United States Public Health Service

Vivera Pharma CEO Exposes Questionable Practices of Importers of Fraudulent Chinese COVID-19 Tests

Friday, April 3, 2020 - 2:00pm

The Company takes the recent surge in fraudulent testing devices from China and elsewhere seriously.

Key Points: 
  • The Company takes the recent surge in fraudulent testing devices from China and elsewhere seriously.
  • Viveras tests are validated by extensive clinical data from its German manufacturing partners.
  • As opportunistic importers of cheaply-made testing devices take unfair advantage of rampant fear, the Food and Drug Administration (FDA) cannot move fast enough to shut them down.
  • FDA is not moving fast enough to approve legitimate tests, and this is allowing too many opportunities for Chinese tests to flood the market.

Novan Receives Verbal Guidance from FDA for SB206 and Announces Sato Program Advancement

Friday, April 3, 2020 - 1:15pm

The purpose of the meeting was to seek FDA feedback on the proposal to conduct one additional, well-controlled confirmatory study of SB206 to support a future New Drug Application (NDA).

Key Points: 
  • The purpose of the meeting was to seek FDA feedback on the proposal to conduct one additional, well-controlled confirmatory study of SB206 to support a future New Drug Application (NDA).
  • Based on guidance received during the meeting, the Company understands the FDA will consider one additional pivotal trial (B-SIMPLE4), if successful, to be supported by the previously completed B-SIMPLE2 trial.
  • In addition, the FDA provided guidance with regard to both the study design for B-SIMPLE4 and expectations for a future NDA submission.
  • Sato is a tremendously valuable business and development partner and we look forward to continued collaboration to progress the program.

BD, BioGX Announce FDA Emergency Use Authorization for New COVID-19 Diagnostic for Use in U.S.

Friday, April 3, 2020 - 11:59am

"We continue to work diligently on an antigen test for our point-of-care BD Veritor System that would complete a full portfolio of COVID-19 tests."

Key Points: 
  • "We continue to work diligently on an antigen test for our point-of-care BD Veritor System that would complete a full portfolio of COVID-19 tests."
  • The BioGX SARS-CoV-2 Reagents for the BD MAX System has not been cleared or approved by FDA.
  • The Sample-ReadyTM technology is at the core of all product offerings for Clinical, Food Safety, Pharma and Water Quality molecular testing.
  • BioGX B.V.'s 50+ molecular diagnostic products are marketed and sold in 100+ countries through its Global Distribution Network.

CytoDyn Files Request with FDA for Preliminary Meeting for Breakthrough Therapy Designation for Leronlimab in the Treatment of Cancer

Friday, April 3, 2020 - 11:15am

The FDA had previously granted Fast Track designation to leronlimab for the treatment of mTNBC.

Key Points: 
  • The FDA had previously granted Fast Track designation to leronlimab for the treatment of mTNBC.
  • Last month, the Company reported that the FDA had recommended such a meeting to provide preliminary advice prior to resubmission of a Breakthrough Therapy designation request.
  • Both types of cancer pose significant challenges for patients due to their aggressiveness and limited treatment options.
  • The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for deadly diseases.

Turning Point Brands Provides Update on PMTA Process and Business Trends

Thursday, April 2, 2020 - 1:00pm

We applaud the swift move by FDA to address the concerns of responsible manufacturers during these unprecedented and extraordinary times.

Key Points: 
  • We applaud the swift move by FDA to address the concerns of responsible manufacturers during these unprecedented and extraordinary times.
  • TPB does not expect the delay of the PMTA process to impact full year guidance provided on February 26, 2020.
  • As noted in that guidance, 2020 projections assume no upside from the PMTA process in 2020.
  • Louisville, Kentucky-based Turning Point Brands, Inc. (NYSE: TPB) is a leading U.S. provider of Other Tobacco Products.

Biomerica Signs Two Definitive Agreements with Mount Sinai Medical School in New York to Scale-up a Laboratory Version Serological Test for COVID-19 That Enables High-Volume Screenings in Labs

Thursday, April 2, 2020 - 12:38pm

Biomerica has extensive serological test development, scale-up and manufacturing capabilities and expertise.

Key Points: 
  • Biomerica has extensive serological test development, scale-up and manufacturing capabilities and expertise.
  • Biomerica will file for expedited clearance with the FDA under the new EUA process for this new test format.
  • Biomerica primarily focus is on Gastrointestinal and inflammatory Diseases where the Company has multiple diagnostic and therapeutic products in development.
  • Accordingly, such results may differ materially from those expressed in any forward-looking statements made by or on behalf of Biomerica.

Paratek Pharmaceuticals Announces Initiation of Funding from BARDA for All FDA Required Post-marketing Studies for NUZYRA• (omadacycline)

Thursday, April 2, 2020 - 1:00pm

In connection with the FDA approval of NUZYRA in October 2018, the FDA required that Paratek complete post-marketing pediatric studies examining the safety and efficacy of NUZYRA in children ages eight to 17 years.

Key Points: 
  • In connection with the FDA approval of NUZYRA in October 2018, the FDA required that Paratek complete post-marketing pediatric studies examining the safety and efficacy of NUZYRA in children ages eight to 17 years.
  • The FDA also required Paratek conduct an additional safety and efficacy study in adults with CABP.
  • Finally, the FDA required a fiveyear postmarketing bacterial surveillance study, which is mandatory for all newly approved antibiotics.
  • We are eager and well-prepared to conduct these studies, which will now be funded entirely through the BARDA Project BioShield public-private partnership award.

Forward Announces the Availability of COVID-19 Rapid Testing

Wednesday, April 1, 2020 - 6:04pm

Forward , the preventive primary care practice combining top rated doctors and advanced medical technology, today announces the availability of rapid blood testing to screen for COVID-19 at clinics and drive-through sites nationwide.

Key Points: 
  • Forward , the preventive primary care practice combining top rated doctors and advanced medical technology, today announces the availability of rapid blood testing to screen for COVID-19 at clinics and drive-through sites nationwide.
  • Per FDA guidance, Forward is not using these rapid serological tests as a sole means of understanding COVID-19 infection status.
  • Forward strives to offer the best possible options, and offering serological testing helps Forward stay proactive in the care of its members.
  • With the expansion into rapid testing, Forward furthers its mission of providing the best quality health care.

Venice Family Clinic Statement On Implementation Of Title X Regulations

Wednesday, April 1, 2020 - 2:10pm

Title X funds provide health care services to some 4 million low-income women nationwide.

Key Points: 
  • Title X funds provide health care services to some 4 million low-income women nationwide.
  • So if a woman finds herself choosing to terminate a pregnancy, these regulations require clinics receiving Title X funds to refer her to prenatal care.
  • "At Venice Family Clinic, we will continue to provide health care services previously funded by Title X.
  • Venice Family Clinic is a leader in providing comprehensive, high-quality primary health care to people living in poverty.

Acasti Pharma Submits FDA Meeting Request on Schedule, and FDA Meeting Expected in the Second Half of June

Wednesday, April 1, 2020 - 1:30pm

The meeting is intended to discuss TRILOGY 1 data, and gain alignment with the FDA on the interpretation of the results.

Key Points: 
  • The meeting is intended to discuss TRILOGY 1 data, and gain alignment with the FDA on the interpretation of the results.
  • As previously noted, upon submission of the meeting request, Acasti anticipates meeting with the FDA in the second half of June.
  • We believe the FDA meeting will provide essential guidance as we prepare to unblind and conduct the topline analysis of the TRILOGY 2 data.
  • We look forward to meeting with the FDA and providing further updates as they unfold.