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GSK gets FDA approval for key triple therapy inhaler

September 20, 2017
Research and Development, Sales and Marketing GSK, Trelegy Ellipta, biotech, drugs, pharma, pharmaceutical

The good news keeps on rolling in for GSK, with the FDA approval for its triple therapy inhaler.

News
acute_leukemia-all

Roche and AbbVie’s leukaemia combo smashes Phase 3 endpoint

September 19, 2017
Manufacturing and Production, Research and Development AbbVie, Rituxan, Roche, Venclexta, Venclyxto, leukaemia, pharma, pharmaceutical

Venclexta/Venclyxto (venetoclax), Roche and AbbVie’s oral B-cell lymphoma-2 (BCL-2) inhibitor, successfully met its primary endpoint in Phase 3 trials, providing …

News
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Janssen reveals positive CHMP opinion, long-term data for psoriasis drug guselkumab

September 19, 2017
Manufacturing and Production, Research and Development, Sales and Marketing EMA< CHMP, Janssen, guselkumab, pharma, pharmaceuticals

Janssen has announced that its psoriasis drug guselkumab has been awarded a positive opinion by the EMA’s Committee for Medicinal …

News
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FDA locks down combo immunotherapy trials, Roche added to hold

September 19, 2017
Manufacturing and Production, Sales and Marketing Roche, biotech, drugs, immunotherapy, pharma, pharmaceutical, tecentriq

The FDA has moved to ensure that all immunotherapy trials studying PD-1/L1 agents, alongside immunomodulatory medicines in certain blood cancers …

News
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Teva completes sale of women’s health for $1.38 billion

September 19, 2017
Manufacturing and Production, Sales and Marketing Teva, biotech, drugs, pharma, pharmaceutical, women's health

Teva announced last week that it had reached an agreement to sell Paragard, an intrauterine copper contraceptive, to CooperSurgical for …

News
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Swine flu pandemic linked to increased incidence of diabetes

September 19, 2017
Manufacturing and Production, Research and Development biotech, diabetes type 1, drugs, influenza, pharma, pharmaceutical, swine flu

The swine flu pandemic that swept the world in 2009 may have had unforeseen consequences in some populations, after researchers …

News
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Scholar Rock prise Regulatory Affairs director away from Biogen

September 18, 2017
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Scholar Rock, biotech, drugs, pharma, pharmaceutical

Scholar Rock has announced that it has moved to appoint Heather Faulds as Vice President of Regulatory Affairs. Faulds joins …

Appointment
novartis_window

Novartis’ Xolair shows strong retreatment efficacy at Phase 3 in chronic spontaneous urticaria

September 18, 2017
Research and Development, Sales and Marketing Novartis, Xolair, chronic spontaneous urticarial, pharma, pharmaceutical

Novartis has released new data demonstrating the efficacy of Xolair (omalizumab) in the treatment of chronic spontaneous urticaria (CSU), a …

News
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Standing together: Supercharging the clinical trial in Europe

September 18, 2017
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing EMA, biotech, clinical trials, drugs, pharma, pharmaceutical

The European Medicines Agency is on the cusp of rolling out one of the most ground-breaking digital platforms for facilitating …

Feature
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FDA approves first medical app, for use in addiction

September 18, 2017
Sales and Marketing Pear Therapeutics, biotech, drugs, pharma, pharmaceutical, reset

The FDA has taken a major step in the digitisation of healthcare by handing out the first medical app approval: …

News
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China’s Fosun Group grabs 74% stake in India’s Gland Pharma for $1.1 billion

September 18, 2017
Sales and Marketing China, Fosun Pharma, Gland Pharma, India, pharma, pharmaceuticals

Chinese conglomerate Fosun has agreed to acquire 74% of India’s Gland Pharma for $1.1 billion, sealing a previously unsuccessful deal …

News

Bayer lymphoma treatment speeds to FDA approval

September 18, 2017
Sales and Marketing Aliqopa, Bayer, biotech, drugs, pharma, pharmaceutical

The FDA gave Bayer priority review for its treatment Aliqopa (copanlisib) in May of this year, and it quickly came …

News

Santhera ‘surprised’ by European rejection of DMD drug

September 18, 2017
Sales and Marketing Duchenne Muscular Dystrophy, biotech, drugs, pharma, pharmaceutical, santhera

Santhera Pharmaceutical has announced the EMA’s CHMP rejected its treatment for Duchenne muscular dystrophy (DMD) but revealed that it planned …

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

September 15, 2017
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Cosentyx, Eli Lilly, Martin Skreli, Teva, pharma, top ten

This week has been a particularly eventful one for the industry: among our top stories, Martin Shkreli finally heads to …

News

Pfizer receives prostate cancer drug boost with trial results

September 15, 2017
Medical Communications, Research and Development Astellas, Pfizer, Xtandi, biotech, drugs, pharma, pharmaceutical

Pfizer, and its partner Astellas Pharma, received a major boost to its plans for prostate cancer treatment, Xtandi, by announcing …

News
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