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FDA approval for TherapeuticsMD, one year after initial rejection

May 30, 2018
Sales and Marketing FDA, TherapeuticsMD, biotech, drugs, pharma, pharmaceutical

TherapeuticsMD has succeeded in changing the FDA’s mind on its Imvexxy product, after an initial rejection in May of last …

Insider Interview: Gilead’s fight against HIV comes into bloom

May 30, 2018
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Gilead, HIV, Insider Interview, pharma

Mike Elliott, Vice President of Medical Affairs at Gilead (pictured, right), chats about the company’s sponsorship of a ‘A life …

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Google AI outperforms 58 dermatologists in detecting melanoma

May 30, 2018
Research and Development AI< Google, Cancer, melanoma, pharma, skin cancer

An deep learning artificial intelligence system has demonstrated its ability to outperform over 50 human dermatologists in the detection of …

Envision Pharma Group supports Otsuka’s medical affairs activities

May 30, 2018
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Envision Pharma Group

Envision Pharma Group announces the successful implementation of iEnvision to connect and support Otsuka’s medical affairs activities. Otsuka Pharmaceutical Development …

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AZ’s hopes for Fasenra in COPD suffer terminal blow

May 30, 2018
Research and Development AstraZeneca, Fasenra, GSK, Nucala, biotech, drugs, pharma, pharmaceutical

It looked unlikely that Fasenra would achieve success in the chronic obstructive pulmonary disease (COPD) area, after it suffered in …

allergan

Allergan recalls 170,000 birth control packs in US over pregnancy fears

May 30, 2018
Research and Development Allergan, FDA, Taytulla, US, birth control, pharma

Allergan has issued a voluntary recall of its birth control medication in the US marketplace after an error in packaging …

NHS England uses £10m fund to retain GPs

May 30, 2018
Medical Communications, Research and Development GP, NHS, UK government, biotech, drugs, pharma, pharmaceutical

On the day that news broke, through Pulse, that over a million patients have had to move GP surgery in …

Head of Sandoz UK becomes BGMA chair

May 30, 2018
Manufacturing and Production, Research and Development British Generic Manufacturers Association, biotech, drugs, pharma, pharmaceutical

Tim de Gavre has been announced as the new chair for the British Generic Manufacturers Association (BGMA), a position he …

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One in 25 English children are severely obese by secondary school, study finds

May 29, 2018
Manufacturing and Production, Research and Development England, UK, childhood obesity, obesity, pharma

A new analysis of Public Health England figures by the Local Government Association (LGA) has revealed that one in 25 …

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AB Science will not seek review of masitinib rejection in Europe

May 29, 2018
Manufacturing and Production, Sales and Marketing EMA, Europe, ab science, als, masitinib, pharma

AB Science has U-turned on its pursuit of a do-over on its marketing application of masitinib in Europe after the …

Roche’s Tecentriq/chemo combo smashes both co-primary endpoints at Phase 3

May 29, 2018
Manufacturing and Production, Research and Development Cancer, NSCLC, Roche, immunotherapy, lung cancer, pharma, tecentriq

Roche has lifted the curtain on new Phase 3 data for its anti-PD-L1 cancer immunotherapy Tecentriq (atezolizumab), showing that the …

UCB’s Cimzia secures first-of-its-kind FDA approval in plaque psoriasis

May 29, 2018
Manufacturing and Production, Sales and Marketing Cimzia, FDA, UCB, US, pharma, psoriasis

The FDA has expanded the label for UCB’s Cimzia (certolizumab pegol) in the US, approving the therapy for the treatment …

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J&J terminates PD-(L)1 combo studies of cancer therapy Darzalex

May 29, 2018
Manufacturing and Production, Research and Development Cancer, Genmab, J&J, JJ, Johnson & Johnson, Roche, darzalex, multiple myeloma, tecentriq

Johnson & Johnson is to terminate its studies investigating Genmab’s CD38-targeting, human IgG1κ monoclonal antibody Darzalex (daratumumab) in combination with …

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Top Ten most popular articles on Pharmafile.com this week

May 25, 2018
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Astellas, Cancer, Gielad, Novartis, brexit, obesity, pharma, top ten

It’s a special Firday here in Europe, as today marks the advent of the General Data Protection Regulation (GDPR), an …

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BioMarin receives FDA nod for its would-be blockbuster

May 25, 2018
Medical Communications, Sales and Marketing BioMarin, biotech, drugs, pharma, pharmaceutical

BioMarin is confident that its newly approved treatment for phenylketonuria (PKU) is set to become a blockbuster and it’s priced the …

AZ’s Imfinzi hits second major milestone at Phase 3 in unresectable lung cancer

May 25, 2018
Medical Communications, Research and Development AstraZeneca, Imfinzi, NSCLC, lung cancer, pharma

AstraZeneca and its global biologics R&D MedImmune have lifted the curtain on new Phase 3 data for their immunotherapy Imfinzi …

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Breast cancer screening scandal potentially involves even more women

May 25, 2018
Medical Communications Jeremy Hunt, NHS, biotech, drugs, pharma, pharmaceutical

The news broke at the start of the month that a number of women who should have been invited to …

prothena-37882-2

Prothena guts workforce by more than half, after trial failure

May 25, 2018
Medical Communications Neil Woodford, Prothena, Roche, biotech, drugs, pharma, pharmaceutical

Prothena Therapeutics has acted drastically by slashing staff numbers by more than half, after the failure of two pivotal trials …

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FDA cracks down on benzocaine teething products

May 24, 2018
Sales and Marketing FDA, benzocaine, pharma, teething products

The FDA has put its foot down on over-the-counter teething products for infants and children which contain benzocaine, a pain …

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