Mundipharma

Cidara Therapeutics Provides Corporate Update and Reports Third Quarter 2023 Financial Results

Retrieved on: 
Thursday, November 2, 2023
Research, Medicare, Influenza, Treatment, European Directive on Traditional Herbal Medicinal Products, New Drug Application, Centers for Medicare & Medicaid Services, Fungal infection, Translation, DFC, CHMP, Committee for Medicinal Products for Human Use, CDTX, European Medicines Agency, Invasive candidiasis, EMA, Safety, CD73, Therapy, Patient, European Commission, ATM, Respect, Committee, Conference, NTAP, New Shrimadhopur DFC Station, Janssen Pharmaceuticals, Tavarua, FDA, IND, EC, Senior, Johnson & Johnson, CMS, SAN, Pharmaceutical industry, Vaccine, Cryptocurrency, Security (finance), Janssen, Mundipharma, Melinta Therapeutics

Nicole is a practicing oncology physician and joins us from Genentech/Roche where she has had substantial cancer-focused product development experience.

Key Points: 
  • Nicole is a practicing oncology physician and joins us from Genentech/Roche where she has had substantial cancer-focused product development experience.
  • Presented at IDWeek 2023: In September 2023, Cidara delivered an oral presentation and two poster presentations highlighting the safety and efficacy of CD388.
  • For the nine months ended September 30, 2023 and 2022, net loss was $17.3 million and $16.4 million, respectively.
  • During the three months ended September 30, 2023, Cidara did not sell shares of common stock pursuant to its at-the-market (ATM) sales agreement.

Cidara Therapeutics and Mundipharma receive positive CHMP opinion for rezafungin for the treatment of Invasive Candidiasis in adults(1)

Retrieved on: 
Friday, October 13, 2023
European, Infection, Restore, Committee for Medicinal Products for Human Use, CHMP, Fungal infection, European Medicines Agency, DFC, CDTX, Mortality, European Commission, Tavarua, Safety, Disease, EMA, Medical Mycology, FDA, Therapy, Phase, EC, Mycology, Committee, Immune system, SAN, News, Candidiasis, Civil service commission, Caspofungin, Patient, Medical device, Pharmaceutical industry, Vaccine, Mundipharma

A new treatment option for these serious infections is a much-needed addition.”

Key Points: 
  • A new treatment option for these serious infections is a much-needed addition.”
    “We would like to thank the CHMP for their careful consideration of the use of rezafungin.
  • This positive opinion represents an important step on the journey towards approval and brings us closer to providing clinicians with an alternative treatment option for invasive Candida infections, giving hope to patients battling this infection and their families,” said Brian Sheehan, Ph.D., Chief Scientific Officer at Mundipharma.
  • The CHMP’s positive opinion on rezafungin for the treatment of serious fungal infections, such as invasive candidiasis in adults, will be referred to the European Commission (EC), which will deliver a final decision in approximately two months.
  • Cidara Therapeutics has partnered with Mundipharma, which has commercial rights to rezafungin outside the U.S. and Japan.

Mundipharma and Cidara Therapeutics receive positive CHMP opinion for rezafungin for the treatment of Invasive Candidiasis in adults1

Retrieved on: 
Friday, October 13, 2023
Health, Infectious Diseases, Other Science, Clinical Trials, Science, Pharmaceutical, Biotechnology, European, Multimedia, Infection, Restore, Committee for Medicinal Products for Human Use, CHMP, Fungal infection, European Medicines Agency, CDTX, Mortality, European Commission, Safety, Disease, EMA, Medical Mycology, FDA, Therapy, Phase, EC, Mycology, Committee, News, Candidiasis, Civil service commission, Caspofungin, Patient, Vaccine, Pharmaceutical industry, Mundipharma

Mundipharma and Cidara Therapeutics (Nasdaq: CDTX) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for rezafungin (rezafungin acetate) for the treatment of invasive candidiasis in adults.1

Key Points: 
  • Mundipharma and Cidara Therapeutics (Nasdaq: CDTX) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for rezafungin (rezafungin acetate) for the treatment of invasive candidiasis in adults.1
    This press release features multimedia.
  • A new treatment option for these serious infections is a much-needed addition.”
    “We would like to thank the CHMP for their careful consideration of the use of rezafungin.
  • The CHMP’s positive opinion on rezafungin for the treatment of serious fungal infections, such as invasive candidiasisin adults, will be referred to the European Commission (EC), which will deliver a final decision in approximately two months.
  • Cidara Therapeutics has partnered with Mundipharma, which has commercial rights to rezafungin outside the U.S. and Japan.

Napp announces acceptance of their Rezafungin Marketing Authorisation Application for the Treatment of Invasive Candidiasis to the UK Medicines and Healthcare Products Regulatory Agency

Retrieved on: 
Wednesday, November 16, 2022
Health, Infectious Diseases, Hospitals, Clinical Trials, Pharmaceutical, Biotechnology, Caspofungin, Auris, Priority review, Cambridge Science Park, Candidiasis, Multimedia, CB4, Pivotal, European Medicines Agency, Safety, Disease, QIDP, Treatment, Hospital, MAA, New Drug Application, Integrity, MHRA, NDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Mortality, Community, Hope, Jean-Louis Vincent, EMA, FDA, European Commission, Therapy, NAPP, McNeil Consumer Healthcare, Fluconazole, The New England Journal of Medicine, Food, US Foods, Medicine, Mycosis, Heart, Pain management, Food and Drug Administration, Patient, Pharmaceutical industry, Medical imaging, Hospitality industry, EU, Restore, Fungemia, Napp, Mundipharma

Napp today announces that the MHRA has accepted a marketing authorisation application for rezafungin, a novel echinocandin in clinical development for the treatment of invasive candidiasis in adult patients.

Key Points: 
  • Napp today announces that the MHRA has accepted a marketing authorisation application for rezafungin, a novel echinocandin in clinical development for the treatment of invasive candidiasis in adult patients.
  • This trial provides evidence of efficacy and the safety profile of rezafungin as a potential treatment for candidemia and invasive candidiasis with a once-weekly dosing schedule.1
    This press release features multimedia.
  • In the ReSTORE trial, rezafungin met the primary endpoint for the European Medicines Agency (EMA) marketing authorisation application of global cure at Day 14.
  • 9 Cidara Therapeutics and Mundipharma Announce Positive Topline Results from the Global Phase 3 Pivotal ReSTORE Trial of Rezafungin for the Treatment of Candidemia and Invasive Candidiasis.

Cidara Therapeutics Provides Corporate Update and Reports Third Quarter 2022 Financial Results

Retrieved on: 
Thursday, November 3, 2022
File, Private Securities Litigation Reform Act, Research, Therapy, LLC, SAN, Food, EMA, Biotechnology, DFC (cipher), Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Fungemia, GLOBE, European Medicines Agency, Restore, FDA, Safety, Priority review, Pharmacokinetics, Adult, Conference, Securities Exchange Act of 1934, Tavarua, COVID-19, QIDP, Standard of care, Marketing, Income, Securities Act of 1933, NDA, U.S. Securities and Exchange Commission, PDUFA, New Drug Application, ID, Forward-looking statement, MAA, NASDAQ, Drug Quality and Security Act, Partnership, Security (finance), Candidiasis, Volunteering, Mycosis, Achievement, Patient, CDTX, Pharmaceutical industry, Vaccine, Medical device, Aquaculture, Janssen, Mundipharma, Melinta Therapeutics

SAN DIEGO, Nov. 03, 2022 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ: CDTX), a biotechnology company developing long-acting therapeutics designed to help improve the standard of care for patients facing serious diseases, today reported financial results for the third quarter ended September30, 2022 and provided an update on its corporate activities and product pipeline.

Key Points: 
  • SAN DIEGO, Nov. 03, 2022 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ: CDTX), a biotechnology company developing long-acting therapeutics designed to help improve the standard of care for patients facing serious diseases, today reported financial results for the third quarter ended September30, 2022 and provided an update on its corporate activities and product pipeline.
  • Announced license agreement with Melinta Therapeutics, LLC: In July 2022, Cidara announced it entered into a license agreement with Melinta Therapeutics, LLC (Melinta) under which Cidara has granted Melinta an exclusive license to commercialize rezafungin in the U.S.
  • Cidara retains the rights to rezafungin in Japan, while Mundipharma retains the commercial rights to rezafungin outside the U.S. and Japan.
  • Presented new data for rezafungin at IDWeek 2022: In October 2022, Cidara presented new clinical and preclinical data for rezafungin in six poster presentations at IDWeek 2022.

Cidara Therapeutics Receives $11.1 Million Milestone Payment from Mundipharma

Retrieved on: 
Tuesday, October 4, 2022
Melinta Therapeutics, Securities Act of 1933, Association, Securities Exchange Act of 1934, NASDAQ, Adult, Time, Respect, QIDP, Private Securities Litigation Reform Act, Drug Quality and Security Act, U.S. Securities and Exchange Commission, Fungemia, Restore, FDA, COVID-19, CDTX, MAA, Therapy, Safety, Biotechnology, Janssen, SAN, European Medicines Agency, Security (finance), Patient, Forward-looking statement, New Shrimadhopur DFC Station, EMA, Tavarua, Marketing, GLOBE, Mycosis, Pharmaceutical industry, Mundipharma, EU

SAN DIEGO, Oct. 04, 2022 (GLOBE NEWSWIRE) --  Cidara Therapeutics, Inc. (NASDAQ: CDTX), a biotechnology company developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases, today announced receipt of an $11 million milestone payment from Mundipharma under the licensing agreement established between the two companies in September 2019. The payment was made in association with the European Medicines Agency (EMA) acceptance of the marketing authorization application (MAA) for rezafungin for the treatment of candidemia and invasive candidiasis in adult patients.

Key Points: 
  • SAN DIEGO, Oct. 04, 2022 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ: CDTX), a biotechnology company developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases, today announced receipt of an $11 million milestone payment from Mundipharma under the licensing agreement established between the two companies in September 2019.
  • With the $11 million milestone payment from Mundipharma, Cidara remains eligible to receive additional non-dilutive capital of up to approximately $108 million in development and regulatory milestones from our existing partnerships based on successful completion of activities planned for the next two years, said Jeffrey Stein, Ph.D., President and Chief Executive Officer of Cidara.
  • Cidara retains the rights to rezafungin in Japan and has licensed the commercial rights to Melinta Therapeutics in the U.S. and Mundipharma Medical in all other geographies.
  • Cidara is developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases.

Veeva Vault RIM Driving Greater Speed and Compliance for More Than 350 Life Sciences Organizations

Retrieved on: 
Tuesday, October 4, 2022
Cloud, Chemistry, Vault, RIM, SEC, Industry, CMC, SOP, Publishing, Mundipharma, Form 10-Q, Professional corporation, Safety, Overalls, NYSE, Efficiency, Organization, Fine chemical, Bank, Risk management, Veeva Systems

PLEASANTON, Calif., Oct. 4, 2022 /PRNewswire/ -- Veeva Systems (NYSE: VEEV) today announced that more than 350 companies are transforming regulatory operations with Veeva Vault RIM Suite applications to speed execution and keep pace with evolving health authority requirements. A growing number of emerging biotechs are adopting Veeva regulatory applications, including more than 65 companies over the last year, to scale operations and simplify submission planning, development, publishing, and archiving.

Key Points: 
  • "The rate of change across requirements and regulatory environments calls for agile systems that can adapt quickly," said Marc Gabriel, vice president, Veeva Vault RIM.
  • Veeva Vault RIM has allowed us to consolidate data and documents from many different sources for greater visibility and efficiency," said Helen Donnelly, head of regulatory operations at Mundipharma.
  • The Vault RIM Suite includes Vault Registrations , Vault Submissions ,Vault Submissions Publishing, and Vault Submissions Archive for unified RIM capabilities on one cloud platform.
  • For more on Veeva Vault RIM Suite, visit: veeva.com/VaultRIM
    Connect with Veeva on LinkedIn: linkedin.com/company/veeva-systems
    Veeva is the global leader in cloud software for the life sciences industry.

Veeva Vault RIM Driving Greater Speed and Compliance for More Than 350 Life Sciences Organizations

Retrieved on: 
Tuesday, October 4, 2022
Cloud, Chemistry, Vault, RIM, SEC, Industry, CMC, Twitter, SOP, Publishing, Mundipharma, Professional corporation, Safety, Overalls, NYSE, Efficiency, Organization, Bank, Risk management, Pharmaceutical industry, Veeva Systems

BARCELONA, Spain, Oct. 4, 2022 /PRNewswire/ -- Veeva Systems (NYSE: VEEV) today announced that more than 350 companies are transforming regulatory operations with Veeva Vault RIM Suite applications to speed execution and keep pace with evolving health authority requirements. A growing number of emerging biotechs are adopting Veeva regulatory applications, including more than 65 companies over the last year, to scale operations and simplify submission planning, development, publishing, and archiving.

Key Points: 
  • "The rate of change across requirements and regulatory environments calls for agile systems that can adapt quickly," said Marc Gabriel, vice president, Veeva Vault RIM.
  • Veeva Vault RIM has allowed us to consolidate data and documents from many different sources for greater visibility and efficiency," said Helen Donnelly, head of regulatory operations at Mundipharma.
  • The Vault RIM Suite includes Vault Registrations , Vault Submissions ,Vault Submissions Publishing, and Vault Submissions Archive for unified RIM capabilities on one cloud platform.
  • For more on Veeva Vault RIM Suite, visit: veeva.com/eu/VaultRIM Connect with Veeva on LinkedIn: linkedin.com/company/veeva-systems Follow @veeva_eu on Twitter: twitter.com/veeva_eu
    Veeva is the global leader in cloud software for the life sciences industry.

European Medicines Agency Accepts Rezafungin Marketing Authorisation Application for the Treatment of Invasive Candidiasis

Retrieved on: 
Monday, August 22, 2022
Infectious Diseases, FDA, Marketing, Communications, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, Caspofungin, Mortality, European Medicines Agency, Treatment, EMA, NDA, Safety, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, View, Therapy, Prestige Consumer Healthcare, Candidiasis, Integrity, Disease, US Foods, QIDP, Heart, Global, MAA, New Drug Application, Hope, Food, Â, Hospital, Mycosis, Community, Medicine, Priority review, FDA, Pain management, Pivotal, Adult, Food and Drug Administration, The New England Journal of Medicine, Jean-Louis Vincent, European Commission, Patient, Pharmaceutical industry, Medical imaging, Restore, EU, Fungemia, Mundipharma

Mundipharma today announced that the European Medicines Agency (EMA) has accepted the marketing authorisation application (MAA) for rezafungin for the treatment of invasive candidiasis in adult patients.

Key Points: 
  • Mundipharma today announced that the European Medicines Agency (EMA) has accepted the marketing authorisation application (MAA) for rezafungin for the treatment of invasive candidiasis in adult patients.
  • Rezafungin, as a next generation echinocandin, represents the first advancement in the treatment of invasive Candida infections in a very long time.
  • We are pleased that the EMA has accepted our marketing authorisation application for rezafungin, and we look forward to working with the EMA to bring this medicine to patients.
  • 6 Cidara Therapeutics and Mundipharma Announce Positive Topline Results from the Global Phase 3 Pivotal ReSTORE Trial of Rezafungin for the Treatment of Candidemia and Invasive Candidiasis.

CENTOGENE Announces Appointment of Miguel Coego Rios as Chief Financial Officer

Retrieved on: 
Monday, June 27, 2022
Diagnosis, Patient, CEO, Shire (pharmaceutical company), Research, EMEA, Legislation, GLOBE, Core business, Growth, CFO, Company, Industry, U.S. Securities and Exchange Commission, Food, Security (finance), Lists of diseases, Nasdaq, General manager, SEC, Instability, Risk, Nature, Regulation of tobacco by the U.S. Food and Drug Administration, Interim, Neurodegeneration, Management, Pharmaceutical industry, Mundipharma

and ROSTOCK, Germany, and BERLIN, June 27, 2022 (GLOBE NEWSWIRE) -- Centogene N.V. (Nasdaq: CNTG), the commercial-stage, essential biodata life science partner for rare and neurodegenerative diseases, today announced the appointment of Miguel Coego Rios as Managing Director and Chief Financial Officer of the Company, effective June 22, 2022.

Key Points: 
  • and ROSTOCK, Germany, and BERLIN, June 27, 2022 (GLOBE NEWSWIRE) -- Centogene N.V. (Nasdaq: CNTG), the commercial-stage, essential biodata life science partner for rare and neurodegenerative diseases, today announced the appointment of Miguel Coego Rios as Managing Director and Chief Financial Officer of the Company, effective June 22, 2022.
  • Miguel Coego Riosstated, "I am excited to formally assume the position as CFO of CENTOGENE.
  • Mr. Coego Rios joined CENTOGENE as EVP Finance & Legal in February 2022 and served as Interim Chief Financial Officer as of April 1, 2022.
  • Prior to joining CENTOGENE, Mr. Coego was Vice President & General Manager South Europe at Orphazyme A/S, a late-stage clinical biotech.