Pharming Group NV

Type: Company

Name: Pharming Group NV

First reported 16 hours ago - Updated 16 hours ago - 1 reports

FDA Accepts Santarus’ Marketing Application for Angioedema Drug

San Diego-based Santarus Inc. announced that the U.S. Food and Drug Administration has accepted the marketing application for its drug, Ruconest.The FDA will complete its review by next April. Santarus applied for market approval with its partner company, ... [Published San Diego Business Journal - 16 hours ago]

Entities: Santarus Inc, Angioedema, FDA Food & Drug Administration, Pharming Group NV, Ruconest

First reported Jun 18 2013 - Updated Jun 18 2013 - 6 reports

Santarus Inc

Santarus And Pharming Announce FDA Acceptance For Review Of Ruconest

(Recombinant Human C1 Esterase Inhibitor) Biologics License Application SAN DIEGO & Leiden, The Netherlands (June 18, 2013) Santarus, Inc. (NASDAQ: SNTS) and Pharming Group NV (NYSE Euronext: PHARM) today announced that the U.S. Food and Drug Administration ... [Published Big News Network - Jun 18 2013]

Entities: Pharming Group NV, Ruconest, Santarus Inc

First reported May 31 2013 - Updated May 31 2013 - 1 reports

Pharming Q1 net loss decreases

Pharming Group NV, a Netherlands-based biotechnology company, has reported that net loss attributable to owners of the parent for the first quarter ended March 31, 2013 was E5.43 million, or E0.05 loss per share, compared to a net loss attributable to ... [Published Individual.com - May 31 2013]

Entities: Pharming Group NV, Biotechnology

First reported Apr 17 2013 - Updated Apr 17 2013 - 1 reports

Pharming, Santarus submit biologics license application for Ruconest

Pharming Group and Santarus have announced the submission of Ruconest (recombinant human C1 esterase inhibitor) biologics license application to the FDA. ... [Published PBR - News - Apr 17 2013]

Entities: Pharming Group NV, Ruconest, Biologics License Application, Santarus Inc

First reported Apr 05 2013 - Updated Apr 05 2013 - 1 reports

EMA clears new manufacturing facility for Ruconest inhibitor

Biotech company Pharming Group has received approval from the European Medicines Agency (EMA) to manufacture drug substance for the company's product Ruconest at its contract manufacturing organization Sanofi Chimie's Aramon site in France.Achieved through ... [Published Pharmaceutical Business Review - Apr 05 2013]

Entities: Ruconest, European Medicines Agency, Pharming Group NV

First reported Apr 01 2013 - Updated Apr 01 2013 - 1 reports

Sanofi SA

Sanofi Chimie gets European nod to manufacture Ruconest at Aramon facility

Biotech company Pharming Group NV (Pharming) has received approval from the European Medicines Agency (EMA) for Sanofi Chimie to manufacture drug substance for Pharming’s product Ruconest at their Aramon (France) site. Sanofi Chimie is acting as Pharming’s ... [Published PharmaBiz - Apr 01 2013]

Entities: Ruconest, Pharming Group NV, Sanofi SA, European Medicines Agency, Hereditary Angioedema

Quotes

...Phase II trial is an important milestone in the clinical development of Pracinostat," said Robert D Mass, MD, Chief Medical Officer of MEI Pharma. "The results from the pilot study reported at ASH were very exciting and helped to inform the design of this more robust, placebo-controlled trial. Now, our goal is to build on these preliminary data and get a more precise estimate of the clinical benefit of Pracinostat in combination with standard-of-care."

ACADIA Issues Multiple Presentations of Data from Trial of Pimavanserin; MEI Begins Phase II Tria ... [Published BioMedReports - Jun 19 2013]

"RUCONEST is the first recombinant C1 esterase inhibitor developed with the goal of treating the pain and swelling associated with acute HAE attacks" said Gerald Proehl, president and chief executive of Santarus

Santarus, Pharming Report FDA Acceptance For Review Of RUCONEST BLA -Quick Facts [Published RTTNews.com - Jun 18 2013]

...Giannetti said that the approval from the EMA to manufacture Ruconest at the Sanofi's France site is an important development for the company. "Importantly, this approval significantly enhances Ruconest's competitive profile, as it enables us to ramp-up manufacturing of Ruconest and optimizing the cost of goods for the product" Giannetti added...

EMA clears new manufacturing facility for Ruconest inhibitor [Published Pharmaceutical Business Review - Apr 05 2013]

Bruno Giannetti, COO of Pharming, said: "The approval from the EMA to manufacture Ruconest at the Sanofi Aramon (France) site is an important development for Pharming as it will allow us to scale up manufacturing of Ruconest ahead of future market demand, particularly as we progress towards US approval of Ruconest with our partner, Santarus. Importantly, this approval significantly enhances Ruconest’s competitive profile, as it enables us to ramp-up manufacturing of Ruconest and optimizing the cost of goods for the product”."

Sanofi Chimie gets European nod to manufacture Ruconest at Aramon facility [Published PharmaBiz - Apr 01 2013]

More Content

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FDA Accepts Santarus’ Marketing Application for... [Published San Diego Business Journal - 16 hours ago]
ACADIA Issues Multiple Presentations of Data fr... [Published BioMedReports - Jun 19 2013]
Santarus And Pharming Announce FDA Acceptance F... [Published Big News Network - Jun 18 2013]
Santarus and Pharming Announce FDA Acceptance f... [Published Investors Business Daily - Jun 18 2013]
Santarus Pharming Group announce FDA acceptance... [Published Big News Network - Jun 18 2013]
Santarus, Pharming Group announce FDA acceptanc... [Published News-Medical.Net - Jun 18 2013]
Santarus and Pharming Announce FDA Acceptance f... [Published Enhanced Online News - Jun 18 2013]
Santarus, Pharming Report FDA Acceptance For Re... [Published RTTNews.com - Jun 18 2013]
Santarus and Pharming announce FDA acceptance f... [Published Marketwire - Breaking News Releases - Jun 18 2013]
Santarus and Pharming announce FDA acceptance f... [Published PR inside - Jun 18 2013]
Santarus and Pharming Announce FDA Acceptance f... [Published Business Wire Health News - Jun 18 2013]
Pharming Q1 net loss decreases [Published Individual.com - May 31 2013]
Pharming reports on financial results first qua... [Published Marketwire - Breaking News Releases - May 16 2013]
Pharming, Santarus submit biologics license app... [Published PBR - News - Apr 17 2013]
Pharming and Santarus announce submission of RU... [Published Marketwire - Breaking News Releases - Apr 17 2013]
EMA clears new manufacturing facility for Rucon... [Published Pharmaceutical Business Review - Apr 05 2013]
Sanofi Chimie gets European nod to manufacture ... [Published PharmaBiz - Apr 01 2013]
Pharming announces EMA approval of new manufact... [Published Marketwire - Breaking News Releases - Mar 28 2013]
Pharming reports on preliminary financial resul... [Published Marketwire - Breaking News Releases - Mar 07 2013]
Pharming Reports on Extraordinary General Meeting [Published Marketwire - Breaking News Releases - Feb 28 2013]
Financings of the Fortnight Jumps On Board The ... [Published The IN VIVO Blog - Jan 25 2013]
Pharming announces EUR16.35 million convertible... [Published Marketwire - Breaking News Releases - Jan 16 2013]
Pharming earns $10m milestone payment from Sant... [Published Pharmaceutical Business Review - Nov 27 2012]

Blogs

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Pharming, Santarus submit biologics license app... [Published PBR - News - Apr 17 2013] Pharming Group and Santarus have announced the submission of Ruconest (recombinant human C1 esterase inhibitor) biologics license application to the FDA. ...
Financings of the Fortnight Jumps On Board The ... [Published The IN VIVO Blog - Jan 25 2013] We're here to point you toward the newly published 2012 A-List , dear readers, but first let's note some big numbers. US listed biotechs raised at least $1.8 billion in stock and debt sales the past couple weeks. We've highlighted two below, Onyx ...

Press Releases

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Santarus and Pharming announce FDA acceptance f... [Published Marketwire - Breaking News Releases - Jun 18 2013]
Santarus and Pharming announce FDA acceptance f... [Published PR inside - Jun 18 2013]
Santarus and Pharming Announce FDA Acceptance f... [Published Business Wire Health News - Jun 18 2013]
Pharming reports on financial results first qua... [Published Marketwire - Breaking News Releases - May 16 2013]
Pharming and Santarus announce submission of RU... [Published Marketwire - Breaking News Releases - Apr 17 2013]