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National Cancer Institute Director Ned Sharpless to become interim FDA Commissioner

March 13, 2019 Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing FDA, Ned Sharpless, Scott Gottlieb, appointment, pharma

Following the surprise resignation of current FDA Commissioner Dr Scott Gottlieb a week earlier, Dr Norman ‘Ned’ Sharpless, Director of …
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

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

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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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

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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Glenmark spinoff name Gilead VP Alessandro Riva as new CEO

March 7, 2019 Business 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 …
Appointment
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Scottish biotech secures initial orders for HIV diagnosis kit from Indonesia, Moldova and Papua New Guinea

March 7, 2019 Business Services, Medical Communications, Research and Development, Sales and Marketing Diagnostics, HIV, Indonesia, Moldova, Scotland, developing coutnries

A small biotech based in Clackmannanshire, Scotland expects to turnover an additional £20 million from sales of its HIV diagnostics …
News
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