Swedish Orphan Biovitrum AB

Type: Company
Name: Swedish Orphan Biovitrum AB (Biovitrum AB)
Nationality: Sweden
Web Address: http://www.biovitrum.com/
Fact Sheet: Fact Sheet for Biovitrum AB
First reported 14 hours ago - Updated 14 hours ago - 1 reports

Orfadin storage

The summary of product characteristics for Orfadin (nitisinone; Swedish Orphan Biovitrum) now states that during the shelf life the patient may store the finished product for a single period of two months at a temperature not above 25°C, after which the ... [Published Pharmaceutical Journal - 14 hours ago]
First reported Aug 21 2014 - Updated Aug 22 2014 - 3 reports

BioSpecifics Technologies Corp. Announces Positive Data From Phase 2a Study Of CCH For Treatment Of Cellulite

LYNBROOK, N.Y."These positive results are very encouraging, particularly because both patients and physicians saw a statistically significant improvement in the appearance of cellulite after CCH treatment," commented Thomas L. WegmanThe Phase 2a study ... [Published TheStreet.com - Aug 21 2014]
First reported Aug 14 2014 - Updated Aug 14 2014 - 1 reports

Biogen Idec’s long-acting agents to have major impact on hemophilia market

The hemophilia treatment landscape is to undergo a radical shift away from established short-acting therapies, beginning with the launch of US biotech firm Biogen Idec’s (Nasdaq: BIIB) long-acting rFVIII and rFIX products this year.According to research ... [Published Pharma Letter - Aug 14 2014]
First reported Aug 11 2014 - Updated Aug 12 2014 - 2 reports

BioSpecifics (BSTC) Q2 2014 Results - Earnings Call Transcript

OperatorGood day. And welcome to the BioSpecifics' Second Quarter Financial Results Conference Call and Webcast. All participants will be in listen-only mode. (Operator Instructions) After today’s presentation, there will be an opportunity to ask questions. ... [Published Seeking Alpha - Aug 12 2014]
First reported Aug 08 2014 - Updated Aug 09 2014 - 2 reports

BioSpecifics Technologies Corp. Announces Initiation of Phase 2 Clinical Study of CCH for Treatment of Lipoma

"Our initiation of this Phase 2 placebo-controlled clinical trial of CCH in patients with lipoma represents another important development milestone for BioSpecifics as we further advance our pipeline and continue to uncover the vast potential of injectable ... [Published Pettinga Financial Advisors - Aug 08 2014]
First reported Aug 04 2014 - Updated Aug 05 2014 - 2 reports

BioSpecifics Technologies Corp. Announces Appointment of Max Link, Ph.D. to Board of Directors

Related Stocks BSTC - Biospecifics Technologies CorpSym Last Chg Pct Volume BSTC26.48+0.29+1.11%41,000 LYNBROOK, N.Y. , Aug. 5, 2014 /PRNewswire/ -- BioSpecifics Technologies Corp. (NASDAQ: BSTC), a biopharmaceutical company developing first in class ... [Published Barchart - Aug 05 2014]
First reported Jul 31 2014 - Updated Jul 31 2014 - 2 reports

Pharming Reports On Financial Results First Half Year 2014

Biotech company Pharming Group NV (“Pharming” or “the Company”) (NYSE Euronext: PHARM) today published its financial report for the six months ended 30 June 2014.On July 16, 2014, the US FDA approved Ruconest® for the treatment of angioedema attacks in ... [Published Pharming - Jul 31 2014]
First reported Jul 23 2014 - Updated Jul 23 2014 - 2 reports

Biogen Idec’s 2nd-qtr 40% revenues growth beats forecasts

Shares of US biotech firm Biogen Idec (Nasdaq: BIIB) jumped 7.35% to $326 in pre-market trading today, as the company reported second-quarter 2014 financial results showing that sales had increased 40% to $2.42 billion, well above the average forecast ... [Published Pharma Letter - Jul 23 2014]
First reported Jun 25 2014 - Updated Jun 26 2014 - 3 reports

Sobi seeks EMA approval for Xiapex for Peyronies disease

Swedish Orphan Biovitrum (Sobi) has filed for an extension of the label for Xiapex with the European Medicines Agency (EMA) to include the indication of Peyronie's disease. ... [Published PBR - News - Jun 26 2014]
First reported May 12 2014 - Updated May 13 2014 - 4 reports

Biogen, Sobi pledge hemophilia drug donation in developing world

Biogen Idec Inc and partner Swedish Orphan Biovitrum AB on Monday said they will donate hemophilia drugs for use in developing nations in quantities large enough to treat tens of thousands of patients over the next decade. The potentially life-sa... ... [Published Yahoo! Health News - May 12 2014]
First reported Apr 14 2014 - Updated Apr 15 2014 - 2 reports

Auxilium, Sobi present data from clinical trials evaluating the use of Xiaflex/Xiapex in adult patients with PD at EAU Congress

Auxilium Pharmaceuticals, Inc., a fully integrated specialty biopharmaceutical company, and Swedish Orphan Biovitrum AB (Sobi), an international specialty healthcare company dedicated to rare diseases, have presented encore data from multiple clinical ... [Published PharmaBiz - Apr 15 2014]
First reported Apr 10 2014 - Updated Apr 11 2014 - 3 reports

Biogen Idec and Sobi Announce Positive Top-Line Efficacy and Safety Results from Phase 3 Pediatric Study of Investigational Therapy Eloctate™ (rFVIIIFc) for Hemophilia A

CAMBRIDGE, Mass. & STOCKHOLM--(BUSINESS WIRE)--Biogen Idec (NASDAQ: BIIB) and Swedish Orphan Biovitrum AB (publ) (Sobi) (STO: SOBI) today released positive top-line results of the Kids A-LONG Phase 3 clinical study that evaluated the safety and efficacy ... [Published Business Wire Photo/Multimedia News - Apr 10 2014]

Quotes

...of infusions required," said Jean St-Louis, director of the Hemostasis Programs of the CHU Sainte-Justine and the Maisonneuve-Rosemont Hospital. "Health Canada's approval of Eloctate provides people with hemophilia A an important new option in maintaining a prophylactic regimen, which may help alleviate this burden, and enable individuals to achieve their target factor levels with less frequent prophylactic dosing than traditional therapy" he noted
"These positive results are very encouraging, particularly because both patients and physicians saw a statistically significant improvement in the appearance of cellulite after CCH treatment" commented Thomas L Wegman
...a statistically significant improvement in the appearance of cellulite after CCH treatment," commented Thomas L Wegman , President of BioSpecifics. "The market for cellulite treatment is large, which makes these data very exciting for the prospective commercial success of CCH in this indication. The results also position CCH as a potential treatment for other aesthetic needs, so we are eager to see continued progress by Auxilium in initiating a subsequent Phase 2b trial of CCH in cellulite in the second quarter of 2015."
...Sijmen de Vries, Chief Executive Officer of Pharming commented: "Earlier this month we announced the US FDA approval for Ruconest®, the first and only recombinant protein replacement therapy for the treatment of acute attacks of angioedema in patient with HAE. Inhibition of C1 esterase is the gold standard for HAE treatment and our US pivotal phase III study has confirmed that Ruconest® demonstrates best-in-class efficacy and the cleanest safety profile of all other treatment options. The approval represents an important addition to the available treatment options for the US HAE patient population and the most significant achievement to date for Pharming. We are now working intensively with our US partner Salix to make Ruconest® available to US HAE patients as soon as feasible. Ahead of that, during the first six months of 2014 we focused on preparing for US market entry by investing in building up inventories of Ruconest®, such that we can now benefit from receiving 30% of net sales of Salix for the supply of Ruconest® in the US. In addition, in April, we strengthened the balance sheet with a "sub-10%" private placement to institutional investors that yielded €14.7 million which ensured that we can now also co-invest to develop our main asset Ruconest® for additional indications, such as Prophylaxis of HAE and, in addition, evaluate options to get directly involved in commercialization activities in certain markets." . In the first half year of 2014, the Company generated revenue from sales of Ruconest® of €1.4 million and deferred licensing fees of €1...

More Content

All (78) | News (34) | Reports (0) | Blogs (15) | Audio/Video (0) | Fact Sheets (2) | Press Releases (26)
sort by: Date | Relevance
Orfadin storage [Published Pharmaceutical Journal - 14 hours ago]
Health Canada OKs Biogen Idec’s hemophilia A th... [Published Pharma Letter - Aug 26 2014]
Company Update: Biogen Idec Inc (NASDAQ:BIIB) –... [Published Jutia Group - Aug 26 2014]
BioSpecifics Technologies Corp. Announces Posit... [Published TheStreet.com - Aug 21 2014]
BioSpecifics Technologies Corp. Announces Posit... [Published Stock Nod - Aug 21 2014]
BioSpecifics Technologies Corp. Announces Posit... [Published Reliance Trust - Aug 21 2014]
Company Update: Biogen Idec Inc (NASDAQ:BIIB) –... [Published Jutia Group - Aug 21 2014]
Pharming Reports On Financial Results First Hal... [Published Noodls - Aug 17 2014]
Market Update: Biogen Idec Inc (NASDAQ:BIIB) – ... [Published Jutia Group - Aug 16 2014]
Biogen Idec’s long-acting agents to have major ... [Published Pharma Letter - Aug 14 2014]
BioSpecifics (BSTC) Q2 2014 Results - Earnings ... [Published Seeking Alpha - Aug 12 2014]
BioSpecifics Technologies Corp. Reports Second ... [Published TickerTech.com - Aug 11 2014]
BioSpecifics Technologies Corp. Announces Initi... [Published Pettinga Financial Advisors - Aug 08 2014]
BioSpecifics Technologies Corp. Announces Initi... [Published TickerTech.com - Aug 08 2014]
BioSpecifics Technologies Corp. Announces Appoi... [Published Barchart - Aug 05 2014]
BioSpecifics Technologies Corp. to Host Confere... [Published FinanzNachrichten.de - Aug 04 2014]
Pharming Reports On Financial Results First Hal... [Published Pharming - Jul 31 2014]
Pharming Group Reports On Financial Results Fir... [Published BioSpace - Jul 31 2014]
New number of shares and votes in Swedish Orpha... [Published GlobeNewswire: Advertising News - Jul 31 2014]
European Medicines Agency renews Marketing Auth... [Published Ysios Capital Partners - Jul 25 2014]
Biogen Idec’s 2nd-qtr 40% revenues growth beats... [Published Pharma Letter - Jul 23 2014]
Biogen Idec Second Quarter 2014 Revenues Increa... [Published Tamar Securities - Jul 23 2014]
Pre-Filled Syringes Market (2nd Edition), 2014 ... [Published RCL Advisors - Jul 21 2014]
FirstWord Lists: Pharma's tax inversion craze h... [Published FirstWord Pharma - Jul 20 2014]
Sobi's board of directors exercises authorisati... [Published GlobeNewswire: Acquisitions News - Jul 18 2014]
Sobi awarded Company of the Year at the Europea... [Published GlobeNewswire: Acquisitions News - Jul 01 2014]
Sobi seeks EMA approval for Xiapex for Peyronie... [Published PBR - News - Jun 26 2014]
BioSpecifics Technologies Corp. Announces Filin... [Published PR Newswire: Health - Jun 25 2014]
Sobi files for EU approval of Xiapex for Peyron... [Published GlobeNewswire: Advertising News - Jun 25 2014]
Sobi files for EU approval of Xiapex for Peyron... [Published PR Newswire: Financial Services - Jun 25 2014]
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Blogs

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Sobi seeks EMA approval for Xiapex for Peyronie... [Published PBR - News - Jun 26 2014]
Swedish Orphan Biovitrum (Sobi) has filed for an extension of the label for Xiapex with the European Medicines Agency (EMA) to include the indication of Peyronie's disease. ...
BioSpecifics Technologies Corp. Announces Filin... [Published PR Newswire: Health - Jun 25 2014]
LYNBROOK, N.Y., June 25, 2014 /PRNewswire/ -- BioSpecifics Technologies Corp. (NASDAQ: BSTC), a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX® in the U.S. and XIAPEX® in the EU, announced today that ...
Sobi files for EU approval of Xiapex for Peyron... [Published PR Newswire: Financial Services - Jun 25 2014]
STOCKHOLM and CHESTERBROOK, Pa., June 25, 2014 /PRNewswire/ -- Swedish Orphan Biovitrum AB (publ) (Sobi) and Auxilium Pharmaceuticals, Inc. today announced that Sobi has filed for an extension of the label for Xiapex® (collagenase clostridium histolyticum) ...
ORFADIN (Nitisinone) Capsule [SWEDISH ORPHAN BI... [Published DailyMed Drug Label Updates for the last seven ... - Jun 15 2014]
Updated Date: Jun 11, 2014 EST ...
Biogen, Sobi pledge hemophilia drug donation in... [Published Yahoo! Health News - May 12 2014]
Biogen Idec Inc and partner Swedish Orphan Biovitrum AB on Monday said they will donate hemophilia drugs for use in developing nations in quantities large enough to treat tens of thousands of patients over the next decade. The potentially life-sa... ...
1 2 3

Press Releases

sort by: Date | Relevance
New number of shares and votes in Swedish Orpha... [Published GlobeNewswire: Advertising News - Jul 31 2014]
Sobi's board of directors exercises authorisati... [Published GlobeNewswire: Acquisitions News - Jul 18 2014]
Sobi awarded Company of the Year at the Europea... [Published GlobeNewswire: Acquisitions News - Jul 01 2014]
Sobi files for EU approval of Xiapex for Peyron... [Published GlobeNewswire: Advertising News - Jun 25 2014]
Sobi to review preclinical data to potentially ... [Published GlobeNewswire: Acquisitions News - Jun 16 2014]
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