PASI

Alvotech and Teva Announce U.S. FDA Approval of SELARSDI™ (ustekinumab-aekn), biosimilar to Stelara® (ustekinumab)

Retrieved on: 
Tuesday, April 16, 2024
Volunteering, FDA, Psoriatic arthritis, Safety, Food, Cytokine, Johnson & Johnson, Teva, TEVA, Inflammation, Partnership, Perfusion, Biotechnology, Senior, Patient, Psoriasis, Marketing, PASI, Teva Pharmaceuticals, Generic drug

Under the strategic partnership between Teva and Alvotech, Teva is responsible for the exclusive commercialization of SELARSDI in the United States.

Key Points: 
  • Under the strategic partnership between Teva and Alvotech, Teva is responsible for the exclusive commercialization of SELARSDI in the United States.
  • Alvotech handles development and manufacturing, while Teva is responsible for the exclusive commercialization in the U.S., which leverages Teva’s experience and extensive sales and marketing infrastructure.
  • SELARSDI is the second biosimilar approved under the strategic partnership: in February 2024, the FDA approved SIMLANDI®, the first high-concentration, citrate-free biosimilar to Humira that has been granted an interchangeability status by the FDA.
  • The FDA approval of SELARSDI, referred to as AVT04 during development, was based on a totality of evidence, including analytical and clinical data.

Alvotech and Teva Announce U.S. FDA Approval of SELARSDI™ (ustekinumab-aekn), biosimilar to Stelara® (ustekinumab)

Retrieved on: 
Tuesday, April 16, 2024
Biotechnology, Pharmaceutical, Oncology, Health, FDA, Health Technology, Genetics, Clinical Trials, Volunteering, Psoriatic arthritis, Safety, Food, Cytokine, Johnson & Johnson, Teva, TEVA, Inflammation, Partnership, Perfusion, Senior, Patient, Psoriasis, Multimedia, Marketing, PASI, Teva Pharmaceuticals, Generic drug

Under the strategic partnership between Teva and Alvotech, Teva is responsible for the exclusive commercialization of SELARSDI in the United States.

Key Points: 
  • Under the strategic partnership between Teva and Alvotech, Teva is responsible for the exclusive commercialization of SELARSDI in the United States.
  • Alvotech handles development and manufacturing, while Teva is responsible for the exclusive commercialization in the U.S., which leverages Teva’s experience and extensive sales and marketing infrastructure.
  • SELARSDI is the second biosimilar approved under the strategic partnership: in February 2024, the FDA approved SIMLANDI®, the first high-concentration, citrate-free biosimilar to Humira that has been granted an interchangeability status by the FDA.
  • The FDA approval of SELARSDI, referred to as AVT04 during development, was based on a totality of evidence, including analytical and clinical data.

Can-Fite Reports 2023 Financial Results and Clinical Update

Retrieved on: 
Thursday, March 28, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Human, Psoriasis, Exercise, ALT, Patent, BID, CANF, Patient, CEE, Journal, Policy, EMA, Security (finance), Inflammation, Cancer, Bank statement, European Medicines Agency, Pancreatic cancer, Annual report, Skin, The Annual Report, PASI, Safety, NASH, Use, Liver cancer, FDA, Food, DSM-IV codes, Pharmaceutical industry

(NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announced financial results and clinical updates for the twelve months ended December 31, 2023.

Key Points: 
  • (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announced financial results and clinical updates for the twelve months ended December 31, 2023.
  • EADV is a top ranked peer reviewed journal (impact factor 9.2) that publishes articles on clinical and basic science topics in dermatology.
  • Financial income (expense), net for the year ended December 31, 2023 aggregated $0.56 million compared to financial expense, net of $(0.07) for the year ended December 31, 2022.
  • The Company's consolidated financial results for the year ended December 31, 2023 are presented in accordance with US GAAP Reporting Standards.

MoonLake announces significant improvements with Nanobody® sonelokimab over 24 weeks in active psoriatic arthritis (PsA) and other important updates at its R&D Day

Retrieved on: 
Sunday, March 10, 2024
Psoriatic arthritis, ACR, Doctor of Philosophy, Adalimumab, Skin, American College, Webcast, Moonlake, HS, Patient, Psoriasis, VELA, MMSc, ARGO, MIRA, EDT, Physician, Inflammation, Safety, Prognosis, Clinical trial, Ankylosing spondylitis, TNF, IL-17A, MDA, American Academy, EMA, Medical college, FDA, Food, Steroid, Prevalence, AAD, Event, Joint, PASI, Hidradenitis suppurativa, PSA, PPP, Disease, Porokeratosis, Medicine, Pharmaceutical industry

In addition, by week 24, over 80% and 60% of patients treated with sonelokimab achieved Psoriasis Area Severity Index (PASI) 90 and 100, respectively.

Key Points: 
  • In addition, by week 24, over 80% and 60% of patients treated with sonelokimab achieved Psoriasis Area Severity Index (PASI) 90 and 100, respectively.
  • Treatment with sonelokimab resulted in unprecedented improvements in composite scores that reflect responses in different domains simultaneously.
  • In all composite scores, sonelokimab showed 16-29 percentage point differences to the reference adalimumab arm, comparatively higher to competitors using the same reference arm.
  • The discontinuation rate of the second part of ARGO remained low at 5%, in line with other sonelokimab trials.

AMGEN PRESENTS NEW RESEARCH ON OTEZLA® (APREMILAST) AT AAD 2024

Retrieved on: 
Saturday, March 9, 2024
Pustulosis palmaris et plantaris, Psoriasis, CPU socket, Aes, Headache, Diarrhea, Amgen, Pain, Pediatrics, DLQI, Skin, Nausea, Vomiting, Queen's University, AMGN, AAD, Safety, University, FRCPC, University of Alberta, PASI, Dermatology Life Quality Index, Patient, PST, Scalp, Ageing, Abdominal pain, Poster, American Academy, Pharmaceutical industry

THOUSAND OAKS, Calif., March 9, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced new, 52-week results from the Phase 3 SPROUT study examining the use of Otezla® (apremilast) in children and adolescents aged 6 to 17 years with moderate to severe plaque psoriasis. These data, along with findings from a Phase 3 late-breaking study on Otezla in palmoplantar pustulosis, will be presented at the 2024 American Academy of Dermatology (AAD) Annual Meeting, March 8-12 in San Diego.                                     

Key Points: 
  • These data, along with findings from a Phase 3 late-breaking study on Otezla in palmoplantar pustulosis, will be presented at the 2024 American Academy of Dermatology (AAD) Annual Meeting, March 8-12 in San Diego.
  • "These data reflect Amgen's commitment to exploring new ways to treat inflammatory skin disease," said Ponda Motsepe-Ditshego, vice president, Global Medical, at Amgen.
  • Continued Otezla use resulted in sustained improvements in psoriasis severity and skin involvement in patients for up to one year.
  • Findings will be presented as a late-breaking oral presentation on Saturday, March 9 at 9:20 a.m. PST.

Surveying Equipment Market size is set to grow by USD 2.86 billion from 2022-2027, The growth of the UAV market to be a major trend - Technavio

Retrieved on: 
Tuesday, February 6, 2024
ADCP, Growth, Target Corporation, Thales Group, Hexagon AB, GIS, Teledyne Technologies, UCLASS, USD, Raytheon Technologies, GNSS, Challenge, Trimble Inc., Environmental science, Unmanned aerial vehicle, Total, Acquisition, Risk, PASI, Construction, UAV, GPS, Software, Calibration, Surveying

NEW YORK, Feb. 5, 2024 /PRNewswire/ -- The global surveying equipment market size is estimated to grow by USD 2.86 billion from 2022 to 2027, according to Technavio.

Key Points: 
  • NEW YORK, Feb. 5, 2024 /PRNewswire/ -- The global surveying equipment market size is estimated to grow by USD 2.86 billion from 2022 to 2027, according to Technavio.
  • A significant trend in the surveying equipment market is the increasing adoption of UAVs, particularly for civil applications, offering cost-effective and rapid geospatial data acquisition.
  • The Industrial Multiprotocol Gateways Market size is estimated to grow at a CAGR of 9.7% between 2022 and 2027.
  • The field devices calibration services market size is estimated to grow at a CAGR of 4.54% between 2022 and 2027.

Can-Fite: Top Scientific Journal Published Positive Data from the COMFORT-1 Phase III Psoriasis Study

Retrieved on: 
Monday, January 29, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Hope, Patient, CANF, European Medicines Agency, Science, EMA, Skin, Food, Journal, PASI, Safety, Inflammation, Psoriasis, FDA, BID, Pharmaceutical industry

EADV is a top ranked peer reviewed journal (impact factor 9.2) that publishes articles on clinical and basic science topics in dermatology.

Key Points: 
  • EADV is a top ranked peer reviewed journal (impact factor 9.2) that publishes articles on clinical and basic science topics in dermatology.
  • The EADV article presents the safety and efficacy of Piclidenoson in the randomized, placebo- and active-controlled, double-blind Phase III COMFORT-1 trial.
  • Piclidenoson’s efficacy continued to increase throughout the study period in a linear manner with an excellent safety and tolerability profile.
  • “We are very much encouraged by the excellent data in the first Phase III study demonstrating the significant effect of Piclidenoson in psoriasis,” stated Dr. Fishman, Can-Fite’s Chief Scientific Officer and Executive Chairman.

Accord BioPharma, Inc. Announces U.S. FDA Acceptance of Biologics License Application for Proposed STELARA® Biosimilar DMB-3115

Retrieved on: 
Thursday, January 4, 2024
Biology, Partnership, Food, Pegfilgrastim, Johnson & Johnson, Trastuzumab, Crohn's disease, FDA, Filgrastim, Ulcerative colitis, PASI, Intas Pharmaceuticals, Ustekinumab, Patient, Safety, Psoriasis, Medicine, BLA, Pharmaceutical industry

DURHAM, N.C., Jan. 4, 2024 /PRNewswire/ -- Accord BioPharma, Inc. the U.S. specialty division of Intas Pharmaceuticals Ltd. focused on development of oncology, immunology, and critical care therapies, announced today the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for DMB-3115. DMB-3115 is a proposed biosimilar to STELARA®, a blockbuster drug developed by Janssen Biotech, Inc. and approved for the treatment of plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. In the U.S., STELARA recorded $13.9 billion in sales (IQVIA Sales in 2022) and is one of the best-selling biologics.

Key Points: 
  • In the U.S., STELARA recorded $13.9 billion in sales (IQVIA Sales in 2022) and is one of the best-selling biologics.
  • The announcement of DMB-3115's BLA acceptance comes as Accord BioPharma awaits a string of additional regulatory milestones.
  • The company has submitted three separate Biologics License Applications to the FDA for biosimilar versions of trastuzumab, pegfilgrastim, and filgrastim.
  • Accord BioPharma is planning to introduce several additional biosimilars to the U.S. market during the next five years.

Human medicines European public assessment report (EPAR): Sotyktu, deucravacitinib, Date of authorisation: 24/03/2023, Revision: 1, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Janus, Patient, Medical Subject Headings, Marketing, Cytokine, Protein, Human, INN, Infection, ATC, Pharyngitis, International, Nose, Language, Mouth, CPU socket, Inflammation, JAK, European Medicines Agency, Lower respiratory tract infection, PASI, Tablet, Select, Cell, Diagnosis, Janus kinase, TYK2, Anatomy, IIA, Skin, Medical device

Human medicines European public assessment report (EPAR): Sotyktu, deucravacitinib, Date of authorisation: 24/03/2023, Revision: 1, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Sotyktu, deucravacitinib, Date of authorisation: 24/03/2023, Revision: 1, Status: Authorised

China Medical System: 4 Products Have Been Newly Included or Continued to be Included in the NRDL

Retrieved on: 
Wednesday, December 13, 2023
Marketing, Shanghai Stock Exchange, Quality of life, Epilepsy, A&B, Peptide, Absorption, National Healthcare, Methotrexate, National Healthcare Security Administration, Insurance, Safety, Tetrabenazine, Heart failure, CMS, Protein, Light, Recombinant, Acute decompensated heart failure, Sun Pharma, Nasal mucosa, PASI, Tablet, Patient, Psoriasis, Chemokine, Diazepam, Huntington's disease, Sale, Social Security, Tildrakizumab, Social, Vitamin E

China Medical System actively responds to national policies to promote innovative products to be included in the NRDL.

Key Points: 
  • China Medical System actively responds to national policies to promote innovative products to be included in the NRDL.
  • In addition, innovative drug Methotrexate Injection (Metoject) indicated for psoriasis approved in March 2023 has been included in category A of the National Reimbursement Drug List.
  • It is the first nasal spray formulation of diazepam in China and the first drug approved in China for the treatment of seizure clusters.
  • CMS actively responds to national policies to promote innovative products to be included in the National Reimbursement Drug List.