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Research and Development

Showing 15 posts of 9614 posts found.

fda

FDA releases biosimilars labelling guidance

April 1, 2016 Manufacturing and Production, Medical Communications, Research and Development FDA, biosimilars

The US Food and Drug Administration (FDA) has issued draft guidance on the labelling of biosimilar drugs. The guidance states …
News

Sanofi and Regeneron announce positive Phase III trial results for chronic skin disease treatment

April 1, 2016 Medical Communications, Research and Development Dupilumab, Regeneron, Sanofi, atopic dermatitis, phase III, skin disease

Sanofi (NYSE: SNY) and Regeneron Pharmaceuticals (NASDAQ: REGN) have announced positive top line results for dupilumab in Phase III clinical …
News
eli_lilly

Lilly’s RA drug baricitinib meets Phase III goals

March 31, 2016 Research and Development Eli Lilly, Incyte, rheumatoid arthritis

Eli Lilly and Incyte have announced the publication of detailed Phase III trial results from a study of their biologic …
News
laboratory-testing-az

Jazz Pharmaceuticals receives FDA approval for rare veno-occlusive disease treatment

March 31, 2016 Research and Development, Sales and Marketing FDA, jazz pharmaceuticals

Jazz Pharmaceuticals (NASDAQ: JAZZ) has announced that the US Food and Drug Administration (FDA) has granted marketing approval for Defitelio …
News
actinium_pharma

Actinium gets Orphan Drug Designation for myeloid leukaemia drug

March 31, 2016 Research and Development Actinium Pharmaceuticals

New York-based biopharma Actinium Pharmaceuticals (NYSE MKT: ATNM) has received orphan drug designation from the US FDA for Iomab-B, a …
News
janssen_latest_logo_on_sign

Janssen-Cilag’s HIV treatment gets NHS backing

March 31, 2016 Manufacturing and Production, Research and Development, Sales and Marketing HIV, Janssen, NHS, drug trial

Janssen-Cilag Ltd (Janssen) has said NHS England (NHSE) will fund its combination treatment for HIV.  The company said following the …
News
aedes_aegypti_mosquito

Roche to initiate testing for Zika virus under FDA investigational new drug application approval

March 31, 2016 Manufacturing and Production, Research and Development Roche, Zika

Roche (SWX: RO) has announced that the US Food and Drug Administration (FDA) has provided approval to initiate the collection …
News
coagadex

Bio Products Laboratory gets European approval for bleeding disorder treatment

March 30, 2016 Research and Development, Sales and Marketing Bio Products Laboratory, Coagadex, human coagulation factor X

UK-based Bio Products Laboratory has received marketing authorisation from the European Medicines Agency for Coagadex – a drug which treats …
News
michel_vounatsos

Biogen appoints Michel Vounatsos executive vice president, chief commercial officer

March 30, 2016 Research and Development, Sales and Marketing

Biogen has appointed Michel Vounatsos as executive vice president and chief commercial officer, from April 18, 2016. Vounatsos will oversee …
Appointment

US lawmakers demand price cut for Astellas, Medivation’s prostate cancer drug Xtandi

March 30, 2016 Business Services, Manufacturing and Production, Research and Development, Sales and Marketing Astellas, Japan, Medivation, US FDA, Xtandi, drug price

US lawmakers have asked the National Institutes of Health and the Department of Health and Human Services to ‘use its …
News
shire_image_4

Shire wins v Allergan in Lialda patent case

March 30, 2016 Research and Development, Sales and Marketing Allergan, Shire, lialda

A US district court has ruled that Shire’s patent for ulcerative colitis drug Lialda is valid through 2020, leaving Allergan …
News
keryx_biopharma

Keryx Biopharmaceuticals announces positive Phase III study results for anaemia treatment

March 30, 2016 Research and Development CKD, anaemia, chronic kidney disease, clinical trial, dialysis, keryx, keryx biopharmaceuticals, kidney, phase 3, phase III

Keryx Biopharmaceuticals (NASDAQ: KERX) has announced positive top-line results for its Phase III study of ferric citrate for the treatment …
News
sunpharma

Sun Pharma forays into Japan with $293 million product buy from Novartis

March 30, 2016 Manufacturing and Production, Research and Development, Sales and Marketing Japan, M&A, MA, Novartis, Sun Pharma, generics

Shares of Sun Pharma (BOM: 524715), the largest Indian drug maker rose over 2% Wednesday as the company announced the …
News
ea_pharma

Eisai announces agreement to set up new gastrointestinal speciality company

March 30, 2016 Manufacturing and Production, Research and Development, Sales and Marketing Ajinomoto, Eisai, absorption, acquisition, ea pharma, gastrointestinal, merger, speciality

Eisai (TYO: 4523) and Ajinomoto Co. (TYO: 2802) have announced an agreement to establish a new gastrointestinal speciality pharmaceutical company, …
News
acadia

FDA says positives outweigh risks on Acadia’s Parkinson’s psychosis drug

March 30, 2016 Research and Development, Sales and Marketing FDA, Parkinson's, Parkinsons, acadia, nuplazid, pimavanserin, psychosis

Acadia Pharmaceuticals (NASDAQ: ACAD) has announced a positive result from the US Food and Drug Administration (FDA) concerning Nuplazid (pimavanserin) …
News
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