FTC files complaint against Endo for blocking generics of its pain drugs

April 1, 2016
Business Services, Manufacturing and Production, Medical Communications, Sales and Marketing Endo International, FTC, legal, regulation

The US Federal Trade Commission (FTC) has filed a complaint against Endo International (Nasdaq: ENDP) alleging the company used illegal …

dynavax

FDA to review investigational hepatitis B vaccine

April 1, 2016
Medical Communications, Research and Development dynavax, hepatitis B, vaccines

Dynavax Technologies (NASDAQ: DVAX) says the FDA has accepted for review the company’s investigational adult hepatitis B vaccine, HEPLISAV-B. The FDA has set …

Whistleblower accuses Novartis of paying bribes in Turkey to push sales

April 1, 2016
Business Services, Medical Communications, Sales and Marketing Financial, Novartis, legal, reuters

An anonymous whistleblower has accused Swiss drugmaker Novartis (SIX: NOVN) of paying bribes in Turkey through a consulting firm to …

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Janssen to stop fulranumab development in osteoarthritis pain

April 1, 2016
Medical Communications, Research and Development, Sales and Marketing Amgen, Janssen

Janssen says it is discontinuing Phase III development for fulranumab in osteoarthritis pain. The J&J company says the decision is …

pfizerbrussels

Fake press release on drug pricing “erroneously attributed” to Pfizer

April 1, 2016
Medical Communications Pfizer, fake, false, legal action, press release, washington post

Pfizer (NYSE: PFE) has issued a statement on a false press release related to drug pricing that was reported on …

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The US Food and Drug Administration (FDA) has issued draft guidance on the labelling of biosimilar drugs.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

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 …

samsung_bioepis

Samsung Bioepis’ Remicade biosimilar set for CHMP verdict

March 31, 2016
Medical Communications, Sales and Marketing Flixabi, Remicade, Samsung Bioepis, biosimilars, infliximab

Samsung Bioepis has confirmed that the European Commission’s scientific committee, the CHMP, is this week discussing the approval of its …

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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 …

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GSK introduces new measures to widen medicines access in poorest countries

March 31, 2016

GSK has set out a series of measures it is introducing to help improve access to the company’s innovative medicines …

Shire hikes CEO pay to £15 million

March 31, 2016
Business Services, Sales and Marketing

UK drug major Shire (LSE: SHP) has raised the compensation for the chief executive Flemming Ornskov to £15 million for …

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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_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 …

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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 …

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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 …

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 …

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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 …

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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 …

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