Business, Finances, Insurance & Regulatory

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... Details

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... Details

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... Details

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... Details

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... Details

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... Details

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... Details

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... Details

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... Details

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... Details