Two strategic biopharmaceutical collaborations were announced, each merging one company’s innovative biologic technology with a second company that can drive potential therapeutics over the finish line to commercialization.
According to a California WARN notice, Sanofi is shuttering Principia Biopharma’s laboratories in San Francisco and laying off about three dozen employees after the Phase III PEGASUS trial failure of rilzabrutinib for pemphigus.
Paris-based Sanofi announced that the company’s Phase III PEGASUS clinical trial of rilzabrutinib for pemphigus failed to hit the primary or key secondary endpoints. Sanofi picked up the drug when the company acquired South San Francisco-based Principia Biopharma in August 2020 for $3.68 billion.
Global pharmaceutical operations and technology company Biogen partnered with Chinese commercial-stage biopharmaceutical firm InnoCare Pharma to develop a treatment for multiple sclerosis.
Evolution of US Payer Management of Oncology, an examination of Non-small Cell Lung Cancer (NSCLC) and Chronic Lymphocytic Leukemia (CLL)
Analysis, Bruton's Tyrosine Kinase (BTK) Inhibitors, Chronic Lymphocytic Leukemia (CLL), Clinical Trials, Insurance Companies, Non-Small Cell Lung Cancer (NSCLC), Oncology, Payers, PD-1/PD-L1 inhibitors, R&D, Surveys, Therapeutics, United StatesTraditional management tools have proven to be ineffective at managing costs for oncology drugs, leading to a hands-off management approach in the United States. But a recent survey from Two Labs – including 25 Pharmacy Directors and Medical Directors at US insurance companies representing 112.5 million covered lives – shows that the situation might be changing. The survey aimed to gather insight about what the industry looks like with increased levels of care management by covering traditional management tools, oncology-specific tools, systemic management tools and shifting risk, value frameworks, and pathways of care.
Calquence met primary efficacy endpoint in head-to-head trial against ibrutinib in CLL
Atrial Fibrillation, Bruton's Tyrosine Kinase (BTK) Inhibitors, Chronic Lymphocytic Leukemia (CLL), Clinical Trial Endpoints, Clinical Trials, Head-to-Head Studies, Primary Endpoints, R&D, Secondary Endpoints, TherapeuticsPositive high-level results from the ELEVATE-RR Phase III trial showed AstraZeneca’s Calquence (acalabrutinib) met the primary endpoint demonstrating non-inferior progression-free survival for adults with previously treated, high-risk chronic lymphocytic leukemia (CLL) compared to ibrutinib.
Fast Track, Breakthrough and Priority Reviews: Sanofi and ViiV
Acid alpha-glucosidase (GAA) enzyme, Biologics License Application (BLA), Breakthrough Therapy Designation, Bruton's Tyrosine Kinase (BTK) Inhibitors, Chronic Immune Thrombocytopenia (ITP), Clinical Trials, Enzyme Replacement Therapy (ERT), Fast Track Designation, FDA, HIV pre-exposure prophylaxis (PrEP), HIV Prevention, Muscle Disease, Orphan Drug Designation, PDUFA, Pompe disease, Priority Review Status, R&D, SanofiThe U.S. Food and Drug Administration granted various designations for Sanofi’s avalglucosidase alfa for Pompe disease, Sanofi’s rilzabrutinib for immune thrombocytopenia, and ViiV Healthcare’s cabotegravir for HIV prevention.
AstraZeneca’s blood cancer treatment Calquence failed to improve survival rates and prevent lung failure in patients hospitalized with symptoms of Covid-19, the drugmaker said, citing results from mid-stage trials.
Sanofi announced the acquisition of Principia Biopharma in a deal valued at about $3.68 billion as the French company continues to transform its R&D division to more heavily emphasize oncology and other lucrative programs.
Sanofi is rumored to have a $50 billion budget for mergers and acquisitions and is taking a look at U.S.-based biotech companies, including South San Francisco-based Principia Biopharma.