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Showing 15 posts of 1442 posts found.

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FDA ask MSD to join blockchain supply chain network

June 14, 2019
Medical 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 …

News
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Catalyst Pharma sues FDA after agency approves Jacobus’ LEMS drug

June 13, 2019
Business 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 …

News
fda2outsideweb

FDA advisory panel backs TB Alliance’s tuberculosis regimen

June 10, 2019
Sales 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 …

News
scott_gottlieb

Former FDA Commissioner returns to venture capital firm

June 4, 2019
Business 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 …

Appointment
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Top Ten most popular articles on Pharmafile.com this week!

May 31, 2019
Business 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 …

News
celgene_building

FDA first as agency expands label on Celgene’s Revlimid in previously treated follicular or marginal zone lymphoma

May 29, 2019
Research 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 …

News

FDA approves Theranica’s smartphone-controlled electroceutical device for migraine

May 29, 2019
Research 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 …

News
novartis_side_building

FDA approves first therapy PIK3CA-mutated HR+/HER2- advanced breast cancer

May 28, 2019
Manufacturing 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 …

News
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Novartis’ $2.15m SMA drug Zolgensma becomes most expensive FDA-approved therapy

May 28, 2019
Manufacturing 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 …

News
spravato

Janssen’s argues for the cost-effectiveness of Spravato in treatment-resistant depression

May 23, 2019
Sales 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 …

News

Children wait six and half years longer than adults for new cancer drugs, study says

May 22, 2019
Research 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 …

News

Pfizer’s Fragmin injection secures FDA approval in paediatric symptomatic venous thromboembolism

May 17, 2019
Medical 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 …

News

FDA greenlights Roche and AbbVie’s Venclexta for chronic lymphocytic leukaemia

May 16, 2019
Sales and Marketing AbbVie, Cancer, FDA, Roche, Venclexta, leukaemia, pharma

Venclexta (venetoclax), the oral B-cell lymphoma-2 (BCL-2) inhibitor co-developed by AbbVie and Roche, has been approved by the FDA in …

News
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Two Daiichi Sankyo drugs dealt a thumbs up and thumbs down by FDA advisory panel

May 15, 2019
Research and Development, Sales and Marketing Daiichi Sankyo, FDA, pexidartinib, pharma, quizartinib

Daiichi Sankyo was left with a bittersweet taste in its mouth after it saw one of its drugs recommended for …

News

Pfizer & Merck’s Inlyta combo becomes first FDA-approved anti-PD-L1 therapy for kidney cancer

May 15, 2019
Research and Development, Sales and Marketing FDA, Merck KGaA, Pfizer, inylta, pharma, renal cell carcinoma

The FDA has approved Bavencio (avelumab) in combination with Inlyta (axitinib) for the treatment of advanced renal cell carcinoma (RCC). …

News
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