CGMP

ROSEN, TOP RANKED INVESTOR COUNSEL, Encourages SCYNEXIS, Inc. Investors to Secure Counsel Before Important Deadline in Securities Class Action – SCYX

Retrieved on: 
Friday, November 24, 2023
Titan, Risk, Class, Court, CGMP, Tablet, Good manufacturing practice, Advertising

WHAT TO DO NEXT: To join the SCYNEXIS class action, go to https://rosenlegal.com/submit-form/?case_id=20281 or call Phillip Kim, Esq.

Key Points: 
  • WHAT TO DO NEXT: To join the SCYNEXIS class action, go to https://rosenlegal.com/submit-form/?case_id=20281 or call Phillip Kim, Esq.
  • The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation.
  • Rosen Law Firm has achieved the largest ever securities class action settlement against a Chinese Company.
  • 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017.

DEADLINE ALERT for HLLY, SCYX, LICY, and FMC: The Law Offices of Frank R. Cruz Reminds Investors of Class Actions on Behalf of Shareholders

Retrieved on: 
Wednesday, November 22, 2023
Suite, Risk, Complaint, CGMP, Law, FMC, COVID, DTC, Tablet, Good manufacturing practice, Investment, Growth, Defendant, Security (finance)

LOS ANGELES, Nov. 22, 2023 (GLOBE NEWSWIRE) -- The Law Offices of Frank R. Cruz reminds investors that class action lawsuits have been filed on behalf of shareholders of the following publicly-traded companies.

Key Points: 
  • LOS ANGELES, Nov. 22, 2023 (GLOBE NEWSWIRE) -- The Law Offices of Frank R. Cruz reminds investors that class action lawsuits have been filed on behalf of shareholders of the following publicly-traded companies.
  • Investors suffering losses on their investments are encouraged to contact The Law Offices of Frank R. Cruz to discuss their legal rights in these class actions at 310-914-5007 or by email to [email protected] .
  • This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.
  • The Law Offices of Frank R. Cruz, Los Angeles

SCYX STOCK NEWS: Investors with Significant Losses in Scynexis, Inc. Should Contact Robbins LLP for Information About the Scynexis, Inc. Class Action

Retrieved on: 
Tuesday, November 21, 2023
8-K, Fungal infection, Candidiasis, Risk, Biotechnology, LLP, FDA, GSK plc, Person, Complaint, CGMP, Incidence, SAN, News, Hypersensitivity, GSK, Allergy, Tablet, Good manufacturing practice, Patient

Scynexis is a biotechnology company that is primarily engaged in the development of ibrexafungerp, a broad-spectrum, intravenous (IV)/oral agent for fungal indications.

Key Points: 
  • Scynexis is a biotechnology company that is primarily engaged in the development of ibrexafungerp, a broad-spectrum, intravenous (IV)/oral agent for fungal indications.
  • For more information, submit a form , email Aaron Dumas, Jr., or give us a call at (800) 350-6003.
  • What Now: Similarly situated shareholders may be eligible to participate in the class action against Scynexis, Inc. Shareholders who want to act as lead plaintiff for the class should contact Robbins LLP.
  • A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.

SCYNEXIS ALERT: Bragar Eagel & Squire, P.C. Reminds Investors that a Class Action Lawsuit Has Been Filed Against SCYNEXIS, Inc. and Encourages Investors to Contact the Firm

Retrieved on: 
Monday, November 20, 2023
Telephone, Risk, FDA, Person, Court, CGMP, News, Hypersensitivity, Allergy, P.C, Tablet, Good manufacturing practice, Defendant, District court, Pharmaceutical industry

Investors have until January 8, 2024 to apply to the Court to be appointed as lead plaintiff in the lawsuit.

Key Points: 
  • Investors have until January 8, 2024 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
  • Click here to participate in the action.
  • On this news, the Company’s shares fell $1.13, or 34.14%, to close at $2.18 per share on September 25, 2023, on unusually heavy trading volume.
  • The complaint filed in this class action alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects.

Pluristyx Announces Major New Funding Round to Bolster Expansion Plans

Retrieved on: 
Thursday, December 21, 2023
Health, Stem Cells, Genetics, General Health, Research, Science, Biotechnology, IPSC, Broad, CGMP

Pluristyx, a leading provider of tools, technologies and services for the development of cell therapies, has today announced the closing of a major fundraising round led by BroadOak Capital Partners.

Key Points: 
  • Pluristyx, a leading provider of tools, technologies and services for the development of cell therapies, has today announced the closing of a major fundraising round led by BroadOak Capital Partners.
  • The oversubscribed funding round also featured participation from existing investors and key opinion leaders across the life sciences industry.
  • This infusion of capital enables Pluristyx to expand its existing cGMP cell line and service portfolio and broaden partner access to Pluristyx’s revolutionary panCELLa platform.
  • As part of the round, Pluristyx is pleased to announce the addition of two experienced life sciences executives, Bryan Poltilove and Jeffrey Allen, to the company as strategic advisors.

TruTag Technologies and Spinnaker Biosciences Partner on a New Targeted, Controlled Release Therapy for Age-Related Macular Degeneration

Retrieved on: 
Wednesday, December 20, 2023
Psi, Partnership, Risk, Infection, AMD, Injection, Porosity, Spinnaker, CGMP, Eye, Ranibizumab, Vance DeGeneres, Pharmaceutical industry

The Spinnaker therapy is a combination product that involves the loading of the biosimilar Ranibizumab into pSi particles.

Key Points: 
  • The Spinnaker therapy is a combination product that involves the loading of the biosimilar Ranibizumab into pSi particles.
  • The pSi utilized in the Spinnaker solution is highly-customized and has to meet precise porosity, pore size and elution specifications.
  • "TruTag Technologies is recognized as leaders in their field, and we are excited to be working with their team.
  • "Spinnaker's drug delivery technology has the potential to be a game-changer that vastly improves therapeutic effectiveness – said Barry McDonogh, CEO of TruTag Technologies.

Genevoyager Unveils Gene Therapy CDMO Facility in Milestone Move

Retrieved on: 
Wednesday, December 20, 2023
FDA, EMA, CDMO, CGMP, Lentivirus, NMPA, AAV, A-DNA, Patient, Potyvirus, Medical device

PHILADELPHIA, Dec. 20, 2023 /PRNewswire/ -- Genevoyager (Wuhan) Co., Ltd. (Genevoyager), a leading provider of one-stop CRO/CDMO services for gene therapy products, proudly announces the official opening of its Contract Development and Manufacturing Organization (CDMO) facility.

Key Points: 
  • PHILADELPHIA, Dec. 20, 2023 /PRNewswire/ -- Genevoyager (Wuhan) Co., Ltd. (Genevoyager), a leading provider of one-stop CRO/CDMO services for gene therapy products, proudly announces the official opening of its Contract Development and Manufacturing Organization (CDMO) facility.
  • This significant milestone marks a major leap forward in the company's commitment to advancing healthcare through innovative gene therapy solutions.
  • Spanning 68,000 square feet, the facility is purpose-built to facilitate the seamless development, manufacturing, and scaling of AAV gene therapy products.
  • With the operation of the facility, Genevoyager will provide development and manufacturing services for AAV, lentivirus, oncolytic viruses, and recombinant proteins.

2 Day Virtual Training Course on Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems

Retrieved on: 
Tuesday, December 19, 2023
Phase, RAC, CGMP, US FDA, MDR, Risk, CFR, Cosmetic, CAPA, FD, Medicine, FDA, QSR, RAPS, Complaint, Public, Safety, Medical device

DUBLIN, Dec. 19, 2023 /PRNewswire/ -- The "Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems" course has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, Dec. 19, 2023 /PRNewswire/ -- The "Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems" course has been added to ResearchAndMarkets.com's offering.
  • This formal postmarket surveillance is the active, systematic, scientifically valid collection, analysis, and interpretation of data or other information about a marketed device.
  • A more generalized "post market surveillance"/complaint handling is also a requirement under the device CGMPs, 21 CFR 820, -.100 - CAPA, and -.198 - Complaints.
  • "Postmarket Surveillance under Section 522 of the Federal Food, Drug, and Cosmetic Act", Guidance, dated October 2022
    21 CFR 822 - Implementing Sec.

SNP Therapeutics Launches Genate™: The First Gene-Guided Precision Nutrition Solution for the Prenatal Market

Retrieved on: 
Tuesday, December 19, 2023
Single-nucleotide polymorphism, Allergen, Pregnancy, Vitamin, Neuron, SNP, Woman, Mineral, FDA, B cell, Nutrient, Health, CGMP, Genetics, Doctor of Philosophy, Therapy, Test, Common, Mother, Essential, Dietary supplement

Genate Prenatal Nutrition will enable women to optimize their nutrition plan based on gene variants associated with nutrient metabolism.

Key Points: 
  • Genate Prenatal Nutrition will enable women to optimize their nutrition plan based on gene variants associated with nutrient metabolism.
  • "We developed Genate Prenatal Nutrition because nutritional needs during pregnancy can vary significantly from one woman to another," said Jon Kleu, CEO of SNP Therapeutics.
  • With the Genate Prenatal Genetic Test and new Genate nutrition line, women have powerful new tools to help them support their pregnancy nutrition plans."
  • Genate Nutrition starts with the Essential Prenatal Nutrition dietary supplement, designed to provide women with a comprehensive base formulation.

EQS-News: Rentschler Biopharma Announces Major Client Project for New U.S. Facility at Milford, MA Site

Retrieved on: 
Wednesday, December 20, 2023
Medicine, Business development, Senior, CGMP, Cancer, CDMO, Cryptocurrency, Fine chemical

Rentschler Biopharma Announces Major Client Project for New U.S.

Key Points: 
  • Rentschler Biopharma Announces Major Client Project for New U.S.
  • Rentschler Biopharma Announces Major Client Project for New U.S.
  • Facility at Milford, MA Site
    Laupheim, Germany and Milford, MA, USA, 20 December, 2023 – Rentschler Biopharma SE, a leading global contract development and manufacturing organization (CDMO) for biopharmaceuticals, today announced that the company has secured a major client for the new Rentschler Biopharma Manufacturing Center (RBMC) facility at its manufacturing site in Milford, Massachusetts.
  • The company, a long-standing client of Rentschler Biopharma in Germany, has contracted to have its product lead manufactured at the RBMC for clinical supply.