FDA Warns on Unapproved Vaginal ‘Rejuvenation’ Procedures

The FDA on Monday warned against device manufacturers marketing energy-based medical devices for cosmetic vaginal procedures, or so-called vaginal “rejuvenation.”

The term is used to describe non-surgical procedures intended to treat vaginal laxity, atrophy, dryness, or itching; reduced sexual sensation; and pain with sex or urination.

“The safety and effectiveness of energy-based medical devices to perform these procedures has not been established,” the agency said in the statement. “Understand that the FDA has not cleared or approved any energy-based medical device for vaginal ‘rejuvenation’ or vaginal cosmetic procedures, or for the treatment of vaginal symptoms related to menopause, urinary incontinence, or sexual function.”

The FDA said that these unapproved therapies — often radiofrequency or laser devices cleared for condylomas, abnormal or pre-cancerous tissue, and other conditions- – could lead to serious side effects, including “vaginal burns, scarring, pain during sexual intercourse, and recurring/chronic pain,” and advised healthcare providers to report any adverse effects of such procedures to the FDA Safety Information and Adverse Event Reporting program, MedWatch.

“We have contacted these manufacturers to share our concerns and will be monitoring their claims about uses of their products,” the agency said. “In addition, we will continue to monitor reports of adverse events associated with this issue and will keep the public informed if significant new information becomes available.”

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Optician’s test could be used to help assess dementia risk

The test is usually performed to detect early signs of eye disease through assessment of the retina, but now scientists have found that individuals who have thinner retinas tend to be at a greater risk of developing problems with memory and reasoning.

The study involved 32,000 individuals (aged 40 to 69 years) who had parts of their retinas measured using optical coherence tomography (OCT) and who were also assessed for memory, reasoning and reaction time.

As reported in the journal JAMA Neurology, individuals with the thinnest retinal nerve fiber layer were more likely to fail one or more of the cognitive tests and were twice as likely to have lower scores in follow-up assessments carried out over the next three years.

Problems such as memory loss and other forms of cognitive decline are known to be early indicators of dementia and the researchers believe this eye test could be used to screen for people at risk of developing the condition.

Study author professor Paul Foster from the University College London Institute of Ophthalmology says:

It is likely that treatments will be more effective in slowing or stopping dementia at earlier stages of the disease. Also, by targeting people in the earlier stages, it should be possible to design better clinical trials for treatments that make a real difference and improve people’s lives.”

Experts say that deterioration of the retinal tissue could be reflective of the changes occurring in the vasculature of the brain, which may play a role in dementia developing.

However, the authors stress that just this test alone would not be enough to screen for dementia, since having a thinner retina is not always associated with the onset of cognitive decline.

Dr Laura Phipps from Alzheimer’s Research UK says: “While a diagnosis of dementia will always rely on results from a number of different tests, further studies should look at how sensitive OCT could be at identifying those most at risk of cognitive decline in the general population.”

Source:

• https://www.bbc.com/news/health-44936752

https://bit.ly/2ApQf9H

DaVita laying off 109 at Orlando facility after selling prescription unit

Dialysis provider DaVita Inc. is laying off 109 employees at a prescription-drug distribution facility in Orlando.

The layoffs come after a sale involving its DaVita Rx prescription-drug unit to pharmacy retailer Walgreens, spokesman Skip Thurman said.

DaVita notified state officials of the layoffs last week.

The cuts impact workers at the facility at 2252 Commerce Park Dr. in Orlando, where employees packaged prescription pharmaceuticals to be distributed to patients undergoing dialysis treatments.Thurman said employees will have the option of working with Walgreens when it takes over the facility in September.

Employees will be let go between Sept. 23 and Dec. 3.

“These are highly sought-after workers,” Thurman said.

Employees were notified last week, he said. Job fairs are scheduled for both DaVita and Walgreens in the coming weeks, he said.

Walgreens confirmed the transaction but did not give a price for the purchase or say what would happen to the employees at the facility.

“On July 25, we reached an agreement with DaVita Rx, a pharmacy owned by DaVita Inc. to service patients with kidney disease, to purchase DaVita’s non-dialysis related prescription files that are billed as a pharmacy benefit, mostly under Medicare Part D,” a Walgreens spokesman said in an emailed statement. “This prescription file-transfer sale is anticipated to close in September and when the anticipated deal closes, patients who use DaVita Rx’s pharmacy mail services will have the opportunity to transition to become Walgreens retail pharmacy patients.”

In 2013, California-based DaVita told the state it planned to hire as many as 100 employees at its Orlando prescription processing facility and could have received up to $360,000 from the State of Florida and Orange County for hitting hiring targets. However, DaVita never received money for the state, according to public databases of state incentive grants.

https://bit.ly/2M7jK1K

FDA approves Progenics cancer radiation drug Azedra

Progenics officially got a thumbs up from the FDA on its cancer radiation therapy Azedra, sending the New York company’s stock climbing Monday afternoon. The drug was approved to treat rare and extremely lethal adrenal gland cancers for which there was no approved treatments. Until now.

Specifically, Azedra will treat pheocromocytoma and paraganglioma, neuroendocrine tumors that form from the same type of tissue. The five-year survival rate of unresectable cases can be as low as 12%. This new drug is a radiotherapy that goes after these tumors with a high, specifically targeted dose. The FDA gave it an orphan drug designation, fast track status, and breakthrough therapy designation.

The drug’s original PDUFA date got pushed back, though, on a three month delay due to some missing info on “chemistry, manufacturing, and controls,” the company said at the time. But the CMC matter seems to be resolved. Investors are pleased with the news, with Progenics’ stock $PGNX climbing nearly 12% since word of the approval broke this afternoon.

Azedra is a new version of the radiopharmaceutical iobenguane I-131. It’s made using a system known as UltraTrace, which results in less non-radioactive iobenguane during enrichment leading to greater delivery of radiation to the tumor. The UltraTrace technology was developed by Molecular Insight Pharmaceuticals, which was acquired by Progenics in early 2013.

https://bit.ly/2OrPGPX

Nutrisystem raises FY18 EPS view to $2.07-$2.17 from $2.04-$2.14

Consensus $2.08

https://bit.ly/2Ka968C

Tandem Diabetes raises FY18 sales view to $140M-$148M from $132M-$140M

Consensus $140.88M.

https://bit.ly/2v1eSVc

Medpace sees 2018 adjusted EPS $2.51-$2.62

Consensus $1.91

https://bit.ly/2vkThGD