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FDA approves Indian firm Alembic’s generic of Teva’s Diamox

February 20, 2019 Research and Development ANDA, Alembic, Gujurat, US FDA, diamox, generics

The US FDA has approved Guajarati firm Alembic Pharmaceuticals generic version of Teva’s Acetazolamide sold under the brand name Diamox, …
News

Pfizer and Eli Lilly’s chronic low back pain (CLBP) treatment meets primary endpoint in Phase 3 trial

February 20, 2019 Research and Development

US firms Pfizer and Eli Lilly have said that NGF inhibitor tanezumab met its primary endpoint in a phase 3 …
News
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Poland and Slovenia included in US-EU mutual recognition agreement

February 20, 2019 Research and Development EU, GMP, Poland, Slovenia, USA, mutual recognition

Poland and Slovenia have been deemed capable of carrying out Good Manufacturing Practice (GMP) inspections at an equivalent level to …
News
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Keytruda falls short at Phase 3 in advanced liver cancer

February 20, 2019 Research and Development Cancer, MSD, keytruda, liver cancer, pharma

MSD has revealed new Phase 3 data which indicates that its blockbuster immunotherapy Keytruda (pembrolizumab), in combination with best supportive …
News
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“Game-changing” osteoarthritis drug receives £675k funding from Innovate UK

February 19, 2019 Manufacturing and Production, Research and Development AKL Research and Development, Innovate UK, osteoarthritis, pharma

A novel and potentially “game-changing” oral therapy for the treatment of osteoarthritis (OA) has received a £675,000 cash injection from …
News
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Beating the flu

February 18, 2019 Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing flu, influenza, pharma, seqirus

On 14 January, the European Commission issued marketing approval for Flucelvax Tetra, the first cell-based, quadrivalent influenza vaccine. Pharmafocus spoke …
Feature

Astellas’ Xtandi “significantly improves” progression-free survival in advanced hormone-sensitive prostate cancer

February 18, 2019 Research and Development, Sales and Marketing Astellas, Cancer, Xtandi, pharma, prostate cancer

Japanese pharma firm Astellas has lifted the curtain on new data for its androgen receptor signalling inhibitor Xtandi (enzalutamide), when …
News
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Bavencio+Inlyta combo boosts progression-free survival in advanced kidney cancer

February 18, 2019 Research and Development, Sales and Marketing Bavencio, Cancer, Kidney cancer, Merck KGaA, Pfizer, inlyta, pharma

New interim data for the combination of Pfizer’s Bavencio (avelumab) and Merck KGaA’s Inlyta (axitinib) have been released, showing that …
News
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Lilly and Boehringer’s Trajenta matches glimepiride in delaying cardiovascular events in type 2 diabetes patients

February 15, 2019 Medical Communications, Research and Development Boehringer, Eli Lilly, cardiovascular disease, pharma, type 2 diabetes

Boehringer Ingelheim and Eli Lilly’s Trajenta (linagliptin) met its primary endpoint in a recent trial, it has emerged, proving itself …
News
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Top Ten most popular articles on Pharmafile.com this week!

February 15, 2019 Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing AMR, Dame Sally Davies, FDA, FMD, antibiotic resistance, esketamine, falsified medicines, top 10

News that the FDA’s advisory panel had recommended Janssen’s intranasal esketamine spray Spravato as a treatment for treatment resistant depression, …
News
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First asthma pill in two decades could treat condition by reducing airway muscle

February 14, 2019 Research and Development asthma, pharma

Researchers at the University of Leicester alongside colleagues in Vancouver, Canada, have revealed data that supports the efficacy of an …
News

J&J acquires lung cancer-focused robotics firm Auris Health in potential $5.75m deal

February 14, 2019 Manufacturing and Production, Research and Development, Sales and Marketing Auris Health, Cancer, J&J, JJ, lung cancer, pharma, robotics

In a bid to bolster its footing in providing surgical treatments, Johnson & Johnson has announced it will acquire robotics …
News

BMS scores expanded European approval for Sprycel in paediatric leukaemia

February 13, 2019 Research and Development, Sales and Marketing BMS, Cancer, Europe, Sprycel, leukaemia, pharma

Bristol-Myers Squibb’s Sprycel (dasatinib) has secured an expanded indication in Europe, the company said, with the European Commission greenlighting the …
News
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Australian firm Althea enters UK medicinal cannabis market

February 13, 2019 Research and Development Epidiolex, GW Pharma, Medical marijuana, NHS, UK, cannabis

Melbourne-based medicinal cannabis company Althea has become one of the first companies to enter the UK market after the British …
News
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Janssen’s esketamine drug recommended by FDA panel for depression

February 13, 2019 Research and Development, Sales and Marketing FDA, Janssen, Spravato, depression, esketamine, major depressive disorder, pharma

In a rare and welcomed development in the treatment of major depressive disorder (MDD), Janssen has announced that its esketamine …
News
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