Dermatology

Samsung Bioepis Gains European Commission Approval For PYZCHIVA™, a Biosimilar to Stelara (Ustekinumab)

Retrieved on: 
Monday, April 22, 2024

INCHEON, Korea, April 22, 2024 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. today announced that the European Commission (EC) has granted marketing authorization for PYZCHIVA™, a biosimilar to Stelara1,2 (ustekinumab), paving the way for expanding its immunology portfolio.

Key Points: 
  • INCHEON, Korea, April 22, 2024 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. today announced that the European Commission (EC) has granted marketing authorization for PYZCHIVA™, a biosimilar to Stelara1,2 (ustekinumab), paving the way for expanding its immunology portfolio.
  • PYZCHIVA is approved for the treatment of certain autoimmune disorders in gastroenterology, dermatology and rheumatology.
  • “We are proud to have our fourth immunology biosimilar approved in Europe,” said Byoungin Jung, Vice President and Regulatory Affairs Team Leader, at Samsung Bioepis.
  • PYZCHIVA will be commercialized by Sandoz under Samsung Bioepis and Sandoz’s partnership.

Sandoz confirms European Commission approval of Pyzchiva® (ustekinumab), further strengthening immunology offering

Retrieved on: 
Monday, April 22, 2024

Pyzchiva® is a key biosimilar value driver for the company over the mid-term and this approval is a major step in advancing Sandoz growth strategy.

Key Points: 
  • Pyzchiva® is a key biosimilar value driver for the company over the mid-term and this approval is a major step in advancing Sandoz growth strategy.
  • This approval is a crucial step towards offering European patients an additional safe and effective treatment option and further demonstrates our commitment to pioneer access to potentially life-changing medicines."
  • Sandoz entered into a development and commercialization agreement for biosimilar ustekinumab with Samsung Bioepis in September 2023.
  • Under the terms of the agreement, Sandoz has the right to commercialize Pyzchiva® in the US, Canada, the European Economic Area (EEA), Switzerland, and the UK.

Southern California Clinic Signs Multi-Year Deal for MedMatrix AI Platform

Retrieved on: 
Tuesday, April 16, 2024

DISCC has been using the MedMatrix platform for several weeks to assess the potential demand in targeted geographic markets with data such as patient demographics, competition, facility costs, payor mix, and several other key factors.

Key Points: 
  • DISCC has been using the MedMatrix platform for several weeks to assess the potential demand in targeted geographic markets with data such as patient demographics, competition, facility costs, payor mix, and several other key factors.
  • With this multi-year contract, DISCC will expand the use of the MedMatrix platform for use in clinical operations optimization and revenue enhancement opportunities.
  • Pursuant to the agreement with DISCC, the Company will offer use of the MedMatrix AI Platform to DISCC for minimum fees of an average of $200 a month for one clinic during the term of the agreement.
  • “Converting beta customers like DISCC into long term revenue generating contracts is a significant validation for the MedMatrix platform,” said Trevor Vieweg, CEO of MedBright.

The United States FDA Awards Orphan Drug Designation (ODD) to NM5072 for Treating Paroxysmal Nocturnal Hemoglobinuria (PNH)

Retrieved on: 
Monday, April 15, 2024

The United States Food and Drug Administration (FDA) has awarded orphan drug designation (ODD) to NM5072 for the treatment of anemia in PNH patients.

Key Points: 
  • The United States Food and Drug Administration (FDA) has awarded orphan drug designation (ODD) to NM5072 for the treatment of anemia in PNH patients.
  • CLEVELAND, April 15, 2024 (GLOBE NEWSWIRE) -- NovelMed today announced that the Food and Drug Administration (FDA) has awarded Orphan Drug Designation (ODD) to NM5072, an Alternative Pathway (AP) blocker anti-Properdin antibody, for the treatment of patients with Paroxysmal Nocturnal Hemoglobinuria (PNH).
  • NM5072 is another drug in our pipeline that has received Orphan Drug Designation in the United States.
  • Among these, Paroxysmal Nocturnal Hemoglobinuria (PNH) emerges as a prominent indication for complement blockers heading towards FDA approval.

Innovaderm, Recognized by Clinical Leaders CRO Leadership Awards for the 4th Consecutive Year

Retrieved on: 
Wednesday, May 1, 2024

Innovaderm , the leading medical dermatology and aesthetics Contract Research Organization (CRO), today announced that it has been selected by Clinical Leaders CRO Leadership Awards for the fourth consecutive year, excelling across core categories of Expertise, Capabilities, Quality, and Reliability.

Key Points: 
  • Innovaderm , the leading medical dermatology and aesthetics Contract Research Organization (CRO), today announced that it has been selected by Clinical Leaders CRO Leadership Awards for the fourth consecutive year, excelling across core categories of Expertise, Capabilities, Quality, and Reliability.
  • Clinical Leaders CRO Leadership Awards, which include a collaboration with ISR Reports, provide readers with accurate and reliable customer feedback to assist them in choosing a reputable CRO partner.
  • “We are proud to be recognized by the CRO Leadership Awards for the 4th year running,” said Cedric Burg, COO at Innovaderm.
  • The CRO’s comprehensive approach includes full-service capabilities and stand-alone biometrics and clinical regulatory services across all phases of clinical trials.

AstraZeneca unveils latest research across key respiratory and immune-mediated diseases at ATS 2024 showcasing strength of its broad pipeline and portfolio

Retrieved on: 
Wednesday, May 1, 2024

In addition, we are also collaborating with AstraZeneca on AMG104/AZD8630, an inhaled anti-TSLP compound currently in development for asthma.

Key Points: 
  • In addition, we are also collaborating with AstraZeneca on AMG104/AZD8630, an inhaled anti-TSLP compound currently in development for asthma.
  • Respiratory & Immunology, part of BioPharmaceuticals, is one of AstraZeneca’s main disease areas and is a key growth driver for the Company.
  • With common pathways and underlying disease drivers across respiratory and immunology, AstraZeneca is following the science from chronic lung diseases to immunology-driven disease areas.
  • AstraZeneca’s ambition in Respiratory & Immunology is to achieve disease modification and durable remission for millions of patients worldwide.

Zoetis Announces First Quarter 2024 Results

Retrieved on: 
Thursday, May 2, 2024

Zoetis Inc. (NYSE:ZTS) today reported its financial results for the first quarter of 2024 and updated its guidance for full year 2024.

Key Points: 
  • Zoetis Inc. (NYSE:ZTS) today reported its financial results for the first quarter of 2024 and updated its guidance for full year 2024.
  • The company reported revenue of $2.2 billion for the first quarter of 2024, an increase of 10% compared with the first quarter of 2023.
  • On an operational1 basis, revenue for the first quarter of 2024 increased 12% compared with the first quarter of 2023.
  • Zoetis will host a webcast and conference call at 8:30 a.m. (ET) today, during which company executives will review first quarter 2024 results, discuss financial guidance and respond to questions from financial analysts.

Naples Soap Company to Launch New Sensitive Skincare Line for High Demand $41 Billion Market

Retrieved on: 
Tuesday, April 30, 2024

The Grow Beautii line is set to serve an unmet segment of the rapidly growing $41 billion global sensitive skin care products market.

Key Points: 
  • The Grow Beautii line is set to serve an unmet segment of the rapidly growing $41 billion global sensitive skin care products market.
  • View the full release here: https://www.businesswire.com/news/home/20240430706613/en/
    Grow Beautii, a new line of skin care products formulated and designed specifically for users with sensitive skin is slated to launch in the fourth quarter of 2024.
  • “Creating self care and beauty products for sensitive skin is in our DNA at Naples Soap Company.
  • This personal journey is what inspired me to create and grow my own skin care line,” said Deanna Wallin, Founder & CEO of Naples Soap Company.

The Transat CIC Started Yesterday: Alberto Bona and the Class40 IBSA in Fourth Position After 24 Hours of Navigation

Retrieved on: 
Monday, April 29, 2024

It was a conservative start for Alberto Bona on the Class40 IBSA, at his eighth regatta with the Swiss multinational pharmaceutical company.

Key Points: 
  • It was a conservative start for Alberto Bona on the Class40 IBSA, at his eighth regatta with the Swiss multinational pharmaceutical company.
  • The wind was found just before dawn today, when the first disturbance brushed the Class40s: Finally, the boats started running.
  • The best a solitary navigator could wish for.”
    Giorgio Pisani, Vice President IBSA Group and leader of the project Sailing into the Future.
  • In 2023, Bona and the Class40 IBSA participated in six regattas, including the Rolex Fastnet Race and the Transat Jacques Vabre.

The Transat CIC Started Yesterday: Alberto Bona and the Class40 IBSA in Fourth Position After 24 Hours of Navigation

Retrieved on: 
Monday, April 29, 2024

A conservative start for Alberto Bona on the Class40 IBSA, at his eighth regatta with the Swiss multinational pharmaceutical company.

Key Points: 
  • A conservative start for Alberto Bona on the Class40 IBSA, at his eighth regatta with the Swiss multinational pharmaceutical company.
  • The wind was found just before dawn today, when the first disturbance brushed the Class40s: finally the boats started running.
  • The best a solitary navigator could wish for.”
    Giorgio Pisani, Vice President IBSA Group and leader of the project Sailing into the Future.
  • In 2023, Bona and the Class40 IBSA participated in six regattas, including the Rolex Fastnet Race and the Transat Jacques Vabre.