US FDA announces impurity screening for all ARB drugs

After experiencing the “toxin gate” of valsartan, the US Food and Drug Administration (FDA) is testing whether all of this class of drugs also contains toxic substances.

According to FDA Director Scott Gottlieb and Janet Woodcock, who is responsible for the FDA’s Center for Drug Evaluation and Research, due to the uncertainty, the FDA is testing all angiotensin II receptor antagonist (ARB) drugs to determine if all such drugs contain the carcinogenic nitrosodimethylamine and ensure that the contaminated drug is The United States is all off the shelves. The FDA said that they attach great importance to drug safety issues and the action will be closely managed by the FDA’s leadership.





Gilead steals new commercial chief from Amgen to tackle big sales challenges

Gilead has some big commercial challenges looming, and it’s tapped the leader who will spearhead them.

The big biotech appointed longtime Amgen veteran Laura Hamill to its top commercial post, it said Tuesday. The move comes after an “extensive search” that began when James Meyers announced in February that he would retire.

To take the Gilead post, Hamill will leave behind her position as Amgen SVP of U.S. business operations, a job she’s held since early 2016. Before that, she spent 16-plus years climbing the Amgen ladder, taking on projects that included launching anti-inflammatory blockbuster Enbrel. (See more details on FirecePharma)


After years of upward ticks, HPV vaccination rates still lag far behind U.S. goal

Centers for Disease Control and Prevention officials have been pushing HPV vaccination, and in 2017—just as in the previous four years—those efforts yielded only a slight increase. About half of U.S. adolescents have been fully vaccinated against the cancer-causing virus, far short of the 80% officials are aiming for by 2020.

The figures come courtesy of the CDC, which reports 65.5% of adolescents received at least one dose of an HPV shot, while 48.6% completed the course. Both numbers represent about a 5% increase over 2016 and follow increases of about the same amount each year since 2013.

Merck & Co. controls the HPV vaccination market in the U.S. with its blockbuster shot Gardasil 9, thanks to GlaxoSmithKline’s decision to pull its rival shot, Cervarix, out of the market. Last year, the Merck vaccine captured $1.57 billion in the US and $2.3 billion around the world. (See more details on FiercePharma)

Judge affirms multibillion-dollar talc verdict against J&J; case set for appeals

Johnson & Johnson last month suffered a costly setback in its talc defense when a St. Louis jury ordered the company to pay nearly $4.7 billion to 22 women or their families who alleged the company’s baby powder caused ovarian cancer. On Wednesday, the trial judge affirmed that verdict, clearing the path to appeals court.

Judge Rex Burlison in St. Louis entered the judgment after J&J didn’t challenge the ruling in post-trial motions. J&J CEO Alex Gorsky said on a recent conference call that his company remains “confident that our products do not contain asbestos and do not cause ovarian cancer and we intend to pursue all available appellate remedies.”

A J&J spokesperson added Thursday that “every verdict against Johnson & Johnson in this court that has gone through the appeals process has been reversed and the multiple errors present in this trial were worse than those in the prior trials which have been reversed.” J&J intends to “pursue all available appellate remedies,” she said.

The July verdict came in the form of a $550 million compensatory damages award plus punitive damages worth $4.14 billion. Mark Lanier, lead trial attorney for the plaintiffs, said at the time he hopes the verdict “will get the attention of the J&J board and that it will lead them to better inform the medical community and the public about the connection between asbestos, talc and ovarian cancer.”

J&J has maintained that its products do not contain asbestos or cause ovarian cancer.

Forever Young

Longevity is the unremitting pursuit of human beings. At present, drugs have entered clinical trials and are likely to be listed in the next few years. Through short-lived animal model studies, more than 2,000 genes have an impact on the lifespan of the organism, and the pathways associated with each gene regulate the organism, which in turn affects the lifespan of the organism.

Metformin is a drug for the treatment of type 2 diabetes, which reduces hepatic glycogen production and insulin sensitivity. Recent preclinical data show that it can increase the lifespan of nematodes by 57%, mice by 6% and rats by 2%. Its mechanism of action includes reducing DNA damage, cellular aging and mitochondrial oxidation. Although metformin is not as effective as other compounds, it is at least a safe drug from clinical data, and metformin is highly likely to be approved by the FDA for anti-aging use.

The emergence of new technologies has reduced the barriers to drug development, and the clinical trials of the first class of drugs will provide valuable experience for the development of later drugs.

cr: Wikipedia

Low-dose aspirin can effectively inhibit HIV infection and spread?

Recently, scientists from institutions such as the University of Manitoba in Canada found that low doses of aspirin may be expected to inhibit the spread of HIV.

The HIV infection rate is still high among the population, especially among young African women. In this study, the researchers tested the effects of acetylsalicylic acid (ASA or aspirin) and other anti-inflammatory drugs on HIV-targeted cells through a joint study of a group of women at low risk of HIV in Kenya. The researchers found that aspirin can be used as an effective anti-inflammatory drug to reduce

hiv-virus-in-pink35% of HIV-targeted cells in the female reproductive tract. In addition, the results of the study showed that the number of HIV-targeted cells in the female body taking aspirin was reduced to the level of Kenyan women who had been infected with high-risk HIV but had not been infected for many years. The ultimate goal of researchers is to develop a new tool to effectively prevent HIV infection and spread.