FDA places a partial hold on all venetoclax clinical trials for multiple myeloma (MM) patients The U.S. Food and Drug Administration (FDA) put the partial hold on all MM trials when they did a pre-planned... March 20, 2019Business, Finances, Insurance & RegulatoryBy Brad Hedrick
Venetoclax Will be Paid for in Australia Venetoclax (Venclexta®), will be added to Australian Pharmaceutical Benefits Scheme (PBS) starting March 1, 2019. Venetoclax was developed in Australia and though... February 26, 2019Business, Finances, Insurance & RegulatoryBy Brad Hedrick
CMS approves CAR-T therapy payment, but with significant strings attached CMS is the the government agency that decides what gets paid for and what doesn't by Medicare and Medicaid. Often... February 20, 2019Business, Finances, Insurance & RegulatoryBy Brad Hedrick
Bristol-Myers Squibb to Acquire Celgene On Jan. 22, 2018, Celgene announced they had acquired Juno Therapeutics. Juno’s CAR-T, JCAR017, looks very promising in CLL and... January 29, 2019Business, Finances, Insurance & RegulatoryBy Brad Hedrick
The FDA’s 10th approval of ibrutinib, this time in combination with obinutuzumab for frontline therapy for CLL Today, Jan. 28., 2019, “FDA approved the use of IMBRUVICA® (ibrutinib) in combination with obinutuzumab (GAZYVA®) for adult patients with... January 29, 2019Business, Finances, Insurance & RegulatoryBy Brad Hedrick
Duvelisib approved for Relapsed and Refractory CLL after failing 2 lines of therapy For chronic lymphocytic leukemia patients, it is always good to have more options. The FDA’s approval of duvelisib, a very effective... September 27, 2018Business, Finances, Insurance & RegulatoryBy Patty Koffman
Minimal Residual Disease Negativity Data, a Measure of Undetectable Disease, Added to Venetoclax tablet Label Minimal residual disease (MRD)-negativity is a big deal and is now being recognized right on the label of venetoclax, a... September 18, 2018Business, Finances, Insurance & RegulatoryBy Brad Hedrick
FDA Approval of Ibrutinib with Rituximab for Waldenström’s Macroglobulinemia Ibrutinib plus Rituximab is now approved by the FDA in Waldenström's Macroglobulinemia (WM), a rare form of non-Hodgkin's lymphoma and... August 28, 2018Business, Finances, Insurance & RegulatoryBy Brad Hedrick
FDA Approval of Venetoclax in Combination with Rituximab (V+R) for Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Patients Who Have Received One Prior Therapy This is great news for CLL patients a few good reasons. First it is the first non-chemo combination approved for... June 9, 2018Business, Finances, Insurance & RegulatoryBy Todd Dennison
FDA Approves Kymriah (tisagenlecleucel) for DLBCL May 7, 2018 - The U.S. Food and Drug Administration (FDA) granted tisagenlecleucel (Kymriah®), formerly known as CTL019, its second... May 8, 2018Business, Finances, Insurance & RegulatoryBy Todd Dennison
