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AZ’s Tagrisso extends median overall survival by over 3 years in metastatic, EGFR-mutated lung cancer

September 30, 2019
Research and Development, Sales and Marketing AstraZeneca, Cancer, ESMO 2019, Tagrisso, lung cancer, pharma

AstraZeneca took to the stage at the 2019 European Society for Medical Oncology (ESMO) Congress in Barcelona to present new …

Roche secures US paediatric approval for Rituxan in two rare forms of vasculitis

September 30, 2019
Sales and Marketing MabThera, Rituxan, Roche, pharma, vasculitis

Roche has revealed that Rituxan (rituximab), also known as MabThera, has been awarded US approval from the FDA in combination …

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Top Ten most popular articles on Pharmafile.com this week

September 27, 2019
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing pharma, top ten

Another week comes to a close, and it’s time to review the biggest stories of the week. Check out the …

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Takeda’s Entyvio outperforms AbbVie’s Humira in moderate-to-severe ulcerative colitis

September 27, 2019
Medical Communications, Research and Development AbbVie, Entyvio, Humira, Takeda, pharma, ulcerative colitis

Takeda has released strong new data for Entyvio (vedolizumab), showing that the gut-selective biologic outperformed AbbVie’s blockbuster anti-tumour necrosis factor-alpha …

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AbbVie’s Mavyret scores FDA label expansion to shorten treatment duration for hepatitis C patients

September 27, 2019
Medical Communications, Sales and Marketing AbbVie, FDA, hepatitis, hepatitis C, mavyret, pharma

The FDA has chosen to expand the existing label for AbbVie’s Mavyret (glecaprevir/pibrentasvir), it has been revealed, to include the …

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FDA approves Genmab’s Darzalex combo in newly diagnosed multiple myeloma

September 27, 2019
Medical Communications, Sales and Marketing FDA, Genmab, darzalex, pharma

Genmab’s CD38 inhibitor Darzalex (daratumumab) has been awarded marketing authorisation from the FDA in combination with bortezomib, thalidomide and dexamethasone …

Iran reveals plans to domestically produce 135 strategic drugs

September 26, 2019
Manufacturing and Production Iran, pharma, production

Iran has announced plans to promote self-sufficiency within the country with regard to its medicines production, with an aim of …

NICE shoots down Novartis’ migraine drug Aimovig outside of Scotland

September 26, 2019
Sales and Marketing Aimovig, NICE, Novartis, UK, migraine, pharma

NICE has announced its decision to reject Novartis’ drug Aimovig (erenumab) for use on the NHS in England and Wales …

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Takeda’s investigational therapy shows promise as cytomegalovirus treatment

September 25, 2019
Research and Development, Sales and Marketing Takeda, cytomegalovirus, maribavir, pharma

New Phase 2 data has been released on Takeda’s investigational antiviral therapy TAK-620 (maribavir) in patients with cytomegalovirus (CMV) infection …

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EMA’s CHMP recommends new dosing schedule for Opdivo in melanoma

September 25, 2019
Research and Development, Sales and Marketing BMS, Bristol-Myers Squibb, CHMP, EMA, melanoma, opdivo, pharma

Bristol-Myers Squibb has revealed that its blockbuster immunotherapy drug Opdivo (nivolumab) has secured recommendation from the EMA’s Committee for Medicinal …

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Celltrion’s subcutaneous infliximab biosimilar secures CHMP recommendation

September 24, 2019
Manufacturing and Production, Sales and Marketing EMA, EU, Europe, biosimilar, celltrion, infliximab, pharma

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has given its recommendation to Celltrion’s CT-P13 SC, the subcutaneous …

Bayer’s Vitravki becomes first EU-approved tumour-agnostic therapy

September 24, 2019
Manufacturing and Production, Research and Development, Sales and Marketing Bayer, Cancer, Vitravki, pharma

Bayer has announced that its tyrosine receptor kinase (TRK) inhibitor Vitrakvi (larotrectinib) has scored approval from the European Commission for …

Living with acute myeloid leukaemia

September 23, 2019
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing acute myeloid leukaemia, feature, patient experience, pharma

Steve Rothberg was blindsided by an AML diagnosis that progressed rapidly with little warning. Ten years later, he discusses his …

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Bluebird bio’s Lenti-D gene therapy shows promise in cerebral adrenoleukodystrophy

September 23, 2019
Research and Development, Sales and Marketing Bluebird Bio, cerebral adrenoleukodystrophy, gene therapy, pharma

Bluebird bio has revealed updated data for its investigational Lenti-D gene therapy in the treatment of cerebral adrenoleukodystrophy (CALD), a …

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Japan approves Astellas and FibroGen’s Evrenzo for anaemia in dialysis patients

September 23, 2019
Sales and Marketing Astellas, anaemia, fibrogen, pharma

Astellas Pharma and FibroGen have revealed that their collaborative drug Evrenzo (roxadustat) has secured marketing authorisation in Japan for the …

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