This week the FDA approved a new treatment for rare adrenal gland tumors. Researchers at Johns Hopkins made a discovery that could lead to breakthroughs in the fight against cancer, and drug companies are talking openly about drug prices. These top stories and more in this week’s Innovation Partners BioBlog.
FDA approves Progenics’ treatment for rare adrenal gland tumors
The FDA approved a new treatment for two types of rare adrenal gland tumors this week. Azedra, manufactured by Progenics, was approved to treat patients above the age of 12 who have either of the two tumors – pheochromocytoma or paraganglioma – and require anti-cancer therapy. The two tumor types affect the adrenal gland that releases the adrenaline hormone, which triggers the body’s defense mechanism. Pheochromocytomas increases production of some of the hormones made in the gland, leading to high blood pressure.
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Centene plans Medicare Advantage joint venture with Ascension
Ascension and Centene announced on Monday a plan to launch a joint Medicare Advantage (MA) plan in 2020. The companies signed a letter of intent to explore a joint venture earlier this week. If it goes forward, the plan would become their preferred model in several geographic markets, though the companies did not specify which markets they plan to target.
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Olaparib for Germline BRCA-Mutated Metastatic Breast Cancer
Early this year, olaparib tablets (Lynparza) were granted regular approval for treatment of patients with deleterious or suspected deleterious germline BRCA-mutated, HER2-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting. Olaparib is the first U.S. Food and Drug Administration (FDA)-approved treatment for germline BRCA-mutated HER2-negative metastatic breast cancer. Patients with hormone receptor–positive disease should have been treated with prior endocrine therapy or considered inappropriate for endocrine treatment. More information on olaparib is available in this article.
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Scientists Discover a Dynamic Cellular Defense Against Breast Cancer Invasion
Johns Hopkins researchers made a startling discovery this week when they identified cells near breast milk duct glands that reach out and ‘grab’ stray cancer cells to keep them from spreading throughout the body. These findings, which were made using mice, indicate that the myoepithelium cell layer is not a stationary boundary but an active barrier to protect the body against cancerous cells.
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CMS Proposes Extended 340B Cuts for 2019
The Centers for Medicare & Medicaid Services (CMS) released its 2019 Hospital Outpatient Prospective Payment System (HOPPS) proposed rule this week. In it, they proposed to extend 2018 reimbursement cuts to the 340B Drug Pricing Program to include currently excepted, off-site hospital-affiliated outpatient clinics. CMS is proposing to extend that cut in 2019 to 340B drug reimbursement even further by applying it to most off-site hospital outpatient clinics except rural sole community hospitals, children’s hospitals, and Medicare Prospective Payment System (PPS)-exempt cancer hospitals. More from the American Society of Clinical Oncology, here.
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Biomarker-Integrated Risk Model for Lung Cancer
Incorporating biomarkers into a lung cancer risk prediction model may improve performance compared with risk based on age and smoking exposure alone, according to a new study published in JAMA. This study provided a proof of principle in showing that a panel of circulating protein biomarkers may improve lung cancer risk assessment and may be used to define eligibility for computed tomography screening. Details of the study are found within the ASCO post.
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Drugmakers sure are eager to talk about drug prices lately
Drugmakers are taking the lead and talking upfront about pricing after Pfizer’s recent tangle with President Trump over the subject. Celgene and others are breaking their silence about drug pricing and coming forward with information and opportunities for dialogue. But are they really concerned or is this just a PR ploy? A look at the conversation on drug pricing.
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