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Thursday, August 26, 2021

Judge allows J&J to split talc liabilities from main business

 

A federal judge has cleared the way for Johnson & Johnson to split its talc-related liabilities from the rest of its business, a decision that could allow the drugmaker to move thousands of claims by people who used its Baby Powder and other talc products into bankruptcy.

U.S. Bankruptcy Judge Laurie Selber Silverstein ruled at a hearing on Thursday in Delaware bankruptcy court.

The ruling came over the objections of lawyers for people who claimed that J&J's talc products contained asbestos and caused them or family members to develop cancer.

Plaintiffs include women who have suffered from ovarian cancer, and others battling mesothelioma.

Moving talc-based claims into the Chapter 11 process could shield J&J from having to defend against cancer claims in jury trials. The New Brunswick, New Jersey-based company has not publicly announced such a plan.

https://www.marketscreener.com/news/latest/Judge-allows-Johnson-Johnson-to-split-talc-liabilities-from-main-business--36259898/

BeyondSpring Shares Up 17% After China Commercialization Deal

 BeyondSpring Inc. shares were up 17% to $29.53 after the pharmaceutical company unveiled a commercialization and co-development agreement with Jiangsu Hengrui Pharmaceuticals.

The agreement with Jiangsu Hengrui is in the Greater China area for BeyondSpring's investigational drug candidate plinabulin. Plinabulin in combination with G-CSF is currently under review by the U.S. Food and Drug Administration and the China National Medical Products Administration to prevent chemotherapy-induced neutropenia. The territory for the agreement includes mainland China, Hong Kong, Macau and Taiwan.

Wanchunbulin, BeyondSpring's 58%-owned subsidiary in China, will partner with Hengrui in China. Wanchunbulin will get up to 1.3 billion yuan, or about $200 million, in milestone payments. This would include CNY200 million, or about $30 million, upfront and up to CNY1.1 billion, or $170 million, in regulatory and sales milestone payments.

Wanchunbulin will book revenue and to pay for 100% cost of goods sold and Hengrui will pay for 100% of the commercialization costs for plinabulin in the territory and receive a pre-determined percentage of net sales.

Wanchunbulin and Hengrui will co-develop additional indications for plinabulin in the territory, the company said.

Hengrui will also make a CNY100 million, or about $15 million, equity investment in Wanchunbulin.

https://www.marketscreener.com/quote/stock/BEYONDSPRING-INC-34241928/news/BeyondSpring-Shares-Up-17-After-China-Commercialization-Deal-36258811/

Texas governor bans COVID-19 vaccine mandates regardless of approval status

 Texas Gov. Greg Abbott (R) issued an executive order on Wednesday banning any governmental entity in the state from requiring a COVID-19 vaccine, regardless of its approval status.

The move comes just days after the Food and Drug Administration granted full approval to the COVID-19 vaccine from Pfizer and BioNTech.

It marks a change from the governor's previous executive order, which banned mandates for vaccines administered under an emergency use authorization.

According to the order, “No governmental entity can compel any individual to receive a COVID-19 vaccine.”

It did not mention employer mandates and preserves exceptions for places such as nursing homes, long-term care facilities and state-supported living centers.

The order also maintains an existing ban on publicly funded facilities requiring proof of vaccination as a condition of entry. 

A law signed by Abbott in June allows state agencies to revoke the licenses of private businesses that require any proof of vaccination or a negative test. 

Additionally, Abbott asked the state legislature to consider whether state and local governments can mandate vaccines, and if so, what exemptions can apply.

"Vaccine requirements and exemptions have historically been determined by the legislature, and their involvement is particularly important to avoid a patchwork of vaccine mandates across Texas," Abbott said in a statement.

Texas lawmakers are currently convening in a special session. The House restored a quorum last week when enough Democrats returned to the state after staging a nearly six-week protest of the GOP’s elections bill.

Outside Texas, the full federal approval of the Pfizer-BioNTech vaccine on Monday led to a host of new vaccination mandates by private and government entities.

https://thehill.com/policy/healthcare/569440-texas-governor-bans-covid-vaccine-mandates-regardless-of-approval-status

Free back-to-school COVID testing for New York students at Rite Aid

 Rite Aid has partnered with the U.S. Department of Health and Human Services and BioReference Laboratories to provide free COVID-19 testing for New York public school students between the ages of 4-17 before school starts.

Students must pre-register and must schedule an appointment at one of 115 Rite Aid drive-thru locations. A parent or guardian must be present with the student at the testing appointment.

“Providing access to COVID-19 testing for school-aged children is critical, particularly for those who are not able to be vaccinated, as we continue to fight the pandemic and get closer to a return to normal,” said Executive Vice President and Chief Pharmacy Officer, Jocelyn Konrad.

Governor Kathy Hochul, who indicated there will more than likely be a mask mandate for schools as well as other measures to protect students on Tuesday, weighed in on the back-to-school testing program.

“As governor, my priorities are now the priorities of the people of New York — and right now that means fighting the Delta variant. Number one on the list is getting children back to school and protecting the environment so they can learn safely,” Gov. Hochul said.

“It is imperative that we support programs that help to provide a safe environment for students to return to in-classroom learning,” said Executive Chairman of BioReference Laboratories, Jon R. Cohen, M.D.

The testing will be done using RT-PCR laboratory COVID tests and results will be digitally delivered. To register a student for testing or learn more about the program visit the BioReference Laboratories website.

https://www.news10.com/news/free-back-to-school-covid-testing-for-new-york-students-at-rite-aid/

Poll: 56% say House GOP probe assertion China committed 'greatest cover-up in human history' is true

 A majority of voters in a new poll said they think that the House Republican Committee’s probe asserting that the coronavirus originated in a lab in Wuhan, China, and the Chinese Communist Party (CCP) engaged in the "greatest cover-up in human history," is a true statement, a new Hill-HarrisX poll finds.

Fifty-six percent of registered voters in the Aug. 13-14 and Aug. 16-17 survey said the probe's conclusion is mostly or somewhat true.

By contrast, 20 percent of respondents said it is mostly or somewhat false and 25 percent said they are unsure.

 

Seventy-two percent of Republican voters said the House GOP probe's assertion is true while 8 percent said it is not true and 20 percent said unsure.

Pluralities of Democrats and independents said the probe's conclusion is mostly or somewhat true, at 44 percent and 49 percent, respectively. 

A June 7-9 Hill-HarrisX survey found roughly half of voters said they believe the COVID-19 virus was created in a lab in Wuhan, China.

Eighty-three percent of voters in a May 30-June 1 Hill-HarrisX survey said they support the U.S. government taking action towards China if new intelligence reveals that COVID-19 originated in a lab in the city of Wuhan, while 17 percent of respondents oppose any action. 

On Tuesday, President Biden received classified findings from an intelligence report on the origins of COVID-19 that could not conclude whether the virus was created naturally or accidentally leaked from a lab.

The most recent Hill-HarrisX poll was conducted online among 1,919 registered voters. It has a margin of error of 2.24 percentage points.

https://thehill.com/hilltv/what-americas-thinking/569378-poll-56-percent-of-voters-say-the-house-gop-committee-probes

US breaks 100K COVID-19 hospitalizations threshold for 1st time since Jan.

 The United States now has more than 100,000 people hospitalized with the coronavirus across the country for the first time since January, according to a new report. 

On Thursday, The Washington Post noted that hospitalization rates are highest in the South, including Florida, where 17,000 people are hospitalized, and Texas, where another 14,000 are receiving care. 

Citing its own coronavirus database, the Post reported 2,100 children have been hospitalized nationally this month, topping 2,000 for the first time since August 2020. 

The newspaper added that about 148,000 new cases are being reported nationwide each day, a figure also not seen since January.

The major difference between January and today is the availability of coronavirus vaccines. Earlier this month, the Post reported nearly 190 million people have received at least one shot and another 163 million are fully vaccinated against the virus. 

The country's vaccination efforts got a boost this week when the Food and Drug Administration (FDA) granted Pfizer's vaccine, one of the first on the market, full approval in a move President Biden celebrated and federal health officials have said they hope reduced vaccine hesitancy nationwide. 

"After a strict process the FDA has reaffirmed its findings that the Pfizer COVID-19 vaccine is safe and effective and the FDA has given its full and final approval," Biden said this week. "So let me say this loudly and clearly: If you're one of the millions of Americans who said that they will not get the shot until it has full and final approval of the FDA, it has now happened."

The delta variant is now accounting for the vast majority of cases in the United States, public health experts have said, with serious illness and death mainly occurring among unvaccinated Americans. 

https://thehill.com/policy/healthcare/public-global-health/569493-us-breaks-100k-covid-19-hospitalizations-threshold-for

Gilead wins reversal of $1.2B fine against Bristol Myers in patent case

 Gilead Sciences Inc GILD.O escaped a $1.2 billion fine, after the Federal Circuit Court of Appeals on Thursday found the relevant parts of a Bristol Myers Squibb BMY.N patent that Gilead's Yescarta cancer drug allegedly infringed were invalid.

Last year, a federal judge increased the damages that Gilead would pay to Bristol Myers Squibb to $1.2 billion in a patent infringement case related to CAR T-cell immunotherapy for cancer.

https://www.nasdaq.com/articles/gilead-sciences-wins-reversal-of-%241.2-bln-fine-against-bristol-myers-in-patent-case-2021