‘Issues’ Tagged Posts

Ministry points contemporary tips on septrin

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FDA Points Security Alert Concerning Intrathecal Supply of Ache Meds

 

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FDA Points CRL Rejecting Waylivra Approval for Familial Chylomicronemia Syndrome

 
An FDA panel voted 12 to 8 in favor of approving Waylivra back in May of this year

An FDA panel voted 12 to 8 in favor of approving Waylivra back in May of this year

Akcea Therapeutics and Ionis Pharmaceuticals announced that they received a Complete Response Letter (CRL) from the Food and Drug Administration (FDA) rejecting the New Drug Application for Waylivra (volanesorsen), an investigational treatment for familial chylomicronemia syndrome (FCS).

The CRL is from the FDA’s Division of Metabolism and Endocrinology Products Committee, who voted 12 to 8 in favor of approving Waylivra, in May of this year. The Company did not state the exact reasons given for the rejection, but CEO of Akcea, Paula Soteropoulos said, “We are extremely disappointed with the FDA’s decision. We continue to feel strongly that Waylivra demonstrates a favorable benefit/risk profile in people with FCS as was reflected in the positive outcome from our Advisory Committee hearing in May. We will continue to work with the FDA to confirm the path forward.” 

Waylivra is designed to lower the production the ApoC-III, a protein produced in the liver that is involved in triglyceride regulation and other metabolic parameters. FCS is characterized by severe hypertriglyceridemia and the risk of unpredictable and potentially fatal acute pancreatitis. 

In May, the FDA’s Committee reviewed findings from two Phase 3 trials (APPROACH, COMPASS) and 1 open-label study (APPROACH) for Waylivra. Results from the APPROACH trial showed that compared to placebo patients who received Waylivra had a mean reduction in triglycerides of 77% from baseline. The most common adverse events were injection site reactions and reductions in platelet levels.

FDA Points Warning Letters to On-line Opioid Suppliers

 

The U.S. Meals and Drug Administration is lastly taking motion in opposition to on-line “pharmacies” promoting unlawful opioid medicines to the general public. A complete of 53 web sites, together with AnonShop and OneStopPharma, are at present operated by 9 corporations which have acquired warning letters from the FDA ordering them to stop operation – or face extra critical penalties.

The FDA can be enlisting social media websites and mail companies to help with controlling the movement of illicit opioids, which embrace unapproved formulations akin to tramadol in addition to counterfeit and misbranded prescriptions. The latter is of explicit concern. In accordance with FDA commissioner Dr. Scott Gottlieb, customers who buy opioids on the Internet imagine they’re buying Vicodin or oxycodone however are sometimes getting fentanyl as a substitute.

These merchandise can also be adulterated or expired. In a press assertion, Gottlieb mentioned, “The web is just about awash in unlawful narcotics…we’re going to be taking new steps to work with legit web corporations to voluntarily crack down on these gross sales.” Earlier this 12 months, Senator Rob Portman (R-OH), who heads the Senate Subcommittee on Investigations, famous that the acquisition of unlawful opioid medicines by Web web sites is “as straightforward as shopping for another product on-line.”

In April, Gottlieb identified that the variety of ads for opioid gross sales with out a prescription has elevated dramatically lately. At the moment, he mentioned, “The straightforward availability and on-line buy of those merchandise from unlawful drug peddlers is rampant and fuels the opioid disaster…Web corporations merely aren’t taking sensible steps to seek out and take away these unlawful opioid listings.”

Considerably, various the opioid web sites operated by the 9 corporations being focused appeared to have gone offline shortly after the FDA made its announcement on Tuesday. A couple of of them, akin to “OnlinePainPharma.com,” are nonetheless up and operating. It isn’t utterly clear how a lot energy the FDA has on this matter, however these corporations receiving warning letters have been given ten days to conform or face seizure of their merchandise and potential lawsuits – and even legal expenses.

All of this comes at a time that opioid dependancy within the U.S. has reached disaster proportions. The Facilities for Illness Management reviews that over 42,000 overdose deaths in 2016 (the newest 12 months for which knowledge is accessible) have been attributable to prescription opioid medicines. On the identical time, legislative makes an attempt on Capitol Hill to handle the issue are assembly stiff resistance from business and insurance coverage firm lobbyists, representing company and moneyed pursuits anxious to protect their earnings.

Gottlieb has referred to as for leaders from a number of Web corporations – together with Fb, Google, Instagram and Twitter – to attend an “opioids summit” on June 27 so as to provide you with efficient methods on controlling the unlawful on-line opioid commerce.

Evaluate identifies moral points in vitamin D analysis involving use of placebos

 

Since World Struggle II, medical ethics in analysis research involving human topics have shifted considerably. Regardless of this necessary development, moral points stay. Diet supplementation analysis doesn’t have pointers round using placebo teams in scientific trials, posing moral points.

A crew led by Leigh Body, PhD, MHS, director for the Integrative Medication Program on the George Washington College Faculty of Medication and Well being Sciences, printed a evaluate of this difficulty in Vitamins, the place she checked out numerous research within the creating area of vitamin D analysis.

“We developed this evaluate with the aim of elevating consciousness and beginning a dialogue in regards to the potential moral points behind examine design,” stated Body. “Relating to ethics in supplementation analysis, we’ve gotten snug with following the requirements. Our crew is questioning if the requirements are literally sufficient.”

The sphere of vitamin D analysis exhibits variation in how placebo teams are used. The crew checked out 4 kinds of management teams presently in use: lively management, placebo management with restrictions on supplementation, placebo management with out supplementation restrictions, and placebo management with rescue repletion remedy.

The primary two management teams spotlight discrete moral points. Lively management teams can restrict the flexibility of the examine to detect a significant impact of the complement. Placebo management with restrictions limits supplementation, probably putting topics in danger in vitamin D poor topics. The final two controls supply potential options to those moral challenges by permitting members entry to dietary supplements to probably mitigate vitamin D deficiency.

The evaluate concludes that there’s a want to ascertain and implement pointers for ethics in supplementation analysis for using placebo management teams and that vitamin D analysis is usually a main instance as the sector continues to develop.

Body and her crew counsel that earlier than utilizing a placebo group, investigators ought to deeply think about the moral implications of placebos of their examine design. The authors additionally advocate that journals and funding businesses request thorough justifications of placebo use, particularly in circumstances of recognized dietary deficiency or in susceptible populations.

“It is necessary to notice that although we targeted on vitamin D analysis for this evaluate, that is only one instance,” Body stated. “That is relevant to any supplementation examine, whether or not it’s nutritional vitamins or protein.”

Supply:

https://smhs.gwu.edu/information/review-vitamin-d-research-identifies-ethical-issues-placebo-use