Drug prices separate haves, have-nots

Drug prices separate haves, have-nots

TRENTON, N.J. – For Bridgett Snelten, changing her health insurance meant enduring wild blood sugar swings, bouts of vomiting and weight gain. The Sandy, Utah, mother of two young girls has diabetes and has had to change health insurance plans three years in a row. Twice, new insurers wouldn’t cover Trulicity, a once-a-week injected diabetes […]

Immune-Based Treatment Helps Fight Aggressive Breast Cancer, Study Finds

Immune-Based Treatment Helps Fight Aggressive Breast Cancer, Study Finds

Women with an aggressive type of breast cancer lived longer if they received immunotherapy plus chemotherapy, rather than chemo alone, a major study has found. The results are expected to change the standard of care for women like those in the clinical trial, who had advanced cases of “triple-negative” breast cancer. That form of the […]

As drug costs rise, gap widens

As drug costs rise, gap widens

In this July 11, 2018, photo Bridgett Snelten holds her medication at her home, in Sandy, Utah. Snelten has diabetes and has had to change health insurance plans three years in a row. (AP Photo/Rick Bowmer) In this July 11, 2018, photo Bridgett Snelten holds her medication at her home, in Sandy, Utah. Snelten has […]

FDA Reorganization Meets Demands for Expedited Approvals

FDA Reorganization Meets Demands for Expedited Approvals

An overview of the regulatory activities of the Office of Oncology Drug Products (OODP) and the Office of Hematology and Oncology Drug Products (OHODP) from 2008 to 2016 suggests that the FDA has made consistent use of regulatory mechanisms to expedite approvals during that period.1 Investigators from the Office of Biostatistics, Center for Drug Evaluation […]

New therapies pack a triple-drug punch to treat cystic fibrosis

New therapies pack a triple-drug punch to treat cystic fibrosis

For years, scientists have struggled to find a therapy that works for most cystic fibrosis sufferers. Now, two new triple-drug approaches, still undergoing testing, are offering hope. Cystic fibrosis is caused by mutations in a gene called CFTR. These mutations mean the body either makes defective versions of a protein, also called CFTR, or none […]

Clovis aims at new market for cancer drug Rubraca

Clovis aims at new market for cancer drug Rubraca

Dive Brief: Clovis Oncology, trailing PARP inhibitor rivals AstraZeneca and Tesaro, aims to jump ahead in a new market for the targeted therapies, announcing Friday positive early data for its drug Rubraca in metastatic castration-resistant prostate cancer. Results from Clovis’ TRITON2 study showed 11 of 25 previously treated patients responded to Rubraca, a finding that […]

Shire Receives Unanimous FDA Advisory Committee Approval Recommendation for Prucalopride

Shire Receives Unanimous FDA Advisory Committee Approval Recommendation for Prucalopride

The FDA Gastrointestinal Drugs Advisory Committee voted unanimously (10 to 0) that the risk-benefit profile of Shire’s prucalopride supports the approval of this New Drug Application (NDA). The FDA will take the advisory committee’s recommendation into consideration when the agency makes a final determination. The Prescription Drug User Fee Act (PDUFA) action date for prucalopride […]

New Restrictions on Vaping, Trans Fats, Food Labeling in FDA Commissioner's Agenda: Reason Roundup

New Restrictions on Vaping, Trans Fats, Food Labeling in FDA Commissioner's Agenda: Reason Roundup

Juul: RONEN ZVULUN/REUTERS/Newscom; milk: Ingram Publishing/NewscomThe FDA’s new regulatory agenda. The U.S. Food and Drug Administration (FDA) is proposing a slew of changes to food, medicine, and e-cigarette regulation, with very few bright spots. Top items on Commissioner Scott Gottlieb’s upcoming food and tobacco agenda include declaring war on e-cigarettes, banning all partially hydrogenated oils […]

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