Category: blood cancer
The FDA has placed a partial clinical fold on clinical trials of Gilead Sciences’ magrolimab, the centre piece of its $4.9 billion acquisition of Forty Seven in 2020. The regulatory move applies only to trials of magrolimab given alongside Bristol-Myers Squibb’s Vidaza (azacitidine), and stems from an “imbalance” in investigator-reported serious adverse events between study […]
Polycythemia vera, a rare blood cancer characterized by the overproduction of red blood cells, now has its first FDA-approved drug treatment. The agency awarded the regulatory nod to a PharmaEssentia drug that reduces the levels of those blood cells.
Fresh from claiming its first bispecific antibody approval, Johnson & Johnson has delved deeper into the category with a deal to license a drug for B-cell cancers developed by Xencor. J&J’s Janssen Biotech unit is paying $100 million upfront to Xencor and making a $25 million equity investment in the biotech in return for rights […]
This thought leadership series has been paid and developed by Kite, a Gilead Company. This Blood Cancer Awareness Month, Blood Cancer UK’s Kate Keightley explains the need for better awareness and understanding of this common, but less-understood disease. Blood cancer is the fifth most common cancer in the UK and the third most deadly, killing […]
Takeda says a phase 3 trial of its cancer candidate pevonedistat – a class-leading NEDD8-activating enzyme inhibitor – has failed to show a benefit in patients with blood cancers, placing its future in doubt. The PANTHER trial looked at the combination of pevonedistat in combination with azacitidine chemotherapy as first-line treatment for patients with higher-risk […]
Sonam: Hello everyone, today we have on our panel discussion round doctor Amit Agarwal with us who is Director Medical Oncology from Fortis Hospital Shalimar Bagh. We welcome your doctor on board. Dr. Amit: Thank you Sonam: So to let you know about Doctor Amit. Doctor Amit brings with him an experience of more than […]
TG Therapeutics has completed its rolling FDA filing for its U2 combination therapy consisting of the antibody ublituximab with the oral drug Ukoniq (umbralisib) as a treatment for chronic lymphocytic leukaemia (CLL). The US pharma is mounting a challenge to Roche, which markets an antibody therapy, Gazyvaro (obinutuzumab) in advanced CLL. Like Gazyvaro, ublituximab targets […]
US biotech TG Therapeutics has begun a rolling filing with the FDA for its combination therapy for chronic lymphocytic leukaemia, in a challenge to Roche. The New York-based firm has requested approval for the combination of its anti-CD20 antibody ublituximab and umralisib, an oral drug that inhibits PI3K-delta and CK-1 epsilon. The FDA had already […]
The San Francisco-based company aims to complete at least one Phase III study by 2025, and it is weighing an IPO next year to fund more.