News Wire

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.

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.

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.

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.

The New England Journal of Medicine (NEJM) describes the recent brouhaha over a paper it published a dispute that the author H. Gilbert Welch, MD, and the two researchers who claim Welch plagiarized them must settle on their own.

Well, here’s a real eye-opener for you: Getting a needle in the eye. Sure, it makes you flinch, but for millions of Medicare beneficiaries getting an injection of Eylea can help them retain vision.

First, the good news. There’s been a recent stock market rally for generic drug manufacturers. The bad news, even after the rally, shares for Teva Pharmaceutical Industries are down nearly 70% from a 2015 high. Mylan shares are down about 50% since then.

The FDA approved Cassipa (buprenorphine and naloxone) sublingual film for the maintenance treatment of opioid dependence. This action provides a new dosage strength (16 milligrams/4 milligrams) of buprenorphine and naloxone sublingual film, which is also approved in both brand name and generic versions and in various strengths.

In the aftermath of hundreds of lawsuits over the years against pharmaceutical giant Purdue Pharma, Colorado’s attorney general is now suing the OxyContin creator for what it calls its “significant role in causing the opioid epidemic.”

A new fast-acting flu drug, baloxavir marboxil (Xofluza, Shinogi), reduced the length of time that people were sick with flu symptoms by a little over a day, according to two recently published clinical trials that were reported in the New England Journal of Medicine (NEJM).

A new study published in Nature Biotechnology reports that experimental software trained on recordings from seven patients with brain implants can decode variations in mood.

Heavy-hitting players in the hospital industry—including Intermountain Healthcare, the Mayo Clinic, and HCA Healthcare—felt that they had little choice but to ban together to fix what they consider a flawed supply chain for generic medications, says Dan Liljenquist, a vice president at Intermountain who initiated the project.

The most extensive analysis ever of metastatic tumors has dredged up hope for cancer patients and their physicians. Metastatic cancer can travel from the primary tumor to everywhere in the body and scientists have long believed that the metastasis in, say, the lungs is genetically different from the metastasis in, say, the liver.

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