AD

Cyclo Therapeutics Provides Business Update and Reports Full Year 2022 Financial Results

Retrieved on: 
Monday, March 20, 2023
Biotechnology, Genetics, Health, Clinical Trials, Society, Priority review, Expanded access, Cholesterol, SIMD, NPC1, CYTH, Organ dysfunction, Research, Cell, Dementia, Science, Death, Genetic disorder, Patient, HIV disease progression rates, Bank, Annual general meeting, NPC, Lysosome, AD, Therapy, Safety, Pharmaceutical industry, Nursing, EU

Cyclo Therapeutics, Inc. (Nasdaq: CYTH) (“Cyclo Therapeutics” or the “Company”), a clinical stage biotechnology company dedicated to developing life-changing medicines through science and innovation for patients and families living with diseases, today reported its financial results for the full year 2022 and provided a business update.

Key Points: 
  • Cyclo Therapeutics, Inc. (Nasdaq: CYTH) (“Cyclo Therapeutics” or the “Company”), a clinical stage biotechnology company dedicated to developing life-changing medicines through science and innovation for patients and families living with diseases, today reported its financial results for the full year 2022 and provided a business update.
  • Further we continue to have encouraging strategic discussions across the industry,” commented N. Scott Fine, CEO of Cyclo Therapeutics.
  • Cyclo Therapeutics received Orphan Drug Designation for Trappsol® Cyclo™ to treat NPC1 in both the U.S. and EU and Fast Track and Rare Pediatric Disease Designations in the U.S.
  • Enrolled patients will be randomized across three study arms: 500 mg/kg or 1000 mg/kg of Trappsol® Cyclo™ and placebo.

Connect Biopharma CBP-201 Atopic Dermatitis China Pivotal Study Showed Rapid Relief of Patient Symptoms

Retrieved on: 
Saturday, March 18, 2023
Health, Other Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Maintenance, Psoriasis Area and Severity Index, EASI, Week, Dermatology, American Academy, Atopic dermatitis, IGA, 2008 Giro d'Italia, Stage 1 to Stage 11, Patient, Itch, AD, Skin, Inflammation, Vaccine

Connect Biopharma Holdings Limited (Nasdaq: CNTB) (Connect Biopharma or the Company), a global clinical-stage biopharmaceutical company developing T cell-driven therapies to treat inflammatory diseases, announced that data from Stage 1 of the ongoing pivotal CBP-201 China trial in moderate-to-severe atopic dermatitis (AD) showed rapid relief from symptoms, as early as week one in some cases, and no efficacy plateau at Week 16.

Key Points: 
  • Connect Biopharma Holdings Limited (Nasdaq: CNTB) (Connect Biopharma or the Company), a global clinical-stage biopharmaceutical company developing T cell-driven therapies to treat inflammatory diseases, announced that data from Stage 1 of the ongoing pivotal CBP-201 China trial in moderate-to-severe atopic dermatitis (AD) showed rapid relief from symptoms, as early as week one in some cases, and no efficacy plateau at Week 16.
  • In the study “CBP-201, a next-generation IL-4Rα antibody, achieved all primary and secondary efficacy endpoints in the treatment of adults with moderate-to-severe atopic dermatitis (AD): A randomized, double-blind, pivotal trial in China (CBP-201-CN002),” researchers reported on results from Stage 1 of the pivotal China trial of CBP-201 in moderate-to-severe AD.
  • Patients on active therapy experienced rapid relief of symptoms, with a reduction in itch at Week 1 and significant improvement in all study endpoints by Week 4, which was sustained to Week 16.
  • “We are honored to have data from our two CBP-201 atopic dermatitis studies at the prestigious American Academy of Dermatology Annual Meeting, showing rapid and sustained relief,” said Zheng Wei, Ph.D., Co-founder and CEO of Connect Biopharma.

Arcutis Presents Late-Breaking Data from the INTEGUMENT Phase 3 Trials in Atopic Dermatitis at American Academy of Dermatology Annual Meeting

Retrieved on: 
Saturday, March 18, 2023
PDE4, American Academy of Dermatology, Arm, AD, Atopic dermatitis, American Academy, AAD, Week, Vaccine

Roflumilast cream is a once-daily, steroid-free topical formulation of a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor.

Key Points: 
  • Roflumilast cream is a once-daily, steroid-free topical formulation of a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor.
  • Over 30% of individuals treated with roflumilast cream in each study achieved Worst Itch Numeric Scale (WI-NRS) Success at Week 4.
  • “Roflumilast cream was also shown to be safe and well-tolerated, critical considerations for the treatment of atopic dermatitis.
  • Local tolerability was favorable with more than 90% of those treated with roflumilast cream reporting no or mild sensation across arms in both trials at any timepoint.

Connect Biopharma CBP-201 Atopic Dermatitis Global Phase 2b Data Showed Rapid and Sustained Improvement Across all Body Regions

Retrieved on: 
Friday, March 17, 2023
Oncology, Health, Hospitals, General Health, Clinical Trials, Pharmaceutical, Biotechnology, Week, EASI, Dermatology, Atopic dermatitis, American Academy, Head, Neck, Patient, AD, Inflammation, Vaccine

This is the first time CBP-201 AD improvements have been broken down by body regions and symptom subtypes.

Key Points: 
  • This is the first time CBP-201 AD improvements have been broken down by body regions and symptom subtypes.
  • In the abstract entitled “Rapid and Sustained Improvements with CBP-201 Across All Body Regions: Treatment of Atopic Dermatitis in a Phase 2b, Randomized, Double-blind, Placebo-controlled Trial (CBP-201-WW001),” researchers reported that CBP-201 demonstrated rapid improvement in AD as early as Week 2 and sustained at Week 16 across four body regions: head and neck, trunk, upper limbs and lower limbs, compared to placebo.
  • In addition to overall AD improvement across all four body regions, researchers also observed improvement for each classification of AD symptoms (signs): erythema, induration/papulation, lichenification and excoriation, within each body region.
  • “CBP 201 also showed good AD reductions in the head and neck region, which is often more difficult to treat.

PREMA is introducing a "Web3 SNS" system to enhance the Web3 social networking and gaming experience

Retrieved on: 
Friday, March 17, 2023
SNS, DAO, Partnership, NFT, Web3, Real Life, Web 3.0, Sale, AD, Cryptocurrency, Online shopping

PREMA can provide users with convenient NFT trading and NFT multifunctional application services.

Key Points: 
  • PREMA can provide users with convenient NFT trading and NFT multifunctional application services.
  • On March 7th, they established a strategic business alliance with Avacus Inc.The company provides distributed social networking services (hereinafter referred to as "Web3 SNS") "Avacus.
  • PREMA develops and services NFT/ blockchain content and operates Samurai Guild Games (SamuraiGG), a gaming guild with 30,000 members (as of February 2023).
  • app will integrate with various Dapps deployed by PREMA, which will increase the functionality of both platforms.

LEO Pharma Presents New Adbry™ (tralokinumab-ldrm) Data in Adolescent Population from ECZTRA 6 and ECZTEND Trials at AAD 2023 Annual Meeting

Retrieved on: 
Friday, March 17, 2023
Pharmaceutical, Health, Clinical Trials, Keratitis, American Academy of Dermatology, University, Paced Auditory Serial Addition Test, Leo Pharma, S. aureus, Week, Dermatitis, Infection, Food, Aes, American Academy, Atopic dermatitis, Skin, Gene expression, Staphylococcus, Staphylococcus aureus, Malignancy, Patient, AAD, Lower respiratory tract infection, LEO, Annual general meeting, European, Adolescence, PYE, University of Rochester Medical Center, Keratoconjunctivitis, Ageing, AD, FDA, Conjunctivitis, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Gene, Safety, Pharmaceutical industry, Medical imaging, Vaccine, Tralokinumab

The data was presented at the American Academy of Dermatology (AAD) 2023 Annual Meeting.

Key Points: 
  • The data was presented at the American Academy of Dermatology (AAD) 2023 Annual Meeting.
  • S. aureus is consistently found in the skin lesions of patients with AD and contributes to skin irritation and infections.
  • “In addition, the latest analysis of data from adolescents in the ECZTEND study shows the long-term safety and efficacy profile of Adbry.
  • Adtralza is approved for use in adults with moderate-to-severe AD in the U.S., United Arab Emirates, Switzerland, and Japan.

AD Solutions Acquires Core Imaging USA

Retrieved on: 
Friday, March 17, 2023
Partnership, IT service management, Core Image, Sharp, Konica Minolta, Acquisition, Fusion Global Business Solutions, AD, SHARP, NEC, Software, Sales

ORLANDO, Fla., March 17, 2023 /PRNewswire/ -- AD Solutions, Inc's Best in Business 2022, an award-winning workplace technology provider and the leading Sharp Platinum Dealership with global headquarters in Orlando, Florida, announces that it has recently acquired Core Imaging USA, an office equipment dealership and Managed IT Services provider with offices in Longwood and Tampa, Florida. 

Key Points: 
  • Founded in 2014, Core Imaging USA is a Business Solutions company that provides Managed IT Services, VOIP Solutions, and document management services, including Konica Minolta copiers.
  • With AD Solutions' dedicated worldwide partnership with Sharp and its unmatched services and products, AD Solutions is primed to expand its delivery of only the very best in print, document, software, network, display, IT solutions, and more to the greater Tampa area.
  • This acquisition undoubtedly expands and improves the products, technology, and services available to Core Imaging and AD Solutions clients resulting in better services and workplace technology now available to a broader range of Florida businesses.
  • Moody Hamdan, Chief Executive Officer of AD Solutions, says," We are excited to have Core Imaging USA join the AD Solutions family.

Aluminum Association Requests Ruling that Certain Imports from Korea are Circumventing Unfair Trade Orders on Common Alloy Aluminum Sheet from China

Retrieved on: 
Thursday, March 16, 2023
CAAS, The Aluminum Association, Office of Inspector General, U.S. Department of Health and Human Services, Working Group, Commerce Department trade mission controversy, Aluminium, Common, Active Measures Working Group, CVD, Kelley Drye & Warren, AD, U.S. Department of Commerce Office of Security, United States Department of Commerce, Commerce, Cryptocurrency, Recycling

“We urge the Commerce Department to take action promptly to enforce our trade laws against efforts by a Chinese producer and its Korean affiliate to evade the unfair trade orders on common alloy aluminum sheet from China,” said Charles Johnson, president and CEO of the Aluminum Association.

Key Points: 
  • “We urge the Commerce Department to take action promptly to enforce our trade laws against efforts by a Chinese producer and its Korean affiliate to evade the unfair trade orders on common alloy aluminum sheet from China,” said Charles Johnson, president and CEO of the Aluminum Association.
  • The aluminum sheet at issue includes both unclad aluminum sheet, as well as multi-alloy, clad aluminum sheet.
  • In February 2019, the Commerce Department published antidumping and countervailing (AD/CVD) orders on imports of CAAS from China following an action by the Aluminum Association’s Common Alloy Aluminum Sheet Trade Enforcement Working Group.
  • Since those orders were published, U.S. imports of aluminum sheet from China have declined substantially.

U.S. Veterans' Health Administration (VHA) Provides Coverage of LEQEMBI (lecanemab-Irmb) Two Months After LEQEMBI's FDA Accelerated Approval for Veterans Living with Early Stages of Alzheimer's Disease

Retrieved on: 
Tuesday, March 14, 2023
The New England Journal of Medicine, Tradition, Brain, Veteran, Pathology, Co-promotion, Priority review, VHA, Lecanemab, Patient, Clarity, FDA, Clinical trial, PDUFA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, AD, Plaque, Immunoglobulin G, Pharmaceutical industry, Alzheimer's disease, Biogen, Disease, Eisai

The VHA's careful consideration and timely action to make LEQEMBI available approximately two months after the FDA approved LEQEMBI under the accelerated approval pathway shows its continued commitment to veterans living with AD.

Key Points: 
  • The VHA's careful consideration and timely action to make LEQEMBI available approximately two months after the FDA approved LEQEMBI under the accelerated approval pathway shows its continued commitment to veterans living with AD.
  • If approved under the traditional pathway, the FDA will update the label for LEQEMBI, which will include new data that has been evaluated by the FDA.
  • The FDA has determined that the results of Clarity AD will serve as the confirmatory study to verify the clinical benefit of LEQEMBI.
  • On the same day that LEQEMBI received its Accelerated approval, Eisai submitted the supplemental Biologics License Application (sBLA) to the FDA for approval under the Traditional pathway.

FDA Accepts Eisai's Filing of a Supplemental Biologics License Application and Grants Priority Review for Traditional Approval of LEQEMBITM (lecanemab-irmb) for the Treatment of Alzheimer's Disease

Retrieved on: 
Monday, March 6, 2023
The New England Journal of Medicine, Brain, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Co-promotion, Pathology, Priority review, BIIB, Lecanemab, Patient, Clarity, FDA, Clinical trial, Oncology Drug Advisory Committee, PDUFA, Prescription Drug User Fee Act, Food, Advisory Committee, AD, Plaque, Immunoglobulin G, Pharmaceutical industry, Medical imaging, Alzheimer's disease, Biogen, Eisai

The LEQEMBI application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of July 6, 2023.

Key Points: 
  • The LEQEMBI application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of July 6, 2023.
  • The FDA is currently planning to hold an Advisory Committee to discuss this application but has not yet publicly announced the date of the meeting.
  • On the same day that LEQEMBI received its accelerated approval, Eisai submitted the sBLA to the FDA for approval under the traditional pathway.
  • The sBLA is based on the findings from Eisai's recently published large, global confirmatory Phase 3 clinical trial, Clarity AD.