Food and Drug Administration

MATEON ANNOUNCES COMPLETION OF ARTI-19 AND PUBLICATION OF POSITIVE INTERIM DATA

Retrieved on: 
Tuesday, February 2, 2021
Health sciences, Health, Clinical research, Drug discovery, Pharmaceutical industry, Food and Drug Administration, Medical research, Clinical trial, Design of experiments

Simultaneously, Mateon published positive interim data as preprint at https://www.medrxiv.org/content/10.1101/2021.01.24.21250418v1 .

Key Points: 
  • Simultaneously, Mateon published positive interim data as preprint at https://www.medrxiv.org/content/10.1101/2021.01.24.21250418v1 .
  • Ltd. (Windlas Biotech), and Abiogenesis Clinpharm Pvt Ltd, connected to the ARTI-19 clinical trial and who were key to the rapid completion of the ARTI-19 trial.
  • Upon completion of the final data analysis, we look forward to submitting our data package to regulatory authorities for Emergency Use Approval (EUA) in India and around the world, said Dr. Vuong Trieu, CEO and Chairman of Mateon.
  • When ARTIVeda / PulmoHeal was added to the standard of care (SOC), more patients recovered faster than SOC alone.

Cerecor Announces Fast Track Designation for CERC-803 for the Treatment of Leukocyte Adhesion Deficiency Type II

Retrieved on: 
Tuesday, February 2, 2021
Food and Drug Administration, Health sciences, Health care, Health, Fast track, Accelerated approval, Breakthrough therapy, Food and Drug Administration Safety and Innovation Act

We are excited to receive Fast Track Designation for CERC-803 to treat LAD-II, said H. Jeffrey Wilkins, MD, Chief Medical Officer of Cerecor.

Key Points: 
  • We are excited to receive Fast Track Designation for CERC-803 to treat LAD-II, said H. Jeffrey Wilkins, MD, Chief Medical Officer of Cerecor.
  • Fast Track Designation offers us broader access to the FDA and an expedited review process, giving us the potential for accelerated approval to bring a much-needed therapy for patients with LAD-II.
  • Fast Track Designation is granted to drugs being developed for the treatment of serious or life-threatening diseases or conditions where there is an unmet medical need.
  • Sponsors of drugs that receive Fast Track Designation have the opportunity for more frequent interactions with the FDA review team throughout the development program.

Eagle Pharmaceuticals Receives Additional FDA Questions Regarding Vasopressin; Court Date Set for July 7, 2021 in Vasopressin Trial

Retrieved on: 
Tuesday, February 2, 2021
Oncology, FDA, Health, Infectious diseases, Pharmaceutical, Biotechnology, Food and Drug Administration, United States Public Health Service

Eagle has now had two conversations with FDA regarding the CRL and will have an additional meeting with FDA within 30 days.

Key Points: 
  • Eagle has now had two conversations with FDA regarding the CRL and will have an additional meeting with FDA within 30 days.
  • Based on similar studies previously run on the Companys vasopressin product, Eagle expects the results will be satisfactory.
  • In other vasopressin news, the patent case against Endo Par Innovation Company, LLC is now scheduled to begin on July 7, 2021.
  • All forward-looking statements contained in this press release speak only as of the date on which they were made.

Pharnext Provides an Update on its Pivotal Clinical Development Program in Charcot-Marie-Tooth Disease Type 1A ('CMT1A')

Retrieved on: 
Monday, February 1, 2021
Communication, Forward-looking statement, FDA Special Protocol Assessment, Food and Drug Administration, Articles, Life sciences, Health

Pharnext has also applied for, and is interacting with the FDA regarding a Special Protocol Assessment ('SPA') for the PREMIER Phase III Trial.

Key Points: 
  • Pharnext has also applied for, and is interacting with the FDA regarding a Special Protocol Assessment ('SPA') for the PREMIER Phase III Trial.
  • Pharnext will be reporting top-line interim data on the safety and efficacy of PXT3003 collected so far from this open label study during Q2 2021.
  • The forward-looking statements contained in this press release are also subject to risks not yet known to Pharnext or not currently considered material by Pharnext.
  • Pharnext disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

Cirtec completes Device Master File (MAF) for their recent acquisition of the Nuvectra Algovita Spinal Cord Stimulation System

Retrieved on: 
Monday, February 1, 2021
Branches of biology, Neurotechnology, Medical technology, Biology, Medical devices, Electrotherapy, Neuromodulation, Neurophysiology, Neurostimulation, Food and Drug Administration, Implant

The System was an FDA and CE Mark approved neurostimulation system with no open field actions at the time of acquisition.

Key Points: 
  • The System was an FDA and CE Mark approved neurostimulation system with no open field actions at the time of acquisition.
  • The withdrawal of the PMA and subsequent creation of the Device Master File aligns with Cirtec's strategy to support Academic, Research and Commercial partners with design, development, and manufacturing of active implantable device.
  • Brian Highly, Cirtec CEO stated, "We are pleased to provide this technology to our neuromodulation development partners.
  • Having access to Cirtec's 'SIMPLIFI' clinical neurostimulation system and Master File can be leveraged to support physician-sponsored IDE studies that would otherwise not be possible."

Sesen Bio Announces Successful Application Orientation Meeting (AOM) with the FDA for Vicineum™

Retrieved on: 
Monday, February 1, 2021
Oncology, FDA, Health, Clinical trials, Pharmaceutical, Biotechnology, Food and Drug Administration, United States Public Health Service, Health, Vicineum™, Sesen Bio

The objectives of an Application Orientation Meeting include familiarizing the FDA with application datasets, discussing scientific aspects including clinical risk-benefit, and establishing early communication between applicants and the FDA.

Key Points: 
  • The objectives of an Application Orientation Meeting include familiarizing the FDA with application datasets, discussing scientific aspects including clinical risk-benefit, and establishing early communication between applicants and the FDA.
  • We are very pleased with the outcome of Fridays 90-minute meeting with the FDA, said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio.
  • We look forward to continuing to work with the FDA to expeditiously bring Vicineum to the market.
  • In December 2020, Sesen Bio completed the BLA submission for Vicineum to the FDA.

Zosano Pharma Announces NDA Resubmission Plans Following Type A Meeting with FDA

Retrieved on: 
Monday, February 1, 2021
Communication, Forward-looking statement, Food and Drug Administration, Articles

Based on feedback from the Type A meeting held with the Division, the company plans to conduct an additional pharmacokinetic (PK) study for inclusion in an NDA resubmission package.

Key Points: 
  • Based on feedback from the Type A meeting held with the Division, the company plans to conduct an additional pharmacokinetic (PK) study for inclusion in an NDA resubmission package.
  • During the meeting, the Division did not request that the company conduct any further clinical efficacy studies to support the resubmission.
  • The companys plans for resubmitting the NDA are based on the discussions between the company and the Division during the Type A meeting and may be subject to change upon receipt of the FDAs official meeting minutes from the Type A meeting.
  • All forward-looking statements are based on information currently available to Zosano and Zosano assumes no obligation to update any such forward-looking statements.

ADMA Biologics Receives FDA Approval for ADMA BioCenters Plasma Collection Facility in Knoxville, TN

Retrieved on: 
Monday, February 1, 2021
Life sciences, Medicine, Health sciences, Plasmapheresis, Transfusion medicine, Biopharmaceutical, Food and Drug Administration, Adma, Plasma

RAMSEY, N.J. and BOCA RATON, Fla. and KNOXVILLE, Tenn., Feb. 01, 2021 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ: ADMA) (ADMA), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, today announced that it has received U.S. Food and Drug Administration (FDA) approval for its ADMA BioCenters plasma collection facility located in Knoxville, Tennessee.

Key Points: 
  • RAMSEY, N.J. and BOCA RATON, Fla. and KNOXVILLE, Tenn., Feb. 01, 2021 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ: ADMA) (ADMA), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, today announced that it has received U.S. Food and Drug Administration (FDA) approval for its ADMA BioCenters plasma collection facility located in Knoxville, Tennessee.
  • This plasma collection facility commenced operations and initiated source plasma collection in the third quarter of 2020, and with todays approval, it is now FDA licensed to collect and introduce into interstate commerce human source plasma for further manufacturing in the U.S.
  • The approval of this plasma collection facility was received well-ahead of the scheduled FDA goal date.
  • ADMA BioCenters is an FDA licensed facility specializing in the collection of human plasma used to make special medications for the treatment and prevention of diseases.

Spectral Medical Appoints Dr. John Kellum as Chief Medical Officer

Retrieved on: 
Monday, February 1, 2021
Health sciences, Health, Kidney diseases, Medical device, Kellum, Acute kidney injury, Food and Drug Administration, Pharmaceutical industry

He will assume the full-time role of Chief Medical Officer at both Spectral and Dialco, where he will be responsible for leading all medical and scientific activities, clinical activities and scientific evaluation of all partnership opportunities.

Key Points: 
  • He will assume the full-time role of Chief Medical Officer at both Spectral and Dialco, where he will be responsible for leading all medical and scientific activities, clinical activities and scientific evaluation of all partnership opportunities.
  • Dr. Kellum is considered one of the leading critical care researchers and worlds foremost experts on blood purification and acute kidney injury (AKI).
  • In addition, Dr. Kellum has served as a consultant to the FDA, the Department of Defense, the medical device industry and the pharmaceutical sector.
  • I am very pleased to join the Spectral and Dialco teams, said Dr. John Kellum.

ANI Pharmaceuticals Announces Launch of Prazosin Hydrochloride (“HCl”) Capsules

Retrieved on: 
Monday, February 1, 2021
Biotechnology, FDA, Pharmaceutical, Health, Organic compounds, Chemical compounds, Anxiolytics, Furans, Guanidines, Prazosin, Quinazolines, Vasodilators, Food and Drug Administration, Functional groups, Prazosin HCl Capsules USP, ANI

ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced the launch of Prazosin HCl Capsules USP, 1mg and 2mg, following the U.S. Food and Drug Administrations (FDA) approval of the Companys prior approval supplement application (PAS).

Key Points: 
  • ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced the launch of Prazosin HCl Capsules USP, 1mg and 2mg, following the U.S. Food and Drug Administrations (FDA) approval of the Companys prior approval supplement application (PAS).
  • "Launch of Prazosin HCl is ANIs fourteenth re-commercialization of a previously discontinued abbreviated new drug application (ANDA) product.
  • Prazosin HCl Capsules are indicated for the treatment of hypertension, to lower blood pressure.
  • ANI Pharmaceuticals, Inc. is an integrated specialty pharmaceutical company developing, manufacturing, and marketing branded and generic prescription pharmaceuticals.