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Zejula(niraparib)/ GSK, ZAI Lab, J&J, Takeda; dostarlimab (TSR-042) / GSK
AnaptysBio and GlaxoSmithKline Amend Strategic Immuno-Oncology Collaboration (GlobeNewswire) - Oct 26, 2020 - "AnaptysBio,Inc...announced that AnaptysBio and GlaxoSmithKline (GSK) have amended their immuno-oncology collaboration agreement. The amended agreement provides AnaptysBio with increased royalties on dostarlimab sales under the collaboration, a royalty on GSK’s Zejula™ and a one-time cash payment. GSK receives freedom to conduct combination development and commercialization of Zejula™ with third party molecules...First US FDA approval of dostarlimab is anticipated in Q4 2020 for the treatment of endometrial cancer, while MAAreview is also underway for the same indication. A second BLA filing for dostarlimab, for the treatment of mismatch repair deficient cancers on a pan-tumor basis, is anticipated in the first half of 2021."
Keytruda(pembrolizumab)/ Merck (MSD); BI-1808 / BioInvent
CTA approval of BioInvent's BI-1808, a first-in-class anti-TNFR2 antibody, sets stage for Phase I/IIa trial (PRNewswire)- Oct 26, 2020 - "BioInvent International AB...announces it has received regulatory authority approval of its clinical trial application (CTA) in Denmark for a Phase I/IIa, first-in-human study of BI-1808, as monotherapy and in combination with the anti-PD-1 therapy Keytruda® (pembrolizumab) for the treatment of solid tumors and cutaneous T-cell lymphoma (CTCL)...The study will explore the safety, tolerability, and potential signs of efficacy of BI-1808 as a single agent and in combination with Keytruda® in patients with ovarian cancer, non-small cell lung cancer and CTCL....The Phase IIa will consist of expansion cohorts to assess signs of efficacy of BI-1808 as single agent and in combination with Keytruda® in lung cancer and ovarian cancer patients. A separate cohort will explore the activity as single agent in CTCL (Sézary syndrome and mycosis fungoides)."
Xarelto(rivaroxaban)/ J&J, Bayer
Janssen Submits Application to U.S. FDA for New Indication to Expand Use of XARELTO(rivaroxaban) in Patients with Peripheral Artery Disease (PRNewswire) - Oct 26, 2020 - "The Janssen Pharmaceutical Companies of Johnson & Johnson announced today it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for a new indication to expand the use of XARELTO®(rivaroxaban) in patients with peripheral artery disease (PAD). If approved, this new indication for the XARELTO® vascular dose (2.5 mg twice daily plus aspirin 75-100 mg once daily) would include reducing the risk of major thrombotic vascular events such as heart attack, stroke and amputation inpatients after recent lower-extremity revascularization."
Pemazyre(pemigatinib)/ Incyte
Incyte Announces Health Canada Acceptance of the New Drug Submission for Pemigatinibas a Treatment for Patients with Cholangiocarcinoma (Canada Newswire) - Oct 26, 2020 -"Incyte...announced that Health Canada has accepted its New Drug Submission (NDS) for pemigatinib, a selective fibroblast growth factor receptor(FGFR) inhibitor, as a treatment for adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma with FGFR2fusion or other rearrangement...The NDS is based on data from the FIGHT-202study..."
Roseomonasmucosa (FB-401)/ Forte Biosci
Forte Biosciences, Inc. Announces the FDA Has Granted Fast Track Designation toFB-401 for the Treatment of Atopic Dermatitis (Businesswire) - Oct 26, 2020 - "Forte Biosciences, Inc....today announced that the U.S. Food and Drug Administration(FDA) has granted Fast Track Designation to FB-401 for the treatment of atopic dermatitis....'We look forward to working closely with the FDA as we accelerate the advancement of FB-401, which has the potential to address a significant unmet need for pediatric and adult patients suffering from atopic dermatitis.'"
