CDC warns against eye drops linked to 1 death, 50 infections in 11 states

 The Centers for Disease Control and Prevention is eye-balling this artificial tear brand closely.

The CDC has urged several doctors and patients to stop using EzriCare Artificial Tears as it has been linked to 50 bacteria-resistant infections and one death in 11 states, according to a report.

Most of the people infected said they used artificial tears, with EzriCare being the most reported brand. EzriCare drops are preservative-free and don’t have any ingredients that prevent bacterial infections from occurring.

“CDC recommends that clinicians and patients 
immediately discontinue the use of EzriCare Artificial Tears until the epidemiological investigation and laboratory analyses are complete,” said the report.

The CDC tested open bottles of EzriCare and found Pseudomonas aeruginosa bacteria that were resistant to carbapenem antibiotics as well as the antibiotics ceftazidime and cefepime. The CDC is testing the bacteria to see if it matches the infection strain in the reported infections.

The CDC has recently urged several doctors and patients to stop using EzriCare Artificial Tears as it has been linked to nearly 50 eye infections in 11 states and even one death.

Getty Images/iStockphoto

Pseudomonas aeruginosa is a bacteria that is usually spread in health care settings and is also commonly found in soil and water, according to the CDC.

Testing of unopened bottles is ongoing.

EzriCare, which is based in New Jersey, issued a statement last week saying that it was not being forced to recall any of the drops nor did it receive any consumer reports.

“EzriCare became aware in the last few days that the Centers for Disease Control (CDC) is conducting an ongoing investigation related to adverse events implicating various Over the Counter (OTC) eye drops,” reads the statement.

“CDC recommends that clinicians and patients immediately discontinue the use of EzriCare Artificial Tears until the epidemiological investigation and laboratory analyses are complete,” said the report.

EzriCare

According to the CDC, the investigation is ongoing.

Getty Images/Science Photo Libra

“EzriCare has received no consumer complaints or adverse event report related to the investigation to date, also, as of this date, EzriCare has not received communication from any regulatory agency providing any outcomes or details to EzriCare about the ongoing investigation.

“We have not been asked to conduct a recall. EzriCare does not manufacture the Lubricant Eye Drops,” continues the statement.

“Nevertheless, and in an abundance of caution, EzriCare recommends that during this evolving situation you discontinue use of any portions of EzriCare Artificial Tears Lubricant Eye Drops you may have until we can discover more details about any potential safety concerns.”

https://nypost.com/2023/02/01/cdc-warns-against-eye-drops-linked-to-death-infections/

Judge blocks NJ law allowing state to sue gun industry

 A federal judge has temporarily blocked a New Jersey law that allowed the state to sue gun manufacturers for creating a “public nuisance” with their sale and marketing of firearms. 

New Jersey Gov. Phil Murphy (D) signed the law in June to create a path for suing companies engaged in the sale, manufacture, distribution, importing or marketing of gun-related products for a public nuisance, defined as conduct that interferes with the public’s rights. 

It also allows liability for gun industry members who fail to “establish, implement, and enforce reasonable controls” on those products. 

But U.S. District Judge Zahid Quraishi ruled Tuesday that the law violates the Protection of Lawful Commerce in Arms Act, a federal law that states that civil actions cannot be brought against a gun manufacturer or seller for injuries that result from the “misuse” of a firearm or related product by a third party. 

The law includes six exceptions, but Quraishi did not immediately find that any of them apply, leading to the preliminary injunction. 

Quraishi said the state law is in “direct conflict” with the federal law’s purpose, also citing concerns about whether the state law is constitutional, though he did not address those questions in the ruling. 

The complaint over the law was filed by the National Shooting Sports Foundation (NSSF), a nonprofit trade association for the hunting and shooting sport industry. 

The ruling comes a day after another federal judge temporarily blocked a New Jersey law that banned firearms at casinos, parks and beaches. That judge also blocked parts of that law that prohibited firearms from being carried at sensitive places like libraries, museums, bars and restaurants where alcohol is sold last month. 

Other states like California have also approved legislation allowing gun manufacturers to be sued if a firearm they sell is used to cause harm. 

Lawrence Keane, a senior vice president for government and public affairs at NSSF, told Politico in an interview that the ruling is important because other states are considering legislation based on the laws in New Jersey and California. He said the organization will file a lawsuit in the coming months to challenge the California law. 

“Today’s decision will be impactful in giving other state legislatures pause before they enact an unconstitutional law,” Keane said. 

Tyler Jones, a spokesperson for Murphy’s office, said the governor is “disappointed” that the court issued the temporary injunction, but he is confident the decision will be “swiftly” reversed on appeal.

“Governor Murphy was proud to sign the public nuisance law, which allows the Attorney General to hold the gun industry accountable for their own misconduct that is causing carnage in this state and across America,” Jones said.

https://thehill.com/regulation/court-battles/3839612-judge-blocks-nj-law-allowing-state-to-sue-gun-industry/

GOP-led states call on court to shut down DACA

 A coalition of nine Republican-led states on Tuesday asked a federal court in Texas to end the Deferred Action for Childhood Arrivals (DACA) program, which shields “Dreamers” from deportation.

The DACA program was implemented under the Obama administration in 2012 as a way to protect undocumented immigrants who were brought into the U.S. as children. Since its inception, it has faced regular legal challenges from conservative groups and states.

This coalition, which is led by Texas, is calling on the Southern District federal court to declare DACA “unlawful” and “unconstitutional,” according to court documents filed on Tuesday. The filings state that DACA should be prevented from accepting any new applicants and, in two years, prevented from approving renewal requests from existing Dreamers.

The Southern District court, at the request of the same group of states, had previously blocked new applications for the program, ruling that “with the creation of DACA and its continued operation,” the Department of Homeland Security (DHS) violated the Administrative Procedure Act.

However, the judge in question, Andrew Hanen, still allowed for current Dreamers to renew their status in the 2021 ruling.

Hanen’s ruling at the time was based largely on the fact that the DACA program was created by a memo under the Obama administration and that it was not a formal rule. In August, DHS issued a final regulation to replace the memo and codify the DACA program and allow new applicants starting in October.

The group of states has now asked Hanen to review the Biden administration’s new regulation, claiming that this new move is also unlawful for the same reasons the initial memo was.

“The Final Rule—as the latest manifestation of the DACA program—is substantively unlawful for the same reasons as the DACA Memorandum. The Court should declare it unlawful and unconstitutional, vacate it in its entirety, and permanently enjoin its implementation (with a prudent transition for existing DACA recipients)” the filing concludes.

As of September, there are nearly 600,000 active DACA recipients whose benefits could be at risk if the program is struck down, according to federal data.

https://thehill.com/regulation/court-battles/3839447-gop-led-states-call-on-court-to-shut-down-daca/

Trump vows to punish doctors, hospitals that provide gender-affirming care to transgender minors

 Former President Trump, in a video released Tuesday on his social media platform, vowed to punish doctors who provide gender-affirming health care to minors if he is reelected next year, wading into a contentious debate that has captured the attention of state and federal lawmakers on both sides of the aisle.

In the nearly four-minute-long, straight-to-camera video, Trump outlined his plan to “protect children from left-wing gender insanity,” unveiling a slate of extreme policy proposals targeting transgender identities, including a federal law that recognizes only two genders and bars transgender women from competing on women’s sports teams.

“No serious country should be telling its children that they were born with the wrong gender,” Trump said in the video before falsely claiming that being transgender is a concept that the “radical left” manufactured “just a few years ago.”

“Under my leadership, this madness will end,” he said.

Trump, who officially announced his 2024 presidential bid in November, added that, if he is reelected, federal agencies will be instructed to immediately cease programs that promote the concept of gender transition “at any age” and promised to prohibit federal tax dollars from being used to help pay for gender-affirming interventions.

The former president said he also plans to pass a law barring minors from receiving gender-affirming health care “in all 50 states” and intends to direct the Justice Department to investigate the pharmaceutical industry and individual hospitals to determine whether they “deliberately covered up horrific long-term side effects of sex transitions in order to get rich.”

Doctors who treat transgender youth will be booted from Medicaid and Medicare under his leadership, Trump said Tuesday, and a private right of action will be established for patients who later regret having received gender-affirming health care as minors to sue their physicians.

Gender-affirming health care — for both youths and adults — is considered safe, medically necessary and often life-saving by most professional medical organizations, including the American Medical Association and American Academy of Pediatrics.

While the former president has not previously weighed in on gender-affirming health care for transgender minors, he has targeted transgender individuals more generally, evidenced in part by his administration’s 2017 ban on transgender people serving in the military, which he said in a series of tweets would burden the government with “tremendous medical costs and disruption.”

Last year, during a campaign rally in Texas, Trump said transgender women should be barred from playing on women’s sports teams, vowing to “ban men from participating in women’s sports” if he is reelected.

At least 18 states have enacted laws that bar transgender athletes from competing on sports teams consistent with their gender identity, and top Republicans in Congress, including Speaker Kevin McCarthy (Calif.), have backed federal legislation to that effect.

Florida Gov. Ron DeSantis, seen as a top GOP contender for the 2024 presidential election, in 2021 signed a law barring transgender athletes from sport, and last year publicly refused to recognize Lia Thomas, a transgender swimmer at the University of Pennsylvania, as the NCAA women’s 500-yard champion, declaring Florida-native Emma Weyant, the second-place finisher, the race’s “rightful winner.”

DeSantis’s administration has also approved a number of controversial health and education policies that target transgender people, including a state rule that prohibits transgender individuals from using Medicaid to help pay for gender-affirming health care and a law barring talk of gender identity and sexual orientation in public school classrooms.

Trump on Tuesday said his proposed policy changes would similarly extend to education, and school officials that suggest a child “could be trapped in the wrong body” will be faced with “severe consequences” if he is reelected next year, including potential civil rights violations for sex discrimination and the elimination of federal funding for schools.

A new credentialing body for teachers, Trump said, would promote “positive education about the nuclear family, the roles of mothers and fathers and celebrating rather than erasing the things that make men and women different and unique.”

https://thehill.com/homenews/3839471-trump-vows-to-punish-doctors-hospitals-that-provide-gender-affirming-care-to-transgender-minors/

GSK gives few clues on plans to replenish medicine cabinet

 

GSK chief executive Emma Walmsley on Wednesday made replenishing the drugmaker's pipeline of vaccines and therapies her number-one priority.

But analysts were disappointed she did not give more details on how she and her management team plan to find the company's next set of blockbuster drugs.

The current pipeline will sustain growth through the end of this decade and beyond, Walmsley said on a call after the world's biggest vaccine maker reported stronger than expected fourth-quarter results.

But analysts say there is not enough in the medicine cabinet to keep the momentum going even beyond the next few years.

Investors were particularly keen to hear about the pipeline strategy after GKS spun off Haleon, its consumer health products business, which makes Sensodyne toothpaste and other staples last July, providing cash to supplement its drugs pipeline.

GSK largely missed out on the lucrative market for COVID-19 vaccines, but has had a string of strong quarters after years of underperformance relative to its peers.

Fourth-quarter results were boosted by sales of its HIV drugs and its blockbuster shingles vaccine Shingrix.

But after an early burst higher, GSK's shares on London's blue-chip FTSE 100 ended down 0.2%.

"We didn't really learn a lot new today in terms of their efforts to broaden out the pipeline," said Barclays analyst Emily Field.

The loss of patent protection by 2027 for dolutegravir, the compound that forms part of four GSK's HIV treatments, is a particular concern because this puts more than 5 billion pounds ($6.2 billion) of sales at risk, Sebastian Skeet, healthcare analyst at research firm Third Bridge.

Among a handful of prospects, GSK is leaning primarily on its vaccine targeted at the respiratory syncytial virus (RSV), which causes thousands of hospitalisations and deaths each year, to least partially offset that loss.

It has been submitted for regulatory review in the United States, European Union and Japan.  

But with rivals Pfizer and Moderna also competing for a slice of the estimated $10 billion market, some analysts expect GSK may end up with only a portion of that, Skeet told Reuters.

"The implication, therefore, is that there is still ground to make up," he said.

The company has announced some acquisitions, including a deal to buy U.S.-based Sierra Oncology in 2022, but it has culled a handful of programmes from its pipeline, including abandoning a cancer-focused pact and the field of cell and gene therapy altogether.

GSK has also suffered setbacks in its marketed cancer drug portfolio in recent months. Meanwhile, analysts say the market for Shingrix will eventually become saturated, further limiting the company's growth prospects.

R&D SPEND

GSK's spending on R&D has long lagged behind its peers, something activist investor Elliott highlighted in a 2021 letter pressuring the company to make sweeping changes.

The company has begun to close the gap somewhat, spending just over 5 billion pounds ($6.2 billion) on R&D in 2022, but is still behind rivals Roche, AstraZeneca and Pfizer, said Andrew McConaghie, senior healthcare analyst at Citeline.

GSK's top scientists say they are working on doubling its R&D productivity from the industry standard of 10% to 20%, or taking 2 in 10 drugs all the way from early trials to market, with the help of technologies like artificial intelligence. 

Some investors and industry experts say there is still time for the company to turn its drug pipeline around.

Lucy Coutts, investment director at wealth management firm JM Finn, which holds GSK shares, there is hope the company will eventually deliver a streamlined and specialist portfolio of blockbuster drugs.

But until that happens, the stock may remain under pressure.

"There is little visibility on that for investors at this stage," she said.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/Analysis-GSK-gives-few-clues-on-plans-to-replenish-medicine-cabinet-42871276/

Coinbase wins dismissal of lawsuit claiming it sold unregistered securities

 A U.S. judge on Wednesday dismissed a lawsuit accusing Coinbase Global Inc of selling unregistered securities and failing to register as a broker dealer.

U.S. District Judge Paul Engelmayer in Manhattan rejected claims in the proposed class action by customers who transacted in digital assets known as tokens on the Coinbase and Coinbase Pro trading platforms.

Engelmayer said customers could not show that Coinbase actually sold or held title to the tokens, despite having allegedly promoted their sale by describing their "purported value proposition" and participating in "airdrops" of free tokens to increase trading volume.

"These activities of an exchange are of a piece with the marketing efforts, materials and services that courts ... have held insufficient" to qualify defendants as sellers, Engelmayer wrote.

Engelmayer dismissed claims brought under federal securities laws with prejudice, meaning they cannot be brought again, and state law-based claims without prejudice.

Lawyers for the customers, Coinbase and the company's lawyers did not immediately respond to requests for comment.

https://www.marketscreener.com/quote/stock/COINBASE-GLOBAL-INC-121300010/news/Coinbase-wins-dismissal-of-lawsuit-claiming-it-sold-unregistered-securities-42871471/

Beam started at Overweight by Cantor

 Target $62

https://finviz.com/quote.ashx?t=BEAM&ty=c&ta=1&p=d