Utah pausing use of rapid antigen tests at state sites

 The Utah Department of Health has announced it will pause its use of COVID-19 rapid antigen tests at state sites. 

In a statement on Monday, UDOH said that state-operated sites, including those run by mobile test teams, TestUtah and TourHealth, will start to offer at-home tests to residents who receive a PCR test but may also want to receive results faster. 

Residents who have received negative rapid tests from state-sponsored locations between Feb. 2 and Feb. 6 should consider returning to one of the sites and be retested with a PCR test, it said. Residents can request an at-home test kit at one of the sites as well. 

“Within the past few weeks, UDOH mobile test teams began using the GenBody rapid antigen test. These teams reported a trend of higher-than-expected negative results from this specific rapid antigen test. This prompted our analysis across a broader timeline and the results motivated our decision to temporarily pause the use of this test,” UDOH state epidemiologist Leisha Nolen said in a statement. 

“This step is necessary to ensure people receive accurate test results,” she added. 

UDOH epidemiologists analyzed test results from almost 18,000 residents who received both the GenBody rapid antigen and PCR tests on the same day, according to the statement. 

UDOH’s analysis also showed positive rapid tests were extremely reliable, meaning if someone tests positive on a rapid test, they do not need to question the result, the statement noted.

https://thehill.com/homenews/state-watch/593136-utah-pausing-use-of-rapid-antigen-tests-at-state-sites

Becerra eyeing bigger public role in wake of criticism

 Health and Human Services (HHS) Secretary Xavier Becerra is reportedly eyeing a more prominent public role following criticism that he’s been an “invisible” leader during the pandemic.

The White House announced Sunday that Becerra will travel to Minnesota with first lady Jill Biden later this week, while CNN reported that Becerra will also have a "substantive" meeting with President Biden and appearances at White House briefings, neither of which he has done since being sworn in 11 months ago.

Health experts and former officials told The Hill last month that Becerra has taken a back seat in the COVID-19 response, ceding his authority to others, including the White House and the Centers for Disease Control and Prevention.

Eric Topol, director of the Scripps Research Translational Institute, said last month that Becerra was seemingly absent “when we need that person the most.”

“Of all the HHS secretaries we’ve had, at least in the last multiple administrations, we’ve never had one that was a ghost when it came to a public health crisis,” Topol told The Hill. “That’s what we have now: an invisible HHS secretary.”

News outlets including NBC News and Politico also published stories featuring stinging criticism of the HHS secretary over the past two months.

Biden himself was disturbed by the critical coverage of Becerra, a former House member who also served as California’s attorney general, and called the secretary on Friday to say he was satisfied with his performance and had his back, CNN reported.

Critics have said confusing messaging and guidance from the administration on topics ranging from masks to booster shots to isolation time conveyed a lack of coordination that was partly due to Becerra’s low profile. 

Becerra acknowledged in an interview with CNN that the federal government's communications surrounding COVID-19 have been confusing.

"The American people don't have a lot of time to try to do the science and crunch the numbers," Becerra told the outlet. "They expect the experts to give them the answer." 

During his confirmation hearing, Republicans attempted to paint Becerra as unqualified for the job for having no background as a health professional.

Becerra’s spokesperson, Sarah Lovenheim, defended him last month, saying he is “tackling a wealth of issues, with COVID being the focus.” 

She added that Becerra “drives agency operations to support carrying out the mission, whether he’s coordinating our agencies to make booster doses accessible, authorizing the distribution of vaccines, or determining how to get masks in the hands of people in need of them.”

The Hill has reached out to HHS and the White House for comment on Becerra’s role.

https://thehill.com/policy/healthcare/593116-becerra-eyeing-bigger-public-role-in-wake-of-criticism-report

Dermata Therapeutics Shares Plunge: What Investors Need To Know

 Dermata Therapeutics Inc 

DRMA-35.6%+ Free Alerts

 has requested the FDA to waive the requirements to complete a 90-day dermal minipig study and a standard dermal pharmacokinetics study before the End of Phase 2 meeting for its DMT310 acne program. 

• The Company said it has already planned and budgeted to conduct both studies. The requests come as DMT310 has been used in clinical trials by over 170 patients exhibiting an acceptable safety and tolerability profile. 
• Further, the FDA approved the Company to use DMT310 in the Company’s ongoing 180-subject Phase 2 study for rosacea. 
• If the FDA grants the waiver request, the Company expects a cost savings of approximately $600,000 in development costs. 
• Alternatively, the FDA may waive the requirement to complete the 90-day dermal minipig study before the Phase 3 acne program but still require it to be completed before a New Drug Application submission.
• The Company has also submitted a request to waive the requirement to conduct the standard dermal pharmacokinetic study, based on the human tolerability and safety profile of DMT310 observed to date. 
• If the FDA grants both waiver requests, the Company plans to immediately request an End of Phase 2 meeting with the FDA and initiate the Phase 3 acne program in 2H of 2022. 
• Suppose the FDA grants the waiver request only for the standard dermal pharmacokinetic study or denies both waiver requests, the Company will start its Phase 3 program in 2023.

https://www.benzinga.com/general/biotech/22/02/25447689/dermata-therapeutics-shares-plunge-20-premarket-what-investors-need-to-know

Catalyst Sees FY22 Revenue Beat Consensus On Continued Recovery In Macroeconomy, Healthcare

 Catalyst Pharmaceuticals Inc 

CPRX+17.2%+ Free Alerts

 anticipates Q4 FY21 sales of approximately $38 million (consensus of $38.09 million), up roughly 24% Y/Y.

• For FY21 total revenues are estimated to be approximately $141 million, an increase of roughly 18% Y/Y, better than the consensus of $138.3 million.
• Last week, Catalyst announced that the District Court Judge in its case against the FDA had issued an order granting Catalyst Summary Judgment in its action against the FDA.
• As a consequence of that order, the FDA has invalidated Jacobus Pharmaceutical Company Inc's Ruzurgi approval for pediatric patients with Lambert-Eaton myasthenic syndrome. 
• The Company has ended the year with cash and investments of approximately $191 million, with no funded debt.
• Guidance: The Company forecasts FY22 sales of $195 million - $205 million, representing a 38%-45% Y/Y increase, compared to the consensus of $163.53 million.

https://www.benzinga.com/general/biotech/22/02/25449790/catalyst-pharma-expects-fy22-revenue-beat-consensus-on-continued-recovery-in-macroeconomic-health