FDA approve valsartan generic after shortages of supply
March 13, 2019Manufacturing and Production, Research and Development FDA, blood pressure drugs, cardiovascular, generic, valsartan
The FDA has approved a new generic version of blood pressure drug valsartan. The approval comes amid shortages in supply …
Innate Pharma hires Jennifer Butlers to lead commercialisation of leukaemia drug Lumoxiti
March 12, 2019Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing
French company Innate Pharma have announced the appointment of Jennifer Butler to the position of Executive Vice President and General …
FDA expands Dupixent indication to include moderate-to-severe atopic dermatitis in adolescent patients
March 12, 2019Manufacturing and Production, Sales and Marketing Dupixent, Regeneron, Sanofi, pharma
Partners Sanofi and Regeneron have both revealed that their jointly developed drug Dupixent (dupilumab) has been authorised by the FDA …
Dr Reddy’s demand more than $70 million from Indivior over generic Suboxone Film
March 12, 2019Manufacturing and Production Dr Reddy's, Suboxone Film, court, indivior, opioid addiction
Indian firm Dr Reddy’s is seeking at least $70 million from British firm Indivior Plc as compensation for lost sales …
NICE recommends Janssen’s Darzalex myeloma combo
March 12, 2019Manufacturing and Production Janssen, NICE, Velcade, darzalex, myeloma
Britain’s cost effectiveness body NICE have recommended Janssen Pharmaceutical’s Darzalex in combination with Velcade and dexamethasone (DVd), for use within …
FDA approves Pfizer’s Herceptin biosimilar Trazimera
March 12, 2019Manufacturing and Production, Sales and Marketing Humira, Pfizer, Trazimera, biosimilar, pharma
Patients in the US will now be able to access another biosimilar version of Herceptin (trastuzumab) with the FDA approval …
Scottish Medicines Consortium rejects Novartis’ CAR T therapy Kymriah
March 12, 2019Manufacturing and Production Kymriah, NICE, Novartis, SMC, Scotland, UK
Scotland’s cost effectiveness body has refused to fund Novartis’ CAR T therapy Kymriah for adult patients with lymphoma. The Scottish …
PV futures: Pharmacovigilance as a solution to the challenges of tomorrow
March 11, 2019Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing drug safety, feature, pharma, pharmacovigilance
Louis Goss asks what the future might hold for the safety of pharmaceuticals and looks into why crucial pharmacovigilance practices …
FDA approves first diagnostic tool to target triple-negative breast cancer patients
March 11, 2019Sales and Marketing Cancer, Roche, Ventana, breast cancer, pharma
Roche’s Ventana PD-L1 Assay has become the first FDA-approved companion diagnostic for the identification of patients with triple-negative breast cancer …
AMAG Pharmaceuticals’ shares fall 21% after failed Makena trial
March 11, 2019Sales and Marketing AMAG Pharmaceuticals, Makena, PROLONG, birth, trials
AMAG Pharmaceuticals’ Makena (hydroxyprogesterone caproate) has failed to meet its co-primary endpoints in a trial of patients with a history …
FDA advisory panel recommends Sanofi’s dengue vaccine in children, but rejects its use in adults
March 11, 2019Sales and Marketing FDA, Sanofi, US, Vaccine, dengue, dengvaxia, pharma
Dengvaxia, Sanofi’s vaccine for dengue fever, has been burdened with further negative scrutiny after the FDA’s vaccine advisory panel passed …
US DoJ launch investigation into Acadia Pharmaceuticals
March 11, 2019Sales and Marketing False Claims Act, SEC, acadia, antipsychotics, kickbacks
The US Department of Justice has launched an investigation into the sales and marketing practices of San Diego firm Acadia …
23andMe to offer genetic reports on diabetes
March 11, 2019Sales and Marketing 23andME, Genentech, GlaxoSmithKline, Lundbeck, diabetes, genetics, genomics
Personal genomics company, 23andMe will offer customers information on the likelihood that they are genetically predisposed to developing type 2 …
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 …
Measles cases in Greater Manchester surge to 32 since January, lack of vaccination blamed
March 8, 2019Medical Communications Europe, MMR, UK, WHO, measles, pharma, vaccines
There has been a sharp increase in cases of measles across Greater Manchester, Public Health England has warned, following increasingly …
Top Ten most popular articles on Pharmafile.com this week!
March 8, 2019Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing AbbVie, Biogen, Gilead, HIV, Novartis, Scott Gottlieb, top 10
HIV hit the headlines this week after it was announced that a British man known only as the ‘London Patient’ …
Monthly injections offer similar efficacy to daily pills in HIV phase 3 trials
March 8, 2019Medical Communications ATLAS, GSK, HIV, ViiV, flair, injectable
A long acting, injectable two drug regimen developed by Pfizer and GSK joint venture ViiV Healthcare and J&J subsidiary Jannsen, …
Roche’s Tecentriq combo scoops up European approval in first-line metastatic lung cancer
March 8, 2019Medical Communications, Sales and Marketing Cancer, Europe, European Commission, NSCLC, Roche, lung cancer, pharma
Roche has announced the approval of the European Commission for its PD-L1 inhibitor Tecentriq (atezolizumab) when used in combination with …
Dutch pharmacists to circumvent Novartis cancer drug market exclusivity
March 8, 2019Medical Communications Bruno Bairns, Cancer, Luathera, Novartis, aaa
Dutch pharmacists have vowed to circumvent rules enforcing Novartis’ market exclusivity for radioactive cancer drug Lutathera. Pharmacists at Erasmus, …
Glenmark spinoff name Gilead VP Alessandro Riva as new CEO
March 7, 2019Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing
Gilead’s Dr Alessandro Riva, is stepping down from his position as the company’s Executive Vice President, Oncology Therapeutics to head …
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