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Thursday, December 1, 2022

Valneva, Pfizer: 6-Month Antibody Persistence Data in Children and Adults for Lyme Vaccine Candidate

 

  • Antibody levels remained above baseline sixmonths aftercompletion ofthree-dose(Month 0-2-6)or a two-dose (Month 0-6) vaccination schedule
  • Higher antibody levels were observedinthe three-dosevaccination schedule versus the two-dose vaccination schedule, further validating the use of this schedule in the ongoing Phase 3 study
  • There were nosafety concerns observed in this six-monthobservational follow up

Major Chinese cities further ease COVID restrictions but police are still patrolling streets

 Major Chinese cities on Thursday announced a further easing of COVID restrictions, as police continued to patrol streets to avert protests and the ruling Communist Party prepared for the funeral of late leader Jiang Jemin, the Associated Press reported Guangzhou in the south, Shijiazhuang in the north, Chengdu in the southwest and other major cities announced they were easing testing requirements and controls on movement. In some areas, markets and bus service reopened. In Beijing, officials will let those infected patients who are low risk to quarantine at home for a week, rather than in a government center, Bloomberg reported, citing sources In the U.S., known cases of COVID are rising again with the daily average standing at 45,219 on Wednesday, according to a New York Times tracker, up 15% from two weeks ago. The daily average for hospitalizations was up 16% at 32,445, while the daily average for deaths is up down 7% to 262. Globally, the confirmed case tally rose above 643.4 million on Thursday, according to data aggregated by Johns Hopkins, while the death toll is above 6.63 million with the U.S leading the world with 98.8 million cases and 1,080,444 fatalities.

https://www.morningstar.com/news/marketwatch/20221201285/coronavirus-tally-major-chinese-cities-further-ease-covid-restrictions-but-police-are-still-patrolling-streets

AbCellera, Rallybio to Team on Antibody-Based Therapeutics

 AbCellera (Nasdaq: ABCL) and Rallybio Corporation (Nasdaq: RLYB) announced today that they have entered into a strategic alliance to discover, develop, and commercialize novel antibody-based therapeutics for rare diseases. This multi-year, multi-target collaboration will combine AbCellera’s antibody discovery engine with Rallybio’s clinical and commercial expertise in rare diseases to identify optimal clinical candidates and ultimately deliver therapies to patients.

https://finance.yahoo.com/news/abcellera-rallybio-announce-strategic-alliance-090000687.html

Innoviva: Priority review for antibiotic

 Innoviva, Inc. (Nasdaq: INVA) ("Innoviva"), a diversified holding company with a portfolio of royalties and other healthcare assets, today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the new drug application (NDA) for SUL-DUR, an investigational drug for the treatment of infections caused by Acinetobacter baumannii-calcoaceticus complex (ABC), including multi-drug resistant and carbapenem-resistant strains. The Agency is currently planning to hold an advisory committee meeting to discuss this application. The target PDUFA date (or action date) is May 29, 2023.

https://finance.yahoo.com/news/innoviva-announces-fda-acceptance-priority-213000714.html

Aurinia: Britain Marketing Authorization of Lupus Therapy

 MHRA Approval follows European Commission marketing authorization of LUPKYNIS to treat adults with active lupus nephritis in 27 European Union Member States

LUPKYNIS is the first oral medicine approved in the U.S. and Europe for the treatment of adults living with active lupus nephritis

https://finance.yahoo.com/news/aurinia-announces-great-britain-marketing-210500772.html

NYPD was ‘blindsided’ by Eric Adams’ plan to involuntarily commit more mentally ill homeless

 The NYPD was “blindsided” by Mayor Eric Adams’ announcement that cops will start taking unhinged homeless people into custody for psychiatric evaluations and potential hospital committal — and scrambled Wednesday to start making it happen, The Post has learned.

Multiple high-ranking law enforcement sources said they weren’t alerted before Adams unveiled his plan Tuesday in a speech that followed a recent surge in horrifying subway attacks.

Police Commissioner Keechant Sewell — who skipped the Adams announcement — as well as newly named acting Chief of Department Jeffrey Maddrey and other top brass huddled with the NYPD’s lawyers Wednesday to review the new directive, sources said.

“It’s kind of a hot mess,” one source said.

The source, who described the NYPD as “blindsided,” also said that City Hall “sort of jumped the gun on this,” adding: “Not sure why they did it.”

Another source said, “Like everything else, it gets dumped in our lap and we’re expected to solve the problem without any guidance.”

The program began on Wednesday.
Mayor Eric Adams’ announced that cops will start taking unhinged homeless people into custody for psychiatric evaluations and potential hospital committal.
AP

The situation is complicated by the fact that NYPD is without a deputy chief for legal matters following what sources described as Sewell’s September ouster of the last person to hold that job, Ernest Hart.

Asked about Sewell’s glaring absence Tuesday, the mayor said during a Q&A afterward, “I spoke to her this morning and she’s a little under the weather.”

But less than two hours later, Sewell attended a farewell ceremony at 1 Police Plaza for retiring Chief of Department Ken Corey and The Post saw her outside afterward, smiling and joking in the cold while waiting for Corey to leave the building.

In his speech, Adams said there was a “misconception” that mentally ill people “must present as ‘imminently dangerous’ in order to be removed from the community,” adding: “This is not the case.”

The directive has been labeled as a "mess" by many.
Police Commissioner Keechant Sewell reviewed the directive Wednesday afternoon.
Michael Brochstein/SOPA Images/Shutterstock

“The first training to this is going to be incorporated today,” Adams said. “This new focus took place this morning and we will soon roll it out to all current members of the mobile crisis teams and the NYPD.”

Several NYPD supervisors told The Post they hadn’t been told anything about the training and only learned about it from media coverage of Adams’ Tuesday speech.

The mayor’s remarks dovetailed with a February memo in which the state Office of Mental Health said law enforcement officials were authorized to force psychiatric examinations of people who appear unable to “meet basic living needs, even when there is no recent dangerous act.”

A spokesperson for the state OMH said Wednesday that training for the NYPD, as well as FDNY EMTs, was “being discussed” with the city Department of Health and Mental Hygiene, and the mayor’s office.

Hochul has been bashed over the city's surge in crime.
Adams and Gov. Hochul previewed plans for the training during a news conference.
Newsday via Getty Images

In late October, Adams and Gov. Kathy Hochul previewed plans for the training during a news conference announcing a “Cops, Cameras, Care” program to increase subway safety.

That move came as Republican challenger Lee Zeldin appeared to be gaining on the Democratic governor, who went on to win the Nov. 8 election, 52.4%-46.7%.

In a prepared statement Wednesday, the NYPD said it was “currently in the process of aligning its policy, guidance and training in conformance with the mayor’s directive which the department received on Tuesday.”

The department issued a subsequent statement hours later that said, “To be clear, every city agency received this directive yesterday, however, we have been working with the mayor’s office for months regarding this important initiative.”

Around the same time the second statement was released, City Hall press secretary Fabien Levy told The Post: “Your sources are wrong.”

“The final directive was just issued yesterday, but we have been working for months with [the NYPD] on this initiative.”

https://nypost.com/2022/11/30/nypd-blindsided-by-eric-adams-plan-to-commit-mentally-ill-homeless/

Wednesday, November 30, 2022

Number Of Handgun Owners Carrying Daily Nearly Doubles In US

 A new study published in the American Journal of Public Health revealed the number of law-abiding Americans carrying a loaded handgun daily nearly doubled between 2015-19. 

The study titled "Trend in Loaded Handgun Carrying Among Adult Handgun Owners in the United States, 2015‒2019" found the number of law-abiding US adults carrying handguns nearly doubled from 9 million in 2015 to 16 million in 2019.

"Proportionally fewer handgun owners carried handguns in states where issuing authorities had substantial discretion in granting permits," the study's authors said. 

The authors claimed that very "little was known about the frequency and features of firearm carrying among adult handgun owners in the United States before this study. In fact, over the past 30 years, only a few peer-reviewed national surveys, conducted in 1994,1995, 1996, and 2015, have provided even the most basic information about firearm carrying frequency."

Research firm Ipsos conducted the national survey between July 2019 and August 2019. Respondents were from firearm-owning households drawn from Ipsos's Knowledge Panel, an online sampling pool of approximately 55,000 adults. 

There was no explanation by the study's authors for the rapid increase in daily handgun-carrying adults. But during the period, social unrest in Ferguson, Missouri, and Baltimore City, Maryland, as well as surging violent crime across certain metro areas, could be the reason behind the trend. 

After all, an overwhelming number of respondents said they were carrying handguns for "personal protection." 

"And all of these increases happened before the Covid lockdowns and the "Summer of Love" where many US cities experienced massive rioting, violence and staggering increases in crime," firearms blog Bearing Arms said. Much of this unleashed a tidal wave of law-abiding citizens panic buying guns, even to this day, for personal protection. 

And then there's this summer's US Supreme Court's NYSRPA v. Bruen ruling affirmed the right-to-carry applies outside the home, which forces states to stop arbitrarily denying carry permits to applicants who didn't meet specific requirements. This ruling has allowed millions of gun owners to conceal carry if they take a two-day class and pass a background check.  

Suppose the authors were to update the study for the pandemic years and the Bruen ruling. In that case, we believe the number of Americans packing heat has dramatically increased as the country is plagued with violent crime in progressively run cities.