Medac

UroGen Pharma Delivers Double Digit JELMYTO® Growth and Prepares for the Next Phase of the Company with on Track Rolling Submission of UGN-102

Retrieved on: 
Thursday, March 14, 2024
Oncology, Health, FDA, Clinical Trials, Pharmaceutical, Biotechnology, Research, Biopsy, Conference, Carcinoma, Chemistry, Webcast, New Drug Application, Medac, Patient, Mitomycins, NDA, CMC, Software, Safety, Nephrectomy, Patent, Medicare, Investment, RTW, ATLAS, Ureteroscopy, Gesellschaft mit beschränkter Haftung, Food, Pharmaceutical industry

The first part of the submission was the Chemistry, Manufacturing and Controls (CMC) sections.

Key Points: 
  • The first part of the submission was the Chemistry, Manufacturing and Controls (CMC) sections.
  • The FDA indicated that evaluation of duration of complete response at 12-months from the pivotal ENVISION trial will be sufficient to support submission of the NDA.
  • The company plans to complete the submission in September 2024 with a potential FDA decision as early as the first quarter of 2025.
  • Generated annual net product revenue of $82.7 million in 2023, compared with $64.4 million in 2022 in representing ~28% annual growth.

medac unveils new Global Corporate Brand

Retrieved on: 
Monday, March 11, 2024
Therapy, Medac, Health, Rheumatology, Urology, Hematology, Growth, Language, Organization, Pharmaceutical industry

After decades of impressive and successful growth, the company is now unveiling a new global brand to express the transformation as a global player and to extent global impact.

Key Points: 
  • After decades of impressive and successful growth, the company is now unveiling a new global brand to express the transformation as a global player and to extent global impact.
  • The newly established unified brand reflects medac’s commitment to excellence and its global reach, consolidating its position as a key player in the pharmaceutical industry.
  • With a new global brand positioning and design, the brand aims to pursue medac’s promises, such as customer proximity and high expertise.
  • The new brand identity is reflected in a new global corporate website, accessible at www.medac-group.com.

Eisai: Metoject Subcutaneous Injection Pen (Methotrexate) Pen-Type Autoinjector Approved in Japan

Retrieved on: 
Friday, February 16, 2024
Arthritis, Marketing, Eisai, MHLW, Skin, Gesellschaft mit beschränkter Haftung, Medac, Safety, Gemeinschaft and Gesellschaft, Rheumatoid arthritis, Patient, Pharmaceutical industry

TOKYO, Feb 16, 2024 - (JCN Newswire) - Eisai Co., Ltd. and nippon medac Co., Ltd., a subsidiary of medac Gesellschaft fur klinische Spezialpraparate mbH announced that they have obtained manufacturing and marketing approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for the additional formulation of Metoject Subcutaneous Injection for the anti-rheumatic agent, pen-type autoinjector "Metoject Subcutaneous Injection 7.5mg Pen 0.15mL, 10mg Pen 0.20mL, 12.5mg Pen 0.25mL and 15mg Pen 0.30mL" (methotrexate).

Key Points: 
  • TOKYO, Feb 16, 2024 - (JCN Newswire) - Eisai Co., Ltd. and nippon medac Co., Ltd., a subsidiary of medac Gesellschaft fur klinische Spezialpraparate mbH announced that they have obtained manufacturing and marketing approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for the additional formulation of Metoject Subcutaneous Injection for the anti-rheumatic agent, pen-type autoinjector "Metoject Subcutaneous Injection 7.5mg Pen 0.15mL, 10mg Pen 0.20mL, 12.5mg Pen 0.25mL and 15mg Pen 0.30mL" (methotrexate).
  • Based on the license agreement signed by Eisai and medac GmbH in May 2019, nippon medac will hold the marketing authorization of Metoject, while Eisai will be responsible for product distribution of Metoject in Japan.
  • This formulation incorporates the previously MHLW-approved Metoject Subcutaneous Injection pre-filled syringe formulation in a pen-type autoinjector and was developed to reduce the burden on patients and improve safety during self-injection.
  • The drug can be self-injected in two steps (1- removing the cap, 2- pressing the pen against the skin).

medac cooperates with Scienta Lab to generate new insights in rheumatology care with AI-powered solutions

Retrieved on: 
Tuesday, December 12, 2023
Research, Ekipa, Patient, Artificial intelligence, Rheumatology, Partnership, AI, Medac, Medical device

WEDEL, Germany, Dec. 12, 2023 /PRNewswire/ -- medac is breaking new ground and cooperating with Scienta Lab, an innovative AI company based in France.

Key Points: 
  • WEDEL, Germany, Dec. 12, 2023 /PRNewswire/ -- medac is breaking new ground and cooperating with Scienta Lab, an innovative AI company based in France.
  • medac has already underlined its commitment to new ideas and digital solutions by initiating the Ekipa Challenge "Innovate Rheumatology".
  • As part of this challenge, the company deepened the contact with Scienta Lab, a French company with expertise in AI and immunology.
  • This partnership demonstrates the commitment of medac to support a personalized therapy journey in rheumatology thanks to innovative solutions.

medac cooperates with Scienta Lab to generate new insights in rheumatology care with AI-powered solutions

Retrieved on: 
Tuesday, December 12, 2023
Research, Ekipa, Patient, Artificial intelligence, Rheumatology, Partnership, AI, Medac, Medical device

WEDEL, Germany, Dec. 12, 2023 /PRNewswire/ -- medac is breaking new ground and cooperating with Scienta Lab, an innovative AI company based in France.

Key Points: 
  • WEDEL, Germany, Dec. 12, 2023 /PRNewswire/ -- medac is breaking new ground and cooperating with Scienta Lab, an innovative AI company based in France.
  • medac has already underlined its commitment to new ideas and digital solutions by initiating the Ekipa Challenge "Innovate Rheumatology".
  • As part of this challenge, the company deepened the contact with Scienta Lab, a French company with expertise in AI and immunology.
  • This partnership demonstrates the commitment of medac to support a personalized therapy journey in rheumatology thanks to innovative solutions.

Medac GmbH Advances Pharmacovigilance Technology for Safety Monitoring of its Drugs with ArisGlobal Solutions

Retrieved on: 
Wednesday, September 13, 2023
Safety, Organization, Patient, Data, Triage, Hematology, Artificial intelligence, Urology, Pharmaceutical industry, Medac

BOSTON, Sept. 13, 2023 /PRNewswire/ -- ArisGlobal, a market-leader in global drug development technology solutions, announced today that medac, a German-based pharmaceutical manufacturer specializing in the fields of oncology and hematology, urology, and autoimmune diseases, has chosen LifeSphere Safety to modernize its drug safety processes. Precise, patient- and population-specific analysis is crucial for minimizing treatment risks for patients and thus supports the best possible treatment outcome. 

Key Points: 
  • BOSTON, Sept. 13, 2023 /PRNewswire/ -- ArisGlobal, a market-leader in global drug development technology solutions, announced today that medac, a German-based pharmaceutical manufacturer specializing in the fields of oncology and hematology, urology, and autoimmune diseases, has chosen LifeSphere Safety to modernize its drug safety processes.
  • "ArisGlobal's Safety solutions will significantly advance the automatization of adverse event management and intelligent safety analysis and will support us in making pharmacovigilance processes even smarter and more efficient," said Doctor Nadine Schreiber, Head of Global Pharmacovigilance of medac.
  • We are confident that medac will see incredible benefit to onboarding these solutions and positively impact safety analysis at scale."
  • Visit ArisGlobal at the 2023 World Drug Safety Congress Europe (Booth 19) and Americas (Booth 202) to learn more about LifeSphere Safety and Data & Analytics solutions.

Medac GmbH Advances Pharmacovigilance Technology for Safety Monitoring of its Drugs with ArisGlobal Solutions

Retrieved on: 
Wednesday, September 13, 2023
Safety, Organization, Patient, Data, Triage, Hematology, Artificial intelligence, Urology, Pharmaceutical industry, Medac

BOSTON, Sept. 13, 2023 /PRNewswire/ -- ArisGlobal, a market-leader in global drug development technology solutions, announced today that medac, a German-based pharmaceutical manufacturer specializing in the fields of oncology and hematology, urology, and autoimmune diseases, has chosen LifeSphere Safety to modernize its drug safety processes. Precise, patient- and population-specific analysis is crucial for minimizing treatment risks for patients and thus supports the best possible treatment outcome. 

Key Points: 
  • BOSTON, Sept. 13, 2023 /PRNewswire/ -- ArisGlobal, a market-leader in global drug development technology solutions, announced today that medac, a German-based pharmaceutical manufacturer specializing in the fields of oncology and hematology, urology, and autoimmune diseases, has chosen LifeSphere Safety to modernize its drug safety processes.
  • "ArisGlobal's Safety solutions will significantly advance the automatization of adverse event management and intelligent safety analysis and will support us in making pharmacovigilance processes even smarter and more efficient," said Doctor Nadine Schreiber, Head of Global Pharmacovigilance of medac.
  • We are confident that medac will see incredible benefit to onboarding these solutions and positively impact safety analysis at scale."
  • Visit ArisGlobal at the 2023 World Drug Safety Congress Europe (Booth 19) and Americas (Booth 202) to learn more about LifeSphere Safety and Data & Analytics solutions.

UnisLink Appoints Bryan Koch as Chief Operating Officer

Retrieved on: 
Tuesday, September 12, 2023
Physician, Medtronic, General partnership, Entrepreneurship, Medac, Riverside Partners, Video game

PHOENIX, Sept. 12, 2023 /PRNewswire/ -- UnisLink, a national leader in revenue cycle and population health management services for independent physician practices, has appointed seasoned revenue cycle executive, Bryan Koch, as COO.

Key Points: 
  • PHOENIX, Sept. 12, 2023 /PRNewswire/ -- UnisLink, a national leader in revenue cycle and population health management services for independent physician practices, has appointed seasoned revenue cycle executive, Bryan Koch, as COO.
  • Mr. Koch, an industry veteran, brings vast revenue cycle experience to help UnisLink's independent practice customers maximize their rightful revenue.
  • Prior to UnisLink, Mr. Koch spent several years at Medtronic, where he led revenue cycle operations for the diabetes division.
  • Mr. Koch remarked, "I am very excited to join an impressive team at UnisLink and build upon its differentiated technology and service.

Medexus Expects Record Revenue for Fiscal Q3 2023 and Provides Business Update

Retrieved on: 
Thursday, January 12, 2023
TSX, FDA, Maintenance, NDA, Marketing, Food, Patient, Clinical trial, Video game, Pharmaceutical industry, Fine chemical, Medac

TORONTO and CHICAGO, Jan. 12, 2023 (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals (Medexus) (TSX: MDP) (OTCQX: MEDXF) is pleased to announce preliminary estimates of the company’s revenue results for the fiscal quarter ended December 31, 2022 (the company’s fiscal Q3 2023) and provide additional business updates to shareholders and other stakeholders.

Key Points: 
  • TORONTO and CHICAGO, Jan. 12, 2023 (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals (Medexus) (TSX: MDP) (OTCQX: MEDXF) is pleased to announce preliminary estimates of the company’s revenue results for the fiscal quarter ended December 31, 2022 (the company’s fiscal Q3 2023) and provide additional business updates to shareholders and other stakeholders.
  • Medexus expects to deliver total revenue between $28.5 million and $29.0 million in fiscal Q3 2023.
  • This will represent another record quarter of revenue for Medexus, and a year-over-year increase of at least 34% and a quarter-over-quarter increase of at least 3%.
  • Primary drivers for the most recent quarter’s improved revenue performance were increases in net sales across Medexus’s portfolio.

Metoject Subcutaneous Injection Syringe (Methotrexate) Launched In Japan For Rheumatoid Arthritis

Retrieved on: 
Wednesday, November 16, 2022
Marketing, Gesellschaft mit beschränkter Haftung, Patient, Medac, MTX, Rheumatoid arthritis, Senior, Gemeinschaft and Gesellschaft, Safety, Pharmaceutical industry, Eisai, Methotrexate

TOKYO, Nov 16, 2022 - (JCN Newswire) - Eisai Co., Ltd. and nippon medac Co., Ltd., a subsidiary of medac Gesellschaft fur klinische Spezialpraparate mbH announced today that they have launched the anti-rheumatic agent "Metoject Subcutaneous Injection 7.5mg syringe 0.15mL, 10mg syringe 0.20mL, 12.5mg syringe 0.25mL and 15mg syringe 0.30mL" (methotrexate, "MTX") in Japan with the indication of rheumatoid arthritis.

Key Points: 
  • TOKYO, Nov 16, 2022 - (JCN Newswire) - Eisai Co., Ltd. and nippon medac Co., Ltd., a subsidiary of medac Gesellschaft fur klinische Spezialpraparate mbH announced today that they have launched the anti-rheumatic agent "Metoject Subcutaneous Injection 7.5mg syringe 0.15mL, 10mg syringe 0.20mL, 12.5mg syringe 0.25mL and 15mg syringe 0.30mL" (methotrexate, "MTX") in Japan with the indication of rheumatoid arthritis.
  • nippon medac obtained the manufacturing and marketing approval of Japan's first self-administrable subcutaneous injection formulation of MTX, a first line option for the treatment of rheumatoid arthritis, on September 26, 2022.
  • "Eisai has established a solid franchise and has extensive sales experience in the rheumatoid arthritis area in Japan.
  • It is also the first self-administrable MTX subcutaneous injection formulation for rheumatoid arthritis in Japan," said Hirohisa Iriyama, Representative Director and President of nippon medac.