Rash

MANDARA Phase III data published in New England Journal of Medicine show remission is an achievable goal in eosinophilic granulomatosis with polyangiitis (EGPA) with FASENRA

Retrieved on: 
Friday, February 23, 2024

AstraZeneca is an established leader in respiratory care with a 50-year heritage and a growing portfolio of medicines in immune-mediated diseases.

Key Points: 
  • AstraZeneca is an established leader in respiratory care with a 50-year heritage and a growing portfolio of medicines in immune-mediated diseases.
  • Fasenra met the primary endpoint in the MANDARA Phase III trial in eosinophilic granulomatosis with polyangiitis (EGPA).
  • Burden of illness and costs associated with eosinophilic granulomatosis with polyangiitis: evidence from a managed care database in the United States.
  • A Phase 3 Study to Evaluate the Efficacy and Safety of Benralizumab in Patients With Hypereosinophilic Syndrome (HES) (NATRON).

Wright State University Foundation, altafiber, Nokia open 5G Test Lab at Emergence Center One

Retrieved on: 
Tuesday, February 20, 2024

The Wright State University Foundation, altafiber, and Nokia are pleased to announce the opening of a 5G Test Lab at Emergence Center One located at 3070 Presidential Drive in Fairborn, Ohio.

Key Points: 
  • The Wright State University Foundation, altafiber, and Nokia are pleased to announce the opening of a 5G Test Lab at Emergence Center One located at 3070 Presidential Drive in Fairborn, Ohio.
  • R. Scott Rash, President & CEO of the Wright State University Foundation, said Studio 5G is an important step for Emergence Center One.
  • “The Foundation’s partnership with altafiber and Nokia around Studio 5G is a great example for why our Foundation building was rebranded as Emergence Center One in 2020.
  • “We appreciate the Wright State University Foundation’s vision to connect business with technology through Emergence Center One, and we are excited to partner with Nokia on the 5G Test Lab,” said Greg Wheeler, President – Business Markets, for altafiber.

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

Retrieved on: 
Tuesday, March 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: 
Monday, March 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.

RYBREVANT® (amivantamab-vmjw) in Combination With Chemotherapy Is the First FDA Approved Therapy for First-line Treatment of Patients With Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

Retrieved on: 
Friday, March 1, 2024

RARITAN, N.J., March 1, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today that following a priority review, the U.S. Food and Drug Administration (FDA) has approved RYBREVANT® (amivantamab-vmjw) in combination with chemotherapy (carboplatin-pemetrexed) for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations as detected by an FDA-approved test.1 This FDA action converts the May 2021 accelerated approval of RYBREVANT® to a full approval based on the confirmatory Phase 3 PAPILLON study.

Key Points: 
  • The approval of RYBREVANT plus chemotherapy heralds a promising new first-line treatment option for patients newly diagnosed with non-small cell lung cancer where their driver mutation is an EGFR exon 20 insertion," said Marcia Horn**, Executive Director of the Exon 20 Group and CEO of ICAN, International Cancer Advocacy Network.
  • We've seen first-hand the extended survival that Exon 20 Group patients experienced on RYBREVANT plus chemotherapy in the PAPILLON study, and we're delighted that this historic treatment option, which specifically targets the EGFR exon 20 insertion mutation, has been approved."
  • "RYBREVANT plus chemotherapy is the first targeted approach approved for the first-line treatment of patients with NSCLC with EGFR exon 20 insertion mutations.
  • We look forward to building on this latest milestone as we continue to accelerate our transformative lung cancer portfolio."

Golden State Dermatology Announces New Torrance Partnership

Retrieved on: 
Wednesday, February 21, 2024

TORRANCE, Calif., Feb. 21, 2024 /PRNewswire/ -- Golden State Dermatology (GSD) is pleased to announce a new partnership with Shirlene Jay, MD, and her team in Torrance. This new practice expands the GSD Network as the fourth location in the Greater Los Angeles Area.

Key Points: 
  • TORRANCE, Calif., Feb. 21, 2024 /PRNewswire/ -- Golden State Dermatology (GSD) is pleased to announce a new partnership with Shirlene Jay, MD, and her team in Torrance.
  • As a member of Golden State Dermatology, I look forward to streamlining administrative duties and channeling my focus and energies even more towards the patient care I enjoy so much," said Shirlene Jay, MD.
  • To learn more about Golden State Dermatology and their new partnership with Shirlene Jay, MD, please visit GoldenStateDermatology.com .
  • The founder of Golden State Dermatology, Edward Becker, MD said, "We're proud to support our clinicians to provide the highest-quality patient-centered care possible.

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

Retrieved on: 
Wednesday, February 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.

FDA Approves First Cellular Therapy to Treat Patients with Unresectable or Metastatic Melanoma

Retrieved on: 
Friday, February 16, 2024

"Unresectable or metastatic melanoma is an aggressive form of cancer that can be fatal," said Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research (CBER).

Key Points: 
  • "Unresectable or metastatic melanoma is an aggressive form of cancer that can be fatal," said Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research (CBER).
  • Melanoma can spread to other parts of the body if not detected and treated early, resulting in metastatic disease.
  • Treatment for unresectable or metastatic melanoma may include immunotherapy using PD-1 inhibitors, which are antibodies targeting certain proteins in the body to help the immune system fight off cancer cells.
  • Those patients whose melanoma has progressed with these therapies have a high unmet medical need.

FDA Approves First Medication to Help Reduce Allergic Reactions to Multiple Foods After Accidental Exposure

Retrieved on: 
Friday, February 16, 2024

Xolair is intended for repeated use to reduce the risk of allergic reactions and is not approved for the immediate emergency treatment of allergic reactions, including anaphylaxis.

Key Points: 
  • Xolair is intended for repeated use to reduce the risk of allergic reactions and is not approved for the immediate emergency treatment of allergic reactions, including anaphylaxis.
  • "While it will not eliminate food allergies or allow patients to consume food allergens freely, its repeated use will help reduce the health impact if accidental exposure occurs."
  • Current treatment requires strict avoidance of the food(s) the patient is allergic to, and prompt administration of epinephrine to treat anaphylaxis should accidental exposures occur.
  • Xolair is the first FDA-approved medication to reduce allergic reactions to more than one type of food after accidental exposure.

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

Retrieved on: 
Friday, February 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