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Navigating the new Clinical Trial Regulation with DIA

November 14, 2017
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing biotech, dia, drugs, pharma, pharmaceutical

For those stakeholders involved with clinical trials in Europe, the new Clinical Trial Regulation to be introduced in 2019 will …

News
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Boehringer celebrates EU approval of Humira biosimilar

November 14, 2017
Manufacturing and Production, Sales and Marketing Boehringer, Boehringer Ingelheim, Cyltezo, EU, Europe, European Commission, Humira, biosimilar

Boehringer Ingelheim has announced that Cyltezo, its biosimilar of Abbvie’s Humira, has received marketing authorisation approval from the European Commission, …

News
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Novartis targets specific patient population with strong Ilaris Phase 3 data

November 14, 2017
Manufacturing and Production, Research and Development Ilaris, Novartis, cardiovascular, heart attack, heart disease, pharma

Novartis has presented new Phase 3 data on its cardiovascular drug Ilaris (canakinumab) which demonstrate particular efficacy in a specific …

News
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Pfizer creates COO role so CEO Ian Read can focus on deal-making

November 14, 2017
Manufacturing and Production, Sales and Marketing Image Credit: Pfizer

In a sizeable shake-up of its business operations, Pfizer has promoted Albert Bourla (pictured) to the role of Chief Operating …

News
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Ex-Lilly exec Trump’s nominee for health secretary

November 14, 2017
Manufacturing and Production, Medical Communications Alex Azar, Donald Trump, biotech, drugs, pharma, pharmaceutical

Alex Azar is officially President Trump’s nominee for the position as head of the Health and Human Services (HHS) agency, …

News

Hansa Medical mourns death of CEO

November 13, 2017
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Hansa Medical, pharma

Swedish biopharma firm Hansa Medical broke tragic and unexpected news in November when it announced the death of its CEO …

Appointment
1707_eu-agencies_relocations_website

EMA Headquarters: There’s no place like home

November 13, 2017
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing EMA, biotech, brexit, drugs, pharma, pharmaceutical

With the result of the Brexit referendum, the future of the EMA’s London headquarters was cast in doubt. Now, 19 …

Feature
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Mylan to withdraw from Tel Aviv Stock Exchange

November 13, 2017
Sales and Marketing Mylan, TASE, pharma

US drug maker Mylan has announced its intention to withdraw from the Tel Aviv Stock Exchange (TASE), ending its involvement …

News
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Novartis touts longer-lasting AMD rival to Eylea

November 13, 2017
Research and Development, Sales and Marketing biotech, drugs, pharma, pharmaceutical

Novartis posted strong results for its wet age-related macular degeneration (AMD) drug, by showing superiority against Eylea in Phase 3 …

News
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EMA recommends approval of Roche’s Ocrevus in relapsing forms of multiple sclerosis

November 13, 2017
Sales and Marketing MS, Ocrevus, Roche, multiple sclerosis, pharma

Roche has revealed that its humanised monoclonal antibody Ocrevus (ocrelizumab) received a positive recommendation from the Committee for Medical Products …

News
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UK rates of obesity increased by 92% over two decades

November 13, 2017
Research and Development, Sales and Marketing OECD, biotech, drugs, obesity, pharma, pharmaceutical

A recent report by the OECD shares concerns that the UK’s overall health looks set to face a crisis due …

News
nigeria

Nigerian agency strongly contests that 70% of drugs are fake

November 13, 2017
Manufacturing and Production, Sales and Marketing Nigeria, biotech, drugs, pharma, pharmaceutical, pwC

Nigeria’s drug regulatory body has fiercely countered claims made by Chief Economist of PwC in West Africa, Andrew Nevin, that …

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

November 10, 2017
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing pharmafile, top ten

Friday again, and we bring you the most read articles on our site this week – one of which was …

News
dynavax

Hep-B vaccine four-year battle for FDA approval is finally won

November 10, 2017
Medical Communications, Sales and Marketing biotech, drugs, dynavax, hepatitis B, pharma, pharmaceutical

Dynavax had said it was the last throw of the dice for its hepatitis B vaccine, Hepislav-B – the data …

News
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Sanofi signs $805 million deal for MS drug

November 10, 2017
Medical Communications, Sales and Marketing Principia Biopharma, Sanofi, biotech, drugs, pharma, pharmaceutical

Sanofi has decided to build its pipeline in neurological disorders with the agreement to develop Principia Biopharma’s BTK inhibitor candidate …

News
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Breast cancer recurrence can occur up to 20 years after treatment, report shows

November 10, 2017
Medical Communications, Research and Development Cancer, breast cancer, pharma, tamoxifen

New findings from the Early Breast Cancer Trialists’ Collaborative Group have demonstrated that oestrogen receptor-positive (ER-positive) breast cancer is able …

News
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Sage scores good but not great P3 postpartum depression drug results

November 10, 2017
Medical Communications, Research and Development Sage Therapeutics, biotech, drugs, pharma, pharmaceutical

Sage Therapeutics share price soared 50% on the release that its two Phase 3 trials of brexanolone showed statistically significant …

News

Recipharm Interim report January – September 2017

November 9, 2017
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Recipharm

Interim report January – September 2017 July – September 2017    

News
Press release

Recipharm to end operations in two facilities in Sweden

November 9, 2017
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Recipharm

Recipharm today announces that it will initiate a process with the intention of discontinuing manufacturing operations at its facilities in …

News
Press release
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NHS England seals access deals with big pharma for breast cancer and MS

November 9, 2017
Sales and Marketing Cancer, Mavenclad, Merck, NHS, NHS England, NICE, Perjeta, Roche, Simon Stevens, breast cancer, multiple sclerosis

NHS England has entered into a commercial agreement with Merck which aims to provide access to innovative treatments for both …

News
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