Swedish Orphan Biovitrum (Sobi) – pharmaceutical daily

December 17, 2021 Off

EMA recommends approval for use of Kineret in COVID-19 to the European Commission

EMA’s human medicines committee (CHMP) has recommended extending the indication of Kineret (anakinra) to include treatment of COVID-19 in adult patients with pneumonia requiring supplemental oxygen (low or high flow oxygen) and who are at risk of developing severe respiratory failure, as determined by blood levels of a protein called suPAR (soluble urokinase plasminogen activator receptor) of at least 6 ng per ml.

October 1, 2019 Off

Sobi buys Dova Pharmaceuticals for $915 million

By Dino Mustafić

Swedish Orphan Biovitrum (Sobi) said Monday it will Dova Pharmaceuticals for an upfront payment of $27.50 per share in cash and, one non-tradeable Contingent Value Right (CVR), with an additional $1.50 for shareholders upon approval of Doptelet for use in Chemotherapy-Induced Thrombocytopenia (CIT) by the US Food and Drug Administration (FDA).

September 4, 2019 Off

Novitium gets Orfadin generic equicalent approval from USFDA

By Dino Mustafić

Novitium Pharma, LLC, a partner of Endo’s subsidiary Endo Ventures Limited, received approval from the U.S. Food and Drug Administration for a room temperature stable, AB-rated, generic equivalent of Swedish Orphan Biovitrum’s Orfadin.

April 4, 2019 Off

Sobi to Showcase Latest Rare Disease and Specialty Care Research at Multiple Spring 2019 Scientific Meetings

By BusinessWire

WALTHAM, Mass.–(BUSINESS WIRE)–Sobi, an international biopharmaceutical company transforming the lives of people affected by rare diseases, announced that investigators will…

March 21, 2018 Off

Sobi launches Ravicti in Europe and advances the care for patients with Urea Cycle Disorders

By Dino Mustafić

Swedish Orphan Biovitrum has gained reimbursement for Ravicti, a new therapy option for the treatment of patients with Urea Cycle…

October 6, 2017 Off

New vice president for Sobi

By Dino Mustafić

Swedish Orphan Biovitrum AB (publ) (Sobi) has appointed Norbert Oppitz as Senior Vice President for the newly established business area Specialty Care.

May 18, 2017 Off

Sobi to sell another rare disease drug in Saudi Arabia

By Dino Mustafić

The Saudi Food & Drug Authority (SFDA) has approved Swedish Orphan Biovitrum’s (Sobi) Elocta (efmoroctocog alfa), a recombinant human factor VIII Fc-fusion protein with an extended half-life, for the treatment of haemophilia A.

May 17, 2017 Off

Sobi’s hereditary tyrosinemia drug approved in Saudi Arabia

By Dino Mustafić

The Saudi Food and Drug Administration (SFDA) has approved Swedish Orphan Biovitrum’s (Sobi) Orfadin (nitisinone) capsules in all strengths (2 mg, 5 mg, 10 mg and 20 mg) for the treatment of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.

May 4, 2017 Off

Sobi welcomes new CEO

By Dino Mustafić

Swedish Orphan Biovitrum (Sobi) has appointed Guido Oelkers as President and Chief Executive Officer effective as of 22 May 2017, succeeding Geoffrey McDonough.

February 21, 2017 Off

Sobi, Valeant sign new agreement for UCDs drug distribution

By Dino Mustafić

Swedish Orphan Biovitrum (Sobi) has entered into a 3-year agreement with Ireland’s Valeant Pharmaceuticals for the distribution of Ammonul injection, an acute Urea Cycle Disorders (UCDs) drug, in Europe, the Middle East and North Africa.