Leap Therapeutics gets FDA orphan status for DKN-01 for gastric and gastroesophageal junction cancer

Leap Therapeutics gets FDA orphan status for DKN-01 for gastric and gastroesophageal junction cancer

US immuno-oncology company Leap Therapeutics has been granted orphan drug designation for DKN-01 from the US Food and Drug Administration (FDA) for the treatment of gastric and gastroesophageal junction cancer. DKN-01, which is a humanized monoclonal antibody, has been designed to bind to and block the activity of the Dickkopf-1 (DKK1) protein, a modulator of […]

Takeda gets extended EC approval for ADCETRIS in sALCL

Takeda gets extended EC approval for ADCETRIS in sALCL

Takeda Pharmaceutical has secured extended approval for ADCETRIS (brentuximab vedotin) in the European Union to include the treatment of previously untreated systemic anaplastic large cell lymphoma (sALCL) in adult patients. The approval from the European Commission (EC) is for the combination of ADCETRIS with CHP (cyclophosphamide, doxorubicin, prednisone. It comes in the wake of a […]

PADCEV, KEYTRUDA combination for advanced bladder cancer gets FDA breakthrough therapy status

PADCEV, KEYTRUDA combination for advanced bladder cancer gets FDA breakthrough therapy status

PADCEV, KEYTRUDA combination : Astellas Pharma and Seattle Genetics said that the combination of PADCEV (enfortumab vedotin-ejfv) and Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) has been given breakthrough therapy designation from the US Food and Drug Administration (FDA) in first-line advanced bladder cancer. The FDA breakthrough therapy status for PADCEV, KEYTRUDA combination is for the treatment […]

Pinpoint Therapeutics secures funds for developing autophagy inhibitors for cancer

Pinpoint Therapeutics secures funds for developing autophagy inhibitors for cancer

Pinpoint Therapeutics, a US biopharma company focused on developing autophagy inhibitors for cancer treatment, has secured $1 million in debt financing led by California-based venture capital firm Kairos Ventures. The preclinical stage company was founded in 2018 through PCI Ventures, a division of the Penn Center for Innovation (PCI) at the University of Pennsylvania. It […]

PACT Pharma raises $75m to develop neoTCR-T cell therapies for solid tumors

PACT Pharma raises $75m to develop neoTCR-T cell therapies for solid tumors

PACT Pharma, a California-based clinical stage company, which is focused on developing fully personalized neoTCR-T cell therapies for solid tumors, has raised $75 million in a Series C financing round. The funding round was led by Vida Ventures, a life science venture firm, with participation from the current investors of PACT Pharma. The clinical stage […]

Amgen, Allergan file BLA to FDA for Rituxan biosimilar ABP 798

Amgen, Allergan file BLA to FDA for Rituxan biosimilar ABP 798

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 […]

Astellas, Seattle Genetics bag Padcev FDA approval for advanced urothelial cancer

Astellas, Seattle Genetics bag Padcev FDA approval for advanced urothelial cancer

Padcev FDA approval : Astellas Pharma and Seattle Genetics have bagged accelerated approval from the US Food and Drug Administration (FDA) for Padcev (enfortumab vedotin-ejfv) for the treatment of advanced urothelial cancer, the most common form of bladder cancer. Padcev, which has been co-developed by the two pharma companies, is a Nectin-4-directed antibody and microtubule […]

Lilly launches LIBRETTO-431 clinical trial for selpercatinib in NSCLC

Lilly launches LIBRETTO-431 clinical trial for selpercatinib in NSCLC

Eli Lilly and Company (Lilly) has initiated the phase 3 LIBRETTO-431 clinical trial to evaluate selpercatinib (LOXO-292) in RET fusion-positive non-small cell lung cancer (NSCLC) in patients who are treatment-naïve. The US pharma company is aiming to enroll 400 patients in the late-stage clinical trial. The patients will be grouped randomly to be subjected to […]

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