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Keytruda scores ground-breaking European approval in lung cancer subgroup

September 10, 2018
Sales and Marketing Cancer, EU, Europe, MSD, Merck, NSCLC, keytruda, lung cancer, pharma

Keytruda (pembrolizumab) has chalked up yet another approval for MSD, this time in Europe in combination with permextred and platinum-based …

News

GSK’s Nucala data insufficient for US COPD approval

September 10, 2018
Sales and Marketing COPD, FDA, GSK, Nucala, US, pharma

GlaxoSmithKline has suffered a regulatory blow in the label expansion of its interleukin-5 (IL5) inhibitor Nucala (mepolizumab), with the FDA …

News

Akcea cuts 10% of staff following FDA rejection

September 10, 2018
Manufacturing and Production, Sales and Marketing Akcea, FDA, Waylivra, pharma

Akcea Therapeutics has been hit hard by the FDA’s decision to reject its drug Waylivra (volanesorsen) for the treatment of …

News

NICE rejects Roche’s Ocrevus in primary progressive multiple sclerosis

September 10, 2018
Sales and Marketing NICE, Ocrevus, Roche, UK, multiple sclerosis, pharma

Of the 100,000 MS patients in England, around one in eight have the primary progressive form (PPMS), which brings debilitating …

News
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UK Government to invest £200m in IT and technology boost for NHS

September 7, 2018
Medical Communications, Sales and Marketing AI, Matt Hancock, NHS, NHS expo, pharma

The UK Government has lifted the curtain on plans invest more than £200 million to leverage innovations in technology and …

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

September 7, 2018
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing EMA, MHRA, Trump, brexit, research, scandal, top 10

Brexit took the top two spots this week after it was revealed that the EMA has awarded Britain’s MHRA just …

News
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BC Liberal criticises opioid lawsuit for focusing too heavily on drugmakers

September 7, 2018
Medical Communications

The British Columbia Liberal opposition Critic for Mental Health and Addictions has tweeted that the lawsuits seeking damages from pharmaceutical …

News
gilead-sciences

Gilead and Galapagos’ ankylosing spondylitis drug hits Phase 2 trial goal

September 7, 2018
Medical Communications, Research and Development Galapagos, Gilead, ankylosing spondylitis, filgotinib, pharma

Gilead and Galapagos have announced that their jointly-developed selective JAK1 inhibitor filgotinib has met its primary endpoint in a Phase …

News
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FDA recruitment official says Trump’s policies are making hiring difficult

September 7, 2018
Medical Communications FDA, Trump, US, hiring, recruitment

Melanie Keller, Acting Associate Commissioner for Scientific and Clinical Recruitment at the US Food and Drug Administration (FDA) has said …

News
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Rheos Medicines appoints Roche Senior Vice President and R&D head as new CEO

September 6, 2018
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Amgen, CEO, Roche, cembridge, massachussets, rheos, sanjay keswani

The Cambridge Massachusetts-based biopharmaceutical company Rheos Medicines has appointed former Roche Senior Vice President and Global R&D Head, Dr Sanjay …

Appointment
pshezhetskiy

A rational new approach to cancer treatment

September 6, 2018
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Cancer, University of East Anglia, feature, pharma

Researchers at the University of East Anglia have developed a new targeted cancer therapy which utilises nanoparticles to deliver treatment …

Feature

Novartis sells key Sandoz US portfolios to Aurobindo for $1bn

September 6, 2018
Sales and Marketing Aurobindo, Novartis, Sandoz, pharma

Novartis has revealed it is to sell the dermatology and generic US oral solids portfolios of its generics arm Sandoz …

News
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Teva drops MS and Huntington’s disease drug laquinimod, leaving rights to Active Biotech

September 6, 2018
Medical Communications, Research and Development Active Biotech, Laquinimod, Teva, pharma

Israeli multinational Teva Pharmaceutical has decided to discontinue the development of laquinimod. As such, all rights for the orally administered …

News
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WHO ship 500 tons of medicine to Yemen

September 6, 2018
Manufacturing and Production Sanaa, WHO, Yemen, middle east, sana'a, war

The World Health Organisation (WHO) has airlifted more than 500 tons of medicines to Yemen over the previous month in …

News
gsk_boronia_australia

GSK to axe 650 positions across US workforce

September 6, 2018
Manufacturing and Production GSK, GlaxoSmithKline, pharma

GlaxoSmithKline has announced its intention to cut 650 employees from its current US workforce, with the cutbacks coming as part …

News
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Ketamine’s antidepressant effects may be linked to brain’s opioid system

September 6, 2018
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Ketamine, antidepressant, depression, mental health, opioid

Ketamine’s antidepressant effect works through the activation of the brains opioid receptors, a new study published in The American Journal …

News
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Agios appoints Celgene’s Jacqualyn Fouse as new CEO

September 5, 2018
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing CEO, COO, Celgene, Jacqualyn Fouse, agios

The Massachusetts-based oncology specialist Agios Pharmaceuticals has appointed former Celgene President and COO Jacqualyn Fouse as their new Chief Executive …

Appointment
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FDA turns to real-world evidence to improve regulatory process

September 5, 2018
Medical Communications, Research and Development, Sales and Marketing FDA, pharma, real world data, real world evidence, real-world data, real-world evidence

The FDA has announced its intention to incorporate real-world data elements to a greater degree into its regulatory decision-making framework …

News

Puma Biotech’s breast cancer drug authorised by European Commission, despite prior concerns

September 5, 2018
Research and Development Cancer, EU, breast cancer, ec approval, puma biotechnology

Puma Biotechnology have received European Commission marketing authorisation for Nerlynx (neratinib) despite prior concerns as to the safety and efficacy …

News

Europe-wide policy could boost generics market, study suggests

September 5, 2018
Research and Development Europe, generics, growth, markets, pharma

A Europe-wide policy covering the generic pharmaceutical market would facilitate significant growth in the pharmaceutical sector according to a new …

News
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