United States Public Health Service

LiquiGlide Announces FDA Device Master File (MAF) for Its Breakthrough Technology to Enable Accelerated Development of Medical Devices

Tuesday, June 15, 2021 - 2:00pm

In addition, it can help reduce yield loss of high value medicines in the manufacturing and production process.

Key Points: 
  • In addition, it can help reduce yield loss of high value medicines in the manufacturing and production process.
  • "This MAF is an exciting accomplishment for LiquiGlide," said Dan Rippy, Executive Vice President and General Manager of LiquiGlide Biomedical.
  • We expect this MAF to be the first of many submissions that LiquiGlide Biomedical makes to the FDA."
  • To learn more about the LiquiGlide Device Master File, its contents, and discuss potential authorization for product registrations, please visit: https://liquiglide.com/industries/medical/ .

BioVaxys Receives Positive FDA Response For Pre-IND Review For CoviDTH Clinical Development

Monday, June 14, 2021 - 1:00pm

The FDA has stated that the Written Response will be available by July 23, 2021.

Key Points: 
  • The FDA has stated that the Written Response will be available by July 23, 2021.
  • BioVaxys submitted a Pre-IND meeting request and briefing package with the FDA's Center for Biologics Evaluation and Research (CBER) for CoviDTH in March of this year.
  • The FDA has the option to not grant a Pre-IND review for substantive reasons such as it being premature for the stage of product development or not providing an adequate basis for the review.
  • Kenneth Kovan, President and Chief Operating Officer of BioVaxys, stated "We are pleased that our Pre-IND submission package was successful in presenting the rationale for CoviDTH and our development plans.

BioVaxys Receives Positive FDA Response For Pre-IND Review For CoviDTH Clinical Development

Monday, June 14, 2021 - 1:00pm

The FDA has stated that the Written Response will be available by July 23, 2021.

Key Points: 
  • The FDA has stated that the Written Response will be available by July 23, 2021.
  • BioVaxys submitted a Pre-IND meeting request and briefing package with the FDA's Center for Biologics Evaluation and Research (CBER) for CoviDTH in March of this year.
  • The FDA has the option to not grant a Pre-IND review for substantive reasons such as it being premature for the stage of product development or not providing an adequate basis for the review.
  • Kenneth Kovan, President and Chief Operating Officer of BioVaxys, stated "We are pleased that our Pre-IND submission package was successful in presenting the rationale for CoviDTH and our development plans.

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

Saturday, June 12, 2021 - 4:00am

Investors have until June 18, 2021 to apply to the Court to be appointed as lead plaintiff in the lawsuit.

Key Points: 
  • Investors have until June 18, 2021 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
  • Acadia is a biopharmaceutical company that focuses on the development and commercialization of small molecule drugs that address unmet medical needs in central nervous system disorders.
  • Acadia advised that [t]he notification does not specify the deficiencies identified by the FDA and there has been no clarification by the FDA at this time.
  • The firm represents individual and institutional investors in commercial, securities, derivative, and other complex litigation in state and federal courts across the country.

2 Day Seminar on Coping with FDA Import Delays, including COVID-19, Expedited Imports and Detentions (August 12-13, 2021) - ResearchAndMarkets.com

Friday, June 11, 2021 - 1:53pm

The "Coping with FDA Import Delays, including COVID-19, Expedited Imports and Detentions" training has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Coping with FDA Import Delays, including COVID-19, Expedited Imports and Detentions" training has been added to ResearchAndMarkets.com's offering.
  • The FDA continues to change its import program to better manage new problems and to use new procedures to make the whole process easier.
  • The FDA and U.S. Customs and Border Protection (CBP) are relying more and more on computer programs to expedite the import process.
  • If you fail to correctly use new import procedures and programs, you will be operating under an expensive disadvantage.

Ensuring Success of NASH Trials: Best Practices for Optimizing Operations, Enrollment and Retention, Upcoming Webinar Hosted by Xtalks

Friday, June 11, 2021 - 1:30pm

With no Food and Drug Administration (FDA)-approved treatments available, patients confront a substantial unmet need.

Key Points: 
  • With no Food and Drug Administration (FDA)-approved treatments available, patients confront a substantial unmet need.
  • However, the prospects for drug development have begun to brighten as understanding of liver disease pathophysiology, diagnosis, epidemiology and natural history evolve at a remarkable pace.
  • For more information, or to register for this event, visit Ensuring Success of NASH Trials: Best Practices for Optimizing Operations, Enrollment and Retention.
  • Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community.

Oncology Analytics Releases Report on FDA's Q1 2021 Drug and Indications Approvals

Thursday, June 10, 2021 - 2:00pm

ATLANTA, June 10, 2021 /PRNewswire/ -- Oncology Analytics , a leading data analytics and technology-enabled service company purpose-built for oncology, has released its Q1 2021 quarterly report on the FDA's newly approved anti-cancer drugs and indications and noted a significant increase in approvals from the final quarter of 2020.

Key Points: 
  • ATLANTA, June 10, 2021 /PRNewswire/ -- Oncology Analytics , a leading data analytics and technology-enabled service company purpose-built for oncology, has released its Q1 2021 quarterly report on the FDA's newly approved anti-cancer drugs and indications and noted a significant increase in approvals from the final quarter of 2020.
  • The report also noted three new CAR-T cell indications that were approved in Q1 2021.
  • Other items of note covered in the Oncology Analytics' report include:
    The number of new FDA indications for both multiple myeloma and non-small cell lung cancer tripled from Q4 2020 to Q1 2021.
  • Oncology Analytics, Inc. provides health plans, providers, and patients with a data-driven, utilization management solution that delivers real-world, evidence-based analytics focused exclusively for oncology.

The Pediatric Research Equity Act (PREA) and Its Implications for Oncology Development, Upcoming Webinar Hosted by Xtalks

Thursday, June 10, 2021 - 1:30pm

It was amended by the FDA Reauthorization Act (FDARA) of 2017, in ways that have had a far-reaching impact on oncology drug developers.

Key Points: 
  • It was amended by the FDA Reauthorization Act (FDARA) of 2017, in ways that have had a far-reaching impact on oncology drug developers.
  • For more information, or to register for this event, visit The Pediatric Research Equity Act (PREA) and Its Implications for Oncology Development.
  • Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community.
  • Every year, thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.)

Ocugen to pursue a BLA path in the US for its COVID-19 vaccine candidate

Thursday, June 10, 2021 - 12:30pm

The FDA provided feedback to Ocugen regarding the Master File the Company had previously submitted and recommended that Ocugen pursue a BLA submission instead of an EUA application for its vaccine candidate and requested additional information and data.

Key Points: 
  • The FDA provided feedback to Ocugen regarding the Master File the Company had previously submitted and recommended that Ocugen pursue a BLA submission instead of an EUA application for its vaccine candidate and requested additional information and data.
  • Ocugen is in discussions with the FDA to understand the additional information required to support a BLA submission.
  • Although we were close to finalizing our EUA application for submission, we received a recommendation from the FDA to pursue a BLA path.
  • Ocugen recently announced that it secured exclusive rights to commercialize COVAXIN in Canada and has initiated discussions with Health Canada for regulatory approval.

The Law Offices of Frank R. Cruz Announces Investigation of AcelRx Pharmaceuticals, Inc. (ACRX) on Behalf of Investors

Wednesday, June 9, 2021 - 10:00pm

The Law Offices of Frank R. Cruz announces an investigation of AcelRx Pharmaceuticals, Inc. (AcelRx or the Company) (NASDAQ: ACRX ) on behalf of investors concerning the Companys possible violations of federal securities laws.

Key Points: 
  • The Law Offices of Frank R. Cruz announces an investigation of AcelRx Pharmaceuticals, Inc. (AcelRx or the Company) (NASDAQ: ACRX ) on behalf of investors concerning the Companys possible violations of federal securities laws.
  • AcelRx is a pharmaceutical company that develops therapies for the treatment of acute pain.
  • On February 16, 2021, AcelRx disclosed that it had received a warning letter from the FDA concerning promotional claims for DSUVIA.
  • This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.