United States Public Health Service

Cellenkos, Inc. Announces FDA Clearance of Investigational New Drug Application for CK0801 for Treatment-Resistant Guillain-Barré Syndrome

Retrieved on: 
Tuesday, October 16, 2018
Health, Clinical research, Food and Drug Administration, United States Public Health Service, Phases of clinical research, Immunosuppressants

Cellenkos submitted its IND application on September 11, 2018 and received approval on October 11, 2018.

Key Points: 
  • Cellenkos submitted its IND application on September 11, 2018 and received approval on October 11, 2018.
  • "The timely clearance of this IND and commencement of the Phase I trial will unlock the tremendous potential of cellular therapy application for neuro-inflammatory disorders.
  • Cellenkos also holds an approved FDA IND to proceed with a phase I study of CK0801 in bone marrow failure syndromes ( www.cellenkosinc.com ).
  • CK0801 will be manufactured in the Cellenkos FDA registered GMP facility located in Houston, Texas.

FDA Grants Coordination Pharmaceuticals IND Approval for CPI-100, a Novel Antitumor Nanomedicine

Retrieved on: 
Friday, October 5, 2018
Health, Pharmaceutical industry, Pharmaceuticals policy, Food and Drug Administration, United States Public Health Service, Communist Party of India, Medication, Pharmaceutical industry in China

"FDA's timely acceptance and approval of CPI-100 IND is an important milestone for the company.

Key Points: 
  • "FDA's timely acceptance and approval of CPI-100 IND is an important milestone for the company.
  • "We expect this study will generate important insights into the safety of CPI-100 and its preliminary therapeutic efficacy in cancer patients."
  • Coordination Pharmaceuticals, Inc. (CPI), is a privately held oncology drug development company that aims to address unmet medical needs and improve patient care.
  • This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995.

FDAnews Announces -- Quality Metrics Redux: Taking Advantage of FDA's Renewed Focus Webinar, Oct. 17, 2018

Retrieved on: 
Friday, October 5, 2018
Food and Drug Administration, United States Public Health Service, Health

FALLS CHURCH, Va., Oct. 05, 2018 /PRNewswire-PRWeb/ -- Quality Metrics Redux:

Key Points: 
  • FALLS CHURCH, Va., Oct. 05, 2018 /PRNewswire-PRWeb/ -- Quality Metrics Redux:
    Quality metrics A scary prospect?
  • After more than a year in regulatory limbo the FDA is breathing new life into its proposed quality metrics program.
  • It intends to use quality metrics to support its risk-based inspection planning with mandatory participation.
  • Previously he worked 15 years for Genentech, Syntex and SYVa in regulatory affairs, quality and manufacturing positions encompassing both drugs and devices.

MedISAO Enters MOU with the U.S. FDA and NH-ISAC

Retrieved on: 
Thursday, October 4, 2018
Security engineering, Cyberwarfare, Health, Food and Drug Administration, United States Public Health Service, Government, Computer security, Medical device

MedISAO, the FDA and NH-ISAC have a shared interest in encouraging the identification, mitigation, and prevention of cybersecurity threats to medical devices.

Key Points: 
  • MedISAO, the FDA and NH-ISAC have a shared interest in encouraging the identification, mitigation, and prevention of cybersecurity threats to medical devices.
  • MedISAO, in conjunction with the FDA and NH-ISAC, is working to create a community that encourages and supports the sharing of information regarding medical device cybersecurity vulnerabilities.
  • "The FDA has made it very clear that cybersecurity is a major concern," said Daniel Beard, Director, MedISAO.
  • MedISAO is a registered ISAO providing compliance with the FDA's recommendation in the Postmarket Management of Cybersecurity in Medical Devices.

FDAnews Announces Livestreaming for the 13th Annual FDA Inspections Summit, Oct. 23-25, 2018, Bethesda, MD

Retrieved on: 
Monday, October 1, 2018
Health, Pharmaceutical industry, Food and Drug Administration, Drug discovery, Clinical research, United States Public Health Service, Clinical trial

Drug and device makers and clinical trial operators flock to Washington each year for the FDA Inspections Summit.

Key Points: 
  • Drug and device makers and clinical trial operators flock to Washington each year for the FDA Inspections Summit.
  • Many people can't be in Washington in October due to deadlines, family, budgets, etc.
  • But there is no need to miss out, because there is an alternative.
  • The entire conference, including standout pre-conference workshops, is available in real time via livestreaming.

FDA Grants Profounda Inc. Competitive Generic Therapy (CGT) Designation for planned ANDA filing of Minocycline Hydrochloride Microspheres,1 mg

Retrieved on: 
Thursday, September 27, 2018
Health, Food and Drug Administration, Pharmaceuticals policy, Food law, United States Public Health Service, Federal Food, Drug, and Cosmetic Act, Minocycline

ORLANDO, Fla., Sept. 27, 2018 /PRNewswire/ -- Profounda, Inc. ("Profounda") announced today that it has received the US Food and Drug Administration's Competitive Generic Therapy (CGT) Designation for the planned future ANDA filing of Minocycline Hydrochloride Microspheres, 1 mg, pursuant to section 506H(b) of the FD&C Act.

Key Points: 
  • ORLANDO, Fla., Sept. 27, 2018 /PRNewswire/ -- Profounda, Inc. ("Profounda") announced today that it has received the US Food and Drug Administration's Competitive Generic Therapy (CGT) Designation for the planned future ANDA filing of Minocycline Hydrochloride Microspheres, 1 mg, pursuant to section 506H(b) of the FD&C Act.
  • The CGT program came into being following the FDA Reauthorization Act 2017 (FDARA) and is designed to reduce the number of review cycles that generic applications usually undergo.
  • A drug can qualify for CGT designation if there is no more than 1 approved drug in the active section of the FDA's Orange Book.
  • Brand sales for this drug exceed $150 Million USD and represent an exciting generic opportunity for the company.

2-Day Course: Ensuring Compliance with Advertising & Promotional Requirements for Drugs & Medical Devices (Boston, United States - November 1-2, 2018)

Retrieved on: 
Wednesday, September 19, 2018
Health, Food and Drug Administration, United States Public Health Service, Medical device, Food law, Pharmaceuticals policy

The "Ensuring Compliance with Advertising and Promotional Requirements for Drugs and Medical Devices" conference has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Ensuring Compliance with Advertising and Promotional Requirements for Drugs and Medical Devices" conference has been added to ResearchAndMarkets.com's offering.
  • This course will explore in detail what FDA requires of drug and device firms as well as recent current hot buttons in FDA enforcement activity for the advertising arena.
  • What's at stake if your advertising and promotional efforts violate the law?
  • Colossal fines - the latest was $3 Billion; criminal liability, including even prison time; and huge disruption in operations while dealing with federal probes into illegal marketing.

Leiters Announces New Repackaged Avastin® Under FDA 2018 Guidance

Retrieved on: 
Wednesday, September 19, 2018
Health, Biotechnology, Specialty drugs, Food and Drug Administration, Pharmaceutical industry, United States Public Health Service, Biologics license application, Bevacizumab, Biopharmaceutical

The 2018 final guidance sets forth FDA's policy regarding the mixing, diluting and repackaging of certain types of biologics outside an approved biologics license application (BLA), including the repackaging of Avastin.

Key Points: 
  • The 2018 final guidance sets forth FDA's policy regarding the mixing, diluting and repackaging of certain types of biologics outside an approved biologics license application (BLA), including the repackaging of Avastin.
  • In response to FDA guidance, Leiters launched an extensive development process to meet the elevated requirements governing the repackaging of Avastin.
  • "Because repackaged Avastin is used as an ophthalmic solution for injection, our development focused on meeting the more stringent requirements of USP CH ," said Chris Zuccarelli, Chief Operating Officer of Leiters.
  • "Leiters invested significant resources in developing the necessary manufacturing processes and testing methodology to comply with the latest FDA requirements for the repackaging of Avastin," said Leiters Chief Executive Officer Robin Smith Hoke.

WuXi Biologics' Chief Quality Officer Received Foreign Post Service Award from FDA

Retrieved on: 
Tuesday, September 18, 2018
Biotechnology, Health, Biology, Food and Drug Administration, United States Public Health Service, Pharmaceutical industry, Biopharmaceutical

SHANGHAI, Sept. 17, 2018 /PRNewswire/ -- WuXi Biologics (2269.HK), a leading global open-access biologics technology platform company offering end-to-end solutions for biologics discovery, development and manufacturing, today announced that Dr. Chiang Syin, Chief Quality Officer of WuXi Biologics, was honored with the "Foreign Post Service Award" for his contributions in the FDA China Office.

Key Points: 
  • SHANGHAI, Sept. 17, 2018 /PRNewswire/ -- WuXi Biologics (2269.HK), a leading global open-access biologics technology platform company offering end-to-end solutions for biologics discovery, development and manufacturing, today announced that Dr. Chiang Syin, Chief Quality Officer of WuXi Biologics, was honored with the "Foreign Post Service Award" for his contributions in the FDA China Office.
  • At the 58th Annual FDA Honor Awards Ceremony, Dr. Chiang Syin received the "Foreign Post Service Award" for his dedicated commitment, contributions, and personal sacrifice to furthering the FDA's mission in China.
  • "Congratulations to Dr. Syin on the 'Foreign Post Service Award'.
  • We believe Dr. Syin's rich experience in biologics quality and compliance will accelerate our path to build a world-class quality organization."

Power to Decide Urges Congress to Support Bipartisan Spending Bill That Funds Programs to Help Young People Plan Their Futures

Retrieved on: 
Saturday, September 15, 2018
Human development, Birth control in the United States, Title X, United States Public Health Service, Teenage pregnancy, The Phoenix Partnership, Ageing, Health

Specifically, the bill includes $101 million in funding for the evidence-based Teen Pregnancy Prevention (TPP) Program, and $286.5 million for the Title X Family Planning Program for FY 2019.

Key Points: 
  • Specifically, the bill includes $101 million in funding for the evidence-based Teen Pregnancy Prevention (TPP) Program, and $286.5 million for the Title X Family Planning Program for FY 2019.
  • The Senate and the U.S. of Representatives are expected to vote on the bill in the next couple of weeks.
  • In response, Ginny Ehrlich, Power to Decide, CEO issued the following statement:
    "We commend the members of Congress who worked hard to negotiate a spending package that maintains strong investments in the TPP Program and Title X.
  • We urge all members of Congress to support the bipartisan bill that will help ensure that all young people have the power to decide if, when, and under what circumstances to get pregnant."