01Jul/13

UPDATE: Piper Jaffray Raises PT on Biogen Idec on Multiple Positive Factors – Benzinga

UPDATE: Piper Jaffray Raises PT on Biogen Idec on Multiple Positive Factors
Benzinga
in particular unpublished estimates) now fully reflect Tecfidera’s strong launch, in our view, and upside in BIIB shares will likely require pipeline success, which is not expected until 2014 data readouts from anti-LINGO Phase II (optic neuritis

and more »

01Jul/13

Second Draft NICE Guidance for Aggressive non-Hodgkin Lymphoma Treatment … – The Herald | HeraldOnline.com

Second Draft NICE Guidance for Aggressive non-Hodgkin Lymphoma Treatment
The Herald | HeraldOnline.com
The European Medicines Agency’s (the EMA) Committee for Medicinal Products for Human Use has accepted PIX306, CTI’s ongoing randomized controlled Phase 3 clinical trial, which compares PIXUVRI-rituximab to gemcitabine-rituximab in patients who 

29Jun/13

European Agency Favors Remicade Biosimilars – MedPage Today


Medical Daily

European Agency Favors Remicade Biosimilars
MedPage Today
Other biosimilars are available in Europe, such as Nivestim, which is similar to the granulocyte colony-stimulating factor analog filgrastim, and product-specific guidelines for monoclonal antibodies have been established by the medicines agency
‘Biosimilar’ drug ruling to hit Big PharmaFinancial Times
EMA’s CHMP backs approval of first two monoclonal antibody biosimilars of The Pharma Letter
A Pivotal Decision By European Drug Regulators on Remicade Is Unlikely To Forbes
Medical Daily –Philadelphia Business Journal –Bloomberg
all 37 news articles »
28Jun/13

European Regulators Back Biosimilar Antibodies – Medscape


Medscape

European Regulators Back Biosimilar Antibodies
Medscape
This is notable because antibodies are inherently difficult to replicate and are subject to posttranslational modifications, such as glycosylation. They also may be heterogenous and often include subtle variants. Tight manufacturing controls
A Landmark For Biosimilars: EU Endorses Copies Of A J and J DrugForbes
‘Biosimilar’ drug ruling to hit Big PharmaFinancial Times
Billion-dollar biotech drug may soon have biosimilar competitionPhiladelphia Business Journal
Medical Daily –Businessweek –PipelineReview.com (press release)
all 28 news articles »
28Jun/13

'Biosimilar' drug ruling to hit Big Pharma – Financial Times


Medical Daily

‘Biosimilar’ drug ruling to hit Big Pharma
Financial Times
The decision is the first time in the industrialised world that the multibillion-dollar annual market for monoclonal antibodies has been opened to generic producers, after a long period during which investors assumed such complex “large molecule
European Agency Favors Remicade BiosimilarsMedPage Today
First Copy of J&J’s $6 Billion Remicade Wins EMA BackingBloomberg
A Pivotal Decision By European Drug Regulators on Remicade Is Unlikely To Forbes
The Pharma Letter –Medical Daily –PipelineReview.com (press release)
all 37 news articles »