Research and Development

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Two Daiichi Sankyo drugs dealt a thumbs up and thumbs down by FDA advisory panel

May 15, 2019 Research and Development, Sales and Marketing Daiichi Sankyo, FDA, pexidartinib, pharma, quizartinib

Daiichi Sankyo was left with a bittersweet taste in its mouth after it saw one of its drugs recommended for …

Pfizer & Merck’s Inlyta combo becomes first FDA-approved anti-PD-L1 therapy for kidney cancer

May 15, 2019 Research and Development, Sales and Marketing FDA, Merck KGaA, Pfizer, inylta, pharma, renal cell carcinoma

The FDA has approved Bavencio (avelumab) in combination with Inlyta (axitinib) for the treatment of advanced renal cell carcinoma (RCC). …

NHS England agree to pay for Biogen’s $750,000 a year SMA treatment Spinraza

May 15, 2019 Research and Development Biogen, NHS England, Spinraza, UK, pharma, sma, spinal muscular atrophy

NHS England has agreed to pay an undisclosed price for Biogen’s spinal muscle atrophy (SMA) treatment Spinraza. England’s National Health …
gilead-sciences

Gilead struck anti-competitive deals to retain dominance in HIV market, lawsuit says

May 15, 2019 Research and Development AIDS, BMS, Gilead, HIV, Janssen, generic drugs

Gilead Sciences struck anti-competitive deals with Janssen and Britsol-Myers Squibb in an effort to retain dominance in the market for …
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Medical Affairs 2025 – Excellence in the era of precision medicine

May 15, 2019 Medical Communications, Research and Development pharma, veeva

Medical affairs is at the leading edge of a trend. As the life sciences industry shifts towards precision medicine, its …

Ex-GSK, Novartis exec named as Mundipharma’s Head of Access

May 14, 2019 Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Mundipharma, appointment, pharma

Mundipharma has announced that Jerome Moreau has joined the company as its new Head of Market Access. Moreau has amassed …
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Prophylactic antibiotic use could halve post-birth maternal infections, study indicates

May 14, 2019 Manufacturing and Production, Research and Development Antibiotics, University of Oxford, pharma

A study led by researchers at the University of Oxford has argued that the administration of preventative antibiotics to all …
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FDA to end controversial “alternative summary reporting” of medical devices in bid to boost transparency

May 10, 2019 Medical Communications, Research and Development, Sales and Marketing FDA, US, adverse events, medical devices, pharma

The FDA has revealed that it plans to terminate its “alternative summary reporting” programme which has allowed the manufacturers of …
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Top Ten most popular articles on Pharmafile.com this week!

May 10, 2019 Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Eli Lilly, GSK, Innoviva, NHS, Novartis, health, migraine, pharma

This week was a particularly bad one for the NHS after it was revealed thousands of EU nurses were leaving …

BMS blockbuster Opdivo falls short at Phase 3 in MGMT-unmethylated glioblastoma multiforme

May 10, 2019 Medical Communications, Research and Development BMS, Bristol-Myers Squibb, glioblastoma multiforme, pharma, trial failure

Bristol-Myers Squibb’s blockbuster immunotherapy Opdivo (nivolumab) has hit a hurdle, failing its primary endpoint in a Phase 3 trial investigating …
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Common diabetes drugs have been linked to a ‘flesh-eating’ genital infection

May 9, 2019 Medical Communications, Research and Development FG, diabetes, gangrene, health, necrotizing fasciitis

Patients taking some newer diabetes medications – SGLT2 inhibitors – have been warned that they may be at risk of …

Pfizer scores conditional European approval in ALK-positive lung cancer with Lorviqua

May 8, 2019 Research and Development Cancer, Europe, Lorviqua, NSCLC, Pfizer, lung cancer, pharma

Pfizer’s Lorviqua (lorlatinib), or Lorbrena as it is known in the US, Canada and Japan, has just been awarded conditional …
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Eli Lilly’s Emgality shows positive Phase 3 results in treatment of migraine

May 8, 2019 Research and Development Eli Lilly, Emgality, cluster headache, headache, migraine, pharma

Eli Lilly has announced positive results from the Phase 3 EVOLVE-1 and EVOLVE-2 trials looking into Emgality (galcanezumab-gnlm) for the …
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AZ ends Calquence trial early after Phase 3 success in chronic lymphocytic leukaemia

May 8, 2019 Research and Development AstraZeneca, Calquence, pharma

AstraZeneca has unveiled new Phase 3 data on the efficacy of its Bruton tyrosine kinase (BTK) inhibitor Calquence (acalabrutinib) in …
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