation from the FDA as a monotherapy …
FDA expand Paragraph IV Patent Certifications List for generic drugmakers
June 19, 2019Research and Development FDA, Hatch-Waxman act, generic drugs, generics, pharma
The FDA has said that it is expanding a database used by generic drugmakers to get information on when their …
Patient dies after receiving faecal transplant
June 17, 2019Sales and Marketing Adverse Event, E.Coli. AMR, FDA, faecal transplant, pharma
A person has died after experiencing an adverse event related to a faecal transplant. The FDA has warned that two …
FDA ask MSD to join blockchain supply chain network
June 14, 2019Medical Communications FDA, MSD, Merck, blockchain, supply chain
The FDA has asked MSD to join a shared permission blockchain network to help track and trace prescription medicines and …
Catalyst Pharma sues FDA after agency approves Jacobus’ LEMS drug
June 13, 2019Business Services, Manufacturing and Production FDA, Jacobus, catalyst, firdapse, pharma, ruzurgi
Florida firm Catalyst Pharmaceuticals is suing the FDA after the agency approved a rival’s drug. The lawsuit alleges the approval …
FDA advisory panel backs TB Alliance’s tuberculosis regimen
June 10, 2019Sales and Marketing FDA, TB Alliance, US, pharma, tuberculosis
An FDA advisory panel has voted to recommend the investigational drug pretomanid, developed by the non-profit organisation TB Alliance, as …
Former FDA Commissioner returns to venture capital firm
June 4, 2019Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing FDA, Scott Gottlieb, appointment, pharma
Dr Scott Gottlieb, former Commissioner for the FDA, has returned to his venture capital background with the announcement that he …
Top Ten most popular articles on Pharmafile.com this week!
May 31, 2019Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing China, FDA, GSK, Novartis, Pfizer, environment, opioids, pharma, pricing
The pharmaceutical industry is a big polluter than the automotive industry. This was our top story this week. The findings …
FDA first as agency expands label on Celgene’s Revlimid in previously treated follicular or marginal zone lymphoma
May 29, 2019Research and Development, Sales and Marketing Cancer, Celgene, FDA, Revlimid, lymphoma, pharma
Celgene has revealed that the FDA has expanded its authorised indications of Revlimid (lenalidomide) to include combination with a rituximab …
FDA approves Theranica’s smartphone-controlled electroceutical device for migraine
May 29, 2019Research and Development FDA, Nerivio Migra, Theranica, migraine, pharma
Biomedical tech company Theranica has secured FDA approval for Nerivio Migra, its wearable, smartphone-controlled electroceutical device, for the acute treatment …
FDA approves first therapy PIK3CA-mutated HR+/HER2- advanced breast cancer
May 28, 2019Manufacturing and Production, Sales and Marketing Cancer, FDA, Novartis, Piqray, breast cancer, fulvestrant, pharma
Novartis’ Piqray (alpelisib) has secured approval from the FDA in combination with AstraZeneca’s Faslodex (fulvestrant) for the treatment of hormone …
Novartis’ $2.15m SMA drug Zolgensma becomes most expensive FDA-approved therapy
May 28, 2019Manufacturing and Production AveXis, FDA, Zolgensma, access, drugs, pricing, sma
The FDA has approved Novartis subsidiary AveXis’ $2.15 million gene therapy Zolgensma for children with spinal muscular atrophy (SMA). The …
Janssen’s argues for the cost-effectiveness of Spravato in treatment-resistant depression
May 23, 2019Sales and Marketing FDA, Janssen, depression, major depressive disorder, pharma, treatment-resistant depression
Janssen has unveiled a new cost-effectiveness analysis for its recently FDA-approved nasal spray Spravato (esketamine) in the treatment of treatment-resistant …
Children wait six and half years longer than adults for new cancer drugs, study says
May 22, 2019Research and Development Cancer, FDA, children, oncology, paediatrics, pharma
Children wait six and half years longer than adults to access new cancer drugs, according to a study from Dana-Farber/Boston …
Pfizer’s Fragmin injection secures FDA approval in paediatric symptomatic venous thromboembolism
May 17, 2019Medical Communications, Sales and Marketing FDA, Fragmin, Pfizer, pharma
The FDA has announced its approval of Pfizer’s anticoagulant injection Fragmin (dalteparin sodium) for subcutaneous use as a treatment to …
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Five Facts about cardiovascular disease
