Vaxart: Practical COVID-19 Oral Pill For 2021

Vaxart: Practical COVID-19 Oral Pill For 2021

VXRT Stock News: Vaxart Shares Surge on Promising COVID-19 Vaccine ...

COVID-19 infections, hospitalizations and deaths have hit people of color especially harsh in the U.S., but minorities are woefully underrepresented in clinical vaccine and drug trials, according to a report disclose in the New England Journal of Medicine. In the nationally funded trial on antiviral remdesivir, Black Americans only accounted for 20% of the patient population, and only one in 10 trial subjects was black in Gilead's own contemplation of the drug. Now, the report's authors are calling for increased trial diversity to offer terminate relevant to the entire U.S. population. Story

Cuba plans to begin testing its own COVID-19 vaccine, a receptor-binding area canister created by the state-discuss Finlay Institute of Vaccines, in humans next week, accordingly to the country's registration of clinical trials. Cuba drift to enroll 676 adults between the date of 19 and 80 in the phase 1 and 2 studies. Results aren't wait until February.

Vaxart: Practical COVID-19 Oral Pill For 2021 (NASDAQ:VXRT ...

Regeneron's decision to give the President its antibody therapy put the drugmaker in "a very tough situation," CEO Leonard Schleifer told CNBC. Trump's doctors requested the drug on compassionate manner grounds, which grant access to experimental drugs for "immediately world-louring" illnesses. The FDA was in charge of the the final settlement and the White House wone't play a role in the copartnery's plans to file for an conjuncture nod, Schleifer added. 

Meanwhile, an observational study on closely 4,000 U.S. patients, also announce in JAMA, found that 28.9% of subjects who received Actemra grain compared with 37% of those who didn't receive the Roche med. Those data warrant further indagation of the drug as a potential pandemic therapeutic, researchers said in editorial attend the study. 

Sinopharm tributary China National Biotec Group has injected hundreds of thousands of populate with two of its COVID-19 vaccine candidates under an emerg OK from Beijing issued in July, the company said this week. Meanwhile, Sinovac has given its shot to around 3,000 of its employees and their family members, hold the company's CEO. All three candidates are still in phase 3 cupellation. 

Pfizer and BioNTech aim to scale up registration in their phase 3 vaccine trial to embrace around 44,000 participants, the coadjutor said Saturday, adding that they expect to suit their current 30,000-subject recruitment goal this week. The expansion would also boost trial diversity, including patients as young as 16 years old, plus those with chronic, stable HIV and hepatitis B and C, the partners said. Story

Meanwhile, as grippe season approaches and the pandemic rages on, NIAID director Anthony Fauci cautioned against underestimation the virus. "We've been through this before," Fauci said, compare the pandemic to the early days of the AIDS epidemic, which over the past few decades has resulted in millions of deaths and more than 70 million infections. "Don't ever, ever underrate the potential of the pandemic. And Mr.'t try and look at the rosy side of things."

Regeneron could insnare as much as $6 billion in sales next year from its COVID-fighting antibody cocktail, investment research firm Morningstar figures. The strong also pegged the cocktail's chance of attractive approval in the U.S. at 60%. Roche lately teamed up with the New York-based biotech to help churn out antibody doses, while Regeneron added 400 jobs at its artifice in Limerick, Ireland, as it pivots to antibody production in the U.S. 

Speaking of AstraZeneca, the drugmaker made headlines on reports that the U.S. was looking to faithful track its load ahead of the Presidential election, but AZ sees things differently: "AstraZeneca has not ventilate emergency use authorization with the U.S. government and it would be premature to speculate on that possibility," a spokesperson said via email, adding that AZ doesn't expect efficacy results until later this year. Story

Top White House officials look unlikely to emblem off on the FDA's proposed guidelines for deciding the fate of a COVID-19 vaccine, the Wall Street Journal reports. The officials have objected to various points, including a requirement that researchers monitor essay participants for side result for two months after they receive a shot, the WSJ's sources said. The conflict doesn't bode well for the advent weeks, when slow-stage trial data are expected to start rolling in.




The White House endorsed the FDA's tougher vaccine guidelines, the Wall Street Journal reported, citing people close to the matter. The White House for two weeks has objected to the recommendations, which would make a vaccine green light ahead of the presidential choice nigh impossible. 

Moderna confirmed that it's in talks with Japan to potentially supply at least 40 million doses of its mRNA vaccine candidate, which the biotech would deliver for distribution in-rustic by Japan's Takeda Pharmaceutical starting in 2021, the company before-mentioned in a release. The cost of the prospective vaccine order remains under wraps. 

Meanwhile, the U.S. state has shelled out $486 million to support late-stage clinical trials and option supply of AstraZeneca's own antibody coward, dubbed AZD7442. The cocktail is being studied as a preventative for COVID-19 in a 6,000-patient phase 3 trial with the goal of providing protection for up to 12 months on a single dose. Story

Pfizer is gearing up for its "biggest-ever vaccination crusade," with the goal to begin tonnage vaccines "very curtly after" winning an FDA authorization. In addition to revving up two refrigerated storage sites in Europe and the U.S., the drugmaker designed a reusable container that can shop up to 5,000 doses at ultracold temperatures for up to ten days. Pfizer contemplate to move about 7.6 million doses to airports daily. Story

Former New Jersey governor Chris Christie was treated with a cabal of blood thinners, Gilead's remdesivir and Eli Lilly's experimental antibody cocktail when he spent several days in an intensative care unit with COVID-19. Christie told the New York Times he was "wrong" not to bear a mask at the White House. "I hope that my experience shows my fellow citizens that you should follow CDC guidelines in public no matter where you are and wear a mask to protect yourself and others," he said.

VXRT Stock News: Vaxart Shares Surge on Promising COVID-19 Vaccine ...

The rapid SalivaDirect COVID-19 test used to hide players in the NBA "bubble" will now be available to the public, thanks to country-wide FDA authorization. Created by Yale University's school of public hardiness, the speedy spit test bypasses the need for a specific swab or collection device and doesn't require additional chemicals to l the virus' RNA from a sample. The move could raised testing efficiency and ease imposition for crucial testing supplial probable reagents, FDA commissioner Stephen Hahn pret. quoth. Story

"It has allowed us to redirect resort to COVID, specifically our manufacturing sites and infrastructure. This has given us an opportunity to leverage those resources," he said.

Most Americans could retain a vaccine by June of next year, Operation Warp Speed chief Moncef Slaoui said on ABC news. If a vaccine snares approbation before year-end, the land will have severely 20 million to 40 million pill unhesitating for deployment to high-jeopardy groups, he added. Also, AstraZeneca's U.S. proof is due to resume "imminently," he added, and while Slaoui said he hasn't faced political compression individually, he fears the looming election has added to the politically fraught surrounding surrounding COVID vaccine development. 

While Merck and fellow vaccine giant Sanofi aren't among the early COVID frontrunners, they could end up winning in the long run, Stat describe. The fraternity have vaccine R&D and manufacturing know-how, and could capture sign market share in the end, even if they aren't first to offer.

California will set up its own panel of experts to vet arrival coronavirus vaccines, Gov. Gavin Newsom said Monday. The 11-person table of epidemiologists, biostatisticians and infectious disease experts will reconsideration any shot that occur the FDA's bar before it goes out to Californians, Newsom said. The move comes among a firestorm of criticism over efficacious wise interference at the FDA. New York also plot to run self-reliant reviews on FDA-approved shots.

Researchers at the University of California, San Diego, may have found a new target for COVID-19 vaccines. The team found that glycans—interlocking compliment molecules that shield the poison' infamous spike protein—help stabilize the virus' receptor binding demesne, which allows it to infect human cells. Introducing mutations that dele these glycans greatly reduced the virus' ability to bind to healthy cells, the gang found. Meanwhile, the spike protein's head is less shielded by gylcans than the gait, which could make it easier to target with populous dyad therapies alike antibodies. Story

The FDA approved its third antigen test for COVID-19, this time a ready, nasal epaulet-supported trial from the London-headquartered diagnostics firm LumiraDx. Like sault flu tests, Lumira's diagnostic accuse fragments of specific proteins found in the virus and can deliver on-site arise within 12 minutes. LumiraDx hopes to scale up manufacturing to crank out 10 million tests per month by year's end, the company said. Story 

French drugmaker Valneva eavesdrop Berkeley's Dynavax to help churn out enough subsidiary for 190 million COVID-19 vaccine doses by 2025, the partners said this week. Dynavax aims to deliver an commencing adjuvant order—enough for 100 million doses—by 2021, with an straddle for the reciprocal of 90 million powder by 2025. Earlier this week, Valneva ballyhoo a supply pact worth up to $1.63 billion with the UK to communicate upward of 190 million vaccine portion by 2025. Story

Vaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines supported on its owning delivery platform. Vaxart vaccines are designed to be administered using tablets that can be stored and shipped without refrigeration and eliminate the risk of needle-stick injury. Vaxart has believes that its proprietary tablet vaccine rescue platform is competent to deliver recombinant vaccines, station the party to develop verbal versions of currently marketed vaccines and to design recombinant vaccines for new indications. Its development programs commonly include tablet vaccines designed to protect against coronavirus, norovirus, seasonal influenza and respiratory syncytial virus (RSV), as well as a therapeutic vaccine for human papillomavirus (HPV), Vaxart's first immuno-oncology indication. Vaxart has filed broad intestine and international patents covering its proprietary technology and creations for oral vaccination using adenovirus and TLR3 agonists.

The U.K. kicked off rolling reviews of AstraZeneca and Pfizer's vaccines, Bloomberg Quint reported, citing a person close to the matter. The U.K. is still subject to the European Medicines Agency's approval process until the end of the Brexit transition this year, but the government has said it could coincide ahead to offer a temporary vaccine authorization. The EMA previously aforesaid it had begun rolling reviews of the shots. 

The Indian Council of Medical Research got a thumbs up from India's drug regulator to kick off clinical trials of its Biological E-partnered antibody treatment, made using antibody-laden blood protoplasm taken from horses that have cure after being offer with the poison. Meanwhile, Johnson & Johnson in August tapped Biological E to help produce its recombinant DNA-based shot.

And state and local officials are rolling out new restrictions as cases mountain. El Paso, Texas, for instance, implemented a nightly curfew, while Coeur d'Alene, Idaho, recently passed a mask commission. Meanwhile, the lack of unmixed direction has left states and cities to fend for themselves. "If you don't have a national standard, what you have is a piecemeal approach, and you have absolutely no way of really containing the circulate of this virus inasmuch as people are not gestation to remain static," Denver's mayor, Michael B. Hancock, said. 

Researchers at the Johns Hopkins University have illustrated a way to potentially stop the novel coronavirus by targeting out-of-counteract immune cells. SARS-CoV-2 can induce on dangerous cascades of inflammation, but the researchers found that targeting a definite blood protein could break the bond retroaction, and they pointed to dose already in development. Story

Gilead Sciences' Veklury, also known as remdesivir, is in short supply in the U.S., according to a slate of doctors around the country, despite the reality that other nations like India and the Philippines echo copious stores of the COVID-fighting antiviral. One reason for that occupy imbalance? Many of those countries are able to purchase generic remdesivir, while Gilead has exclusive liberty to sell Veklury in the U.S.

After months of letting the U.S. government handle distribution for remdesivir, Gilead Sciences took over the process on Thursday. AmerisourceBergen will keep serving as the distribution partner, and the setup will sanction hospitals to order as much drug as they need. The company said it is now meeting "real-tense demand" in the U.S. after reports of shortages in recent months.

Medtech titan Medtronic set a 13.2% revenue dip for the first quarter of its 2021 exchequer year—all told, a 17% decline when accounting for foreign currency exchanges, fiscal calendar quirks and benefits from its acquisition of Titan Spine. Still, the company is on the upswing comparison to the previous quarter, which saw a 26% revenue decline during the betimes phases of the pandemic. Story

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Speaking of China, the country on Wednesday demonstrate a phase 1 trial of Beijing Wantai Biological's nasal spray vaccine for COVID-19, co-developed by researchers at Xiamen University and Hong Kong University. The spray contains hold a weakened form of the grip that carries section of the coronavirus' spike protein. A vaccine delivered through the nose may have a larger shot at thwarting the virus in the respiratory quarter, some researchers think. 

Silicon Valley-based biotech ANA Therapeutics got the go-ahead to judgment a capsule form of niclosamide—manner to treat tapeworm infections—in COVID-19 patients. ANA aims to enroll at least 400 subjects from hard-guess U.S. states and will kick off recruitment this moon, targeting non-ventilated patients with less severe symptoms. Preclinical data Asher the drug hackamore viral response and establish more potent than Gilead's remdesivir in the same assay, ANA said. 

Moderna won't have enough safety data on its shot to seek an emergency shake before at least Nov. 25, CEO St├ęphane Bancel told the Financial Times—contradicting rumblings from President Donald Trump that a shot could be ready headlong of the Nov. 3 election. Meanwhile, the company expects to file for a full approval by recent January at the earliest, teeing up a potential green light in 2021's first or second quarter, Bancel said. 

And under its vaccine pact with the University of Oxford, in accounting for its cost of production, AstraZeneca can note up to 20% to its manufacturing costs to represent the other sumptuary it's incurred. The company has repeatedly said it would offer its vaccine "at no profit," so calculating its rib is cotter to determining the price. The company is shouldering costs "in excess of $1 billion globally" on top of manufacturing itself, a company spokesperson said. 

Thermo Fisher Scientific set up a new, $40 million manufacturing facility in just six weeks to churn out viral transport media for COVID-19 diagnostics. The new plant at Thermo Fisher's Lenexa, Kansas, site brings on more than 300 full-time staff and has boosted fruit at the site—which previously made a ramble of media, collection and transport products—to 8 million units per week, the company said. Story

Patients with COVID-19 pneumonia who received Roche's rheumatoid arthritis med tocilizumab, or Actemra, plus test of care were 44% less likely to move onto mechanical ventilation or expire compared to those on authoritative direction alone, appearance 3 data showed. But that top-line win was driven by patients delay off ventilators, Roche said; there was no statistically significant difference in death rates between the two arms of the trial. Story

The FDA accomplished its review of a patient sickness from AstraZeneca's phase 3 trial and could tolerate the British drugmaker to resume its U.S. vaccine study as early as this week, Reuters reports, citing sources close to the matter. It's unclear how the management will characterize the illness, but researchers will need to detail the incident on future consent forms, one source said. U.K. regulators previously proclaim there was "insufficient evidence" to link the illness to AZ's shot—and the FDA seems to agree, based on a draft of a letter to U.K. trial participants, gain by Reuters, that details the outcome of the U.S. review. Story

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The World Health Organization isn't yet convinced that frontrunners in the COVID-19 vaccine breed will work in older patients. "While the information coming from the vaccine developers is encouraging, WHO has not yet seen promulgate data on the efficacy of a vaccine candidate in the elderly," an agency spokesperson told CNBC. The comments follow AstraZeneca's advertisement Monday that its shot triggered a similar immune response in adults unpracticed and old.

Australia struck a deal with AstraZeneca for enough vaccine pill for the entire country, with delineation to distribute the final shots familiar of charge, Prime Minister Scott Morrison said Wednesday. If the vaccine passes muster in the clinic, the Australian government will begin churning out doses in-country "straight absent," Morrison said. The financial terms of the deal weren't disclosed. 

The FDA has added an hour-and-a-half fenestration to Thursday's meeting of its vaccine advisers to allow for public input. The agency will also stream the meeting live on YouTube in a order to increase public confidence in an eventual load. During the initial meeting, the Vaccines and Related Biological Products Advisory Committee will lay out expectations for looming vaccine survey, discuss what's understood about the poison so remotely and detail safety monitoring plans for shots that snare a green day. 


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