The FDA announced Breakthrough Therapy Designation (BTD) for acalabrutinib (Calquence) as a single agent to treat chronic lymphocytic leukemia (CLL) Acalabrutinib is already approved to treat mantle cell lymphoma, but with BTD for CLL, that means it is one step... August 15, 2019Business, Finances, Insurance & RegulatoryBy Brad Hedrick
Ibrutinib and Rituximab (IR) is Superior to Chemo-immunotherapy (CIT) in CLL: Big News, or is it really? And did they get it right? When CNN has a headline that Chemo-free drug combo shows 'dramatic' improvement against common leukemia in adults and reports on... August 6, 2019ClinicalBy Brad Hedrick
Shuttering of the Biden Cancer Initiative The cancer moonshot lead by VP Joe Biden started with such promise, but it is on hold now due to... August 5, 2019Business, Finances, Insurance & RegulatoryBy Brad Hedrick
Approval of a biosimilar for Rituximab The approval of Ruxience (rituximab-pvvr) (Pfizer) a biosimilar for the originator product Rituxan (Genentech) brings the total number of FDA... July 29, 2019Business, Finances, Insurance & RegulatoryBy Brad Hedrick
AbbVie reaches an agreement with the pan-Canadian Pharmaceutical Alliance (pCPA) for VENCLEXTA®, a treatment for chronic lymphocytic leukemia (CLL) "MONTREAL , May 23, 2019 /CNW/ - AbbVie (ABBV), a global, research and development-driven biopharmaceutical company, announced today that Ontario... May 29, 2019Business, Finances, Insurance & RegulatoryBy Brad Hedrick
May 15, 2019: FDA approved venetoclax in combination with obinutuzumab for the treatment of people with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) This is very big news. This is the first non-chemotherapy based fixed duration treatment for CLL in treatment naïve patients. Until this... May 20, 2019Business, Finances, Insurance & RegulatoryBy Brad Hedrick
Acalabrutinib Phase III ASCEND trial met primary endpoint at interim analysis in relapsed or refractory chronic lymphocytic leukemia and will stop early This trial in previously treated CLL patients showed a clinically significant progression free survival when compared to a combination regimen... May 10, 2019ClinicalBy Brad Hedrick
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
