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Higher mutational burdens in tumours linked to greater immunotherapy success, study finds

December 21, 2017
Research and Development Cancer, Johns Hopkins Kimmel Cancer Center, checkpoint inhibitors, mutational burden, pharma

New research from the Johns Hopkins Kimmel Cancer Center and its Bloomberg-Kimmel Cancer Institute for Cancer Immunotherapy has indicated that …

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FDA grants breast cancer approval to Roche’s Perjeta/Herceptin combo therapy

December 21, 2017
Sales and Marketing Cancer, FDA, Herceptin, Perjeta, Roche, breast cancer, pharma

Roche has announced that the FDA has granted approval to Perjeta (pertuzumab) in combination with Herceptin (trastuzumab) and a (Perjeta-based) …

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The rare disease climate in Europe

December 21, 2017
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing biotech, drugs, pharma, pharmaceutical, rare disease

Continuing on from this week’s earlier feature on the rare disease situation in the US, Pharmafile moves its attention onto …

Feature

Pfizer’s Bosulif scores US green light in leukaemia sub-type

December 21, 2017
Sales and Marketing FDA, Pfizer, bosulif, leukaemia, leukemia, pharma

Pfizer has revealed that its tyrosine kinase inhibitor Bosulif (bosutinib) has been awarded marketing authorisation from the FDA in the …

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MSD and Pfizer receive approval for combo diabetes therapy

December 21, 2017
Sales and Marketing MSD, Pfizer, biotech, diabetes, drugs, pharma, pharmaceutical

MSD (known as Merck in North America) and Pfizer have announced that their sodium-glucose co-transporter 2 (SGLT2) inhibitor has received …

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Death in trial blackens AbbVie’s positive rheumatoid arthritis data

December 21, 2017
Research and Development AbbVie, biotech, drugs, pharma, pharmaceutical, rheumatoid arthritis

AbbVie posted strong results from its Phase 3 trial into its treatment for rheumatoid arthritis, upadacitinib, but discussions of the …

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J&J struck by €25m fine over fentanyl pain patch

December 20, 2017
Research and Development, Sales and Marketing Johnson & Johnson, biotech, drugs, fentanyl, pharma, pharmaceutical

Johnson & Johnson has been fined by France’s competition authority, Autorité de la Concurrence, after it alleges the company had …

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Genentech seals deal with DiCE Molecules

December 20, 2017
Research and Development, Sales and Marketing DiCE, Genentech, Sanofi, biotech, drugs, pharma, pharmaceutical

Genentech has followed in the footsteps of its parent company by signing a drug discovery agreement with DiCE Molecules. The …

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NICE recommends Novartis’ Extavia for MS, but knocks back a raft of other beta interferons

December 20, 2017
Research and Development, Sales and Marketing Extavia, MS, NICE, Novartis, beta interferon, multiple sclerosis

NICE has revealed that it has passed draft guidance that recommends Novartis’ Extavia (interferon beta 1b) for the treatment of …

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GSK forced to pay back £1.5m to Scottish Government after recent job cuts

December 20, 2017
Manufacturing and Production, Research and Development GSK, GlaxoSmithKline, pharma

British pharmaceutical giant GlaxoSmithKline has been ordered to pay back £1.5 million to the Scottish Government because of its failure …

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Spark gains approval for gene therapy, paving way for first $1m treatment

December 20, 2017
Research and Development, Sales and Marketing Spark Therapeutics, biotech, drugs, gene therapy, pharma, pharmaceutical

The FDA handed approval to Spark Therapeutics’ gene therapy for an inherited eye disorder, making it the first treatment of …

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allergan

Allergan and Gedeon Richter’s Vraylar posts strong Phase 3 data in bipolar depression

December 19, 2017
Manufacturing and Production, Research and Development Allergan, Gedeon Richter, Vraylar, bipolar, bipolar depression, pharma

Vraylar (cariprazine), a drug developed as part of a partnership between Allergan and Gedeon Richter, has demonstrated strong results at …

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Boehringer scoops schizophrenia candidates for €627.5m

December 19, 2017
Manufacturing and Production, Sales and Marketing Autifony, Boehringer Ingelheim, biotech, drugs, pharma, pharmaceutical

Boehringer Ingelheim has moved early to secure an exclusive option on Autifony’s lead candidate for the treatment of schizophrenia, AUT00206, …

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FDA pledges to crack down on homeopathy treatments

December 19, 2017
Manufacturing and Production, Sales and Marketing FDA homeopathy, US, pharma

Following in the steps of authorities in the European Union, Australia and the United Kingdom, the FDA has pledged to …

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100,000 vacancies contribute to NHS crisis

December 19, 2017
Manufacturing and Production, Medical Communications NHS, UK, biotech, drugs, nurses, pharma, pharmaceutical

Warning shots have been fired by both the General Medical Council (GMC) and the Labour Party about the recruitment issues …

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Novartis snaps up Priority Review Voucher for $130m

December 18, 2017
Manufacturing and Production, Sales and Marketing Novartis, Ultragenyx, biotech, drugs, pharma, pharmaceutical

Novartis has got its wallet out to pick up a Priority Review Voucher (PRV) from Ultragenyx, forking out $130 million …

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Rare disease medicines access faces a perfect storm

December 18, 2017
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing biotech, drugs, pharma, pharmaceutical, rare disease

With access to rare disease treatments coming under increasing attention, both in the EU and the US, Pharmafile.com took the …

Feature

FDA approves Pfizer’s Xeljanz for psoriatic arthritis

December 18, 2017
Sales and Marketing FDA, Pfizer, Xeljanz, pharma, psoriatic arthritis

Pfizer has revealed that the FDA has passed marketing approval for Xeljanz (tofacitinib) for the treatment of active psoriatic arthritis …

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Apotex founder found dead at home

December 18, 2017
Medical Communications, Sales and Marketing Apotex, biotech, drugs, pharma, pharmaceutical

Apotex, the world’s seventh largest generics manufacturer, has lost its Chairman and founder, after Barry Sherman and his wife, Honey, …

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Boehringer loses CFO over financial strategy dispute

December 18, 2017
Medical Communications, Sales and Marketing Boehringer, Boehringer Ingelheim, appointment, pharma

Boehringer Ingelheim is set to part ways with its Chief Financial Officer Simone Menne after 16 months due to fundamental …

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