FDA Approves Daxxify, the newest BOTOX alternative
Daxxify is in a family of medicines known as neuromodulators, which includes the drugs Botox, Dysport, Xeomin, and Jeuveau. The effects of these established neuromodulators typically last about three months, according to the American Society for Dermatologic Surgery (ASDS). The key differentiator for Daxxify is its staying power, which may keep wrinkles at bay for longer.
The cosmetic treatment temporarily removes moderate to severe glabellar (frown) lines. Like Botox, Daxxify is an injected neuromodulator. But Revance’s product is the first based on peptide exchange technology.
In clinical trials submitted to the FDA for approval, 80 percent of the treatment providers saw no or mild facial lines at four months after injection and about half saw the effect through six months.
Daxxify is expected to be available in 2023.
FDA Approves JUVÉDERM® VOLUX™ XC for Improvement of Jawline Definition
Revance Launches RHA Dermal Filler Line in U.S.
The resilient hyaluronic acid fillers are designed to adapt to facial dynamics and represent the first step in Revance’s plans to develop a prestige line of products for aesthetic practices.
A new line of dermal fillers is coming to the U.S. market. Revance, a biotechnology company focused on aesthetic and therapeutic offerings including its investigational neuromodulator product, DaxibotulinumtoxinA for Injection, has announced the launch of the RHA (resilient hyaluronic acid) collection of fillers.
8 Filler Updates Happening Right Now
According to the American Society of Plastic Surgeons, fillers continue to top the most popular nonsurgical treatment list—right behind neurotoxin injections—in the No. 2 spot year after year. With close to 3 million filler injections performed last year and 96 percent of those being performed on female patients, it’s safe to say our love of fillers isn’t going anywhere anytime soon. So, what’s next in the world of volume-boosting injectables? Expert injectors predict next-level fillers to be more sophisticated, approved for use in more areas and sometimes even longer-lasting.
Galderma Receives FDA Approval for Restylane® Defyne for Chin AugmentationFORT WORTH, Texas, Feb. 1, 2021 /PRNewswire/ — Galderma announces that the U.S. Food and Drug Administration (FDA) has approved Restylane® Defyne for the augmentation and correction of mild to moderate chin retrusion for adults over the age of 21.1 In 2020 alone, online searches for chin enhancement increased by 185 percent, reinforcing the emerging patient need for a product like Restylane Defyne.2 Restylane Defyne is the first and only chin filler to demonstrate results* across a wide range of participants†, including participants† with all skin types§, male subjects† and subjects† over the age of 52.3 Restylane Defyne is a hyaluronic acid (HA) dermal filler that was first approved in 2016 by the FDA for mid-to-deep injection into the facial tissue for the correction of moderate to severe deep facial wrinkles and folds, such as nasolabial folds, in subjects† over age 21.1,4
Passive Immune Prophylaxis preventing COVID-19 with ‘Acellular-Convalescent Plasma’ (A-CP): a new technology introduced by Regen Lab®
Switzerland, October 27, 2020
Convalescent Plasma (CP), also called Passive Antibody Therapy for the treatment of COVID-19 infected patients was approved by the US-FDA on August 23, 2020!
This great news was based on a nationwide evaluation in 14 US medical institutions. A report on 20,000 patients shows the safety and benefit of CP, specifically on the seven-day mortality rate as published by Dr. Michael Joyner and Prof. Arturo Casadevall and has justified the “breakthrough” acceleration process for the US-FDA approval.
As a specialist of plasma technologies, Regen Lab has designed and patented a new 20 ml tube for the reproducible and standardized production of 10 ml of convalescent plasma, the Acellular-Convalescent Plasma Tube (A-CP).
This new A-CP tube encompasses different published recommandations. The first studies performed in 1945 with the low-doses of human immune serum to prevent several infectious diseases, such as Hepatitis or Smallpox during epidemic period, showed great success:
the first study showing the efficacy of human plasma was performed by Dr Neefe and Dr Stokes in 1945! This study was performed on more than 10 000 patients and it showed a reduction of the hepatitis incidence from 3 to 8 times for patients receiving 10cc of human plasma!
another study was performed by the same doctors during an extensive hepatitis outbreak on 331 patients. For patients receiving a small dose of human plasma (0,33mL/kg which correspond to ~ 20mL/patient) this study showed an 87% reduction in the attack rate!
World Health Organization published as well a study in 1962 in order to determine the prophylactic value of immune gammaglobulin on a total of 705 patients suffering from smallpox with 5 or 10mL pooled plasma injected intramuscularly. This study showed a reduction of the smallpox incidence by 70%!
It emcompasses also the published recommendations of Prof. Arturo Casadevall, who leads the research in this critical passive antibody therapy since the first SARS 1 outbreak in 2003, i.e., small doses of CP (from 10 to 40 mL) for the treatment and prophylaxis for personal health care and early infected patients or patients having a high exposure risk.
During the lockdown, the Regen Lab R&D team has been focused on the design of new 20 ml tubes for different therapeutic applications:
new medical devices containing a specific and complex polymer for the depletion of all cellular blood components developed with the support of InnoSuisse, except useful antibodies, for the preparation of convalescent plasma;
the 20 ml tube is processed and ready to use in 20 minutes which is significantly faster than plasmapheresis which takes 24 hours or more,
An evaluation performed by Dr Luca Santoleri, head of the transfusion department at the San Raffaele Hospital (Milan, Italy), showed recovery of almost 100% of the IgG antibodies without cellular contamination.
Furthermore, the patent has been listed in March 2020.
Despite the consequences of the pandemic around our planet, stars are lining up for the Regen Lab team!
Regen Lab, founded in 2003 by Mr. Antoine Turzi with its HQ/facility in Switzerland and R&D in Europe and New York, is a leading innovator of medical devices for the preparation of platelet rich plasma (PRP) and combination therapies with hyaluronic acid, which it markets under the well-recognized REGENLAB®, REGENKIT® and CELLULAR MATRIX® brands.
Chrissy Teigen turns to Botox to treat pregnancy headaches: ‘I see the light finally’
Angeline Jane Bernabe, September 7, 2020
Pregnancy isn’t always easy for expectant moms, and that includes mogul and author Chrissy Teigen, who is expecting her third child.
Teigen shared on Twitter on Sept. 4 that she’s been suffering from “bad pregnancy headaches,” which she also struggled with during her second pregnancy.
FDA approves hyaluronic acid lip filler Restylane Kysse.
Morgan Petronelli, May 6, 2020
“Restylane Kysse is a new lip filler that offers key attributes both providers and their patients desire in a lip injection – high satisfaction, consistent results and a proven clinical-safety profile,” says Alisa Lask, general manager and vice president of the U.S. Aesthetic Business at Galderma.
Revance to introduce TEOXANE RHA® fillers in the U.S.
Katie Hobbins, Jan 13, 2020
“Revance Therapeutics, a biotechnology company specializing in neuromodulator innovations, recently announced a U.S. distribution agreement with Swiss hyaluronic acid (HA)-based dermal filler manufacturing company, TEOXANE SA.
The partnership gives Revance immediate and exclusive access to the company’s range of Resilient HA (RHA) fillers in the United States, with TEOXANE gaining 2.5 million shares of Revance common stock in return, according to the press release.”
Brotox: the new job security for men?
FOXBusiness, Aug 3, 2019
“Job security is a real concern among aging employees in the workplace but there’s a discreet trend among men who want to stay competitive in today’s tightening job market.
It’s called Brotox. That’s right, botox for men.”
Bellus Medical, the Aesthetics Division of Crown Laboratories, Announces Acquisition of Healeon Medical’s HD PRP System for Aesthetic Marketplace
PRNewswire: DALLAS, May 23, 2019
Bellus Medical is proud to announce the acquisition of Healeon Medical, Inc.’s HD PRP system for the aesthetic marketplace. This specialized system is designed to meet the demands of busy practices seeking higher volume and higher yield Platelet Rich Plasma procedures; with the most efficient and convenient system on the market. As part of their expanding Platelet Rich Plasma portfolio, Bellus Medical will re-brand their suite of offerings as the ProGen PRP™ Advantage and ProGen PRP™ Versa lines; both high-yield systems for use in Platelet Rich Plasma procedures.
New Injectable Neurotoxin Cleared for Spring 2019 Launch
Jeff Frentzen, Feb 1, 2019
The U.S. aesthetic neurotoxin marketplace is set to expand somewhat dramatically in 2019. On February 1, 2019, Evolus, Inc. (Irvine, Calif.), announced the FDA has approved Jeuveau™ (prabotulinumtoxinA-xvfs), its injectable neurotoxin for temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and / or procerus muscle activity in adults.
Evolus Receives FDA Approval for Jeuveau™ prabotulinumtoxinA-xvfs for Injection
Evolus, Feb 1, 2019
NEWPORT BEACH, Calif., Feb. 01, 2019 (GLOBE NEWSWIRE) — Evolus, Inc. (NASDAQ: EOLS) today announced that the U.S. Food and Drug Administration (“FDA”) has approved its lead product, Jeuveau™, for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adults.
Prollenium US Announces the Release of Revanesse Versa + With Lidocaine
RALEIGH, N.C., Dec. 17, 2018 /PRNewswire/ — Prollenium® US is proud to announce the immediate availability of Revanesse® Versa +™. Revanesse® Versa +™ has been developed due to high levels of provider and patient interest in a dermal filler with all the benefits of Revanesse® Versa™ plus the addition of Lidocaine.
Galderma Launches Restylane® Silk – First and Only FDA Approved Filler Indicated for Lip Enhancement and Treatment of Perioral Lines
Galderma, Jan 29, 2015
FORT WORTH, Texas, Jan. 29, 2015 /PRNewswire/ — Galderma, a global healthcare company focused on skin health, today announced the launch of Restylane® Silk, the first and only dermal filler approved by the U.S. Food and Drug Administration (FDA) for lip enhancement and the treatment of wrinkles and lines around the mouth in people over the age of 21. Restylane® Silk is a smooth gel designed to restore natural youthful definition and symmetry to the lip and mouth area.