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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
scott_gottlieb

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
vaccination_2

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

Dutch pharmacists to circumvent Novartis cancer drug market exclusivity

March 8, 2019
Medical 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, …

News
alessandro_riva

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
gilead-sciences

Gilead’s Biktarvy maintains HIV suppression for 48 weeks in children and adolescents

March 7, 2019
Research and Development Biktarvy, Gilead, HIV, pharma

Gilead has lifted the curtain on new Phase 2/3 efficacy data for Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 …

News
scotland-2016-aerial-clackmannan_tower_01

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
allergan

Allergan’s depression drug rapastinel fails to outperform placebo at Phase 3

March 7, 2019
Research and Development Allergan, FDA, depression, major depressive disorder, pharma, rapastinel

As Janssen celebrated the FDA approval of the first novel therapy for depression in three decades with Spravato, Allergan released …

News
nhs_andrew_tatlow

Public satisfaction with NHS falls to lowest point since 2007

March 7, 2019
Medical Communications England, King's, NHS, Nuffield, Scotland, UK, Wales, kings, public stisfaction

Public satisfaction with the NHS has fallen to lowest levels since 2007, according to analysis of the 2018 British Social …

News
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Médecins Sans Frontières (MSF)/ Doctors Without Borders calls on CEPI to revise ‘toothless’ access policy

March 6, 2019
Sales and Marketing CEPI, MSF, access, public health, tokyo, vaccines

The humanitarian organisation Médecins Sans Frontières (MSF) has called on The Coalition for Epidemic Preparedness Innovations (CEPI) to revise their …

News
scott_gottlieb

FDA Commissioner Scott Gottlieb announces resignation

March 6, 2019
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing FDA, Scott Gottlieb, opioid crisis, pharma

Dr Scott Gottlieb, the 23rd Commissioner of the US Food and Drug Administration (FDA), stoked surprise throughout the industry with …

News
16854249705_06b9d59c29_z

Indian measles vaccination campaign saved tens of thousands of lives

March 6, 2019
Research and Development Asia, India, South Asia, infectious diseases, measles, vaccines

A measles vaccination campaign saved tens of thousands of children’s lives in India between 2010 and 2013, according to a …

News
spravato

Janssen’s party drug-based nasal spray becomes first new FDA-approved depression treatment in 30 years

March 6, 2019
Research and Development, Sales and Marketing Janssen, Spravato, depression, esketamine, pharma

The field of depression therapy has seen its biggest leap forward in over three decades, the FDA approval of Janssen’s …

News
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