Research and Development

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trials

Marathon Pharma submits application for Duchenne muscular dystrophy drug to FDA

June 15, 2016 Research and Development, Sales and Marketing FDA, duchenne, marathon pharmaceuticals

Marathon Pharmaceuticals has announced that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration …
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Phase II failure sees stock plunge and job cutbacks for Infinity Pharmaceuticals

June 15, 2016 Research and Development, Sales and Marketing AbbVie, infinity pharmaceuticals, non-Hodgkin lymphoma, trial failure

Shares at Infinity Pharmaceuticals (NASDAQ: INFI) fell around 70% upon the announcement of new Phase II data for their non-Hodgkin …
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Sobi says US FDA approves higher dose of Orfadin to treat rare genetic disorder

June 15, 2016 Research and Development, Sales and Marketing US FDA, genetic disorder, regulation, sobi

Swedish Orphan Biovitrum AB (Sobi) on Wednesday said the US Food and Drug Administration (FDA) has approved a higher strength …

FDA issues warnings on Janssen, AstraZeneca diabetes drugs

June 15, 2016 Research and Development, Sales and Marketing AstraZeneca, FDA, Janssen, farxiga, invokana

The US Food and Drug Administration has issued a warning of the risk of acute kidney injury for the type-2 …
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German Supreme Court grants Lilly appeal to block Alimta generics

June 15, 2016 Research and Development, Sales and Marketing Actavis, Alimta, Eli Lilly

Eli Lilly (NYSE: LLY) has announced that it has been granted an appeal by the German Federal Supreme Court, in …
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Actelion says blood pressure drug Uptravi now available in Germany

June 15, 2016 Research and Development, Sales and Marketing Actelion, EU, blood pressure, product launch

Actelion (SIX: ATLN) said its high blood pressure drug Uptravi (selexipag) is now available in Germany.  The European Commission granted …

Novartis says to develop antimalarial treatment with Medicines for Malaria Venture

June 15, 2016 Research and Development, Sales and Marketing Novartis, antimalarial drug, drug trial

Swiss pharma major Novartis (NYSE: NVS) said it has partnered with Medicines for Malaria Venture (MMV) and the Bill & Melinda …
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Shire adds to gastrointestinal portfolio with Pfizer compound acquisition

June 14, 2016 Research and Development, Sales and Marketing Pfizer, Shire, acquisition, compound

Shire (LSE: SHP) has announced that it has acquired an investigational biologic for the treatment inflammatory bowel disease from Pfizer …
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Janssen says Imbruvica shows improved PFS in blood cancer in long-term effectiveness study

June 14, 2016 Manufacturing and Production, Research and Development Janssen, blood cancer, drug trial, imbruvica

Janssen said late-stage studies to test long-term effectiveness for its Imbruvica (ibrutinib) in blood cancer showed improved progression free survival …
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Marinus says will stop developing adult focal onset seizure drug as Phase III trials fail; shares plunge

June 14, 2016 Manufacturing and Production, Research and Development Drug-Resistant Epilepsy, Marinus Pharmaceuticals, drug trial, ganaxolone

Shares in Marinus Pharmaceuticals (Nasdaq: MRNS) more than halved in value Monday after the company said it plans to stop …
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MSD insulin glargine biosimilar meets primary endpoint in late-stage trials

June 14, 2016 Manufacturing and Production, Research and Development, Sales and Marketing MSD, Merck, biosimilar, insulin, insuline glargine

MSD (NYSE: MRK), known as Merck in the US and Canada, has announced results from two Phase III studies evaluating …
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FDA to review data on Amgen’s Humira biosimilar

June 14, 2016 Manufacturing and Production, Research and Development, Sales and Marketing Amgen, FDA, Humira, biosimilar

Amgen (NASDAQ: AMGN) has announced the US Food and Drug Administration’s (FDA) Arthritis Advisory Committee will review data supporting the …
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Novo Nordisk says Victoza lowers risk of heart attacks in diabetes patients

June 14, 2016 Manufacturing and Production, Research and Development Novo Nordisk, Victoza, drug trial, type 2 diabetes

Danish diabetes drugmaker giant Novo Nordisk (NYSE: NVO) on Tuesday said a large study showed its Victoza (liraglutide) reduced the risk of …
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New COO appointed at X4 Pharmaceuticals

June 13, 2016 Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing

X4 Pharmaceuticals has announced the appointment of John K. Celebi as its new chief operating officer. Celebi will bring over …
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Shire gets FDA breakthrough therapy designation for two rare disease drugs

June 13, 2016 Manufacturing and Production, Research and Development, Sales and Marketing Breakthrough Therapy Designation, Shire, US FDA, rare disease, rare disease drugs

Ireland headquartered Shire (LSE: SHP) on Monday said the US Food and Drug Administration (FDA) has granted breakthrough therapy designation …
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