VBI Vaccines Inc. (Nasdaq: VBIV) announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for VBI-1901, VBI’s cancer vaccine immunotherapeutic candidate for the treatment of recurrent glioblastoma (GBM) patients with first tumor recurrence. Fast Track Designation facilitates the development and expedites the review of new therapies to treat serious conditions and fill an unmet medical need.
Tuesday, June 8, 2021
Pfizer COVID-19 vaccine trials in kids 5 and up begin
Seven-year-old Russell Bright squeezed his dad’s hand tightly as tests of Pfizer's COVID-19 vaccine started Monday in Louisiana for children ages 5 through 11.
Children held stuffed animals, played under chairs and a few cried at Ochsner Medical Center, just outside New Orleans. Their temperature and blood pressure were checked, their noses swabbed and their blood drawn for tests. Finally, they got a shot of either the vaccine or a placebo.
Ochsner is among 98 facilities in 26 states, the District of Columbia, Finland, Poland and Spain where the tests are taking place or planned.
Families won’t know for six months whether their children actually were vaccinated. At that point, children who didn't get the vaccine will have the chance to do so.
The Pfizer vaccine was approved May 10 for children aged 12-15.
Adam Bright, whose younger son Tucker, 5, also is participating, said it was worth the chance to be a part of the trial.
"I want to do my part and have my kids do their part," he said. "Both me and my wife are already vaccinated, and so the sooner I can get them vaccinated and to feel comfortable being outside, not having to wear a mask, I thought the easiest way to get it is to go through the trial."
Russell, wearing a Spiderman mask, said he longs for a summer vacation that can include the water park or a longer trip – and then school without masks and social distancing.
"I’m looking forward to seeing my friends more and not wearing masks," he said. "You can’t see if I’m making a frown or a smile. I don’t like to wear them."
June 7, 2021: From left, 7-year-old Russell Bright, 5-year-old Tucker Bright, and dad Adam Bright pose for a picture at Ochsner Medical Center in Jefferson, La. (AP Photo/Stacey Plaisance)
Five-year-old Kalil Chaudhry-Halperin held a stuffed toy Bruni — the lizard-like fire spirit in the movie Frozen 2 — as he waited at Ochsner.
He was shy and a bit nervous, but his dad, Jason Halperin, says Kalil was excited, because he knows his parents and his 12-year-old sister have all been vaccinated.
"You know how much we’ve all been through, our entire community, but now we have safe, effective, life-saving vaccines, and it not only helps him but the entire community and anyone vulnerable around our family," Jason Halperin said. "That’s a great lesson to impart to our children."
Adam Bright said he’s confident the Pfizer vaccine is safe, especially after seeing how smoothly vaccinations seem to be going for the next age group up.
Russell said he hopes that if and when the vaccine is cleared for emergency use for kids his age, they'll take advantage of the chance.
"Be brave and do it," he said.
https://www.foxnews.com/health/covid-19-vaccine-trials-begin-kids-5-up
Inovio expands partnership with Advaccine for COVID-19 vaccine study
Inovio Pharmaceuticals Inc on Tuesday expanded its partnership with Advaccine Biopharmaceuticals to conduct a late-stage trial of its COVID-19 vaccine candidate, expected to start in the summer.
Inovio and Advaccine had entered into an agreement in January, under which Advaccine gained the exclusive right to develop and market the DNA vaccine, INO-4800, within Greater China. https://bit.ly/2TbavG8
Under the expanded deal, the companies expect to equally share the total cost of the late-stage trial, expected to be about $100 million, Inovio said.
Advaccine will also get rights to additional Asian countries outside of Greater China.
Inovio has fallen behind rivals in the race to develop a COVID-19 vaccine after the U.S. health regulator last year put the Phase 3 portion of its mid-to-late stage trial on hold for more information on the device used to deliver the vaccine candidate into skin cells.
The company said the potential vaccine, INO-4800, will be tested among those who are 18 years and older across several countries, mainly in Latin America and Asia.
https://finance.yahoo.com/news/1-inovio-expands-partnership-advaccine-123025577.html
Monday, June 7, 2021
Ontario to loosen COVID-19 restrictions starting June 11, ahead of initial schedule
Ontario will loosen COVID-19 restrictions starting June 11, three days ahead of schedule, Premier Doug Ford announced on Monday.
The province will enter step one of its reopening plan, allowing non-essential retail to operate at 15% capacity, outdoor dining with a maximum of four people per table, and outdoor gatherings of up to 10 people to take place.
Taiwan mayor says too early to say if tech hub safe from COVID spike
It is still too early to say whether the major chip companies that operate in Taiwan's tech hub of Hsinchu will be safe from the latest increase in COVID-19 infections, its mayor said, though chip giant TSMC said it had seen no impact so far.
After months of relative safety, Taiwan is dealing with a rise in domestic infections, which have since last week begun impacting a small number of tech firms in Miaoli, the town adjacent to Hsinchu, including chip test and packaging firm King Yuan Electronics and semiconductor equipment provider Foxsemicon Integrated Technology.
Taiwan is a major producer of semiconductors and is central to global efforts to resolve a chip shortage that has shuttered some car plants around the world and is now starting to affect consumer electronics.
Hsinchu, home to Taiwan Semiconductor Manufacturing Co Ltd (TSMC) , the world's largest contract chip maker, has set up an "anti-epidemic combat alliance" with Miaoli to ensure infections do not spread.
President Tsai Ing-wen has vowed to build a "line of defence" to protect what she called an "industry of national importance," sending soldiers last week to help build test stations in Hsinchu Science Park.
Hsinchu Mayor Lin Chih-chien, in an interview with Reuters late on Monday, said that he could not guarantee total safety for the city's tech firms, but that the government had rolled out rapid testing stations.
"I don't dare to say there is absolutely no problem. If there were no problem, then we wouldn't need to set up rapid testing stations in the science park so urgently and quickly," said Lin, a member of the ruling Democratic Progressive Party.
On Sunday he said they had tested more than 1,800 migrant workers and found five positive cases.
He said it was "too early to say" whether the city's tech firms were totally safe.
Hsinchu's science park is home to more than 10,000 migrant workers, with almost 68,000 in the city, its neighbouring county and Miaoli, with some dormitories housing more than 10 people per room, creating a possible "hotbed" for transmission, Lin said.
TSMC SEES NO IMPACT
So far the pandemic has not had a major impact on TSMC, which last month began stepped up disease-prevention measures, including separating work teams and telling staff and vendors not to move across its main production sites in Hsinchu, Taichung and Tainan.
TSMC said in a statement the company had not started mass testing of employees.
"Regarding the rise in infections in Miaoli, we have not seen any impact so far, and we are monitoring the situation closely," the company said.
By Tuesday morning, more than 250 cases had been reported in four tech companies in the area, the majority of which were in migrant workers from Southeast Asian countries.
Companies affected included chip packaging and testing firm Greatek Electronics Inc and telecom equipment maker Accton Technology Corp.
In a statement to the stock exchange on Monday, King Yuan, which has recorded more than 200 infections, said it expected a 30%-35% impact on production in June.
https://finance.yahoo.com/news/1-taiwan-mayor-says-too-024904673.html
Clover Health Emerges As Top WallStreetBets Interest
Clover Health Investments Corp
CLOV 32.44% emerged as the most discussed name on r/WallStreetBets, or WSB, a popular retail-investor-centric Reddit forum.
What Happened: Clover Health, which operates as a Medicare Advantage insurer, attracted 1,635 mentions on the investor forum that took the limelight for a short squeeze in shares of GameStop Corp GME 12.71% earlier this year.
BlackBerry Ltd BB 13.46% received 1,595 mentions on Monday night. Clean Energy Fuels Corp CLNE 11.28%, AMC Entertainment Holdings Inc AMC 14.61% and GameStop attracted 1,471, 1,072, and 591 mentions respectively.
"SPAC King" Chamath Palihapitiya-backed Clover Health also rose to the most-discussed stonk status earlier in the month. Stonks are shares favored by retail investors.
On Monday, Clover Health shares soared 32.44% in the regular session to $11.92 and rose another 8.22% in the after-hours trading to $12.90.
Other retail favorites whose shares spiked in the regular session on Monday were AMC, which shot up 14.8% to $55, Blackberry, which gained 13.78% to $15.77, and GameStop, which rose 12.74% to $280.01.
Why It Matters: Clover Health has a short interest of 36.10% of the total float of 112.06 million, according to highshortinterest.com, a website that tracks stocks with short interest of over 20%.
On Monday, a poster on Reddit noted that Clover Health is “being added to the Russell index” — adding, “I believe that CLOV is about to match the uptick with the likes of AMC and GME.”
The annual reconstitution of Russell U.S. indexes will take place after the market close on 25 June.
Clover Health features on a list of additions to the Russell 3000 index maintained by the FTSE Russell, which tracks the performance of the largest U.S. traded stocks.
Another poster expressed a contrarian view making a case for why he does not like the stock, citing “shady dealings” of the company’s CEO and the fact that the company is “currently burning through cash without a healthy balance sheet to hold them through which means that it is likely they will issue additional equities to stay afloat.”
The critical Reddit post also touched on a Hindenburg Research short-report that disclosed an investigation by authorities related to predatory marketing practices.
Biogen CEO: $56,000 Annual Price For Alzheimer's Drug Reflects 'Two Decades Of No Innovation'
Biogen Inc
BIIB 38.34% CEO Michel Vounatsos has justified the annual $56,000 list price for its newly approved Alzheimer’s disease drug aducanumab as “fair,” CNBC reported Monday.
What Happened: Speaking on CNBC’s “Power Lunch” program Vounatsos said the price of the drug reflects “two decades of no innovation” and will help the drugmaker invest in medicines for other diseases.
The executive disclosed that the company is working closely with Medicare as well as private insurers.
Vounatsos was asked about pushback by patients on the high cost and in response said that the disease and other types of dementia cost the United States over $600 billion annually and the patients $500,000 per year. He told CNBC it was time to “invest” in the treatment.
Biogen was given approval by the U.S. Food and Drug Administration for aducanumab on Monday under its accelerated approval pathway.
The drug is sold under the brand name Aduhelm and is the first Alzheimer's treatment approved since 2003.
The FDA admitted that the clinical benefit of the treatment is marred by uncertainties.
In November, aducanumab, an antibody that targets amyloid-beta plaques, failed to win the backing of a critical FDA panel.
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