Swedish Orphan ADR (SWTUY) 11.7100 $SWTUY
Sobi's board of directors exercises authorisation for repurchase of shares for the purpose of securing the company's commitments under the incentive program
Thomson Reuters ONE - Fri Jul 18, 2:01AM CDT
The annual general meeting of Swedish Orphan Biovitrum AB (publ) on 8 May 2014 resolved - for the purpose of ensuring that the company can fulfill its commitments under the long-term incentive program resolved by the annual general meeting - on a directed share issue of no more than 396,180 redeemable and convertible class C shares.
Sobi publishes Report for the Second Quarter 2014
Thomson Reuters ONE - Fri Jul 18, 1:01AM CDT
Swedish Orphan Biovitrum AB (publ) (Sobi) announced today its results for the second quarter 2014. Revenues totalled SEK 662.5 M (520.2), an increase of 27 per cent with contribution from all areas of the portfolio. The 2014 outlook is unchanged.
Invitation - Presentation of Sobi's second quarter results 2014
Thomson Reuters ONE - Wed Jul 09, 1:00AM CDT
On 18 July Swedish Orphan Biovitrum AB (publ) (Sobi) will publish its report for the second quarter 2014.
Sobi awarded Company of the Year at the European Mediscience Awards 2014
GlobeNewswire - Tue Jul 01, 2:32AM CDT
Swedish Orphan Biovitrum AB (publ) (Sobi) has been awarded the Company of the Year Award at the European Mediscience Awards 2014. The Company of the Year Award is awarded to a company who has gained recognition from analysts and investors for management, financial stability, and growth with a well-defined strategy to deliver its key financial, ethical and social ambitions.
Sobi files for EU approval of Xiapex for Peyronies disease
Thomson Reuters ONE - Thu Jun 26, 9:46PM CDT
Swedish Orphan Biovitrum AB (publ) (Sobi) and Auxilium Pharmaceuticals, Inc.today announced that Sobi has filed for an extension of the label for Xiapex(R) (collagenase clostridium histolyticum) with the European Medicines Agency (EMA) to include the indication of Peyronie's disease.
BioSpecifics Technologies Corp. Announces Filing by Sobi for EU Approval of XIAPEX for Peyronies Disease
PR Newswire - Wed Jun 25, 3:01PM CDT
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 Swedish Orphan Biovitrum AB (Sobi) has filed for an extension of the label for XIAPEX (the EU trade name for collagenase clostridium histolyticum or CCH) with the European Medicines Agency (EMA) to include the indication of Peyronie's disease. XIAPEX is currently approved for the treatment of Dupuytren's contracture in adult patients with a palpable cord. BioSpecifics' partner, Auxilium Pharmaceuticals, Inc. (Auxilium) is partnered with Sobi for the marketing of XIAPEX in 71 Eurasian and African countries for the treatment of Dupuytren's contracture, and Peyronie's disease pending applicable regulatory approvals.
Sobi to review preclinical data to potentially add future haemophilia A candidate to collaboration agreement with Biogen Idec
Thomson Reuters ONE - Mon Jun 16, 1:01AM CDT
On Friday, 13 June, Swedish Orphan Biovitrum AB's (publ) (Sobi) received a data package from Biogen Idec regarding a preclinical Hemophilia A program based on Amunix's proprietary XTEN technology. Amunix and Biogen Idec signed a worldwide license agreement in April 2014. Under the terms of Sobi and Biogen Idec's agreement, Sobi has the right to elect to obtain an option to add potential additional Factor VIII:Fc Constructs to the collaboration. Sobi has 120 days to review the preclinincal data, and to determine whether to elect to obtain such option under the collaboration. If Sobi elects to aquire its option, the company will be required to make a payment to Biogen Idec.
Graft Versus Host Disease (GVHD) - Pipeline Review, H1 2014
M2 - Tue Jun 10, 3:51AM CDT
Research and Markets (http://www.researchandmarkets.com/research/wd6llq/graft_versus_host) has announced the addition of the "Graft Versus Host Disease (GVHD) - Pipeline Review, H1 2014" report to their offering. This report provides comprehensive information on the therapeutic development for Graft Versus Host Disease (GVHD), complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Graft Versus Host Disease (GVHD) and special features on late-stage and discontinued projects. The report features investigational drugs from across globe covering over 20 therapy areas and nearly 3,000 indications. The report is built using data and information sourced from proprietary databases, Company/University websites, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources. Drug profiles/records featured in the report undergoes periodic updation following a stringent set of processes that ensures that all the profiles are updated with the latest set of information. Companies Mentioned: - F. Hoffmann-La Roche Ltd. - Osiris Therapeutics, Inc. - Athersys, Inc. - Seattle Genetics, Inc. - Millennium Pharmaceuticals, Inc. - Novartis AG - Rigel Pharmaceuticals, Inc. - Gentium S.p.A. - Immunomedics, Inc. - Mesoblast Limited - Swedish Orphan Biovitrum AB - Accentia Biopharmaceuticals, Inc. - Jazz Pharmaceuticals plc - Soligenix, Inc. - NeoStem, Inc. - Pluristem Therapeutics Inc. - MediPost Co., Ltd. - Alder Biopharmaceuticals Inc. - MSM Protein Technologies, Inc. - Tobira Therapeutics, Inc. - REGiMMUNE Corporation - Adienne Pharma & Biotech - Nephrx Corporation - Dr. Falk Pharma GmbH - Lycera Corp. - Neopharm Ltd. - Pharmicell Co., Ltd. - Sigmoid Pharma Ltd. - Targazyme, Inc. - Kadmon Pharmaceuticals, LLC For more information visit http://www.researchandmarkets.com/research/wd...ersus_host
Idiopathic Juvenile Arthritis (Still's Disease) - Pipeline Review, H1 2014
M2 - Mon Jun 09, 10:52AM CDT
Research and Markets (http://www.researchandmarkets.com/research/zrx5qq/idiopathic) has announced the addition of the "Idiopathic Juvenile Arthritis (Still's Disease) - Pipeline Review, H1 2014" report to their offering. This report provides comprehensive information on the therapeutic development for Idiopathic Juvenile Arthritis (Still's Disease), complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Idiopathic Juvenile Arthritis (Still's Disease) and special features on late-stage and discontinued projects. This report features investigational drugs from across globe covering over 20 therapy areas and nearly 3,000 indications. The report is built using data and information sourced from proprietary databases, Company/University websites, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources. Drug profiles/records featured in the report undergoes periodic updation following a stringent set of processes that ensures that all the profiles are updated with the latest set of information. Additionally, processes including live news & deals tracking, browser based alert-box and clinical trials registries tracking ensure that the most recent developments are captured on a real time basis. The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products. Companies Mentioned: - Celltrion, Inc. - Biocon Limited - Pfizer Inc. - UCB S.A. - Sandoz Inc. - Swedish Orphan Biovitrum AB - Biosidus S.A. - Genor BioPharma Co., Ltd. - AbbVie Inc. - Epirus Biopharmaceuticals, Inc. - AlphaMab Co., Ltd For more information visit http://www.researchandmarkets.com/research/zrx5qq/idiopathic
The US Food and Drug Administration (FDA) approves Eloctate(TM)
Thomson Reuters ONE - Mon Jun 09, 1:02AM CDT
Swedish Orphan Biovitrum AB (publ) (Sobi) partner Biogen Idechas announced that the US Food and Drug Administration (FDA) has approved Eloctate [Antihaemophilic Factor VIII (Recombinant), Fc Fusion Protein] for the control and prevention of bleeding episodes, perioperative (surgical) management and routine prophylaxis in adults and children with haemophilia A.This is the first regulatory approval worldwide for Eloctate and the therapy is currently under review by regulatory authorities in several other countries including Canada, Australia and Japan.
Sobi Establishes North American Office in Massachusetts
GlobeNewswire - Thu Jun 05, 1:08AM CDT
Swedish Orphan Biovitrum AB (publ) (Sobi) today announced that the Company has decided to establish its North American operations in Waltham, Massachusetts. Sobi had originally set up its US affiliate in 2012 in Ardmore, Pennsylvania. Sobi's office will open on 16 June 2014.
Swedish Orphan Biovitrum AB (publ): Sobi appoints Kirsti Gjellan as Senior Vice President Manufacturing Operations
Thomson Reuters ONE - Mon May 26, 8:32AM CDT
Swedish Orphan Biovitrum AB (publ) (Sobi) today announced that Kirsti Gjellan has been appointed Senior Vice President Manufacturing Operations. Gjellan joins Sobi from global pharmaceutical company Pfizer where she has been Managing Director and Site Leader at the Strangnas site for Pfizer Health AB as well as Member of the Pfizer Health AB Board.
Sobi assumes direct responsibility for Orfadin(r) (nitisinone) in US and Canada and introduces Orfadin4U(TM)
GlobeNewswire - Tue Apr 01, 1:08AM CDT
Swedish Orphan Biovitrum AB (publ) (Sobi) today assumed direct responsibility for the distribution of its proprietary product Orfadin in the United States and Canada. Orfadin is the only FDA approved therapy for use as an adjunct to dietary restriction of tyrosine and phenylalanine for the treatment of hereditary tyrosinaemia type 1 (HT-1). Sobi has been responsible for the worldwide development and commercialisation of Orfadin since 1993 and currently distributes the product in over 50 countries around the globe.
Sobi: US FDA approves Alprolix(TM)
GlobeNewswire - Mon Mar 31, 1:05AM CDT
Swedish Orphan Biovitrum AB's (publ) (Sobi) partner Biogen Idec have announced that the US Food and Drug Administration (FDA) has approved Alprolix (Coagulation Factor IX (Recombinant), Fc fusion protein), the first recombinant, DNA derived haemophilia B therapy with prolonged circulation in the body. Alprolix is indicated for the control and prevention of bleeding episodes, perioperative (surgical) management and routine prophylaxis in adults and children with haemophilia B. The therapy is shown to reduce bleeding episodes with prophylactic (protective) infusions starting at least a week apart.
Sobi: Kiobrina pivotal phase 3 study did not meet primary endpoint
GlobeNewswire - Wed Mar 26, 7:08AM CDT
Swedish Orphan Biovitrum AB (publ) (Sobi) today announced topline data from the company's pivotal phase 3 study of its enzyme therapy Kiobrina (rhBSSL - recombinant human Bile Salt Stimulated Lipase). The primary endpoint of the study - growth velocity measured after four weeks of treatment with rhBSSL - was not met. No statistically significant improvement in growth velocity was demonstrated in preterm infants treated with rhBSSL compared to placebo.
Sobi's board of directors exercises authorisation for repurchase of shares for the purpose of securing the company's commitments under the incentive program
Thomson Reuters ONE - Fri Jul 18, 2:01AM CDT
The annual general meeting of Swedish Orphan Biovitrum AB (publ) on 8 May 2014 resolved - for the purpose of ensuring that the company can fulfill its commitments under the long-term incentive program resolved by the annual general meeting - on a directed share issue of no more than 396,180 redeemable and convertible class C shares.
Sobi publishes Report for the Second Quarter 2014
Thomson Reuters ONE - Fri Jul 18, 1:01AM CDT
Swedish Orphan Biovitrum AB (publ) (Sobi) announced today its results for the second quarter 2014. Revenues totalled SEK 662.5 M (520.2), an increase of 27 per cent with contribution from all areas of the portfolio. The 2014 outlook is unchanged.
Invitation - Presentation of Sobi's second quarter results 2014
Thomson Reuters ONE - Wed Jul 09, 1:00AM CDT
On 18 July Swedish Orphan Biovitrum AB (publ) (Sobi) will publish its report for the second quarter 2014.
Sobi awarded Company of the Year at the European Mediscience Awards 2014
GlobeNewswire - Tue Jul 01, 2:32AM CDT
Swedish Orphan Biovitrum AB (publ) (Sobi) has been awarded the Company of the Year Award at the European Mediscience Awards 2014. The Company of the Year Award is awarded to a company who has gained recognition from analysts and investors for management, financial stability, and growth with a well-defined strategy to deliver its key financial, ethical and social ambitions.
Sobi files for EU approval of Xiapex for Peyronies disease
Thomson Reuters ONE - Thu Jun 26, 9:46PM CDT
Swedish Orphan Biovitrum AB (publ) (Sobi) and Auxilium Pharmaceuticals, Inc.today announced that Sobi has filed for an extension of the label for Xiapex(R) (collagenase clostridium histolyticum) with the European Medicines Agency (EMA) to include the indication of Peyronie's disease.
BioSpecifics Technologies Corp. Announces Filing by Sobi for EU Approval of XIAPEX for Peyronies Disease
PR Newswire - Wed Jun 25, 3:01PM CDT
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 Swedish Orphan Biovitrum AB (Sobi) has filed for an extension of the label for XIAPEX (the EU trade name for collagenase clostridium histolyticum or CCH) with the European Medicines Agency (EMA) to include the indication of Peyronie's disease. XIAPEX is currently approved for the treatment of Dupuytren's contracture in adult patients with a palpable cord. BioSpecifics' partner, Auxilium Pharmaceuticals, Inc. (Auxilium) is partnered with Sobi for the marketing of XIAPEX in 71 Eurasian and African countries for the treatment of Dupuytren's contracture, and Peyronie's disease pending applicable regulatory approvals.
Sobi to review preclinical data to potentially add future haemophilia A candidate to collaboration agreement with Biogen Idec
Thomson Reuters ONE - Mon Jun 16, 1:01AM CDT
On Friday, 13 June, Swedish Orphan Biovitrum AB's (publ) (Sobi) received a data package from Biogen Idec regarding a preclinical Hemophilia A program based on Amunix's proprietary XTEN technology. Amunix and Biogen Idec signed a worldwide license agreement in April 2014. Under the terms of Sobi and Biogen Idec's agreement, Sobi has the right to elect to obtain an option to add potential additional Factor VIII:Fc Constructs to the collaboration. Sobi has 120 days to review the preclinincal data, and to determine whether to elect to obtain such option under the collaboration. If Sobi elects to aquire its option, the company will be required to make a payment to Biogen Idec.
Graft Versus Host Disease (GVHD) - Pipeline Review, H1 2014
M2 - Tue Jun 10, 3:51AM CDT
Research and Markets (http://www.researchandmarkets.com/research/wd6llq/graft_versus_host) has announced the addition of the "Graft Versus Host Disease (GVHD) - Pipeline Review, H1 2014" report to their offering. This report provides comprehensive information on the therapeutic development for Graft Versus Host Disease (GVHD), complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Graft Versus Host Disease (GVHD) and special features on late-stage and discontinued projects. The report features investigational drugs from across globe covering over 20 therapy areas and nearly 3,000 indications. The report is built using data and information sourced from proprietary databases, Company/University websites, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources. Drug profiles/records featured in the report undergoes periodic updation following a stringent set of processes that ensures that all the profiles are updated with the latest set of information. Companies Mentioned: - F. Hoffmann-La Roche Ltd. - Osiris Therapeutics, Inc. - Athersys, Inc. - Seattle Genetics, Inc. - Millennium Pharmaceuticals, Inc. - Novartis AG - Rigel Pharmaceuticals, Inc. - Gentium S.p.A. - Immunomedics, Inc. - Mesoblast Limited - Swedish Orphan Biovitrum AB - Accentia Biopharmaceuticals, Inc. - Jazz Pharmaceuticals plc - Soligenix, Inc. - NeoStem, Inc. - Pluristem Therapeutics Inc. - MediPost Co., Ltd. - Alder Biopharmaceuticals Inc. - MSM Protein Technologies, Inc. - Tobira Therapeutics, Inc. - REGiMMUNE Corporation - Adienne Pharma & Biotech - Nephrx Corporation - Dr. Falk Pharma GmbH - Lycera Corp. - Neopharm Ltd. - Pharmicell Co., Ltd. - Sigmoid Pharma Ltd. - Targazyme, Inc. - Kadmon Pharmaceuticals, LLC For more information visit http://www.researchandmarkets.com/research/wd...ersus_host
Idiopathic Juvenile Arthritis (Still's Disease) - Pipeline Review, H1 2014
M2 - Mon Jun 09, 10:52AM CDT
Research and Markets (http://www.researchandmarkets.com/research/zrx5qq/idiopathic) has announced the addition of the "Idiopathic Juvenile Arthritis (Still's Disease) - Pipeline Review, H1 2014" report to their offering. This report provides comprehensive information on the therapeutic development for Idiopathic Juvenile Arthritis (Still's Disease), complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Idiopathic Juvenile Arthritis (Still's Disease) and special features on late-stage and discontinued projects. This report features investigational drugs from across globe covering over 20 therapy areas and nearly 3,000 indications. The report is built using data and information sourced from proprietary databases, Company/University websites, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources. Drug profiles/records featured in the report undergoes periodic updation following a stringent set of processes that ensures that all the profiles are updated with the latest set of information. Additionally, processes including live news & deals tracking, browser based alert-box and clinical trials registries tracking ensure that the most recent developments are captured on a real time basis. The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products. Companies Mentioned: - Celltrion, Inc. - Biocon Limited - Pfizer Inc. - UCB S.A. - Sandoz Inc. - Swedish Orphan Biovitrum AB - Biosidus S.A. - Genor BioPharma Co., Ltd. - AbbVie Inc. - Epirus Biopharmaceuticals, Inc. - AlphaMab Co., Ltd For more information visit http://www.researchandmarkets.com/research/zrx5qq/idiopathic
The US Food and Drug Administration (FDA) approves Eloctate(TM)
Thomson Reuters ONE - Mon Jun 09, 1:02AM CDT
Swedish Orphan Biovitrum AB (publ) (Sobi) partner Biogen Idechas announced that the US Food and Drug Administration (FDA) has approved Eloctate [Antihaemophilic Factor VIII (Recombinant), Fc Fusion Protein] for the control and prevention of bleeding episodes, perioperative (surgical) management and routine prophylaxis in adults and children with haemophilia A.This is the first regulatory approval worldwide for Eloctate and the therapy is currently under review by regulatory authorities in several other countries including Canada, Australia and Japan.
Sobi Establishes North American Office in Massachusetts
GlobeNewswire - Thu Jun 05, 1:08AM CDT
Swedish Orphan Biovitrum AB (publ) (Sobi) today announced that the Company has decided to establish its North American operations in Waltham, Massachusetts. Sobi had originally set up its US affiliate in 2012 in Ardmore, Pennsylvania. Sobi's office will open on 16 June 2014.
Swedish Orphan Biovitrum AB (publ): Sobi appoints Kirsti Gjellan as Senior Vice President Manufacturing Operations
Thomson Reuters ONE - Mon May 26, 8:32AM CDT
Swedish Orphan Biovitrum AB (publ) (Sobi) today announced that Kirsti Gjellan has been appointed Senior Vice President Manufacturing Operations. Gjellan joins Sobi from global pharmaceutical company Pfizer where she has been Managing Director and Site Leader at the Strangnas site for Pfizer Health AB as well as Member of the Pfizer Health AB Board.
Sobi assumes direct responsibility for Orfadin(r) (nitisinone) in US and Canada and introduces Orfadin4U(TM)
GlobeNewswire - Tue Apr 01, 1:08AM CDT
Swedish Orphan Biovitrum AB (publ) (Sobi) today assumed direct responsibility for the distribution of its proprietary product Orfadin in the United States and Canada. Orfadin is the only FDA approved therapy for use as an adjunct to dietary restriction of tyrosine and phenylalanine for the treatment of hereditary tyrosinaemia type 1 (HT-1). Sobi has been responsible for the worldwide development and commercialisation of Orfadin since 1993 and currently distributes the product in over 50 countries around the globe.
Sobi: US FDA approves Alprolix(TM)
GlobeNewswire - Mon Mar 31, 1:05AM CDT
Swedish Orphan Biovitrum AB's (publ) (Sobi) partner Biogen Idec have announced that the US Food and Drug Administration (FDA) has approved Alprolix (Coagulation Factor IX (Recombinant), Fc fusion protein), the first recombinant, DNA derived haemophilia B therapy with prolonged circulation in the body. Alprolix is indicated for the control and prevention of bleeding episodes, perioperative (surgical) management and routine prophylaxis in adults and children with haemophilia B. The therapy is shown to reduce bleeding episodes with prophylactic (protective) infusions starting at least a week apart.
Sobi: Kiobrina pivotal phase 3 study did not meet primary endpoint
GlobeNewswire - Wed Mar 26, 7:08AM CDT
Swedish Orphan Biovitrum AB (publ) (Sobi) today announced topline data from the company's pivotal phase 3 study of its enzyme therapy Kiobrina (rhBSSL - recombinant human Bile Salt Stimulated Lipase). The primary endpoint of the study - growth velocity measured after four weeks of treatment with rhBSSL - was not met. No statistically significant improvement in growth velocity was demonstrated in preterm infants treated with rhBSSL compared to placebo.
