Careers article - April 6, 2022
Sobi to cease ReFacto manufacturing
Sobi has announced that its contract with Pfizer for the manufacture of drug substance for ReFacto AF/Xyntha (ReFacto) has been amended due to clarity of final order volumes and will now expire in the first quarter of 2024, earlier than the previous expiry date at the end of 2025. Manufacturing of drug substance for ReFacto […]
Pharma Business - February 28, 2022
Sobi’s Gamifant recommended for approval in China
The Center for Drug Evaluation (CDE) has recommended approval of Gamifant to the National Medical Products Administration of China (NMPA). The indication is for treatment of adult and paediatric (newborn and older) patients with primary haemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance to conventional HLH therapy. “We are gratified that CDE […]
COVID-19 - December 20, 2021
Sobi’s Kinaret receives positive opinion from the CHMP
The Committee for Medicinal Products for Human Use of the EMA has adopted a positive opinion of Kineret for the treatment of COVID-19 in adult patients with pneumonia requiring supplemental oxygen who are at risk of progressing to severe respiratory failure determined by plasma concentration of soluble urokinase plasminogen activator receptor ≥ 6ng/ml. EMA has […]
Acquisition - December 5, 2021
Advent withdraws its Sobi bid
The company in September agreed to an 8 billion USD takeover by Advent and Aurora, an investment vehicle of Singapore’s GIC Pte Ltd, through Agnafit Bidco. “Since the acceptance level condition has not been fulfilled, Agnafit Bidco hereby withdraws the offer,” Agnafit Bidco said in a statement. Commenting on the bid process, the Chairman of […]
Acquisition - October 26, 2021
Agnafit Bidco extends the acceptance period for the Sobi offer
Following receipt of all regulatory approvals, Agnafit Bidco extends the acceptance period for the public offer to the shareholders of Sobi and announces its intention not to increase the price of SEK 235 per share in the Offer. On 2 September 2021, Advent International Corporation1 and Aurora Investment Pte Ltd2, an affiliate of GIC Pte […]
Pharma Business - October 22, 2021
Sobi’s Aspaveli receives positive CHMP opinion
Swedish Orphan Biovitrum (Sobi) and Apellis Pharmaceuticals have announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending the marketing authorisation of Aspaveli (pegcetacoplan) for the treatment of adults with paroxysmal nocturnal haemoglobinuria (PNH) who are anaemic after treatment with a C5 inhibitor […]
