Search This Blog

Monday, January 3, 2022

Spero gets Priority Review for UTI med

 Spero Therapeutics, Inc. (Nasdaq: SPRO), today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review designation and confirmed the acceptance for substantive review of the New Drug Application (NDA) seeking approval for tebipenem HBr oral tablets for treatment in adult patients with complicated urinary tract infections (cUTI), including acute pyelonephritis, caused by susceptible microorganisms. Tebipenem HBr has been granted Qualified Infectious Disease Product (QIDP), Fast Track, and Priority Review designations for these cUTI indications. The Agency is planning to hold an Advisory Committee meeting to discuss this application and has also set a Prescription Drug User Fee Act (PDUFA) target action date of June 27, 2022.

https://finance.yahoo.com/news/spero-therapeutics-announces-fda-acceptance-130500833.html

Gottlieb: Omicron appears "milder strain" of COVID-19, but pediatric danger remains

 Former FDA commissioner Dr. Scott Gottlieb said Sunday that the Omicron variant appears to be a "milder strain" of COVID-19, but there still remains a danger to children. 

"There's a very clear, as I said, decoupling between cases and hospitalizations and does appear now based on a lot of experimental evidence that we've gotten just in the last two weeks, that this is a milder form of the coronavirus appears to be a more of an upper airway disease and a lower airway disease that's good for most Americans," Gottlieb said on "Face the Nation." "The one group that may be a problem is very young kids, very young children, toddlers who have trouble with upper airway infections, and you're in fact seeing more croup-like infections and bronchiolitis in New York City among children." 

Acting New York Health Commissioner Dr. Mary T. Bassett said last week that pediatric hospitalizations had risen 395% in New York City since the week ending December 11. 

According to the latest data from the American Academy of Pediatrics COVID-19 cases among children have been increasing throughout the month of December, with nearly 199,000 reported for the week that ended December 23, which made up more than 20% of all weekly reported case. Among the 24 states reporting, children ranged from 1.8%-4.1% of total hospitalizations, and 0.1%-1.8% of all pediatric COVID-19 cases resulted in hospitalization.  

Moving into the New Year, Gottlieb said the focus should be on the hospitalization rates and how many people are becoming severely ill. 

"There is a very clear decoupling between cases at this point in hospitalizations and ICU admissions. This does appear to be a milder strain of coronavirus and we also have a lot of immunity in the population," Gottlieb said. 

Gottlieb also noted that places that have been hard hit early by the Omicron variant, such as the mid-Atlantic, the Northeast, New England, Florida and parts of the Pacific Northwest, are as soon as "two weeks away from peaking, but the rest of the country probably faces a hard month ahead of us." Gottlieb predicted the country won't start to see a national peak until February, since there are parts of the country that haven't yet been hit by the Omicron variant.

Gottlieb said that at this point in the pandemic, cloth masks do not provide individuals with maximum protection against COVID-19 infection. 

"This is an airborne illness," Gottlieb said. "We now understand that, and a cloth mask is not going to protect you from a virus that spreads through airborne transmission. It could protect better through droplet transmission, something like the flu, but not something like this coronavirus." 

He said individuals who want the maximum amount of protection should seek to wear well N95 and KN95 masks as opposed to cloth and surgical masks. States like Connecticut and New York have already started to distribute high-quality masks to residents.

https://www.cbsnews.com/news/covid-omicron-variant-milder-strain-danger-gottlieb-face-the-nation/

Evotec Receives € 7.5 m Grant for Development of COVID-19 Therapeutic

 Evotec SE (Frankfurt Stock Exchange:EVT) MDAX/TecDAX, ISIN: DE0005664809 (NASDAQ:EVO) announced today that the Company has been selected by the German Federal Ministry of Education and Research ("BMBF") to receive a grant for the development of EVT075, a potential first-in-class immunomodulatory therapy against COVID-19. Evotec is one of three companies receiving a highly competitive grant as part of a new initiative by the BMBF to support the clinical development of novel therapeutic candidates against COVID-19.


Under the € 7.5 m grant, Evotec will use clinical material manufactured within its Just - Evotec Biologics manufacturing platform to initiate the clinical development of a potentially highly potent immunomodulatory molecule. Utilising the assays developed as part of the Company's global Pandemic Preparedness and Rapid Response initiative "PRROTECT", Evotec has demonstrated potent activity of the molecule in pre-clinical in-vitro studies. The molecule has shown great potential to produce a powerful antiviral response against infections with SARS-CoV-2 ("coronavirus"). By amplifying the immune response against coronavirus infections, the molecule can potentially reduce the viral load. Thus, the early administration of this biologic may significantly lower the risk of a severe progression of COVID-19 that requires hospitalisation of patients.

Evotec intends to use the grant to initiate clinical studies assessing the safety and efficacy of the compound and to determine the optimal dose-range in healthy volunteers as well as COVID-19 patients.

HGEN: Lenzilumab Treatment Response in Hospitalized COVID-19 Patients

 

  • Multi-variate analysis of LIVE-AIR Phase 3 data demonstrates that elevated baseline C-Reactive Protein ("CRP") is the most predictive feature for progression to invasive mechanical ventilation ("IMV") or death and may be a useful biomarker to guide therapeutic intervention

  • Patients with baseline CRP<150 mg/L who received lenzilumab had a more than 2.5-fold higher likelihood to survive without IMV than patients who received placebo (p<0.001)

  • Findings suggest hospitalized COVID-19 patients who are early in the hyper-immune response, with lower baseline CRP levels (CRP<150 mg/l), achieve even greater clinical benefit from lenzilumab treatment

Humanigen, Inc. (Nasdaq:HGEN) ("Humanigen"), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with its lead drug candidate, lenzilumab, announced that a manuscript detailing the results of an analysis of CRP levels from the LIVE-AIR Phase 3 study is available on medRxiv (https://www.medrxiv.org/content/10.1101/2021.12.30.21267140v1) . The results indicate the greatest clinical benefit of lenzilumab treatment may be achieved in hospitalized COVID-19 patients with lower baseline CRP levels, which typically occur earlier in the progression of the disease.

Ovid Therapeutics Expands Epilepsy Franchise

 

  • Exclusive license from AstraZeneca adds a unique candidate and a broad library of compounds to Ovid’s franchise of potential first-in-class anti-epileptic therapies

  • Collaboration with Dr. Stephen Moss, founder of Tufts Laboratory for Basic and Translational Neuroscience Research, and expert team in neuropharmacology

  • Transaction is the first business development activity that seeks to enhance Ovid’s pipeline of small-molecule and genetic CNS medicines

Applied Therapeutics to hold on submitting NDA for Galactosemia treatment

 Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today provided a regulatory update on the AT-007 Galactosemia program.

Following discussions with the FDA at the end of the year, the Company has decided to hold on submitting an NDA for AT-007 for treatment of Galactosemia pending additional discussions with the agency. Although the Galactosemia program had previously been discussed in the context of an NDA for Accelerated Approval based on reduction in galactitol, the FDA has now indicated that clinical outcomes data will likely be required for approval.

The ongoing ACTION-Galactosemia Kids Phase 3 study is evaluating the impact of AT-007 treatment vs. placebo on clinical outcomes over time, including cognition, speech, behavior and motor skills. Clinical outcomes are assessed every 6 months by a firewalled committee. The first assessment will be completed in the first quarter of 2022, and then every 6 months thereafter until the study reaches statistical significance.

“While disappointed by this change in direction by the FDA, we remain committed to bringing this important treatment to patients with Galactosemia,” said Shoshana Shendelman, PhD, CEO, Founder and Chair of the Board of Applied Therapeutics. “We will continue to work with the FDA to determine the most expeditious path forward to regulatory approval and will provide an update on timing and plans accordingly.”

https://finance.yahoo.com/news/applied-therapeutics-provides-regulatory-galactosemia-120000065.html

NRx Files Provisional Patent for Stable Aviptadil for Covid Lung Disease

 "In our previous guidance to investors, we advised that there were no filed patents protecting the manufacture of ZYESAMI. With the filing of this patent and the inventions described within, we at NRx believe we have a path to a long term commercial life for a stable and pharmaceutically active form of VIP as an innovative drug," said Prof Jonathan Javitt, MD, MPH, Chairman and CEO of NRx Pharmaceuticals. "Although, for obvious reasons, our initial focus has been the use of VIP in lung disease caused by COVID-19, we are now considering potential use of ZYESAMI in non COVID-related lung disease, liver disease, eye disease, and organ transplantation. We are deeply grateful to our partners at Nephron Pharmaceuticals for working with us and embracing the painstaking work required to bring a seventy-year-old dormant drug to life."

https://finance.yahoo.com/news/nrx-pharmaceuticals-files-provisional-patent-121600329.html