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FDA Approves First Treatment to Reduce Risk of Serious Heart Problems Specifically in Adults with Obesity or Overweight

Retrieved on: 
fredag, mars 8, 2024

"This patient population has a higher risk of cardiovascular death, heart attack and stroke.

Key Points: 
  • "This patient population has a higher risk of cardiovascular death, heart attack and stroke.
  • Providing a treatment option that is proven to lower this cardiovascular risk is a major advance for public health."
  • Obesity or overweight affect approximately 70% of American adults.
  • Obesity and overweight are serious health issues that increase the risk for premature death and a variety of health problems, including heart attack and stroke.

JUVÉDERM® VOLUMA® XC For Temple Hollows Receives U.S. FDA Approval

Retrieved on: 
tisdag, mars 5, 2024

IRVINE, Calif., March 5, 2024 /PRNewswire/ -- Today, Allergan Aesthetics, an AbbVie company (NYSE: ABBV), announced the U.S. FDA approval of JUVÉDERM® VOLUMA® XC for injection in the temple region to improve moderate to severe temple hollowing in adults over the age of 21.1 JUVÉDERM® VOLUMA® XC is the first and only hyaluronic acid (HA) dermal filler to receive U.S. FDA approval for the improvement of moderate to severe temple hollowing with results lasting up to 13 months with optimal treatment.*1

Key Points: 
  • *1
    "The approval of JUVÉDERM® VOLUMA® XC to treat temple hollows further demonstrates Allergan Aesthetics commitment to innovation and addressing patient needs," said Carrie Strom, President, Allergan Aesthetics and Senior Vice President, AbbVie.
  • "This is the first U.S. FDA approval of a hyaluronic acid dermal filler for use in the upper face and addresses a real unmet need for patients."
  • The safety of JUVÉDERM® VOLUMA® XC in patients with a history of excessive scarring or pigmentation disorders has not been studied.
  • To report a side effect with any product in the JUVÉDERM® Collection, please call the Allergan® Product Support Department at 1‑877‑345‑5372.

Hugel Receives FDA Approval in the United States of Letybo (letibotulinumtoxinA-wlbg) for Injection for the Treatment of Glabellar Lines

Retrieved on: 
måndag, mars 4, 2024

NEWPORT BEACH, Calif., March 4, 2024 /PRNewswire/ -- Hugel America, Inc., a division of Hugel Inc., a global leader in the medical aesthetics industry, today announced it received United States (U.S.) Food and Drug Administration (FDA) approval on its neurotoxin, Letybo to treat moderate-to-severe glabellar (frown) lines in adults. In the coming months, Hugel plans to accelerate its transition for approved medical use with the goal of launching to aesthetic clinicians in the back half of 2024.

Key Points: 
  • NEWPORT BEACH, Calif., March 4, 2024 /PRNewswire/ -- Hugel America, Inc., a division of Hugel Inc., a global leader in the medical aesthetics industry, today announced it received United States (U.S.) Food and Drug Administration (FDA) approval on its neurotoxin, Letybo to treat moderate-to-severe glabellar (frown) lines in adults.
  • This is a huge achievement for Hugel as we focus on becoming a top aesthetics brand in the U.S.," stated James Hartman, President, Hugel America.
  • Joely Kaufman, MD, commented, "The results from the clinical trials for letibotulinumtoxinA demonstrate efficacy, and a convincing safety profile in the treatment of glabellar lines1.
  • FDA approval is supported by positive results from three completed phase III trials that enrolled more than 1,000 subjects in the U.S. and Europe1.

Huawei Releases the High-Quality 10 Gbps Campus Network Construction White Paper Supported by WBA

Retrieved on: 
onsdag, februari 28, 2024

BARCELONA, Spain, Feb. 28, 2024 /PRNewswire/ -- During the Mobile World Congress 2024, Huawei released the High-Quality 10 Gbps Campus Network Construction White Paper supported by WBA (Wireless Broadband Alliance) at the summit themed "Huawei Intelligent Cloud-Network, Accelerating Industrial Intelligence". This white paper puts forwards the philosophy of experience-centric campus network construction; it also delves into how Huawei's High-Quality 10 Gbps CloudCampus Solution offers three types of experience upgrade — wireless, application, and Operations and Maintenance (O&M) — to accelerate enterprises' digital and intelligent journey.

Key Points: 
  • BARCELONA, Spain, Feb. 28, 2024 /PRNewswire/ -- During the Mobile World Congress 2024, Huawei released the High-Quality 10 Gbps Campus Network Construction White Paper supported by WBA (Wireless Broadband Alliance) at the summit themed "Huawei Intelligent Cloud-Network, Accelerating Industrial Intelligence".
  • This white paper puts forwards the philosophy of experience-centric campus network construction; it also delves into how Huawei's High-Quality 10 Gbps CloudCampus Solution offers three types of experience upgrade — wireless, application, and Operations and Maintenance (O&M) — to accelerate enterprises' digital and intelligent journey.
  • To keep up with these changes, campus networks need to evolve from connectivity-centric to experience-centric.
  • This white paper explores the new campus network trends and maps out the campus network evolution direction for enterprises to accelerate their digital and intelligent journey.

Aucta Pharmaceuticals, Inc. ("Aucta Pharmaceuticals") launches MOTPOLY XR™ (lacosamide) extended-release capsules C-V, the first, and only once-daily formulation of lacosamide

Retrieved on: 
måndag, februari 26, 2024

MOTPOLY XR is approved for the treatment of partial-onset seizures in adults and in pediatric patients weighing at least 50 kg.

Key Points: 
  • MOTPOLY XR is approved for the treatment of partial-onset seizures in adults and in pediatric patients weighing at least 50 kg.
  • MOTPOLY XR is bioequivalent to Vimpat® (lacosamide) film-coated tablets, C-V and provides a new once-daily option at equivalent doses.
  • "MOTPOLY XR marks a major milestone for Aucta as our 1st branded pharmaceutical product to enter the US market.
  • To report SUSPECTED ADVERSE REACTIONS, contact Aucta Pharmaceuticals, Inc. at 1-800-655-9902 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

BOTOX® Cosmetic (onabotulinumtoxinA) Announces Its 2024 Grant Program Supporting Women Entrepreneurs

Retrieved on: 
onsdag, februari 21, 2024

IRVINE, Calif., Feb. 21, 2024 /PRNewswire/ -- Today, Allergan Aesthetics, an AbbVie company (NYSE: ABBV), announced that applications are open for the 2024 BOTOX® Cosmetic grant program supporting women entrepreneurs. BOTOX® Cosmetic partnered with IFundWomen to launch the program in 2023, and in the second year, will award a new group of 20 women entrepreneurs each with $25,000 grants to fund and grow their businesses. Additionally, BOTOX® Cosmetic continues to support these businesses through mentorship, coaching, crowdfunding, and community.

Key Points: 
  • FOR THE SECOND YEAR, BOTOX® COSMETIC WILL HELP WOMEN ENTREPRENEURS CLOSE THE CONFIDENCE GAP THROUGH FUNDING, MENTORSHIP, COACHING, AND COMMUNITY
    IRVINE, Calif., Feb. 21, 2024 /PRNewswire/ -- Today, Allergan Aesthetics, an AbbVie company (NYSE: ABBV), announced that applications are open for the 2024 BOTOX® Cosmetic grant program supporting women entrepreneurs.
  • We are grateful to learn from them and thrilled to continue this program into a second year with a new cohort of extraordinary women entrepreneurs."
  • I am forever grateful to this program for connecting me to a group of women entrepreneurs who together are helping to bridge the Confidence Gap.
  • Starting today, women entrepreneurs across the country can apply for the BOTOX® Cosmetic x IFundWomen grant at www.botoxcosmetic.com/realimpact for the chance to be one of 20 recipients.

Herbal medicinal product: Agni casti fructusArray, C: ongoing call for scientific data

Retrieved on: 
fredag, februari 16, 2024

Herbal medicinal product: Agni casti fructusArray, C: ongoing call for scientific data

Key Points: 


Herbal medicinal product: Agni casti fructusArray, C: ongoing call for scientific data

Spice: the ‘zombie drug’ being found in some vape liquids

Retrieved on: 
torsdag, februari 15, 2024

This incident is only the latest in what appears to be a growing problem in the UK with unregulated vape liquids, especially those marketed as containing THC or cannabis.

Key Points: 
  • This incident is only the latest in what appears to be a growing problem in the UK with unregulated vape liquids, especially those marketed as containing THC or cannabis.
  • This is why it’s so important for users to think carefully about what vape products they use.

What is spice?

  • While these lab-made drugs are designed to mimic the effects of cannabis, they tend to be far more unpredictable and harmful.
  • There’s currently no data on how these drugs are manufactured in clandestine laboratories thought to be located in China and India.
  • But we do have some idea of how spice may be synthesised, based on academic experiments that have been published in peer-reviewed journals.

What makes spice harmful?

  • Studies have shown that the compounds contained in spice act on both types of cannabinoid receptors that the body has.
  • Those who use spice repeatedly can develop a tolerance to it, requiring more to achieve the desired effect – ultimately putting them at higher risk of harm.

How does spice affect users?


Synthetic cannabinoid receptor agonists were initially explored as experimental drugs to alleviate suffering related to a variety of conditions – including pain, anorexia, muscle spasms and glaucoma.

  • Many people use spice in the hopes of experiencing effects similar to those caused by cannabis.
  • It isn’t possible to predict who will suffer which of these side effects, but all spice users are at risk.

Is spice a growing problem?

  • One investigation even found that nearly half of male prison deaths that happened between 2015-2020 in England and Wales were due to Spice.
  • There is also an increasing number of reports in the press of vape liquids being laced with spice – leading public health authorities to issue warnings.
  • There are now calls to make young people more aware of the dangers of spice and using certain types of vape liquids.


Michael Cole receives funding and "in kind" support from the European Union and a number police forces and forensic science organisations around the world to carry out research.

Starton Therapeutics Announces Opening of Second Clinical Site for STAR-LLD Phase 1b Trial in Multiple Myeloma and Provides Study Update

Retrieved on: 
onsdag, februari 14, 2024

The ongoing study evaluates the safety, pharmacokinetics, and efficacy of continuous subcutaneous administration of low-dose lenalidomide (STAR-LLD) in conjunction with dexamethasone and bortezomib (Velcade®).

Key Points: 
  • The ongoing study evaluates the safety, pharmacokinetics, and efficacy of continuous subcutaneous administration of low-dose lenalidomide (STAR-LLD) in conjunction with dexamethasone and bortezomib (Velcade®).
  • Remarkably, the trial is progressing ahead of schedule and with the addition of RMOC is now projected to conclude enrollment by Q1/2024.
  • I’m excited about the potential opportunity STAR-LLD can bring to multiple myeloma patients.”
    Earlier last month, Starton disclosed preliminary trial findings regarding the safety and efficacy of STAR-LLD for multiple myeloma.
  • Notably, no hematologic toxicities greater than Grade 1 have been observed following up to 3 cycles of treatment thus far.

FDA Approves First Medication to Treat Severe Frostbite

Retrieved on: 
onsdag, februari 14, 2024

SILVER SPRING, Md., Feb. 14, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Aurlumyn (iloprost) injection to treat severe frostbite in adults to reduce the risk of finger or toe amputation.

Key Points: 
  • SILVER SPRING, Md., Feb. 14, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Aurlumyn (iloprost) injection to treat severe frostbite in adults to reduce the risk of finger or toe amputation.
  • Frostbite can occur in several stages, ranging from mild frostbite that does not require medical intervention and does not cause permanent skin damage, to severe frostbite when both the skin and underlying tissue are frozen and blood flow is stopped, sometimes requiring amputation.
  • Iloprost's efficacy in treating severe frostbite was primarily established in an open-label, controlled trial that randomized 47 adults with severe frostbite, who all received aspirin by vein and standard of care, into one of three treatment groups.
  • The two other groups received other medications that are unapproved for frostbite, given with iloprost (Group 2) or without iloprost (Group 3).