In a significant development for the pharmaceutical industry, Dr. Reddy’s Laboratories Ltd. has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) regarding its proposed biosimilar, DRL_RI, also known as ITUXREDI. This endorsement could pave the way for the launch of this promising biosimilar across European […]
Dr. Reddy’s Laboratories, an Indian pharmaceutical company, announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for a comprehensive review of its proposed biosimilar rituximab candidate, DRL_RI. This news comes on the heels of similar acceptance from the European Medicines Agency (EMA) and the United Kingdom’s Medicines and […]
Dr. Reddy’s Laboratories, an Indian pharmaceutical company, announced a significant milestone as its tocilizumab biosimilar candidate, DRL_TC, successfully met primary and secondary endpoints in a phase 1 clinical trial. The early-stage study, titled ‘A Phase I, Double Blind, Randomized, Parallel-group, Single dose, Three arm, Comparative Pharmacokinetic and Pharmacodynamic Study of Dr. Reddy’s Laboratories’ Tocilizumab (DRL_TC), […]
BeiGene has secured the approval of the US Food and Drug Administration (FDA) for the company’s Brukinsa (zanubrutinib) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Brukinsa FDA approval is backed by the findings of two global phase 3 clinical trials wherein Brukinsa showed superior efficacy and […]
French pharma company Ipsen has agreed to acquire Epizyme, a Massachusetts-based commercial-stage biopharma company for an initial consideration of $247 million. Epizyme, which is listed on Nasdaq, is focused on developing and delivering therapies against novel epigenetic targets for patients with different types of cancer. Through the deal, Ipsen gets access to Tazverik (tazemetostat), the […]
Chronos-3 trial results : Bayer said that the investigational combination of Aliqopa (copanlisib) and rituximab considerably increased progression-free survival (PFS) in patients having relapsed indolent non-Hodgkin’s Lymphoma (iNHL) in the phase 3 CHRONOS-3 clinical trial. The late-stage trial, which featured 458 patients, compared the Aliqopa, rituximab combo in comparison to the combination of rituximab and […]
Rituxan biosimilar ABP 798 : US biopharma company Amgen and Irish pharma company Allergan have submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for ABP 798, a biosimilar candidate to Roche’s cancer drug Rituxan (rituximab). Rituxan, which is a CD20-directed cytolytic antibody, has approval across various regions for the […]
Pixuvri EMA approval : French pharma company Servier has secured full approval for Pixuvri (pixantrone) from the European Commission (EC) as monotherapy for aggressive non-Hodgkin B-cell lymphoma (NHL) in adult patients whose condition is multiply relapsed or refractory. Pixuvri EMA approval Since 2012, Pixantrone has been available in Europe to patients following conditional approval, which […]
Nordic Nanovector has commenced the dosing of the first patient in its Phase 1b clinical trial, dubbed Archer-1, which aims to evaluate the combination of its investigational lymphoma drug Betalutin (177Lu-satetraxetan-lilotomab) with Roche’s rituximab (RTX) as a second-line treatment for follicular lymphoma (2L FL). This trial is a critical step in exploring novel treatments for […]
Janssen Pharmaceutical, a subsidiary of Johnson & Johnson, has received approval from the US Food and Drug Administration (FDA) for its combination treatment of IMBRUVICA (ibrutinib) and rituximab for Waldenström’s macroglobulinemia (WM), a rare form of blood cancer. This latest approval expands the use of IMBRUVICA in treating WM from monotherapy to now include combination […]