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Lilly’s Cyramza hits Phase 3 endpoint in first-line metastatic lung cancer treatment

March 13, 2019
Research and Development Cancer, Eli Lilly, cyramza, lung cancer, pharma

Eli Lilly’s vascular endothelial growth factor (VEGF) Receptor 2 antagonist Cyramza (ramucirumab) has succeeded in hitting its primary endpoint at …

News
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Healthcare industry could take up to five years to stabilise after no-deal Brexit

March 13, 2019
Manufacturing and Production, Medical Communications, Research and Development GlobalData, analysis, brexit, no-deal Brexit, surveys

The healthcare industry could take up to five years to stabilise in the event of a no-deal Brexit, according to …

News
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FDA approve valsartan generic after shortages of supply

March 13, 2019
Manufacturing 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 …

News
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Innate Pharma hires Jennifer Butlers to lead commercialisation of leukaemia drug Lumoxiti

March 12, 2019
Business 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 …

Appointment
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FDA expands Dupixent indication to include moderate-to-severe atopic dermatitis in adolescent patients

March 12, 2019
Manufacturing 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 …

News
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Dr Reddy’s demand more than $70 million from Indivior over generic Suboxone Film

March 12, 2019
Manufacturing 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 …

News
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NICE recommends Janssen’s Darzalex myeloma combo

March 12, 2019
Manufacturing 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 …

News

FDA approves Pfizer’s Herceptin biosimilar Trazimera

March 12, 2019
Manufacturing 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 …

News

Scottish Medicines Consortium rejects Novartis’ CAR T therapy Kymriah

March 12, 2019
Manufacturing 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 …

News

PV futures: Pharmacovigilance as a solution to the challenges of tomorrow

March 11, 2019
Business 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 …

Feature

FDA approves first diagnostic tool to target triple-negative breast cancer patients

March 11, 2019
Sales 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 …

News

AMAG Pharmaceuticals’ shares fall 21% after failed Makena trial

March 11, 2019
Sales 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 …

News

FDA advisory panel recommends Sanofi’s dengue vaccine in children, but rejects its use in adults

March 11, 2019
Sales 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 …

News

US DoJ launch investigation into Acadia Pharmaceuticals

March 11, 2019
Sales 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 …

News

23andMe to offer genetic reports on diabetes

March 11, 2019
Sales 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 …

News
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FDA Commissioner Scott Gottlieb announces resignation

March 8, 2019
Business 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 …

Appointment
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Measles cases in Greater Manchester surge to 32 since January, lack of vaccination blamed

March 8, 2019
Medical 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 …

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

March 8, 2019
Business 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’ …

News

Monthly injections offer similar efficacy to daily pills in HIV phase 3 trials

March 8, 2019
Medical 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, …

News

Roche’s Tecentriq combo scoops up European approval in first-line metastatic lung cancer

March 8, 2019
Medical 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 …

News
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