Contract manufacturing organization

Pasithea Therapeutics Signs CMC Development and Manufacturing Agreement for the Production of PAS-004

Retrieved on: 
Wednesday, January 18, 2023
IND, API, Neurofibromatosis, Clinical trial, MEK inhibitor, CMC, CNS, MIAMI, NF1, FDA, Research, Central nervous system, Contract manufacturing organization, Wuxi, STA, Chemistry, KTTA, GMP, Pharmaceutical industry, Fine chemical

MIAMI BEACH, Fla., Jan. 18, 2023 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a biotechnology company focused on the discovery, research and development of innovative treatments for Central Nervous System (CNS) disorders, today announced its contract with WuXi STA, a subsidiary of WuXi AppTec, to manufacture the active pharmaceutical ingredient (“API”) for Pasithea’s macrocyclic, next-generation MEK Inhibitor, PAS-004 (formerly CIP-137401).

Key Points: 
  • WuXi STA is recognized as an industry leader in “end-to-end” chemistry, manufacturing, and controls (CMC) services, for both API and finished dosage forms, with extensive expertise and track record for meeting global quality standards.
  • “​We are delighted to be working with WuXi STA, one of the largest and most well-respected Contract, Development, and Manufacturing Organizations (CDMOs) in the world.
  • We remain on track with PAS-004 development and look forward to our IND submission followed by the initiation of our Phase 1 clinical trial,” commented Pasithea CEO, Dr. Tiago Reis Marques.
  • “WuXi STA has a proven track record of manufacturing success to FDA standards and we believe that their high-quality capabilities will support progression of our drug candidate into the clinic.

WuXi Biologics and GSK Enter into License Agreement on Multiple Novel Bi- & Multi-specific T Cell Engagers

Retrieved on: 
Thursday, January 5, 2023
Contract research organization, Contract manufacturing organization, Research, GSK, TAA, TCE, CD3, Patient, WuXi Biologics, HK, Therapy, Antibody, Senior, Pharmaceutical industry

SHANGHAI, Jan. 4, 2023 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.

Key Points: 
  • SHANGHAI, Jan. 4, 2023 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.
  • HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), today announced a license agreement with GSK plc (LSE/NYSE: GSK) under which GSK will have exclusive licenses for up to four bi- & multi-specific TCE antibodies developed using WuXi Biologics' proprietary technology platforms.
  • WuXi Biologics will receive a $40 million upfront payment and up to $1.46 billion in additional payments for research, development, regulatory and commercial milestones across the four TCE antibodies.
  • Dr. Chris Chen, CEO of WuXi Biologics, commented, "This license agreement with GSK represents an important validation of our potential best-in-class CD3 platform and WuXiBody® platform, the 'R' in our CRDMO business model.

WuXi Biologics and GSK Enter into License Agreement on Multiple Novel Bi- & Multi-specific T Cell Engagers

Retrieved on: 
Thursday, January 5, 2023
Contract research organization, Contract manufacturing organization, Research, GSK, TAA, TCE, CD3, Patient, WuXi Biologics, HK, Therapy, Antibody, Senior, Pharmaceutical industry

SHANGHAI, Jan. 5, 2023 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.

Key Points: 
  • SHANGHAI, Jan. 5, 2023 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.
  • HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), today announced a license agreement with GSK plc (LSE/NYSE: GSK) under which GSK will have exclusive licenses for up to four bi- & multi-specific TCE antibodies developed using WuXi Biologics' proprietary technology platforms.
  • WuXi Biologics will receive a $40 million upfront payment and up to $1.46 billion in additional payments for research, development, regulatory and commercial milestones across the four TCE antibodies.
  • Dr. Chris Chen, CEO of WuXi Biologics, commented, "This license agreement with GSK represents an important validation of our potential best-in-class CD3 platform and WuXiBody® platform, the 'R' in our CRDMO business model.

Vantage Hemp Co. Looks Ahead to 2023 After a Breakout Year in International Markets and New Industries

Retrieved on: 
Thursday, December 15, 2022
GMP, Health, Accreditation, Safety, Contract manufacturing organization, Growth, Vantage, Thought, United Kingdom, Partnership, Fine chemical, CBD

The Company developed the extraction and conversion process, and Psyched Wellness' tincture formulation including the flavor profile.

Key Points: 
  • The Company developed the extraction and conversion process, and Psyched Wellness' tincture formulation including the flavor profile.
  • Vantage plans to play a significant role in the flourishing revolution of plant-based wellness.
  • Vantage is dedicated to providing more businesses with extensive product capabilities, flexible manufacturing capacity, and high-quality products,” says Vantage Hemp Co.’s Chief Operating Officer, Deepank Utkhede.
  • With large-scale extraction facilities, Colorado-based Vantage Hemp Co. delivers pharmaceutical-grade GMP-compliant CBD extracts (including full-spectrum oil, distillate and isolate) that companies can trust.

WuXi STA and Multiply Labs Announce Partnership and Successfully Deploy Robotic Manufacturing System for Personalized Drugs

Retrieved on: 
Thursday, December 1, 2022
Data Management, Biotechnology, Technology, Manufacturing, Health, Pharmaceutical, Robotics, Artificial Intelligence, Internet, Machinery, Hardware, API, Contract research organization, Drug combination, Multiplication, CMC, Multimedia, Partnership, Patient, Wuxi, Capsule, Powder, MIT, Disease, GMP, Robotics, Automation, SVP, Precision medicine, Pharmaceutical Development and Technology, Contract manufacturing organization, Fine chemical, Development, STA

View the full release here: https://www.businesswire.com/news/home/20221201005249/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20221201005249/en/
    The Robotic Cluster in Wuxi City, China (Photo: Business Wire)
    The focus of the partnership is to enable the manufacturing of personalized drugs for patients.
  • The WuXi STA - Multiply Labs partnership addresses these challenges through the unique combination of robotic technology and drug product manufacturing expertise.
  • As part of the partnership, Multiply Labs has completed the deployment of a robotic system in WuXi STAs drug product manufacturing site in Wuxi city, China.
  • The manufacturing applications of the robotic system focuses on the development and GMP manufacturing of capsules with personalized doses.

CorMedix Inc. Reports Third Quarter 2022 Financial Results and Provides Business Update

Retrieved on: 
Thursday, November 10, 2022
GLOBE, Federal, Marketing, Investment, CMS, CMO, Contract, Nasdaq, Center, Hand, NTAP, Processor register, Contract manufacturing organization, Heparin, Hospital, Centers for Medicare & Medicaid Services, Company, Medicare, Patient, API, NDA, FDA, Medical device, Pharmaceutical industry, Fine chemical

The Companys target is to resubmit the DefenCath NDA by the end of the first quarter of 2023.

Key Points: 
  • The Companys target is to resubmit the DefenCath NDA by the end of the first quarter of 2023.
  • The lower net loss recognized during the third quarter of 2022 compared with 2021 was due to the net decrease in operating expenses.
  • Operating expenses in the third quarter of 2022 decreased approximately 19% to $7.0 million, compared with $8.6 million in the third quarter of 2021.
  • The management team of CorMedix will host a conference call and webcast today, November 10, 2022, at 8:30 AM Eastern Time, to discuss recent corporate developments and financial results.

Global Healthcare CMO Market Report 2022: Escalating Role of Artificial Intelligence Technology Presents Opportunities - ResearchAndMarkets.com

Retrieved on: 
Tuesday, November 8, 2022
Pharmaceutical, Health, Medical Devices, Organization, Medicine, ROW, Industry, Growth, Others, CAGR, CMOS, Contract, Medical device, Disease, Drug discovery, CMO, Drug development, COVID-19, US, Pharmacy, API, Health, Hospital, Contract manufacturing organization, Medication, Active ingredient, Cosmetics, AI, Safety, Technology, Time, Pharmaceutical industry

The global healthcare CMO market was valued at US$115.90 billion in 2021, and is predicted to grow to US$230.24 billion in 2027.

Key Points: 
  • The global healthcare CMO market was valued at US$115.90 billion in 2021, and is predicted to grow to US$230.24 billion in 2027.
  • The global healthcare CMO market is determined to grow at a CAGR of 12.12% over the forecasted period of 2022-2027.
  • By Region: In the report, the global healthcare CMO market is divided into four regions: North America, Europe, Asia Pacific, and ROW.
  • Trends: The market is projected to grow at a fast pace during the forecast period, due to escalating role of artificial intelligence technology and evolution of advanced respiratory equipment.

Avirmax CMC Inc. Received License for cGMP Gene Therapy Vector Production by the California Department of Public Health

Retrieved on: 
Monday, October 31, 2022
Bayer, HEK293, AAV, Founder CEO, CDMO, California Department, Knowledge, CEO, Sf9, Contract manufacturing organization, CGMP, BHK, Public health, Technology, Drug development, SUB, A-DNA, DNA, DVM, Rita Raave, Therapy, CHO, Vaccine, Fine chemical, San Francisco Bay Area, Genentech

The facility has received cGMP license approval by the California Department of Public Health (CDPH)-Food & Drug Branch, for the production of rAAV drug products for use in clinical investigations.

Key Points: 
  • The facility has received cGMP license approval by the California Department of Public Health (CDPH)-Food & Drug Branch, for the production of rAAV drug products for use in clinical investigations.
  • The new cGMP facility will support us to deliver high yield and quality vectors efficiently, timely and cost effectively
    The new 20,000 sq.ft.
  • Production scales at 50L, 200L and 1000L, are available to customers depending on their clinical trial size and dose requirements.
  • With our new facility, Avirmax CMC Inc. is able to deliver high yield and quality vectors efficiently, timely and cost effectively.

LAXAI Receives Investment from SIGNET Healthcare Partners

Retrieved on: 
Monday, October 24, 2022
Chemicals, Plastics, Health, Manufacturing, Research, Pharmaceutical, Science, Sheppard, Growth, GMP, St John's Innovation Centre, Drug development, Associate, Solicitor, Knowledge, Drug discovery, Contract research organization, Contract manufacturing organization, Signet, FDA, Solution, Fine chemical, EU

LAXAI Inc. (LAXAI) announced today that it has received a growth capital investment from SIGNET Healthcare Partners (SIGNET), a New York-based healthcare private equity firm.

Key Points: 
  • LAXAI Inc. (LAXAI) announced today that it has received a growth capital investment from SIGNET Healthcare Partners (SIGNET), a New York-based healthcare private equity firm.
  • This significant equity investment from SIGNET aims to provide LAXAI with a long-term, well-capitalized financial partner that will support LAXAIs growth strategy.
  • SIGNETs investment will enhance LAXAIs infrastructure and further augment operations to help our customers and partners maximize innovation and productivity.
  • As an active investor, SIGNET partners closely with its companies to build their value including facilitating activities between portfolio companies.

OraSure Technologies Receives $8.6 Million BARDA Contract to Develop 2nd Generation Ebola Test

Retrieved on: 
Wednesday, September 28, 2022
Health, Government, Development, Federal, Algorithm, De novo, Biomedical Advanced Research and Development Authority, Department, COVID-19, Center, Risk, FDA, Food, United States Department of Health and Human Services, BARDA, Administration, OraSure Technologies, HIV, Exemptions for hydraulic fracturing under United States federal law, Company, Antigen, Intellectual property, Forward-looking statement, Regulation of tobacco by the U.S. Food and Drug Administration, Automation, Technology, Human services, Public health, Solution, Uncertainty, Annual report, Coronavirus, NASDAQ, Korea Disease Control and Prevention Agency, Collection, Federation, Research, GLOBE, COVID-19 testing, SEC, Hospital, Patent, Disagreement, Informatics, Disease, Contract manufacturing organization, Chemistry, Medical device, Pharmaceutical industry, Diagnosis

BETHLEHEM, Pa., Sept. 28, 2022 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (NASDAQ: OSUR), a global leader in point-of-care and home diagnostic testing and sample collection technologies, announced today that the Biomedical Advanced Research and Development Authority (BARDA) has issued the Company an $8.6 million contract to develop a 2nd generation Ebola test on the OraQuick testing platform.

Key Points: 
  • BETHLEHEM, Pa., Sept. 28, 2022 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (NASDAQ: OSUR), a global leader in point-of-care and home diagnostic testing and sample collection technologies, announced today that the Biomedical Advanced Research and Development Authority (BARDA) has issued the Company an $8.6 million contract to develop a 2nd generation Ebola test on the OraQuick testing platform.
  • We are proud to partner with BARDA to develop a 2nd generation Ebola test and help prevent the spread of a disease which impacts some of our most vulnerable global communities, said Lisa Nibauer, President of Diagnostics for OraSure Technologies.
  • OraSures current OraQuick Ebola Rapid Antigen Test is de novo authorized for use with whole blood or cadaveric oral fluid.
  • The forward-looking statements are made as of the date of this press release and OraSure Technologies undertakes no duty to update these statements.