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 …

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 …

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 …

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 …

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 …

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 …

Life sciences strength will drive UK pharma sector growth

March 30, 2016
Sales and Marketing

The UK pharmaceutical market is set to grow from $28.8 billion in 2015 to approximately $43 billion by 2020, at …

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 …

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 …

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 …

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 …

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, …

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) …

Biosimilars could save healthcare systems $100bn by 2020

March 30, 2016
Research and Development, Sales and Marketing biosimilars

The growth of the market for biosimilar drugs has the potential to save EU and US healthcare systems up to …

Lupin drops on FDA observations; company reassures of no disruption at facility

March 29, 2016
Business Services, Manufacturing and Production, Sales and Marketing Lupin, US FDA, regulation

Shares of India’s Lupin dropped over 14% Tuesday following news the US Food and Drug Administration (FDA) has made observations …

GSK’s Nucala gets regulatory approval in Japan to treat bronchial asthma

March 29, 2016
Manufacturing and Production, Research and Development GlaxoSmithKline, Japan, Nucala, US FDA, bronchial asthma

GlaxoSmithKline (LSE: GSK) on Tuesday said the Japanese regulators have approved its drug to treat bronchial asthma.  The Japanese Ministry …

Valeant’s outgoing CEO subpoenaed by US congressional committee

March 29, 2016
Medical Communications, Research and Development Drug pricing, Michael Pearson, US, Valeant, committee, pearson, pharma, price hikes, senate aging committee, subpoena, subpoenaed

The US Senate Aging Committee has announced the issuing of a subpoena to the outgoing CEO of Valeant Pharmaceuticals, Michael …

TREND: Rare disease, cancer drugs will drive pharma M&A’s, growth

March 29, 2016
Manufacturing and Production, Research and Development, Sales and Marketing M&A, MA, Orphan Drugs, cancer drugs

Moody’s Investor Service lowered its growth outlook for the global pharma sector but maintained the mergers and acquisitions in the …

Novo Nordisk breaks ground on new $2 billion production facility in North Carolina

March 29, 2016
Manufacturing and Production, Research and Development $2 billion, Clayton, Novo, Novo Nordisk, building, diabetes, nordisk, north carolina, production facility

Novo Nordisk has begun work on a new $2 billion production facility in Clayton, North Carolina, which will produce active …

US FDA issues observations for Natco Pharma’s Indian plants

March 29, 2016
Manufacturing and Production, Research and Development, Sales and Marketing

Shares in India-based Natco Pharma (BOM: 524816) dropped on the Bombay Stock Exchange following news the US Food and Drug …

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