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Swedish Orphan ADR (SWTUY) 12.2100 $SWTUY

FDA approves a new dosing option of ORFADIN® (nitisinone) -- 20 mg Capsule
CNW Group - Wed Jun 15, 10:33AM CDT
Swedish Orphan Biovitrum AB (Sobi), an international specialty healthcare company dedicated to rare diseases, announced today that the Food and Drug Administration (FDA) has approved ORFADIN® 20 mg Capsule for the treatment of Hereditary Tyrosinemia Type 1 (HT-1). This is the second time this year Sobi is expanding the ORFADIN dosing options for HT-1 patients. ORFADIN is indicated for use in combination with dietary restriction of tyrosine and phenylalanine.

Swedish Orphan Biovitrum AB: Sobi: First Alprolix(R) Sales in the EU
BusinessWire - Mon Jun 06, 1:40AM CDT
Following the recent approval of the extended half-life therapy Alprolix(R) by the European Commission for the treatment of haemophilia B, Swedish Orphan Biovitrum AB (publ) (http://www.sobi.com/) (Sobi) (STO:SOBI) today announced the first sales of Alprolix in Germany.

Alprolix(R) (rFIXFc) Approved in the EU for the Treatment of Haemophilia B
BusinessWire - Fri May 13, 1:47AM CDT
Swedish Orphan Biovitrum AB (publ) (Sobi(TM)) (STO:SOBI) and Biogen (NASDAQ:BIIB) today announced that the European Commission (EC) has approved Alprolix(R) (rFIXFc), their extended half-life therapy, for the treatment of haemophilia B in all 28 European Union (EU) member states and maintained its orphan designation. Alprolix is the only recombinant factor IX Fc Fusion protein therapy for haemophilia B to offer people in the EU prolonged protection against bleeding episodes with fewer prophylactic injections.
BIIB: 313.19 (-0.63)

Swedish Orphan Biovitrum AB (publ): Bo Jesper Hansen sells 8 million shares
Globe Newswire - Wed May 04, 1:00AM CDT
Bo Jesper Hansen sells 8 million shares

Sobi publishes its report for the first quarter 2016
Globe Newswire - Wed Apr 27, 1:00AM CDT
Swedish Orphan Biovitrum AB (publ) (Sobi(TM)) today announced its results for the first quarter 2016. Revenue for the quarter totalled SEK 1,273 M (865), an increase of 47 per cent compared to previous year. All parts of the business contributed to the result with Orfadin(R) and Kineret(R) delivering strong performance.

Sobi publishes 2015 Annual Report
Globe Newswire - Wed Apr 27, 12:45AM CDT
Swedish Orphan Biovitrum AB (publ) (Sobi(TM)) today published its 2015 Annual Report, themed "A new chapter of our story". The integrated report summarises the business as well as financial highlights for 2015, and gives a deeper insight into the company's strategic agenda and its patient-centric innovation model.

FDA approves ORFADIN® (nitisinone) Oral Suspension
PR Newswire - Tue Apr 26, 12:52PM CDT
Swedish Orphan Biovitrum AB (Sobi), an international specialty healthcare company dedicated to rare diseases, today announced that the Food and Drug Administration (FDA) has approved ORFADIN® Oral Suspension for the treatment of Hereditary Tyrosinemia Type 1 (HT-1). ORFADIN is indicated for use in combination with dietary restriction of tyrosine and phenylalanine.

Orfadin(R) Oral Suspension approved in the US
Globe Newswire - Tue Apr 26, 1:08AM CDT
Swedish Orphan Biovitrum AB (publ) (Sobi(TM)) announced today that the US Food and Drug Administration (FDA) has as of 22 April 2016, approved Orfadin(R) (nitisinone) Oral Suspension for the treatment of hereditary tyrosinaemia type-1 (HT-1) in combination with dietary restriction of tyrosine and phenylanine. HT-1 is a rare genetic disease that affects infants and children. It is progressive and may result in liver and kidney complications and can be fatal if untreated.

Sobi signs licensing agreement with Affibody for IL-1
Globe Newswire - Fri Apr 22, 1:01AM CDT
Swedish Orphan Biovitrum AB (publ) (Sobi) today announced that it has exercised its option to sign a licensing agreement with Swedish biotech company Affibody AB for the development of novel treatments for inflammatory diseases where interleukin-1 (IL-1) is involved.

European patent granted on new formulation of Kineret(R) (anakinra)
Globe Newswire - Thu Apr 21, 1:01AM CDT
Swedish Orphan Biovitrum AB (publ) (Sobi(TM)) (STO:SOBI) today announced that the company has been granted a patent (EP2672985) in Europe for a new, citrate free formulation for Kineret(R) (anakinra). The European Patent Office (EPO) will publish the patent on 27 April 2016 and the patent will be validated in all available contracting states of the EPO. The patents will expire in February 2032.

Notice of annual general meeting in Swedish Orphan Biovitrum AB (publ)
Globe Newswire - Wed Apr 20, 1:02AM CDT
The shareholders in Swedish Orphan Biovitrum AB (publ), Reg. No. 556038-9321, are hereby summoned to the annual general meeting (the "Meeting" , to be held on Tuesday 24 May 2016 at 3.00 p.m. in Wallenbergsalen, the Royal Swedish Academy of Engineering Sciences (IVA), Grev Turegatan 16, Stockholm, Sweden.

Invitation - Presentation of Sobi's first quarter results 2016
Globe Newswire - Tue Apr 19, 1:00AM CDT
On 27 April 2016, at 08:00 CET, Swedish Orphan Biovitrum AB (publ) (Sobi(TM)) will publish its report for the first quarter 2016.

European Commission approves transfer of marketing authorisation for Elocta(R) to Sobi
Globe Newswire - Thu Mar 24, 2:32AM CDT
Swedish Orphan Biovitrum AB (publ) (Sobi) today announced that the European Commission (EC) has approved the transfer of the marketing authorisation for Elocta(R) (efmoroctocog alfa) from Biogen[1] to Sobi, making Sobi the marketing authorisation holder (MAH) of Elocta in the EU.

Mucopolysaccharidosis III (MPS III) (Sanfilippo Syndrome) - Pipeline Review 2015
M2 - Fri Jan 29, 9:53AM CST
Research and Markets (http://www.researchandmarkets.com/research/d6m6lb/mucopolysaccharido) has announced the addition of the "Mucopolysaccharidosis III (MPS III) (Sanfilippo Syndrome) - Pipeline Review, H2 2015" report to their offering. This report provides comprehensive information on the therapeutic development for Mucopolysaccharidosis III (MPS III) (Sanfilippo Syndrome), 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 Mucopolysaccharidosis III (MPS III) (Sanfilippo Syndrome) and special features on late-stage and discontinued projects. 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: - Abeona Therapeutics, Inc. - Alexion Pharmaceuticals, Inc. - ArmaGen,Inc. - Axcentua Pharmaceuticals AB - BioMarin Pharmaceutical Inc. - Dorphan S.A. - Laboratorios Del Dr. Esteve S.A. - Lysogene - Phoenix Nest, Inc. - Shire Plc - Swedish Orphan Biovitrum AB - uniQure N.V. Key Topics Covered: - Introduction - Mucopolysaccharidosis III (MPS III) (Sanfilippo Syndrome) Overview - Therapeutics Development - Pipeline Products for Mucopolysaccharidosis III (MPS III) (Sanfilippo Syndrome) - Overview - Pipeline Products for Mucopolysaccharidosis III (MPS III) (Sanfilippo Syndrome) - Comparative Analysis - Mucopolysaccharidosis III (MPS III) (Sanfilippo Syndrome) - Therapeutics under Development by Companies - Mucopolysaccharidosis III (MPS III) (Sanfilippo Syndrome) - Therapeutics under Investigation by Universities/Institutes - Mucopolysaccharidosis III (MPS III) (Sanfilippo Syndrome) - Pipeline Products Glance - Late Stage Products - Clinical Stage Products - Early Stage Products - Mucopolysaccharidosis III (MPS III) (Sanfilippo Syndrome) - Products under Development by Companies - Mucopolysaccharidosis III (MPS III) (Sanfilippo Syndrome) - Products under Investigation by Universities/Institutes - Mucopolysaccharidosis III (MPS III) (Sanfilippo Syndrome) - Companies Involved in Therapeutics Development For more information visit http://www.researchandmarkets.com/research/d6...saccharido
BMRN: 93.60 (+0.30), SHPG: 198.40 (+1.71), ALXN: 132.60 (-0.46), ABEO: 4.28 (+0.20)

Sobi to present new interim ASPIRE data at EAHAD congress suggesting that patients can reduce bleeding rates with long-term Elocta(R) treatment
Thomson Reuters ONE - Thu Jan 28, 1:00AM CST
New interim results from ASPIRE, the ongoing long-term extension study of Elocta(R) (efmoroctocog alfa), marketed by Biogen as Eloctate(R) (Antihemophilic Factor (Recombinant), Fc Fusion Protein) in the United States, suggest that patients can maintain prolonged protection against bleeding episodes at extended prophylactic dosing intervals. The data will be presented by Swedish Orphan Biovitrum AB (publ) (Sobi) (STO: SOBI) and Biogen (NASDAQ: BIIB) at the 9th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD), taking place in Malmo, Sweden, 3-5 February, 2016.
BIIB: 313.19 (-0.63)

Sobi's Orfadin(R) oral suspension granted European patent
Thomson Reuters ONE - Tue Jan 19, 1:00AM CST
Swedish Orphan Biovitrum AB (publ) (Sobi) today announced that the European Patent Office (EPO) has decided to grant a European patent for the Orfadin(R) (nitisinone) oral suspension formulation, which was approved by the European Commission for the treatment of Hereditary Tyrosinaemia type-1 (HT-1) in 2015. HT-1 is a rare genetic disease that affects infants and children. It is progressive and may result in liver and kidney complications and can be fatal if untreated.

Psoriatic Arthritis Therapeutics - Pipeline Review, H2 2015
M2 - Mon Jan 18, 5:59AM CST
Research and Markets (http://www.researchandmarkets.com/research/lw4ffj/psoriatic) has announced the addition of the "Psoriatic Arthritis - Pipeline Review, H2 2015" report to their offering. This report provides comprehensive information on the therapeutic development for Psoriatic Arthritis, 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 Psoriatic Arthritis and special features on late-stage and discontinued projects. 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. Key Topics Covered: - Introduction - Psoriatic Arthritis Overview - Therapeutics Development - Pipeline Products for Psoriatic Arthritis - Overview - Pipeline Products for Psoriatic Arthritis - Comparative Analysis - Psoriatic Arthritis - Therapeutics under Development by Companies - Psoriatic Arthritis - Therapeutics under Investigation by Universities/Institutes - Psoriatic Arthritis - Pipeline Products Glance - Late Stage Products - Clinical Stage Products - Early Stage Products - Psoriatic Arthritis - Products under Development by Companies - Psoriatic Arthritis - Products under Investigation by Universities/Institutes - Psoriatic Arthritis - Companies Involved in Therapeutics Development - AbbVie Inc. - AbGenomics International, Inc. - Alder Biopharmaceuticals Inc. - Amgen Inc. - AstraZeneca Plc - Avesthagen Limited - Berg LLC - BIOCAD - Biocon Limited - Bionovis SA - Boehringer Ingelheim GmbH - Bristol-Myers Squibb Company - Celgene Corporation - Celltrion, Inc. - Coherus BioSciences, Inc. - Eli Lilly and Company - Epirus Biopharmaceuticals, Inc. - Forward Pharma A/S - Genor BioPharma Co., Ltd. - Hetero Drugs Limited - Inbiopro Solutions Pvt. Ltd. - Innovent Biologics, Inc. - Johnson & Johnson - Kineta, Inc. - Mabion SA - Mabtech Limited - Momenta Pharmaceuticals, Inc. - Mycenax Biotech Inc. - Novartis AG - Novo Nordisk A/S - Oncobiologics, Inc. - Panacea Biotec Limited - Pfizer Inc. - Sandoz International GmbH - Swedish Orphan Biovitrum AB For more information visit http://www.researchandmarkets.com/research/lw4ffj/psoriatic
PFE: 35.03 (-0.11), AMGN: 174.65 (+0.34), LLY: 79.65 (-0.46), BMY: 58.57 (+0.27), MNTA: 12.10 (+0.17), CHRS: 30.03 (+0.32), JNJ: 120.31 (-1.00), ALDR: 30.59 (+0.30), NVO: 46.95 (-0.22), FWP: 22.44 (-0.55), AZN: 33.52 (-0.10), ABBV: 66.69 (-0.14), NVS: 81.90 (+0.12), CELGZ: 1.11 (-0.12)

Chief Medical Officer Birgitte Volck to leave Sobi
Thomson Reuters ONE - Thu Jan 14, 1:01AM CST
Swedish Orphan Biovitrum AB (publ) (Sobi) today announced that Birgitte Volck, M.D., Ph.D., Senior Vice President of Development and Chief Medical Officer (CMO) of Sobi, will leave the company to join the rare disease research group at GlaxoSmithKline as Head of R&D Rare Diseases. Birgitte will work through a six month notice period before leaving Sobi.
GSK: 44.43 (+0.04)

Sobi(TM) announces commercial launch of Elocta(R) in first countries in Europe
Thomson Reuters ONE - Mon Jan 11, 1:00AM CST
Swedish Orphan Biovitrum AB (publ) (Sobi(TM)) today announced the commercial launch of Elocta(R) (efmoroctocog alfa) in first countries in Europe. Elocta is a recombinant human factor VIII Fc fusion protein with an extended half-life, and is the first haemophilia A treatment in the EU to offer prolonged protection against bleeding episodes with prophylactic injections every three to five days.

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