LDH

Aspaveli®/Empaveli™ (pegcetacoplan) demonstrated sustained normalisation of clinical measures in a broad PNH patient population

Retrieved on: 
Monday, December 13, 2021
Patient, Hemoglobinuria, Society, Disease, Standard of care, PRINCE, Nasdaq, LDH, Swedish Orphan Biovitrum, PNH, ASH, Pharmaceutical industry

STOCKHOLM, Dec. 13, 2021 /PRNewswire/ -- Swedish Orphan Biovitrum AB (publ) (Sobi™) (STO:SOBI) and Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) announced today new data demonstrating that Aspaveli®/Empaveli™ (pegcetacoplan) provides consistent, sustained normalisation of clinical measures across patients with paroxysmal nocturnal haemoglobinuria (PNH) who are treatment-naïve and patients with baseline haemoglobin levels greater than or equal to 10.0 g/dL. The data were presented at the American Society of Hematology Annual Meeting (ASH) taking place 11 – 14 December 2021. 

Key Points: 
  • The data were presented at the American Society of Hematology Annual Meeting (ASH) taking place 11 14 December 2021.
  • "Pegcetacoplan has the potential to elevate the standard of care for adults with PNH regardless of prior treatment or baseline haemoglobin levels."
  • The PRINCE study (NCT04085601) was a randomised, multi-centre, open-label, controlledphase 3 study in 53 treatment-nave adults with paroxysmal nocturnal haemoglobinuria (PNH).
  • The PEGASUS study (NCT03500549) was a multi-centre, randomised, head-to-headphase 3 study in 80 adults with paroxysmal nocturnal haemoglobinuria (PNH).

Crescent Canna Registers Legal THC Gummies for Adult Use in Louisiana

Retrieved on: 
Tuesday, November 30, 2021
CEO, Safety, Industry, Cannabis, Total, Louisiana Department of Health, THC, LDH, Research, GLOBE, Friends, Crescent, Cannabinoid, Airline

Crescent Canna is proud to be the first New Orleans-based business to successfully register Delta-8 THC products in Louisiana.

Key Points: 
  • Crescent Canna is proud to be the first New Orleans-based business to successfully register Delta-8 THC products in Louisiana.
  • Crescent Canna's LDH-registered Delta-8 products include 25 mg Delta-8 THC Sour Space Cadets and 30 mg Delta-8 THC Rocket Bites .
  • Delta-8 THC is a naturally occurring cannabinoidwith psychoactive effects that are similar to but milder than those of its more famous cousin, Delta-9 THC.
  • "We are so proud to finally bring hemp-derived THC products to our friends and customers throughout Louisiana," says Crescent Canna Chief Marketing Officer David Reich.

Positive Phase 2b results in 2nd line melanoma

Retrieved on: 
Friday, November 12, 2021
MSD, Ipilimumab, Safety, SITC, Cancer, DCR, Therapy, Durable, Neoplasm, LBA, Antigen presentation, EST, CEO, RNA, Disease, Pembrolizumab, Immunotherapy, Patient, Annual general meeting, GLOBE, LDH, The Society, Highlight, Society for Immunotherapy of Cancer, CT, Melanoma, FDA, Pharmaceutical industry

MADRID, Spain, Nov. 12, 2021 (GLOBE NEWSWIRE) -- Highlight Therapeutics, ("Highlight"), a clinical-stage biopharmaceutical company developing RNA-based therapies against cancer, today announced positive preliminary results of a Phase 2 study of intratumoral administration of BO-112 with pembrolizumab in patients with advanced melanoma whose disease had progressed on first-line anti-PD1-based therapy. BO-112 is a dsRNA agonist targeting anti-PD1 resistance, which has been successfully tested in several previous Phase 1b studies.

Key Points: 
  • BO-112 is a dsRNA agonist targeting anti-PD1 resistance, which has been successfully tested in several previous Phase 1b studies.
  • "These are potentially game-changing results showing that BO-112 can rescue melanoma patients who have failed first-line immune-therapy with anti-PD1," said Dr Carlos Paya, Executive Chairman of Highlight Therapeutics.
  • These initial Phase 2 results show that BO-112 combined with a leading PD1 inhibitor rescue around 65% of anti-PD1 failing patients, making many of them respond to the combined treatment.
  • With a median follow up of three months, there is a clear clinical benefit in patients with confirmed anti-PD1-resistant melanoma, with a 27% ORR and a 65% DCR, superior to 2nd line Standard of Care in stage III/IV melanoma of ~8% (continuing with anti-PD1 Ab) or 13% (second line ipilimumab).

Intensity Therapeutics Reports Use of INT230-6 Alone or in Combination with Ipilimumab Shows Evidence of Direct Tumor Necrosis and Promising Overall Survival Results in Adult Subjects with Metastatic Sarcomas at the Connective Tissue Oncology Society (CTO

Retrieved on: 
Friday, November 12, 2021
Cancer, Therapy, Breast, Poster, Safety, Ottawa Hospital Research Institute, Bristol Myers Squibb, Intensity, Pain, Columbia University Vagelos College of Physicians and Surgeons, STS, Review, Colon, CTOS, Merck Sharp & Dohme Federal Credit Union, NCI, Injection, Cisplatin, Woman, Ontario Institute for Cancer Research, National Cancer Institute, Survival, Patient, Immunosuppression, Diffusion, FDA, Ipilimumab, Sarcoma, Neoplasm, Division, Pembrolizumab, Publication, Fatigue, Hematology, Vinblastine, NCT, LDH, Surgeon, ECOG, Agency, MD, SHAO, Merck, Immune system, Appetite, Cooperative research and development agreement, BMS, Haematoxylin, Eosin, Company, Development, CRADA, Physician, Assistant, Pharmaceutical industry, Vaccine

These results provide further evidence to continue studying this novel therapeutic drug approach."

Key Points: 
  • These results provide further evidence to continue studying this novel therapeutic drug approach."
  • The data presented included results from 19 patients with different metastatic sarcomas treated with INT230-6 either as a monotherapy (n=10), or in combination with a checkpoint inhibitor (n=8) primarily ipilimumab.
  • For sarcoma subjects dosed to >40% of their total tumor burden, approximately 60% of subjects will be alive at 1 year.
  • Intensity Therapeutics, Inc. is a privately held, clinical-stage biotechnology company pioneering a new immune-based approach to treat solid tumor cancers.

Positive Phase 2b results in 2nd line melanoma

Retrieved on: 
Friday, November 12, 2021
MSD, Ipilimumab, Safety, SITC, Cancer, DCR, Therapy, Durable, Neoplasm, LBA, Antigen presentation, EST, CEO, RNA, Disease, Pembrolizumab, Immunotherapy, Patient, Annual general meeting, GLOBE, LDH, The Society, Highlight, Society for Immunotherapy of Cancer, CT, Melanoma, FDA, Pharmaceutical industry

BO-112 is a dsRNA agonist targeting anti-PD1 resistance, which has been successfully tested in several previous Phase 1b studies.

Key Points: 
  • BO-112 is a dsRNA agonist targeting anti-PD1 resistance, which has been successfully tested in several previous Phase 1b studies.
  • "These are potentially game-changing results showing that BO-112 can rescue melanoma patients who have failed first-line immune-therapy with anti-PD1," said Dr Carlos Paya, Executive Chairman of Highlight Therapeutics.
  • These initial Phase 2 results show that BO-112 combined with a leading PD1 inhibitor rescue around 65% of anti-PD1 failing patients, making many of them respond to the combined treatment.
  • With a median follow up of three months, there is a clear clinical benefit in patients with confirmed anti-PD1-resistant melanoma, with a 27% ORR and a 65% DCR, superior to 2nd line Standard of Care in stage III/IV melanoma of ~8% (continuing with anti-PD1 Ab) or 13% (second line ipilimumab).

Apellis to Present New Data Reinforcing EMPAVELI™ (pegcetacoplan) Efficacy and Safety in Patients with PNH at the 2021 ASH Annual Meeting

Retrieved on: 
Thursday, November 4, 2021
Real-World Evidence, Safety, Congress Center, APLS, Paroxysmal nocturnal hemoglobinuria, Quality, 2021 Essex County Council election, Disease, Correlation and dependence, Ravulizumab, Efficacy, Eculizumab, LDH, ASH, PM, PNH, Effect, Standard of care, Quality of life, Nasdaq, PRINCE, Society, GLOBE, PEGASUS, Week, Georgia World Congress Center, Pharmaceutical industry

The new data further support the positive efficacy and safety profile of EMPAVELI, the first and only targeted C3 therapy, for the treatment of paroxysmal nocturnal hemoglobinuria (PNH).

Key Points: 
  • The new data further support the positive efficacy and safety profile of EMPAVELI, the first and only targeted C3 therapy, for the treatment of paroxysmal nocturnal hemoglobinuria (PNH).
  • The PEGASUS study (NCT03500549) is a multi-center, randomized, head-to-head Phase 3 study in 80 adults with paroxysmal nocturnal hemoglobinuria (PNH).
  • The primary objective of this study was to establish the efficacy and safety of EMPAVELI compared to eculizumab.
  • Closely monitor patients for early signs and symptoms of serious infection and evaluate patients immediately if an infection is suspected.

Dicerna Announces Results for PHYOX™4, Single-Dose Study of Nedosiran in Primary Hyperoxaluria Type 3 (PH3)

Retrieved on: 
Tuesday, October 19, 2021
Science, Other Science, Biotechnology, Research, Pharmaceutical, Health, Genetics, Clinical Trials, Back pain, Clinical trial, AES, Roche, Caregiver, Gene, PH3, Form 10-K, Metabolism, Risk, United States Census Bureau, Technology, Observation, Novo Nordisk, COVID-19, Chronic kidney disease, Primary hyperoxaluria, Lists of diseases, Patient, U.S. Securities and Exchange Commission, Tissue, Security (finance), Trial of the century, Skin, Liver, Nephrocalcinosis, LDH, NDA, Therapy, Disease, Mutation, Pain, Research, Intellectual property, Medication, RNA interference, FDA, Safety, Health, PH1, Eli Lilly, PH2, Kidney, Neurodegeneration, Heart, AE, Company, Pharmaceutical industry, Primary Hyperoxaluria (PH), Nedosiran, Dicerna Pharmaceuticals, Inc., PRIMARY HYPEROXALURIA (PH), NEDOSIRAN, DICERNA PHARMACEUTICALS, INC.

Nedosiran demonstrated safety and tolerability results in this trial consistent with previously reported studies in the PHYOX clinical development program.

Key Points: 
  • Nedosiran demonstrated safety and tolerability results in this trial consistent with previously reported studies in the PHYOX clinical development program.
  • Dicerna plans to submit an NDA to the FDA for nedosiran for the treatment of PH1 in the fourth quarter of 2021.
  • I would like to extend our sincere thanks to the patients, caregivers, investigators and their staff involved in the PHYOX4 study for their important contributions.
  • Primary hyperoxaluria (PH) is a family of ultra-rare, life-threatening genetic disorders that initially manifest with complications in the kidneys.

Dicerna Announces Data to Be Presented at American Society of Nephrology (ASN) Kidney Week 2021

Retrieved on: 
Friday, October 15, 2021
Science, Other Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Clinical Trials, RNA interference, Form 10-Q, Technology, Eli Lilly, Liver, American Society of Nephrology, Primary hyperoxaluria, Heart, Lists of diseases, Gene, Pain, NDA, Chronic kidney disease, Metabolism, Tissue, Roche, PH3, SEC, Therapy, Disease, Mutation, Nephrocalcinosis, FDA, United States Census Bureau, Skin, Health, LDH, Patient, Form, Neurodegeneration, Society, ASN, Novo Nordisk, Kidney, Form 10-K, Company, PH2, EDT, Research, PH1, Medication, Pharmaceutical industry, Primary Hyperoxaluria (PH), Nedosiran, Dicerna Pharmaceuticals, Inc., PRIMARY HYPEROXALURIA (PH), NEDOSIRAN, DICERNA PHARMACEUTICALS, INC.

Given the significant unmet medical need, we believe further assessment of nedosirans potential in treating PH2 is warranted.

Key Points: 
  • Given the significant unmet medical need, we believe further assessment of nedosirans potential in treating PH2 is warranted.
  • Primary hyperoxaluria (PH) is a family of ultra-rare, life-threatening genetic disorders that initially manifest with complications in the kidneys.
  • There are three known subtypes of PH (PH1, PH2 and PH3), each resulting from a mutation in one of three different genes.
  • Excess production and accumulation of oxalate leads to recurrent kidney stones, nephrocalcinosis and chronic kidney disease that may progress to end-stage renal disease requiring intensive dialysis.

Envoc's Digital Driver's License App, LA Wallet onboards Over 1 Million Citizens

Retrieved on: 
Monday, September 13, 2021
LA, Google Play, Travel, App Store (iOS/iPadOS), LDH, Louisiana Department of Health, Work, COVID-19, Motor vehicle, BATON, Cryptocurrency

In addition to holding a legal, digital version of a citizen's driver's license, LA Wallet can also hold the official digital version of a citizen's COVID-19 vaccination status on file with the Louisiana Department of Health (LDH).

Key Points: 
  • In addition to holding a legal, digital version of a citizen's driver's license, LA Wallet can also hold the official digital version of a citizen's COVID-19 vaccination status on file with the Louisiana Department of Health (LDH).
  • To date, over 460,000 Louisiana citizens have their digital SMART Health Card containing their COVID-19 status installed on LA Wallet.
  • "In October of 2021, LA Wallet will be extended to include the ability to display a citizen's hunting and fishing licenses within the app.
  • LA Wallet is completely free to use, and Louisiana residents can download LA Wallet from the Apple App Store and Google Play store.

Vitabrid C12 Announces Saks Fifth Avenue as New National Retail Partner

Retrieved on: 
Thursday, September 2, 2021
Hair, Ageing, Partnership, SKU, Layered double hydroxides, Saks Fifth Avenue, FACE, VP, Vitamin C, SAN, LDH, Scalp, HAIR, Nanotechnology, Collagen, Man, Woman, Hair loss, Secret Code, Peptide, Acosta Sales & Marketing, Skin, Chemistry (relationship), Biotechnology, Perfume, Dietary supplement, Cosmetics, Online shopping

SAN JOSE, Calif., Sept. 1, 2021 /PRNewswire/ -- Vitabrid C12 continues its retail expansion in the United States, announcing saksfifthavenue.com as the brand's latest retail partner.

Key Points: 
  • SAN JOSE, Calif., Sept. 1, 2021 /PRNewswire/ -- Vitabrid C12 continues its retail expansion in the United States, announcing saksfifthavenue.com as the brand's latest retail partner.
  • "We are honored and thrilled to announce our new partnership with Saks Fifth Avenue, a storied destination for the ultimate in luxury and modern beauty.
  • Vitabrid CG is a stabilized form of 12-hour Vitamin C, developed by submerging pure Vitamin C in between bio-friendly mineral layers.
  • Saks Fifth Avenue's e-commerce site will retail ten of Vitabrid C's products including many of their hero SKU's like FACE Brightening and HAIR Tonic Professional.