Latest Swedish Orphan ADR (SWTUY) Headlines
Sobi receives EURORDIS Company Award 2014
Thomson Reuters ONE - Wed Feb 26, 1:01AM CST
Swedish Orphan Biovitrum AB (publ) (Sobi) was awarded the EURORDIS Company Award 2014 at the EURORDIS Black Pearl Gala Dinner on February 25. The award recognises pioneering companies developing treatments for rare diseases. Sobi was honoured based on the treatments in the company's commercial and development portfolio, on the company's policy and track record on access to drugs, and on its collaboration with patient organisations.
Form 4: Update Filing for Skywest Inc (SKYW)
Vickers Stock Research - Fri Feb 21, 6:41PM CST
The Board of Directors of Swedish Orphan Biovitrum AB (Sobi) has decided to issue an additional nominal amount of up to SEK 200 million under the current bond loan with a loan frame of SEK 1 billion. Sobi has previously issued SEK 600 million in nominal amount under the bond loan which is admitted to trading on NASDAQ OMX Stockholm.
Sobi publishes its Report for the Fourth Quarter and Full Year 2013
Thomson Reuters ONE - Thu Feb 20, 1:01AM CST
Swedish Orphan Biovitrum AB (publ) (Sobi) today announced its results for the fourth quarter and full year 2013. Revenues for the year totalled SEK 2,177 M (1,923), an increase of 13 per cent. Revenues in the fourth quarter were 29 per cent higher compared to the previous year. All parts of the business contributed to the result with Kineret(R) and Partner Products delivering strong performance.
Invitation - Presentation of Sobi's fourth quarter and full year results 2013
Thomson Reuters ONE - Mon Feb 10, 1:00AM CST
On 20 February, at 08:00 CET, Swedish Orphan Biovitrum AB (publ) (Sobi) will publish its report for the fourth quarter and full year, 2013.
Form 4: Update Filing for Avista Corp (AVA)
Vickers Stock Research - Sat Feb 08, 4:26AM CST
BIOGEN IDEC CONTACT:
Sobi to temporarily withdraw New Drug Application for Orfadin(R) oral suspension in the US
GlobeNewswire - Fri Dec 27, 1:08AM CST
Swedish Orphan Biovitrum AB (publ) (Sobi) announced today its decision to withdraw the company's New Drug Application for an oral suspension of Orfadin in the US. The decision to withdraw the current application is based on a request for further information by the US Food and Drug Administration (FDA) regarding the usability by the intended user population of the Orfadin oral suspension and the oral syringe to be included in the package.
Sobi to temporarily withdraw New Drug Application for Orfadin® oral suspension in the US
Thomson Reuters ONE - Fri Dec 27, 1:02AM CST
Swedish Orphan Biovitrum AB (publ) (Sobi) announced today its decision to withdraw the company's New Drug Application for an oral suspension of Orfadin in the US. The decision to withdraw the current application is based on a request for further information by the US Food and Drug Administration (FDA) regarding the usability by the intended user population of the Orfadin oral suspension and the oral syringe to be included in the package.
Sobi to take direct responsibility for Orfadin in the US, Canada and Latin America
GlobeNewswire - Fri Dec 20, 5:09AM CST
Swedish Orphan Biovitrum AB (publ) (Sobi) announced today that the company has decided to take direct responsibility for Orfadin(R) in the US, Canada, and Latin America by terminating the current distributorship agreement with their partner Rare Disease Therapeutics, Inc (RDT). Financial details were not disclosed.
Sobi moves to Large Cap
Thomson Reuters ONE - Thu Dec 19, 5:01AM CST
NASDAQ OMX today announced that Swedish Orphan Biovitrum AB (publ) (Sobi) will, as per 2 January 2014, move to the Large Cap listing on the NASDAQ OMX Stockholm Stock Exchange.
Swedish Orphan Biovitrum AB (publ): New phase 3 data confirm long-lasting characteristics of rFIXFc and rFVIIIFc across multiple haemophilia populations
Thomson Reuters ONE - Mon Dec 09, 10:31AM CST
Interim analyses from phase 3 paediatric studies suggest prolonged half-life of investigational long-lasting therapies in children under age 12.
Sobi's partner Biogen Idec to present phase 3 data on prolonged half-life of Haemophilia candidates in young children at annual ASH meeting
Thomson Reuters ONE - Tue Dec 03, 6:31AM CST
Swedish Orphan Biovitrum AB's (publ ) (Sobi) partner Biogen Idec today announced that new data from their haemophilia clinical development and research programs will be presented at the 55th Annual Meeting of the American Society of Hematology (ASH), taking place in New Orleans, December 7-10. Researchers will discuss 10 abstracts covering the breadth of the company's comprehensive basic and clinical research programs. This includes new interim data from Phase 3 studies in paediatric populations evaluating the company's investigational long-lasting recombinant factor VIII Fc fusion protein candidate for haemophilia A and factor IX Fc fusion protein candidate for haemophilia B.
Sobi's partner Biogen Idec receives notification from FDA of PDUFA date extension for ALPROLIX(TM)
GlobeNewswire - Mon Dec 02, 6:33AM CST
Swedish Orphan Biovitrum AB's (publ) (Sobi) partner Biogen Idec announced today that the U.S. Food and Drug Administration (FDA) has extended the initial Prescription Drug User Fee Act (PDUFA) date for its review of the Biologics License Application (BLA) for ALPROLIX, the company's investigational long-lasting recombinant factor IX Fc fusion protein candidate for hemophilia B. The PDUFA date has been extended by three months, which is the standard extension period.
New number of shares and votes in Swedish Orphan Biovitrum AB (publ)
Thomson Reuters ONE - Fri Nov 29, 1:01AM CST
The total number of shares in Swedish Orphan Biovitrum AB (publ) (Sobi) as per 29 November 2013 amounts to 270,389,770 shares, all common shares, corresponding to in total 270,389,770 votes. The increase in the number of common shares and votes results from a conversion of all 5,163,172 class C shares held by the company into common shares. The shares are intended to ensure fulfillment of commitments under incentive programs.
Sobi awarded Best Biotech Pipeline at World Orphan Drug Congress
Thomson Reuters ONE - Thu Nov 21, 1:30AM CST
Swedish Orphan Biovitrum AB (publ) (Sobi) has been awarded Best Biotech Pipeline at the World Orphan Drug Congress in Geneva. The award recognises the size and range of Sobi's orphan pipeline and also the mix across designation and authorisation phases within the portfolio. The judging panel also acknowledged Sobi's long-term future as well as the company's pioneering development approach and commitment to the rare disease and orphan drug space.
Sobi receives approval for Kineret® for treatment of rare disease CAPS
Thomson Reuters ONE - Wed Nov 20, 1:01AM CST
Swedish Orphan Biovitrum AB (publ) (Sobi) announced today that the European Commission (EC) has approved Kineret (anakinra) for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS). The decision follows a positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in September 2013.
LEADING HEMATOLOGY JOURNAL PUBLISHES PIVOTAL ELOCTATE(TM) DATA THAT DEMONSTRATED EFFICACY AND SAFETY OF INVESTIGATIONAL LONG-LASTING THERAPY FOR HEMOPHILIA A
Thomson Reuters ONE - Wed Nov 13, 11:30AM CST
- Phase 3 Study Showed Potential for Once- or Twice-Weekly Prophylactic Dosing Regimens -
Sobi's partner Biogen Idec expects mid-2014 US launch of ELOCTATE®
Thomson Reuters ONE - Tue Nov 12, 11:33AM CST
Swedish Orphan Biovitrum AB's (publ) (Sobi) partner Biogen Idec today, at the Credit Suisse Global Healthcare Conference in Phoenix, stated that the US Food and Drug Administration (FDA) has requested additional information pertaining to process validation of certain steps in the manufacturing process for ELOCTATE. As a result, Biogen Idec expects a PDUFA extension for ELOCTATE and the company is now planning for a mid-2014 commercial launch in the US based on on-going discussions with the FDA. Sobi believes that this updated timeline for FDA approval is unlikely to impact planned European approval timelines.
Sobi receives EURORDIS Company Award 2014
Thomson Reuters ONE - Wed Feb 26, 1:01AM CST
Swedish Orphan Biovitrum AB (publ) (Sobi) was awarded the EURORDIS Company Award 2014 at the EURORDIS Black Pearl Gala Dinner on February 25. The award recognises pioneering companies developing treatments for rare diseases. Sobi was honoured based on the treatments in the company's commercial and development portfolio, on the company's policy and track record on access to drugs, and on its collaboration with patient organisations.
Form 4: Update Filing for Skywest Inc (SKYW)
Vickers Stock Research - Fri Feb 21, 6:41PM CST
The Board of Directors of Swedish Orphan Biovitrum AB (Sobi) has decided to issue an additional nominal amount of up to SEK 200 million under the current bond loan with a loan frame of SEK 1 billion. Sobi has previously issued SEK 600 million in nominal amount under the bond loan which is admitted to trading on NASDAQ OMX Stockholm.
Sobi publishes its Report for the Fourth Quarter and Full Year 2013
Thomson Reuters ONE - Thu Feb 20, 1:01AM CST
Swedish Orphan Biovitrum AB (publ) (Sobi) today announced its results for the fourth quarter and full year 2013. Revenues for the year totalled SEK 2,177 M (1,923), an increase of 13 per cent. Revenues in the fourth quarter were 29 per cent higher compared to the previous year. All parts of the business contributed to the result with Kineret(R) and Partner Products delivering strong performance.
Invitation - Presentation of Sobi's fourth quarter and full year results 2013
Thomson Reuters ONE - Mon Feb 10, 1:00AM CST
On 20 February, at 08:00 CET, Swedish Orphan Biovitrum AB (publ) (Sobi) will publish its report for the fourth quarter and full year, 2013.
Form 4: Update Filing for Avista Corp (AVA)
Vickers Stock Research - Sat Feb 08, 4:26AM CST
BIOGEN IDEC CONTACT:
Sobi to temporarily withdraw New Drug Application for Orfadin(R) oral suspension in the US
GlobeNewswire - Fri Dec 27, 1:08AM CST
Swedish Orphan Biovitrum AB (publ) (Sobi) announced today its decision to withdraw the company's New Drug Application for an oral suspension of Orfadin in the US. The decision to withdraw the current application is based on a request for further information by the US Food and Drug Administration (FDA) regarding the usability by the intended user population of the Orfadin oral suspension and the oral syringe to be included in the package.
Sobi to temporarily withdraw New Drug Application for Orfadin® oral suspension in the US
Thomson Reuters ONE - Fri Dec 27, 1:02AM CST
Swedish Orphan Biovitrum AB (publ) (Sobi) announced today its decision to withdraw the company's New Drug Application for an oral suspension of Orfadin in the US. The decision to withdraw the current application is based on a request for further information by the US Food and Drug Administration (FDA) regarding the usability by the intended user population of the Orfadin oral suspension and the oral syringe to be included in the package.
Sobi to take direct responsibility for Orfadin in the US, Canada and Latin America
GlobeNewswire - Fri Dec 20, 5:09AM CST
Swedish Orphan Biovitrum AB (publ) (Sobi) announced today that the company has decided to take direct responsibility for Orfadin(R) in the US, Canada, and Latin America by terminating the current distributorship agreement with their partner Rare Disease Therapeutics, Inc (RDT). Financial details were not disclosed.
Sobi moves to Large Cap
Thomson Reuters ONE - Thu Dec 19, 5:01AM CST
NASDAQ OMX today announced that Swedish Orphan Biovitrum AB (publ) (Sobi) will, as per 2 January 2014, move to the Large Cap listing on the NASDAQ OMX Stockholm Stock Exchange.
Swedish Orphan Biovitrum AB (publ): New phase 3 data confirm long-lasting characteristics of rFIXFc and rFVIIIFc across multiple haemophilia populations
Thomson Reuters ONE - Mon Dec 09, 10:31AM CST
Interim analyses from phase 3 paediatric studies suggest prolonged half-life of investigational long-lasting therapies in children under age 12.
Sobi's partner Biogen Idec to present phase 3 data on prolonged half-life of Haemophilia candidates in young children at annual ASH meeting
Thomson Reuters ONE - Tue Dec 03, 6:31AM CST
Swedish Orphan Biovitrum AB's (publ ) (Sobi) partner Biogen Idec today announced that new data from their haemophilia clinical development and research programs will be presented at the 55th Annual Meeting of the American Society of Hematology (ASH), taking place in New Orleans, December 7-10. Researchers will discuss 10 abstracts covering the breadth of the company's comprehensive basic and clinical research programs. This includes new interim data from Phase 3 studies in paediatric populations evaluating the company's investigational long-lasting recombinant factor VIII Fc fusion protein candidate for haemophilia A and factor IX Fc fusion protein candidate for haemophilia B.
Sobi's partner Biogen Idec receives notification from FDA of PDUFA date extension for ALPROLIX(TM)
GlobeNewswire - Mon Dec 02, 6:33AM CST
Swedish Orphan Biovitrum AB's (publ) (Sobi) partner Biogen Idec announced today that the U.S. Food and Drug Administration (FDA) has extended the initial Prescription Drug User Fee Act (PDUFA) date for its review of the Biologics License Application (BLA) for ALPROLIX, the company's investigational long-lasting recombinant factor IX Fc fusion protein candidate for hemophilia B. The PDUFA date has been extended by three months, which is the standard extension period.
New number of shares and votes in Swedish Orphan Biovitrum AB (publ)
Thomson Reuters ONE - Fri Nov 29, 1:01AM CST
The total number of shares in Swedish Orphan Biovitrum AB (publ) (Sobi) as per 29 November 2013 amounts to 270,389,770 shares, all common shares, corresponding to in total 270,389,770 votes. The increase in the number of common shares and votes results from a conversion of all 5,163,172 class C shares held by the company into common shares. The shares are intended to ensure fulfillment of commitments under incentive programs.
Sobi awarded Best Biotech Pipeline at World Orphan Drug Congress
Thomson Reuters ONE - Thu Nov 21, 1:30AM CST
Swedish Orphan Biovitrum AB (publ) (Sobi) has been awarded Best Biotech Pipeline at the World Orphan Drug Congress in Geneva. The award recognises the size and range of Sobi's orphan pipeline and also the mix across designation and authorisation phases within the portfolio. The judging panel also acknowledged Sobi's long-term future as well as the company's pioneering development approach and commitment to the rare disease and orphan drug space.
Sobi receives approval for Kineret® for treatment of rare disease CAPS
Thomson Reuters ONE - Wed Nov 20, 1:01AM CST
Swedish Orphan Biovitrum AB (publ) (Sobi) announced today that the European Commission (EC) has approved Kineret (anakinra) for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS). The decision follows a positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in September 2013.
LEADING HEMATOLOGY JOURNAL PUBLISHES PIVOTAL ELOCTATE(TM) DATA THAT DEMONSTRATED EFFICACY AND SAFETY OF INVESTIGATIONAL LONG-LASTING THERAPY FOR HEMOPHILIA A
Thomson Reuters ONE - Wed Nov 13, 11:30AM CST
- Phase 3 Study Showed Potential for Once- or Twice-Weekly Prophylactic Dosing Regimens -
Sobi's partner Biogen Idec expects mid-2014 US launch of ELOCTATE®
Thomson Reuters ONE - Tue Nov 12, 11:33AM CST
Swedish Orphan Biovitrum AB's (publ) (Sobi) partner Biogen Idec today, at the Credit Suisse Global Healthcare Conference in Phoenix, stated that the US Food and Drug Administration (FDA) has requested additional information pertaining to process validation of certain steps in the manufacturing process for ELOCTATE. As a result, Biogen Idec expects a PDUFA extension for ELOCTATE and the company is now planning for a mid-2014 commercial launch in the US based on on-going discussions with the FDA. Sobi believes that this updated timeline for FDA approval is unlikely to impact planned European approval timelines.
