Manufacturing and Production

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Array BioPharma in disarray over withdrawal of NDA

March 20, 2017 Manufacturing and Production, Sales and Marketing Array Biopharma

Array BioPharma has announced that it has pulled its new drug application (NDA) for its drug, binimetinib, for the treatment …
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Top Ten most popular articles on Pharmafile.com this week

March 17, 2017 Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing

As another week comes and goes, waves were sent through the industry as Trump announced his pick as the new …
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FDA warns API manufacturer about river water as ingredient

March 17, 2017 Manufacturing and Production, Medical Communications Badrivishal Chemicals & Pharmaceuticals, FDA, India

The FDA has issued Badrivishal Chemicals & Pharmaceuticals a warning letter regarding numerous violations of manufacturing codes. The most worrying …
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Biogen swoops to appoint Ex-Roche Vice President

March 16, 2017 Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Biogen

Biogen have appointed Anirvan Ghosh to the position of Senior Vice President of research and Early Development. Ghosh is slated …
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The rising threat of antibiotic resistance

March 16, 2017 Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing antibiotic resistance

Last month, researchers from the University of California, Los Angeles (UCLA) revealed findings that showed that utilising antibiotics in combination …
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FDA warns China’s Lumis over misbranded APIs

March 16, 2017 Manufacturing and Production FDA, Lumis

Chinese firm Lumis Global Pharmaceuticals became the latest to face the FDA’s ire as it was hit by a warning …

SHL to Present at Pharmapack Symposium Taiwan 2017

March 16, 2017 Manufacturing and Production auto injectors, extractables and leachables, prefilled syringe

Olle Ljungquist, Senior Scientist at SHL Group, will give a talk on the “Requirements and Test Methods for Finished Prefilled …

Novartis secures first-line FDA approval in breast cancer indication

March 14, 2017 Manufacturing and Production, Sales and Marketing Kisqali, Novartis, breast cancer

The FDA has approved Kisqali (ribociclib) in combination with letrozole for the first-line treatment of postmenopausal women with hormone receptor …
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Survivors of Hodgkin lymphoma over twice as likely to suffer second cancer

March 14, 2017 Manufacturing and Production, Research and Development Hodgkin lymphoma, ICR

New research emerging from the Institute for Cancer Research (ICR) has found that those previously treated for Hodgkin lymphoma are …
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FDA lifts block on Sun Pharma facility

March 14, 2017 Manufacturing and Production FDA, Sun Pharma

Sun Pharma has announced that the FDA informed it that the Import Alert in place upon its Mohali manufacturing facility …
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One in five women with breast cancer could benefit from existing therapy

March 14, 2017 Manufacturing and Production, Research and Development Wellcome Trust Sanger Institute, breast cancer, parp inhibitors

A new study emerging from the Wellcome Trust Sanger Institute has discovered that there are more cases of breast cancer …
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XTuit Pharmaceuticals move to appoint biotech veteran as CEO

March 13, 2017 Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing XTuit Pharmaceuticals

XTuit Pharmaceuticals has revealed the appointment of Deborah Dunshire as its new President and CEO. XTuit Pharmaceuticals is a biotech …
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Mylan’s pathway to launch of biosimilar to Herceptin cleared by Roche

March 13, 2017 Manufacturing and Production, Sales and Marketing Genentech, Herceptin, Mylan, Roche, biosimilar

Mylan scored a big victory in its plan to launch its biosimilar to Roche’s blockbuster, Herceptin, after Roche and itself …
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Immunotherapy: The three major treatments that are changing cancer prognoses

March 13, 2017 Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing BMS, Cancer, MSD, Roche, immunotherapy, keytruda, oncology, opdivo, tecentriq

The promise of Immunotherapy as a game-changer for cancer treatment has been evident since its advent in the space. However, …
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Oxford BioDynamics installs new SVP of Commercial Development

March 10, 2017 Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Oxford BioDynamics

Oxford BioDynamics, a biotech focused on the discovery and development of novel epigenetics biomarkers, has announced the appointment of Martin …
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