China's CanSino Biologics Inc is formally seeking emergency use authorization in Mexico for its Covid-19 vaccine, Mexico's foreign minister said on Friday, as the company seeks quick approval prior to wide-scale distribution.
Foreign Minister Marcelo Ebrard wrote on Twitter that the one-dose CanSino vaccine has been successfully tested on more than 14,000 volunteers in Mexico since last October.
The Super Bowl typically creates a legal gambling frenzy in Nevada but fewer tourists in the Western state due to COVID-19 will likely keep wagers from setting a record despite Sunday's mouthwatering matchup.
Plenty of money is still expected to be wagered in Nevada ahead of the Super Bowl showdown between the defending champion Kansas City Chiefs and host Tampa Bay Buccaneers - but topping the record $158.6 million handle, or total amount of bets, set in 2018 is unlikely.
"In Nevada, (the) Super Bowl handle is driven by visitation dollars, and Las Vegas, along with other areas across the state, are destination markets for customers to come and wager on the game," Mike Lawton, senior research analyst for the Nevada Gaming Control Board said in an email.
Lawton also said that, due to the capacity limits sportsbooks are required to comply with because of the pandemic, "we estimate that betting totals will be softer when compared to amounts recorded over the last few years in spite of a great matchup."
Last year, sports bettors wagered $154.7 million in Nevada on the Super Bowl that pitted the Chiefs against the San Francisco 49ers. That was 6% above the 2019 championship game and 2.5% below the record $158.6 million wagered in the previous year.
The Chiefs, led by dynamic 25-year-old quarterback Patrick Mahomes, are vying to become the National Football League's first repeat champion in 16 years. On the other side, Bucs veteran quarterback Tom Brady, 43, is seeking a record-extending seventh Super Bowl championship.
The impact of COVID-19 on Super Bowl bets this year is expected to be felt across the United States, according to a recent survey by the American Gaming Association (AGA) industry group.
The AGA forecast $4.3 billion will be wagered on the NFL's championship game, down nearly 37% from last year, a drop attributed to pandemic restrictions at retail sportsbook operations and fewer casual bets in office pools or social settings.
But the pandemic has boosted online and phone betting. Among Super Bowl bettors, a record 7.6 million will place wagers on online sportsbooks this year, up 63 percent year-over-year, the AGA said. And phone betting has accounted for 82% of all legal sports betting nationwide during the crisis, according to the group.
Aside from the more traditional bets, gamblers can take a chance on proposition bets, such as the outcome of the coin toss before the game, deciding which team will score first, and what color liquid will be poured on the winning coach.
Among some of the more unique proposition bets offered are how many times Brady's supermodel wife Gisele Bundchen will be shown during the broadcast and which coach will lower their protective mask first and expose their nostrils.
Pompe disease is a hereditary genetic disorder caused by a deficiency of acid alpha-glucosidase leading to build-up of glycogen in the lyosomes, which then causes cell damage in various tissues, in particular the heart, the muscles, the liver and the nervous system.
In patients living with late-onset Pompe disease the respiratory system and mobility are most frequently the most affected by the disease, often requiring the use of a wheelchair and respiratory assistance, and life expectancy can be reduced.
The company Spark Therapeutics has just announced that a first study participant has been dosed in the USA as part of an international gene therapy clinical trial. The product tested - SPK-3006 - is the result of collaboration with Genethon. It utilizes technologies developed at Genethon, and which, in mouse models, have already helped correct the build-up of glycogen in the muscles and nervous system.
The purpose of this study is to evaluate the safety, tolerability, and efficacy of a single intravenous infusion of SPK-3006 in adults with clinically moderate, late-onset Pompe disease receiving enzyme replacement therapy (ERT). This study is taking place first in centers in the USA, and then should be continuing in Europe.
The study plans to recruit and treat around twenty patients, and is set to end in October 2023.
The very public and very bitter fight between Ziopharm Oncology and a minority activist investor continued Friday with the resignation of a board member to whom the latter had objected.
In a letter to shareholders sent Friday morning, Ziopharm announced it had accepted the resignation of Elan Ezickson, following calls to replace him from 3.3% stakeholder WaterMill Asset Management Corp. Ziopharm has not announced a replacement and it remains to be seen if they will, effectively shrinking the board to seven for the time being.
“Over the last several weeks the Board has taken further actions in response to shareholder feedback, including most recently accepting the resignation of Director Elan Ezickson,” Ziopharm said in a statement. “We sincerely thank Mr. Ezickson for his many contributions to the Board and wish him well.”
Ziopharm’s board has seen heavy churn in the last 18 months, appointing 5 new members during that time.
WaterMill launched its activist attack in early November, seeking to oust four of its then-eight board members and replace them with three individuals it had nominated itself — including WaterMill founder Robert Postma. Two of the four, Ezickson and Scott Braunstein, have now been replaced or left entirely, but WaterMill continues to call for Ziopharm chairman Scott Tarriff to step down as well.
The minority shareholder had also raised objections over a former board member at Ziopharm’s annual investor meeting over the summer, and that individual was replaced in September.
For those keeping score at home, WaterMill has essentially pressured out three of Ziopharm’s board members over the last six months. But Ziopharm has not nominated any of the three individuals put forth by WaterMill and continues to object to one specific nominee, Holger Weis.
After the proxy adviser Institutional Shareholder Services recommended last week that Ezickson and Tariff step down in favor of Weis and another WaterMill nominee, Ziopharm claimed Weis proved a key force in driving the biotech DemeRx to bankruptcy in 2018. Ziopharm highlighted several pieces from a publicly available Chapter 11 filing in 2018 detailing what it says shows a history of Weis’ corporate malpractice during his tenure as president, COO and CFO of DemeRx. The company reiterated those concerns in its Friday letter.
WaterMill subsequently accused Ziopharm of engaging in a “desperate, low-road smear campaign” and maintained Weis is a highly qualified nominee. Postma noted two former DemeRx executives vouched for Weis and claimed the filing from which Ziopharm quoted was cherry-picked and “completely unsubstantiated.”
With WaterMill aiming to submit its written consent letters next Friday, this drama may likely soon draw to a close, and Ziopharm acknowledged in its statement it’s “open to reaching a resolution.” But if the last month has given any indication — with the two entities fighting over the Thanksgiving weekend — the final act may not be pretty.
Terns Pharmaceuticals, a Phase 2 biotech developing small molecule therapies for NASH, raised $128 million by offering 7.5 million shares at $17, the high end of the range of $15 to $17. The company offered 1.3 million more shares than anticipated. At pricing, Terns commands a fully diluted market value of $430 million.
The FDA granted accelerated approval to umbralisib for two types of relapsed or refractory lymphoma.
The approval applies to use of the agent for adults with marginal zone lymphoma who received at least one prior anti-CD20-based regimen, as well as adults with follicular lymphoma who received at least three prior lines of systemic therapy.
Umbralisib (Ukoniq, TG Therapeutics) is a dual inhibitor of the PI3 kinase-delta and CK1-epsilon.
The FDA based the approval on results of two single-arm cohorts of the open-label, multicenter UTX-TGR-205 trial.
The trial included 69 patients with marginal zone lymphoma who received at least one prior therapy, and 117 patients with follicular lymphoma who received at least two prior systemic therapies.
Patients received umbralisib dosed at 800 mg orally once daily. Treatment continued until disease progression or unacceptable toxicity.
Overall response rate and duration of response as assessed by an independent review committee served as key efficacy outcomes.
In the marginal zone lymphoma subgroup, researchers reported an ORR of 49% (95% CI, 37-61.6), with 16% of patients achieving complete response. Median duration of response was not reached (95% CI, 9.3-not estimable).
In the follicular lymphoma subgroup, researchers reported an ORR of 43% (95% CI, 33.6-52.2), with 3% of patients achieving complete responses. Median duration of response was 11.1 months (95% CI, 8.3-16.4).
The most common adverse events among umbralisib-treated patients included increased creatinine, diarrhea-colitis, fatigue, nausea, neutropenia, transaminase elevation, musculoskeletal pain, anemia, thrombocytopenia, upper respiratory tract infection, vomiting, abdominal pain, decreased appetite and rash.
Eighteen percent of patients experienced serious adverse events, the most common of which were diarrhea-colitis and infection.
The FDA previously granted orphan drug designation to umbralisib for both indications, as well as priority review for the marginal zone lymphoma indication.
After regulatory delays and manufacturing issues caused Bristol Myers Squibb investors to miss out on the lucrative Celgene contingent value right, the closely watched CAR-T drug liso-cel has finally scored an FDA nod.
On Friday, the agency endorsed the drug, to be called Breyanzi, to treat patients with certain types of large B-cell lymphoma who haven’t responded to two other systemic treatments or who have relapsed after receiving those treatments.
Like other CAR-T drugs, doses of Breyanzi are individually tailored. They’re created using a patient’s own T cells, which are extracted, genetically modified and then infused back into patients to help the body kill lymphoma cells.
In a trial of more than 250 patients, 54% of patients who received the CAR-T therapy achieved complete remission. The drug’s label carries a boxed warning for cytokine release syndrome, which can be severe. Because of safety risks, the FDA is requiring centers that administer the drug have a certification indicating that staff have been trained and are able to recognize side effects.
On a conference call earlier this week, Bristol's chief commercialization officer Chris Boerner said the company expects the opportunity to launch liso-cel "imminently." The company is "going to be very much focused on ensuring at launch that sites are activated very quickly, that we're able to get patients efficiently moved on to therapy," he added.
Looking forward, the company will look to drive referrals to the medicine and expand the number of sites able to administer it. In the long run, BMS wants to "leverage what we believe to be a differentiated product profile in order to drive brand share," Boerner said.
But while BMS aims to be quick to roll out Breyanzi, the process of getting it approved was anything but. Multiple delays pushed the FDA's decision past the original deadline of mid-August 2020—and ultimately cost investors about $6.4 billion in contingent value rights that came out of BMS' $74 billion Celgene buy.
Nearly 715 million CVRs worth $9 per share were outstanding at the end of the year, and since BMS didn’t meet all of the CVR requirements, they were worthless when the calendar year flipped to 2021. Aside from an approval for liso-cel, the CVRs also required an FDA approval for multiple myeloma CAR-T med ide-cel by March 31, 2021, and an FDA nod for Zeposia, a multiple sclerosis drug. Zeposia scored its FDA approval last March, and ide-cel is set for an FDA decision by March 27.
https://www.fiercepharma.com/pharma/after-delays-and-a-cvr-miss-bristol-s-liso-cel-wins-its-fda-nod
