Cleveland-based startup hires new CEO and prepares for market clearance

Phase 3 SPARTAN data served as basis for approval, which showed apalutamide decreased the risk of distant metastasis or death by 72 percent and improved median metastasis-free survival by more than two years

Epizyme, Inc. (Nasdaq: EPZM), a clinical-stage company developing novel epigenetic therapies, announced a comprehensive set of pipeline updates, including that the company has identified a path to submission for accelerated approval of tazemetostat for patients with relapsed and/or refractory follicular lymphoma (FL), both with and without EZH2 activating mutations.

Updated Phase 3 ALCYONE results, featured as oral presentation at ASH 2018, show improved progression-free survival in newly diagnosed patients

AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to VENCLEXTA® (venetoclax tablets) in combination with azacitidine, or decitabine, or low-dose cytarabine (LDAC) for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

Partner Therapeutics, Inc. (PTx), a commercial biotechnology company, announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Leukine® (sargramostim), a yeast-derived recombinant human granulocyte-macrophage colony stimulating factor (rhu-GM-CSF), for the treatment of pulmonary alveolar proteinosis (PAP).

Ensuring patients with heart failure have access to the latest evidence-based care, and improved outcomes and quality of life, is at the core of a hospital certification program offered by the American Heart Association, the world’s leading voluntary organization dedicated to building healthier lives, free of cardiovascular diseases and stroke, and The Joint Commission, the nation’s largest independent health care evaluation organization.

Today the American Cancer Society Cancer Action Network (ACS CAN) submitted comments to the Department of Health and Human Services (HHS) regarding proposals to reduce prescription drug costs outlined in the administration’s Request for Information (RFI) regarding its Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (blueprint).

LUPUS Foundation of America issued the following announcement on July 11.House Committee Approves Funding of Critical Lupus Programs House Appropriations Committee Chairman Rodney Frelinghuysen (R-NJ) with lupus advocates.

Today, the Centers for Medicare & Medicaid Services (CMS) proposed changes to the Medicaid Provider Reassignment regulation that would eliminate state’s ability to divert Medicaid payments away from providers, with the exception of payment arrangements explicitly authorized by statute.

The Senate health committee today passed legislation sponsored by Senator Lamar Alexander (R-Tenn.) and Senator Michael Bennet (D-Colo.) to reduce infant deaths and improve infant health by continuing research and education programs aimed at preventing preterm births.

Today the Department of Labor issued final rules governing the creation of association health plans (AHP).

Today, the House and Senate released the new bipartisan, bicameral agreement on the Synthetics Trafficking and Overdose Prevention (STOP) Act, legislation to help prevent the shipment of synthetic opioids into the United States through the international mail system.

The Department of Justice (DOJ) announced last night it will not defend several critical patient protections in the health law and instead is arguing to end them.

Penn Medicine researchers are calling for greater precision in Medicare performance reporting for patients with gastrointestinal (GI) bleeding following an evaluation of patients with the condition.

The American Cancer Society Cancer Action Network (ACS CAN), Friends of Cancer Research (FOCR), and the National Organization for Rare Disorders (NORD) along with more than 100 advocacy groups representing millions of patients submitted a letter to Members of the House of Representatives strongly opposing the Senate Right-to-Try Act (S. 204).

Starting Wednesday, a new law will protect New Mexico’s cancer patients from health risks caused by step therapy — also known as “fail first” therapy.

Today, the American Hospital Association (AHA) commended the introduction of the Rural Emergency Medical Center (REMC) Act of 2018 (H.R. 5678) by Representatives Lynn Jenkins (R-KS), Ron Kind (D-WI) and Terri Sewell (D-AL).

The Biotechnology Innovation Organization (BIO) and BioForward Wisconsin commend Governor Scott Walker for signing critical legislation to create a pathway for the substitution of interchangeable biologic medicines, with appropriate communication to patients and physicians.

The U.S. Food and Drug Administration (FDA) has expanded approval for a personalized cellular therapy developed at the University of Pennsylvania’s Abramson Cancer Center, this time for the treatment of adult patients with relapsed or refractory large B-Cell lymphoma after two or more lines of systemic therapy.