Evolutionary models of human drug use

Genixus Receives Federal Registration & State Licensing to Begin Production of KinetiX™ Ready-to-Administer (RTA) Syringe Platform for Acute and Critical Care Medicines

Retrieved on: 
Wednesday, August 3, 2022
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KANNAPOLIS, N.C., Aug. 3, 2022 /PRNewswire/ -- Genixus, a pharmaceutical company focused on transforming acute and critical care medicines, today announced that it has received both federal registration and state licensing to begin commercial production of its new KinetiX™ RTA Platform brand of pre-filled syringes. The company recently received federal 503B and Repackaging registration from the U.S. Food & Drug Administration under the Human Drug Outsourcing Facilities of the FD&C Act and Current Good Manufacturing Practices (CGMP), in addition to North Carolina Drug Manufacturing and Repackaging licensure.

Key Points: 
  • KANNAPOLIS, N.C., Aug. 3, 2022 /PRNewswire/ -- Genixus, a pharmaceutical company focused on transforming acute and critical care medicines, today announced that it has received both federal registration and state licensing to begin commercial production of its new KinetiX RTA Platform brand of pre-filled syringes.
  • The federal registration and state licensing at its state-of-the-art facility in Kannapolis, NC will enable Genixus to initiate commercialization of the KinetiX RTA Platform of pre-filled syringe medications beginning later this year.
  • Driven by quality, simplicity, and transparency, the KinetiX RTA Platform is designed to deliver clinical tools that seamlessly integrate into the acute and critical care setting.
  • Genixus is a development stage pharmaceutical manufacturer and FDA-registered outsourcing provider of high-quality easy-to-use ready-to-administer products for the acute and critical care setting.

Phathom Pharmaceuticals Reports Second Quarter 2022 Financial Results and Provides Business Updates

Retrieved on: 
Tuesday, August 2, 2022
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On May 4, 2022, Phathom announced the signing of a revenue interest financing agreement for up to $260 million of non-dilutive financing.

Key Points: 
  • On May 4, 2022, Phathom announced the signing of a revenue interest financing agreement for up to $260 million of non-dilutive financing.
  • Second Quarter 2022 Financial Results:
    Net loss for the second quarter ended June 30, 2022 was $50.9 million, compared to $36.6 million for second quarter 2021.
  • Second quarter 2022 net loss included a non-cash charge related to stock-based compensation of $5.9 million compared to the second quarter of 2021 non-cash charge related to stock-based compensation of $4.2 million.
  • Phathom Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of novel treatments for gastrointestinal diseases and disorders.

Leiters, a WCAS Portfolio Company, Joins the End Drug Shortages Alliance

Retrieved on: 
Wednesday, June 29, 2022
Health, FDA, East End Drugs, Patient, CEO, CGMP, Good manufacturing practice, FD, Evolutionary models of human drug use, Industry, Mayo Clinic, Organization, Quality of life, Alliance, IV, Hospital, Medical device, Pharmaceutical industry, Michael Leiter

The End Drug Shortages Alliance provides a forum for key stakeholders to take strategic aim at one of health care's more pressing and enduring issues, drug shortages that disrupt patient care.

Key Points: 
  • The End Drug Shortages Alliance provides a forum for key stakeholders to take strategic aim at one of health care's more pressing and enduring issues, drug shortages that disrupt patient care.
  • "Drug shortages impact the delivery of critical medicines and the delivery of patient care," said Robin Smith Hoke, President and CEO of Leiters.
  • "As a member of the alliance, we will work collaboratively across the supply chain to develop strategies to address factors that contribute to these shortages."
  • The End Drug Shortages Alliance was launched in late 2021 to bring together industry stakeholders, including providers, group purchasing organizations, manufacturers, distributors and other industry thought leaders and champions.

Memorial Hermann Health System Joins Existing Investors in Leiters, a 503B Outsourced Pharmaceutical Compounding Industry Leader

Retrieved on: 
Thursday, June 9, 2022
Leadership, WCAS, McGovern Medical School, IV, Hoke, Memorial Hermann Health System, EVP, Welsh, Carson, Anderson & Stowe, Novant Health, Investment, Good manufacturing practice, Physician, Accountable care organization, HEALTH, FDA, Patient, Hospital, Health, Evolutionary models of human drug use, CGMP, Memorial Hermann–Texas Medical Center, University of Texas Health Science Center at Houston, UNC Health Care, Mayo Clinic, FD, Management, Financial services, Healthcare, Greater Houston, Yechiel Leiter

Robin Smith Hoke, Leiters' President and Chief Executive Officer said, "We are very pleased to welcome Memorial Hermann to our team of health system investor partners.

Key Points: 
  • Robin Smith Hoke, Leiters' President and Chief Executive Officer said, "We are very pleased to welcome Memorial Hermann to our team of health system investor partners.
  • Memorial Hermann joins Leiters' existing health system investors including Intermountain Ventures, Kaiser Permanente Ventures, Mayo Clinic, Novant Health, Rex Health Ventures, Spectrum Health Ventures and UNC Health.
  • "As a non-profit, values-driven, community-owned health system, Memorial Hermann takes its dual roles of being a responsible financial steward and a trusted healthcare provider extremely seriously," said Feby Abraham, EVP and Chief Strategy Officer at Memorial Hermann Health System.
  • *Memorial Hermann Health System owns and operates 14 hospitals and has joint ventures with three other hospital facilities, including Memorial Hermann Surgical Hospital First Colony, Memorial Hermann Surgical Hospital Kingwood and Memorial Hermann Rehabilitation Hospital-Katy.

Leiters Announces Facility Acquisition to Increase Capacity, Accommodate Growth and Expand Portfolio

Retrieved on: 
Tuesday, February 8, 2022
Medicine, Investment, Company, Evolutionary models of human drug use, Ophthalmology, Welsh, General partnership, FDA, Patient, Compliance, CGMP, FD, CEO, Welsh, Carson, Anderson & Stowe, Good manufacturing practice, R, Acquisition, Pharmaceutical industry, Michael Leiter

The 110,000 square foot facility was previously used to manufacture prescription products, including sterile preparations.

Key Points: 
  • The 110,000 square foot facility was previously used to manufacture prescription products, including sterile preparations.
  • The former pharmaceutical company owner made considerable capital investments to expand and upgrade the facility, including manufacturing capabilities for injectables, R&D, and labs.
  • This second facility will meaningfully increase Leiters' manufacturing capacity, enable new product capabilities, and provide additional warehousing of sterile compounded preparations for the 503B market.
  • Leiters combines a highly experienced team, with robust automated processes, in a state-of-the-art outsourcing facility, to ensure delivery of the highest quality medicines.