Paediatric-use marketing authorisation

Endexx Initiates TPD Registration in Europe

Retrieved on: 
Tuesday, November 14, 2023
OTCQB, Hyla, Tobacco, Nicotine, HYLA, Paediatric-use marketing authorisation, CAVE, CPG, TPD, Beauty salon, Czech Republic

CAVE CREEK, AZ, Nov. 14, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – Endexx® Corporation (OTCQB: EDXC), a provider of innovative plant-based wellness and nutritional products, today announced that its HYLA division has completed preliminary review of its premium vegan formulated traditional e-cigarette products. Hyla is filing its TPD application in Europe. TPD is (The “Tobacco Products Directive” (2014/40/EU) which aims to improve the functioning of the internal market for tobacco and related products, while ensuring a high level of health protection for European citizens.)

Key Points: 
  • Hyla is filing its TPD application in Europe.
  • The demand for the HYLA non-nicotine products is quickly gaining market share in the initial markets in Europe.
  • The TPD registration completely opens the European market to all HYLA’s products.
  • “This registration process helps secure the success of our long- term target of being a dominant player in the international age-restricted CPG markets.”

The European Commission granted Marketing Authorisation for Vueway® (gadopiclenol) in the European Union

Retrieved on: 
Monday, December 11, 2023
CNS, Lung, Health, Neck, Prostate, Medical University of Vienna, Breast, Brain, Safety, Food, European Medicines Agency, Paediatric-use marketing authorisation, European Commission, Head, University, Medical imaging, Human, Liver, Spine, GBCA, Google Images, PICTURE, Gadolinium, EMA, Civil service commission, Patient, Marketing authorisation, European, Gadobutrol, Neurology, FDA, Kidney, Pancreas, European Committee for Standardization, CHMP, BBB, Monroe Dunaway Anderson, Committee, Pathology, Gastroenterology, MRI, Central nervous system, MD Anderson Cancer Center, Medical school, Environment, Vaccine, Rare-earth element

Following the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), and the recommendation sent by EMA to the European Committee (EC), the EC has granted Marketing Authorisation for Vueway® (gadopiclenol) in the European Union.

Key Points: 
  • Following the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), and the recommendation sent by EMA to the European Committee (EC), the EC has granted Marketing Authorisation for Vueway® (gadopiclenol) in the European Union.
  • MILAN, Dec. 11, 2023 /PRNewswire/ -- Bracco Imaging S.p.A., an innovative world leader delivering end-to-end products and solutions through a comprehensive portfolio inclusive of precision diagnostic imaging modalities, announces that on December 7, 2023 the European Commission (EC) has granted the Marketing Authorisation for Vueway® (gadopiclenol) in the European Union (EU).
  • 1,2
    "The final approval of gadopiclenol by the European Commission marks a significant milestone in the field of diagnostic imaging.
  • This innovation benefits healthcare providers but also, more importantly, patients who undergo MRI scans and those living with chronic conditions.

The European Commission granted Marketing Authorisation for Vueway® (gadopiclenol) in the European Union

Retrieved on: 
Monday, December 11, 2023
CNS, Lung, Health, Neck, Prostate, Medical University of Vienna, Breast, Brain, Safety, Food, European Medicines Agency, Paediatric-use marketing authorisation, European Commission, Head, University, Medical imaging, Human, Liver, Spine, GBCA, Google Images, PICTURE, Gadolinium, EMA, Civil service commission, Patient, Marketing authorisation, European, Gadobutrol, Neurology, FDA, Kidney, Pancreas, European Committee for Standardization, CHMP, BBB, Monroe Dunaway Anderson, Committee, Pathology, Gastroenterology, MRI, Central nervous system, MD Anderson Cancer Center, Medical school, Environment, Vaccine, Rare-earth element

Following the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), and the recommendation sent by EMA to the European Committee (EC), the EC has granted Marketing Authorisation for Vueway® (gadopiclenol) in the European Union.

Key Points: 
  • Following the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), and the recommendation sent by EMA to the European Committee (EC), the EC has granted Marketing Authorisation for Vueway® (gadopiclenol) in the European Union.
  • MILAN, Dec. 11, 2023 /PRNewswire/ -- Bracco Imaging S.p.A., an innovative world leader delivering end-to-end products and solutions through a comprehensive portfolio inclusive of precision diagnostic imaging modalities, announces that on December 7, 2023 the European Commission (EC) has granted the Marketing Authorisation for Vueway® (gadopiclenol) in the European Union (EU).
  • 1,2
    "The final approval of gadopiclenol by the European Commission marks a significant milestone in the field of diagnostic imaging.
  • This innovation benefits healthcare providers but also, more importantly, patients who undergo MRI scans and those living with chronic conditions.

NovaBone's New Bioactive Glass Syringe for Foot & Ankle

Retrieved on: 
Monday, September 18, 2023
Ankle, Surgeon, Foot, Putty, Marketing, Bioactive glass, Hemostasis, Patient, Glass, FDA, Paediatric-use marketing authorisation

ALACHUA, Fla., Sept. 18, 2023 /PRNewswire-PRWeb/ -- NovaBone Products, leader in synthetic biologics, is pleased to announce the company has made commercially available a new syringe for targeted delivery of its 45S5 bioactive glass putty device for the foot and ankle market. The newly launched syringe comes in both a 2.5cc and a 5cc formulation.

Key Points: 
  • NovaBone Products launches a first foot and ankle-specific syringe delivery system for its bioactive glass delivery system.
  • ALACHUA, Fla., Sept. 18, 2023 /PRNewswire-PRWeb/ -- NovaBone Products, leader in synthetic biologics, is pleased to announce the company has made commercially available a new syringe for targeted delivery of its 45S5 bioactive glass putty device for the foot and ankle market.
  • "We are excited to provide our foot and ankle surgeons with a specific solution to deliver our best-in-class synthetic putty to their patients.
  • Dr. Charles E. Cook of Dallas, Texas, was the first foot and ankle surgeon to use the new product designed for medical use of bioactive glass.

Sientra Announces FDA-Clearance of Next Generation AlloX2 Pro™ Tissue Expander

Retrieved on: 
Thursday, June 8, 2023
Federal Food, Drug, and Cosmetic Act, Drainage, Quality of life, Woman, Food and Drug Administration Amendments Act of 2007, Magnetic resonance imaging, Patient, Health, FDA, Paediatric-use marketing authorisation, Food, Breast cancer, Medical imaging

IRVINE, Calif., June 08, 2023 (GLOBE NEWSWIRE) -- Sientra, Inc. (NASDAQ: SIEN) (“Sientra” or the “Company”), a medical aesthetics company focused on enhancing lives by advancing the art of plastic surgery, announced that the Food and Drug Administration (FDA) has granted a 510k-clearance for the Company’s novel, patented1 AlloX2 Pro Tissue Expander. Building upon the proprietary dual port technology of the Company’s ground-breaking AlloX2® tissue expander, the AlloX2 Pro expands this platform by removing 95% of the metal traditionally associated with tissue expander ports. This innovation allows the AlloX2 Pro to be labeled as MRI-conditional, making it the only tissue expander cleared in the United States for exposure to magnetic resonance imaging, an important screening tool for breast reconstruction patients.   Other innovative features of the AlloX2 Pro include minimal interference with radiation therapy for post-mastectomy patients,2 faster port filling and drainage, and a softer drain for enhanced patient comfort.

Key Points: 
  • Building upon the proprietary dual port technology of the Company’s ground-breaking AlloX2® tissue expander, the AlloX2 Pro expands this platform by removing 95% of the metal traditionally associated with tissue expander ports.
  • This innovation allows the AlloX2 Pro to be labeled as MRI-conditional, making it the only tissue expander cleared in the United States for exposure to magnetic resonance imaging, an important screening tool for breast reconstruction patients.
  • Other innovative features of the AlloX2 Pro include minimal interference with radiation therapy for post-mastectomy patients,2 faster port filling and drainage, and a softer drain for enhanced patient comfort.
  • “I am extremely proud to have partnered with Sientra to bring the AlloX2 Pro to market,” commented Dr. Thomas McClellan, a board-certified plastic surgeon in West Virginia and inventor of AlloX2.

EMERGENTMEDTECH ANNOUNCES LAUNCH OF NEOGEN PSR AS EXCLUSIVE U.S. DISTRIBUTOR TO BUILD NATIONWIDE NETWORK OF PROVIDERS

Retrieved on: 
Saturday, May 6, 2023
Boston Park Plaza, LIVE, Skin care, Marketing, Energistics, Elastin, Scar, PSR, Fitzpatrick scale, Pigment, Acne, Patient, Business manager, Collagen, Health, FDA, Paediatric-use marketing authorisation, Family, Skin, Neogen, Pharmaceutical industry, Nursing, Dentistry

NeoGen PSR provides the most advanced nonsurgical facial rejuvenation treatment available with award-winning results.

Key Points: 
  • NeoGen PSR provides the most advanced nonsurgical facial rejuvenation treatment available with award-winning results.
  • "Everyone at Energist is delighted and excited to appoint Emergentmedtech as our Exclusive USA NeoGen Partner.
  • "When we started with NeoGen, we just treated friends and family including Co-owner and NeoGen PSR treatment specialist Shaun Spanos' grandmother.
  • Emergentmedtech is building a national network of NeoGen PSR Providers to bring this innovative technology to people all over America.

BD Introduces Advanced Ultrasound Technology to Help Drive First-Stick Success for IV Insertions

Retrieved on: 
Tuesday, April 11, 2023
Maintenance, Apple II system clocks, Emergency medicine, Vein, Heart failure, User experience, Anxiety, Learning curve, Journal of Clinical Nursing, Pain, Becton, Dickinson and Company headquarters, NYSE, Patient, Standard of care, Risk, Bahl, MA, American Institute of Ultrasound in Medicine, Prevalence, Becton, Research, Paediatric-use marketing authorisation, American Institute, BDX, BD, Medical device, Medical imaging, Nursing, K, Medicine

More than 90 percent of hospitalized patients receive IV therapy through a peripheral IV catheter2  -- representing hundreds of millions of patients a year.3 However, nearly two-thirds4 of these patients have vessels that are difficult to visualize and access, often resulting in additional needlesticks, vessel damage and infiltration into the surrounding tissue. 

Key Points: 
  • The BD Prevue™ II System addresses an unmet need in IV access through real-time needle depth markers.
  • "BD is advancing the vision of a 'One-Stick Hospital Stay,' and first-stick success is the first requirement to fulfill that vision.
  • First-stick success also reduces the pain and anxiety patients often experience while undergoing multiple IV access attempts and provides clinicians with IV workflow efficiencies and confidence."
  • The system is designed with clinician-friendly features to help expand the use of ultrasound in IV placement.

MAYBELLINE NEW YORK PARTNERS WITH CHLOE FINEMAN FOR NEW DIGITAL CAMPAIGN FEATURING NEW TATTOO STUDIO INK PEN LINER

Retrieved on: 
Monday, April 3, 2023
Music, Paediatric-use marketing authorisation, Tears, CVS, SRP, Maybelline, Marketing, Assistant, Target, Victoria Georgieva, Personality, Ulta Beauty, Rain, Video game, Cosmetics, Amazon

NEW YORK, April 3, 2023 /PRNewswire/ -- Maybelline New York, the #1 Cosmetics Brand in the world, today launched its latest campaign with comedian Chloe Fineman to showcase the durability of the brand's all-new Tattoo Studio Ink Pen Eyeliner in a campaign titled, "Ugly Cry, Perfect Liner."

Key Points: 
  • NEW YORK, April 3, 2023 /PRNewswire/ -- Maybelline New York , the #1 Cosmetics Brand in the world, today launched its latest campaign with comedian Chloe Fineman to showcase the durability of the brand's all-new Tattoo Studio Ink Pen Eyeliner in a campaign titled, "Ugly Cry, Perfect Liner."
  • "We're thrilled to be partnering with Chloe for our new Tattoo Studio Ink Liner campaign, leaning into her engaging personality, and the 'cry-proof' nature of the product.
  • Apply the Tattoo Studio Ink Pen Liner starting with the inner corner and glide the tip along the lash line.
  • Tattoo Studio Ink Pen Liner is now available online and at mass-market retailers nationwide, including Target, CVS, Ulta Beauty, Amazon, and more.

DISPOSABLE VAPE COMPANIES CONTINUE USING SOCIAL MEDIA YOUTH-MARKETING TACTICS

Retrieved on: 
Thursday, January 19, 2023
Social media, ELF, United States Customs Service, Government, DOJ, Tobacco, FDA, Fruit, Marketing, Herbal cigarette, Paediatric-use marketing authorisation, JUUL, Minor

Tampa, FLA, Jan. 19, 2023 (GLOBE NEWSWIRE) -- Youth-targeted social media marketing is rearing its ugly head once again.

Key Points: 
  • Tampa, FLA, Jan. 19, 2023 (GLOBE NEWSWIRE) -- Youth-targeted social media marketing is rearing its ugly head once again.
  • Illegal Chinese disposable vape brands like ELF and Puff Bar can be spotted all over popular social platforms like TikTok, spewing content specifically made to appeal to young consumers.
  • With most of the world’s teenage population spending so much time on social media platforms like TikTok and Instagram, it is imperative that we protect this group from exposure to youth-appealing content coming from illegal disposable vape brands.
  • If you witness illegal disposable vape products being marketed online or in a store near you, demand action and report the potential tobacco violation to the FDA.

FDA “CRACKS DOWN” ON THE VAPE INDUSTRY – BUT WHERE IS THE ENFORCEMENT?

Retrieved on: 
Thursday, December 29, 2022
Customs, Government, Justice, School, Herbal cigarette, United States Customs Service, Vuse, CDC, DOJ, Paediatric-use marketing authorisation, JUUL, FDA, Statistics, California Department of Justice, Tobacco

Where did all of these illegal devices come from and how are so many of them ending up in the hands of our youth?

Key Points: 
  • Where did all of these illegal devices come from and how are so many of them ending up in the hands of our youth?
  • If the intent of government regulations is to keep Americans safe, including protecting our youth from being intentionally targeted by unethical brands selling illegal vape products, why are we seeing such a lack of enforcement?
  • What if the flow of illegal vape products that are flooding our schools could be stopped overnight?
  • Why is our government not stopping the infiltration of these illegal vape products at Customs?