Governors urge administration to defend ACA provisions | Roche touts positive final data for lymphocytic leukemia combo regimen | GSK's Benlysta for SLE found safe over time
June 19, 2018
Specialty Pharmacy SmartBrief
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Leading News
Governors urge administration to defend ACA provisions
A bipartisan coalition of nine governors urged the Trump administration to reverse its decision not to defend in court the Affordable Care Act's protections for people with pre-existing conditions, noting the move "threatens health care coverage for many in our states with pre-existing conditions and adds uncertainty and higher costs for Americans who purchase their own health insurance." The governors said the administration should instead work with them and with Congress to develop "bipartisan solutions to protect coverage and lower health care costs for all Americans."
The Hill (6/18),  The Associated Press (6/18) 
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Specialty Pharmacy Update
Roche touts positive final data for lymphocytic leukemia combo regimen
The final analysis and data from the late-stage study to assess the efficacy and safety of Roche's Gazyva/Gazyvaro, or obinutuzumab, plus chlorambucil treatment in untreated patients with chronic lymphocytic leukemia, was presented at the annual congress of the European Hematology Association. Roche revealed that Gazyva/Gazyvaro combined with chlorambucil met multiple study endpoints, producing clinically significant improvements in comparison with MabThera/Rituxan, or rituximab, plus chlorambucil, reducing patients' mortality risk by 24%.
PharmaBiz (India) (6/16) 
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GSK's Benlysta for SLE found safe over time
Results from a study sponsored by GlaxoSmithKline looking at Benlysta, or belimumab, for the treatment of systemic lupus erythematosus, show that the safety profile has remained stable over time. Patients treated with belimumab for up to nine years experience few if any adverse events in the later years of treatment.
MedPage Today (free registration) (6/18) 
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Note rounds nab $100M for Stealth
Stealth BioTherapeutics intends to use the $100 million raised from two convertible note rounds to launch a Phase IIb study of elamipretide for the treatment of patients with intermediate dry age-related macular degeneration. The drug is also in a Phase II/III trial for Barth syndrome and Leber's hereditary optic neuropathy and a late-stage study for mitochondrial myopathy.
BioCentury (6/18) 
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Untranched funding round brings in $32.5M for WindMIL
An untranched round of Series B funding raised $32.5 million for WindMIL Therapeutics. The company has an ongoing midstage trial of unmodified marrow-infiltrating lymphocytes for the treatment of multiple myeloma.
BioCentury (6/18) 
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Legislation & Regulation
Senators ask FDA to determine cause of nationwide drug shortages
Senators ask FDA to determine cause of nationwide drug shortages
Gottlieb (Drew Angerer/Getty Images)
A bipartisan group of 31 senators sent a letter to FDA Commissioner Scott Gottlieb asking the agency to convene its Drug Shortages Task Force to find out the possible causes of nationwide drug shortages, particularly of local anesthetics, sterile IV fluids and other routinely used medications. The senators also asked the agency to come up with policy recommendations on how to address the shortages by the end of next year at the latest.
The Hill (6/18) 
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FDA allows Duchenne muscular dystrophy trial to continue
The FDA lifted the clinical hold it placed in May on the Phase I/II trial of Solid Biosciences' Duchenne muscular dystrophy candidate SGT-001, saying the firm satisfactorily addressed its questions. The clinical hold was put in place after the first patient to receive the drug was hospitalized.
Genetic Engineering & Biotechnology News (6/18) 
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FDA fast-tracks ImmunoGen's treatment-resistant ovarian cancer therapy
The FDA awarded fast-track status to ImmunoGen's mirvetuximab soravtansine, being developed to treat patients with medium to high folate receptor alpha-positive platinum-resistant ovarian cancer who have had up to three prior treatments and are eligible to receive a single-agent chemotherapy as their next line of treatment.
Seeking Alpha (6/18) 
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Clinical & Research News
Positive data from Phase Ib/II duvelisib leukemia study announced
Data from Verastem's Phase Ib/II trial to assess the efficacy of duvelisib in combination with the chemotherapy regimen FCR, or fludarabine, cyclophosphamide and rituximab, as a first-line treatment for young patients with chronic lymphocytic leukemia was presented at the European Hematology Association's annual meeting. Results showed 76% of patients achieved bone marrow minimal residual disease negativity, with 26% attaining complete response and 68% achieving a partial response.
Seeking Alpha (6/18) 
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Small-cell lung cancer patients benefit from PARP inhibitor
Recent study data shows that adding the poly ADP-ribose polymerase (PARP) inhibitor veliparib to standard chemotherapy improved overall response rate for patients with small-cell lung cancer. The Phase II study at the University of Texas MD Anderson Cancer Center also led to the discovery of a biomarker that may indicate which patients will derive the most benefit from the treatment protocol.
Specialty Pharmacy Times (6/18) 
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It is an impressively arrogant move to conclude that just because you don't like something, it is empirically not good.
Tina Fey,
entertainer, writer and producer
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