News Wire

Congress is expected to finalize within days a new law to expand transparency surrounding payment to non-physician providers. Beginning in 2020, pharmaceutical and medical device companies must disclose payments made to those providers for speaking or consulting, as they must do now with physicians.

European health officials have been much more open to biosimilars than their counterparts in the United States.

The Department of Health and Human Services (HHS) recently canceled a $15,900 contract with fetal research company Advanced Bioscience Resources (ABR) over concerns that the contract failed to include “the appropriate protections applicable to fetal tissue research or met all other procurement requirements.”

More and more miracle drugs are coming to the market, giving a niche group of patients hope where once there had been none. But with this hope comes a caveat: the prohibitive cost. How can the health system bear such a price tag?

Mark Merritt says his record is 15 and 0 over the course of his 15 years as head of the Pharmaceutical Care Management Association. He departs in less than a month, handing over the reins to the new CEO, J.C. Scott.

The FDA has approved a final Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) that includes several measures to help better communicate the serious risks about the use of opioid pain medications to patients and health care professionals.

The biopharma company Amarin surprised critics with the results of the REDUCE-IT (Reduction of Cardiovascular Events With EPA-Intervention Trial) study, which showed that its proprietary, prescription formulation of fish oil, called Vascepa, significantly reduced the risk of deaths, heart attacks, strokes, and other serious cardiovascular events compared to placebo.

About 42 percent of the money allocated this week by the FDA’s Orphan Products Clinical Trials Grants Program will go to the development of medications for rare diseases that affect children and adolescents, the FDA announced.

More fuel to the growing fire of controversy over the cost of diabetes medications. A study in BMJ Global Health says that the prices currently charged for insulin in the United States and other countries are way too high and that they could be cut and the manufacturers would still make a good profit.

Huge exposé this morning in Stat (which relies heavily on data collected by ProPublica) about the dearth of black patients in clinical trials for breakthrough drugs. As the length of the piece suggests, it’s a complex issue with many variables in play.

Thousands of foster children may be getting powerful psychiatric drugs prescribed to them without basic safeguards, according to a report released by the Health and Human Services (HHS) inspector general’s office. The report found that about 1 in 3 foster kids from a sample of states were prescribed psychiatric drugs without treatment plans or follow-up, standard steps in good medical care.

The FDA has approved a device intended to treat acute coronary artery perforations that can occur during percutaneous coronary intervention (PCI) procedures. The PK Papyrus Covered Coronary Stent System (Biotronik) is the first device approved for this indication in 17 years.

The FDA has discovered a new impurity in three lots of Torrent Pharmaceuticals’ recalled valsartan drug products. This second impurity, N-Nitrosodiethylamine (NDEA), is a known animal and suspected human carcinogen. These Torrent products were included in the company’s earlier recall on August 23, 2018.

Lumoxiti injection (moxetumomab pasudotox-tdfk, Astra Zeneca) has been approved to treat certain instances of relapsed or refractory "hairy cell" leukemia (HCL) in adults. The new drug is the latest addition to a novel class of drugs called CD22-directed cytotoxins to treat HCL, the FDA announced. The drug was approved for adults who have had at least two prior therapies for the disease.

In what has been called a possible game-changing development in health care, the Department of Justice today approved of Cigna’s proposed purchase of the biggest PBM in the country, Express Scripts.

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