Glybera

Type: Product

Name: Glybera

First reported May 17 2013 - Updated May 18 2013 - 1 reports

Financings of the Fortnight Waits For Public Investors To Hop On Bluebird

It’s been another IPO-intensive couple of weeks here at FOTF HQ. We keep looking for other things to write about, but sometimes the fastest shave on deadline is with Occam’s razor. Or something like that. We didn't exactly ace our philosophy classes ... [Published The IN VIVO Blog - May 17 2013]

Entities: IPOs, Stocks, Gene Therapy

First reported May 16 2013 - Updated May 17 2013 - 1 reports

French National Centre for Scientific Research

Resistance to visceral leishmaniasis : new mechanisms involved

Researchers from CNRS, Université Toulouse III - Paul Sabatier and IRD have elucidated new molecular mechanisms involved in resistance to visceral leishmaniasis, a serious parasitic infection.They have shown that dectin-1 and mannose receptors participate ... [Published Health Canal - May 16 2013]

Entities: Mechanic, Receptor, French National Centre for Scientific Research, Infection

First reported May 15 2013 - Updated May 16 2013 - 5 reports

WATCH: The Story Behind Glybera Approval

Late last year the European Medicines Agency (EMEA) granted marketing approval for the Western world’s first gene therapy product, Glybera, which is intended for the treatment of lipoprotein lipase deficiency, a rare inherited disease. The EMEA approval ... [Published Genetic Engineering News - May 16 2013]

Entities: Glybera, Human Gene Therapy, Gene Therapy

First reported May 15 2013 - Updated May 15 2013 - 1 reports

uniQure raises EUR 14.1m in new investment led by Coller Capital

- uniQure B.V., the leader in human gene therapy, today announced it has successfully raised a total of EUR 14.1 million in new investment led by Coller Capital (London, UK) with participation by other existing investors.uniQure raised EUR 13.5 million ... [Published Noodls - May 15 2013]

Entities: Coller Capital, UniQure BV, Gene Therapy, Gilde, Conversion Price

First reported Apr 22 2013 - Updated Apr 22 2013 - 1 reports

European drug applications 'stable but more complex in 2012'

Despite austerity measures, EMA's annual report shows signs of biopharma resilienceThe European Medicines Agency (EMA) saw the number of marketing authorisation applications (MAAs) it received in 2012 stay pretty much in line with the previous year, with ... [Published PMLive - Apr 22 2013]

Entities: European Medicines Agency, Glybera, Drugs

First reported Feb 06 2013 - Updated Feb 06 2013 - 1 reports

uniQure makes milestone payment to Xenon for European approval of Glybera

uniQure has made a milestone payment to Xenon for marketing approval of Glybera gene therapy in Europe. ... [Published PBR - News - Feb 06 2013]

Entities: Glybera, Xenon, Gene Therapy

First reported Dec 23 2012 - Updated Dec 23 2012 - 1 reports

Still Waiting For A Biotech Revolution

The first attempts at human gene therapy were made in 1990. The excitement around gene therapy was high in the 1990s. Yet not till 22 years later in 2012 the first gene therapy drug, Glybera for a rare genetic disease called lipoprotein lipase deficiency, ... [Published FuturePundit - Dec 23 2012]

Entities: Gene Therapy, Biotechnology, Human Gene Therapy, Glybera

First reported Dec 18 2012 - Updated Dec 18 2012 - 1 reports

Financing Deal of the Year Nominee: bluebird bio

It's time for the IN VIVO Blog's Fifth Annual Deal of the Year! competition. This year we're once again presenting awards in three categories to highlight the most interesting and creative deal making solutions of the year. The categories are: M&A ... [Published The IN VIVO Blog - Dec 18 2012]

Entities: Gene Therapy, Glybera, Sickle-Cell Disease

Quotes

...Hayden's laboratory to develop a gene replacement therapy. In the article "From Mutation Identification to Therapy: Discovery and Origins of the First Approved Gene Therapy in the Western World" the authors recount the many failures and successes and the significant delays that finally ended on November 2, 2012, when the European Medicines Agency...

Scientists reveal inside story of European regulatory review and approval of Glybera [Published News-Medical.Net - May 16 2013]

...and coauthors give a behind-the-scenes view of the protracted clinical development, review, and approval process for Glybera in the Commentary "Lessons Learned from the Clinical Development and Market Authorization of Glybera." Although Glybera's safety was not an issue, its efficacy in the relatively small number of patients who received the therapy was questionable...

The Inside Story Behind the Approval of the Gene Therapy Drug Glybera [Published Prlog - May 15 2013]

...gene therapy approved in the western world, we are at an exciting time for this emerging sector," says Stephen Hurly, CEO of Burrill Securities. "We've seen waves of enthusiasm toward gene therapy surge and then quickly recede with high profile setbacks. This meeting will examine what's different now and why Big Pharma and Big Biotech have growing interests in the area."

Burrill Securities Launches Institutional Breakthrough Series [Published I Stock Analyst - Apr 29 2013]

Nevertheless "the lessons learnt from this case are multiple and pave the way for approval of similarly complex medicines in the future, as more gene therapies for rare diseases, personalised medicines and nanomedicines are on their way" says the agency...

European drug applications 'stable but more complex in 2012' [Published PMLive - Apr 22 2013]

More Content

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Financings of the Fortnight Waits For Public In... [Published The IN VIVO Blog - May 17 2013]
WATCH: The Story Behind Glybera Approval [Published Genetic Engineering News - May 16 2013]
Scientists reveal inside story of European regu... [Published News-Medical.Net - May 16 2013]
Resistance to visceral leishmaniasis : new mech... [Published Health Canal - May 16 2013]
Inside Story Behind Glybera's Development and A... [Published Genetic Engineering News - May 16 2013]
The Inside Story Behind the Approval of the Gen... [Published Health Canal - May 15 2013]
The Inside Story Behind the Approval of the Gen... [Published Prlog - May 15 2013]
uniQure raises EUR 14.1m in new investment led ... [Published Noodls - May 15 2013]
Burrill Securities Launches Institutional Break... [Published I Stock Analyst - Apr 29 2013]
Burrill Securities Launches Institutional Break... [Published PR inside - Apr 29 2013]
Burrill Securities Launches Institutional Break... [Published FinanzNachrichten.de - Apr 29 2013]
Burrill Securities Launches Institutional Break... [Published Digital Journal - Apr 29 2013]
European drug applications 'stable but more com... [Published PMLive - Apr 22 2013]
Xenon Named Company of the Year by BIOTECanada [Published FinanzNachrichten.de - Apr 22 2013]
Noted Atherosclerosis Researcher Joins AtheroNo... [Published TickerTech.com - Apr 17 2013]
Noted Atherosclerosis Researcher Joins AtheroNo... [Published BioMedReports - Apr 15 2013]
/C O R R E C T I O N -- AtheroNova Inc./ [Published TickerTech.com - Apr 15 2013]
uniQure makes milestone payment to Xenon for Eu... [Published PBR - News - Feb 06 2013]
Xenon Receives a Milestone Payment for Marketin... [Published PR Newswire: General Business - Feb 05 2013]
Deals of the Week Ponders Eleventh-Hour Risk [Published The IN VIVO Blog - Jan 25 2013]
Still Waiting For A Biotech Revolution [Published FuturePundit - Dec 23 2012]
Financing Deal of the Year Nominee: bluebird bio [Published The IN VIVO Blog - Dec 18 2012]
There's A Financings of the Fortnight In Every ... [Published The IN VIVO Blog - Nov 30 2012]
uniQureâs Glybera First Gene Therapy Approved B... [Published Bioresearch Online - Nov 06 2012]
European Commission approves uniQureâs gene the... [Published PharmaBiz - Nov 05 2012]
Glybera® von uniQure - Die erste von der Europä... [Published PR Newswire - Nov 02 2012]
uniQure's Glybera® als eerste gentherapie goedg... [Published PR Newswire - Nov 02 2012]
Articles Firstline erlotinib in patients with a... [Published BioPortfolio - Oct 17 2012]
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Software Developed That Facilitates LargeScale ... [Published BioPortfolio - Oct 11 2012]