Oncology February 14, 2022 US FDA accepts Spectrum Pharmaceuticals’ poziotinib NDA for review By vbandhakavi The acceptance by the FDA is based on the positive data from a Phase II study in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)
Drug DiscoveryResearch & Development February 10, 2022 Seismic raises $101m to advance two drug programmes to clinic By PBR Staff Writer Lead founding investors Polaris Partners and Timothy A. Springer participated in the funding round, in addition to new investors Samsara BioCapital, Boxer Capital, GV, and management and founders.
Drug DiscoveryResearch & Development February 9, 2022 Healx secures option to license rights from Ovid to develop gaboxadol By PBR Staff Writer As per the agreement, Healx intends to investigate the compound as part of a potential combination therapy for Fragile X syndrome and treatment for other indications. Fragile X
Drug Discovery February 8, 2022 NHS to roll out new drug to treat advanced womb cancer By PBR Staff Writer The drug attaches to a specific protein on the cancer cells’ surface and helps the immune system to detect and attack them. Approximately 100 women with advanced and
RegulationApprovals February 7, 2022 US FDA approves Sanofi’s Enjaymo for cold agglutinin disease treatment By PBR Staff Writer Enjaymo is intended to reduce the need for red blood cell transfusion caused due to hemolysis in CAD patients. The drug is a humanised monoclonal antibody that selectively
Drug DiscoveryResearch & Development February 4, 2022 Mersana, Janssen Biotech partner to discover new ADC product candidates By PBR Staff Writer As part of the collaboration, Janssen will provide its antibodies and Mersana will apply its Dolasynthen platform and expertise for the discovery of the new ADC product candidates.
Research & DevelopmentDrug Manufacturing February 3, 2022 Alvotech, BiosanaPharma partner to develop biosimilar for Xolair By PBR Staff Writer As part of the collaboration, both the companies will co-develop AVT23, an investigational compound, that is now in late development stage. The companies will develop the proposed biosimilar
RegulationApprovals February 2, 2022 ViiV Healthcare gets FDA nod for two-month dosing of Cabenuva to treat HIV By PBR Staff Writer Cabenuva has now been cleared for every-two-month dosing for the treatment of HIV-1 in people who are virologically suppressed on a stable regimen, with no prior treatment failure,
RegulationApprovals February 1, 2022 Novavax seeks EUA from FDA for Covid-19 vaccine By PBR Staff Writer The protein-based vaccine candidate is intended to immunise individuals aged 18 years and above against Covid-19. Developed using Novavax’ recombinant nanoparticle technology, NVX-CoV2373 is engineered from the genetic
RegulationApprovals January 31, 2022 EMA’s CHMP recommends approval for Bristol Myers’s Breyanzi to treat lymphoma By PBR Staff Writer The drug is intended to treat relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), and follicular lymphoma grade 3B (FL3B) in