Oncoheroes will fund and advance the clinical development of both dovitinib and stenoparib in pediatric cancers, utilizing Allarity’s DRP® companion diagnostics
Allarity has submitted a new drug application (NDA) for the U.S. approval of dovitinib in renal cell carcinoma (RCC) together with the Dovitinib-DRP® companion diagnostic
https://finance.yahoo.com/news/allarity-therapeutics-oncoheroes-biosciences-sign-130000918.html
The US Food and Drug Administration on Monday expanded the emergency use authorization for the Pfizer/BioNTech Covid-19 vaccine boosters for children ages 12 to 15.
The agency also shortened the time needed between an initial series of vaccine and a booster from at least six months after completion of an initial series to at least five months for everyone 12 and older.
Pfizer’s booster dose contains the same amount of the vaccine as the initial doses: 30 micrograms.
Adolescents in this age group became eligible to receive their initial series of the Pfizer/BioNTech Covid-19 vaccine in mid-May, opening vaccinations up to about 17 million additional people.
Now, about half of the populations aged 12 to 15 – about 8.7 million – is fully vaccinated, according to data from the US Centers for Disease Control and Prevention. About 5 million of them have been fully vaccinated for more than five months and are now eligible to receive a booster shot.
Children in this age group represent about 5% of the total US population. They account for about 4% of the fully vaccinated population in the US and about 3% of those eligible to receive a booster shot, according to the latest CDC data.
In October, the CDC recommended that everyone age 16 and up who completed their initial series of the Pfizer/BioNTech or Moderna vaccine at least six months ago receive a booster shot, along with those who received their initial Johnson & Johnson shot at least two months ago.
The FDA also authorized a third dose as part of the primary series for certain immunocompromised children ages 5 to 11, including those who have received an organ transplant.
Overall, about 68.8 million people are fully vaccinated and boosted against Covid-19. That’s less than half of the nearly 180 million people who are eligible to receive their booster shot and about a fifth of the total US population. And at least 69 million people ages 5 and up have not received their first dose of Covid-19 vaccine, according to the latest CDC data.
Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for the Company’s lead drug candidate, REQORSA™ Immunogene Therapy, in combination with Merck & Co’s Keytruda® in patients with histologically-confirmed unresectable stage III or IV non-small cell lung cancer (NSCLC) whose disease progressed after treatment with Keytruda. In the first quarter of 2022, Genprex expects to initiate its Acclaim-2 clinical trial, which is an open-label, multi-center Phase 1/2 clinical trial evaluating REQORSA in combination with Keytruda, for this patient population. The Company previously received its first FTD for REQORSA in combination with AstraZeneca PLC’s Tagrisso® in patients with histologically confirmed unresectable stage III or IV NSCLC, with EGFR mutations that progressed after treatment with Tagrisso.
https://finance.yahoo.com/news/genprex-receives-u-fda-fast-130000882.html
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
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 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.
