Pharmaceuticals, Biotechnology and Life Sciences
Faron Pharmaceuticals said Friday that Independent Data Monitoring Committee (the IDMC) has recommended that the Interest trial for Traumakine should continue as planned with no changes, consistent with the previous four IDMC recommendations. Faron said it expects to recruit 300 patients during the fourth quarter of 2017.
André C. Muller, CFO of Idorsia, said: “We launched Idorsia on 15 June 2017 with a fully operational research and development engine and CHF 1 billion in cash. For the shortened financial year of 2017, we expect our non-GAAP operating expenses to be between CHF 180-190 million.”
BioMarin Pharmaceutical said Wednesday it plans to expand its development plan for BMN 270, its investigational gene therapy for hemophilia A, to include an additional Phase 3 study of the 4e13 vg/kg dose from its ongoing open-label Phase 1/2 study of BMN 270.
Orexo AB said on Wednesday that Zubsolv tablet’s position has changed from excluded from reimbursement to reimbursed as a preferred product. Zubsolv is buprenorphine and naloxone sublingual tablet (CIII) managed care formulary position with CVS Caremark for patients suffering from opioid dependence.
Arix Bioscience has acquired an interest in Amplyx Pharmaceuticals – San Diego-based Amplyx is focused on developing novel, broad-spectrum antifungal agents for the treatment of life-threatening fungal infections – as part of an oversubscribed $67 million Series C financing round.
The US Food and Drug Administration (FDA) has accepted and granted priority review for the New Drug Application (NDA) for acalabrutinib, a highly-selective, potent, Bruton tyrosine kinase (BTK) inhibitor, developed by AstraZeneca and its haematology research and development centre of excellence, Acerta Pharma. This potential new medicine is in development for the treatment of multiple B-cell and other cancers.
Nordic Nanovector has appointed Dr. Reza Safaei, MD as Head of Medical Affairs to lead the development and execution of Nordic Nanovector’s medical affairs strategy for Betalutin.
CTI BioPharma has completed enrollment in the Phase 3 PIX306 trial of PIXUVRI (pixantrone).
Celgene Corporation and Agios Pharmaceuticals, Inc. today announced that IDHIFA was granted approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory AML (R/R AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA approved test.
AstraZeneca and its haematology research and development centre of excellence, Acerta Pharma, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for acalabrutinib for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.