Rapid Micro Biosystems, Inc. (Nasdaq: RPID) (the “Company”), an innovative life sciences technology company providing mission critical automation solutions to facilitate the efficient manufacturing and fast, safe release of healthcare products, today announced that Samsung Biologics (KRX: 207940.KS) has selected the Growth Direct® platform to automate its microbial quality control processes to deliver increased efficiency, more robust data integrity and scalable quality control operations.
Thursday, January 4, 2024
Adicet Corporate Update and Strategic Priorities
Expanding clinical development of ADI-001 into autoimmune diseases following clearance of Investigational New Drug Application (IND); plan to initiate Phase 1 clinical study in 2Q 2024
Focusing enrollment on mantle cell lymphoma (MCL) in ongoing ADI-001 Phase 1 clinical trial given favorable complete response (CR) rate, durability, and safety
ADI-001 clinical update expected 2H 2024
ADI-270 IND submission in renal cell carcinoma expected in 2Q 2024
Updated cash runway into 2H 2025
Wegovy maker Novo Nordisk signs research partnerships with U.S. biotech firms
Blockbuster weight-loss drug maker Novo Nordisk announced on Thursday research collaborations with two U.S. biotech firms, part of its efforts to stay ahead in big pharma's race to develop more treatments for cardiometabolic diseases.
Novo, a Danish drugmaker whose share price rose 49% last year as demand soared for its new weight-loss medicine Wegovy, said the partnerships with Omega Therapeutics and Cellarity Inc could lead to new treatments for people living with obesity and a type of liver disease known as MASH.
The two separate research and development collaborations are the first announced under a framework deal that Novo signed in 2022 with Flagship Pioneering, a U.S. investment firm focused on life sciences.
Omega and Cellarity are both portfolio companies of Flagship. The companies will jointly conduct pre-clinical trial drug development work with Novo. After that, Novo could advance the programmes into clinical studies, it said in a statement.
Under the terms of the respective agreements, Novo will reimburse research and development (R&D) costs. Each agreement may pay up to $532 million in upfront, development and commercial milestone payments, as well as tiered royalties on annual net sales of a licensed product, to be shared between the respective companies and Flagship.
Uli Stilz, Vice President of Novo's Bio Innovation Hub in Cambridge, Massachusetts, told Reuters that the project will enable innovation which neither Novo nor the other companies could do alone.
Stilz, who will run the research partnerships, said the work runs in parallel to Novo's later stage clinical collaborations and its acquisition of other companies through bolt-on deals which ramped up last year as Novo's war chest grew on record profit. "I can confirm that we will do all of it."
https://finance.yahoo.com/news/wegovy-maker-novo-nordisk-signs-110000290.html
Wednesday, January 3, 2024
Not just Trump: Democrats are moving to bar Republicans from ballots nationwide
As the decisions disqualifying former President Donald Trump from the 2024 election work their way through the courts, a new filing in Pennsylvania seeks the same “ballot cleansing” by barring Rep. Scott Perry.
It’s only the latest effort targeting congressional candidates as Democrats seek to bar opponents as “insurrectionists” for questioning the election of President Biden.
We have become a nation of Madame Defarges — eagerly knitting names of those to be subject to arbitrary justice.
Former congressional candidate Gene Stilp, who’s made headlines by burning MAGA flags with swastikas outside courthouses, filed the challenge.
Using the 14th Amendment to disqualify candidates like Perry is consistent with Stilp’s signature flag-burning stunts.
But what’s chilling is how many support such efforts, including Democratic officeholders from Maine’s secretary of state to dozens of members of Congress.
New Jersey Rep. Bill Pascrell sought to bar 126 members of Congress under the same theory for challenging the election before Jan. 6, 2021.
Rep. Cori Bush’s similar legislation to disqualify members got 63 cosponsors, all Democrats, including New York Reps. Alexandria Ocasio-Cortez, Jamaal Bowman and Ritchie Torres and Squad members Ilhan Omar and Rashida Tlaib.
When Maine’s secretary of state disqualified Trump, three in the state’s congressional delegation — Sens. Angus King (I) and Susan Collins (R) and Rep. Jared Golden (D) — condemned the decision. But others supported the antidemocratic action.
The grounds were virtually identical to those of Stilp. He accuses Perry of supporting challenges to Biden’s election and opposing its certification.
Of course, he ignores Democratic members who sought to block certification of Republican presidents under the very same law with no factual or legal basis.
Former Speaker Nancy Pelosi and Senate Judiciary Committee Chairman Dick Durbin praised the effort then-Sen. Barbara Boxer organized to challenge the certification of President George W. Bush’s 2004 reelection.
Jan. 6 committee head Bennie Thompson voted to challenge it in the House.
Rep. Jamie Raskin sought to block certification of the 2016 election result — particularly ironic since he’s a leading voice calling for Trump to be disqualified.
He insisted last week on CNN that the effort to prevent citizens from voting for Trump is the very embodiment of democracy: “If you think about it, of all of the forms of disqualification that we have, the one that disqualifies people for engaging in insurrection is the most democratic because it’s the one where people choose themselves to be disqualified.”
That is akin to treating every criminal charge as a consensual act of incarceration because the accused chose his path in life.
This is also being played out in state races.
The filing against Perry came the same day Pennsylvania Democratic state Sen. Art Haywood made public a complaint to the Senate Ethics Committee against his Republican colleague Doug Mastriano accusing him of playing a role in the plot to overturn the election.
Notably, in his effort to “hold insurrectionists accountable,” Haywood admitted he relied on the same evidence from Citizens for Responsibility and Ethics in Washington that was used in the Colorado case.
“Insurrectionist” is the newest label to excuse any abuse.
During the McCarthy period, individuals were accused of being Communists or “fellow travelers.”
These Democratic members and activists vividly demonstrated this unfounded theory’s dangerous implications.
Figures like Stilp are wrong on the law but right about one thing: There are few real limits once you embrace this theory.
If the challenges work, there is no reason they can’t be used unilaterally against any candidate (and without any criminal charges, let alone convictions).
It is instantly both self-executing and self-satisfying. It would put the world’s most successful democracy on a slippery slope to political chaos.
That is why the Supreme Court needs to take up this issue and put this pernicious theory to bed once and for all.
Until the court rejects this antidemocratic ploy, activists eager to win elections through the courts will keep using it, and it will metastasize throughout our body politic.
With the support of elected officials across the country, they can then join Stilp in moving from burning flags to torching the Constitution in a fit of exhilarating rage.
Jonathan Turley is an attorney and professor at George Washington University Law School.
Multiple state capitols receive bomb threats, prompting lockdowns
At least six state capitols across the country received bomb threats early Wednesday morning, prompting evacuations and lockdowns, though no dangerous items were immediately discovered.
Evacuations and lockdowns were reported at state capitols in Georgia, Kentucky, Mississippi, Montana, Connecticut and Michigan due to apparent bomb threats. It’s not clear whether or how the incidents might be connected.
The FBI said in a statement to The Hill that it was aware of the multiple threats, urging members of the public “to remain vigilant, and report any and all suspicious activity and/or individuals to law enforcement immediately.”
“The FBI takes hoax threats very seriously because it puts innocent people at risk. While we have no information to indicate a specific and credible threat, we will continue to work with our local, state, and federal law enforcement partners to gather, share, and act upon threat information as it comes to our attention,” the agency said in a statement.
Kentucky Gov. Andy Beshear posted on X, formerly Twitter, that the Kentucky State Police (KSP) was investigating a threat and had evacuated the state capitol in Frankfort.
“While everyone is safe, KSP has asked everyone to evacuate the state Capitol and is investigating a threat received by the Secretary of State’s Office,” Beshear posted. “We are aware of similar threats made to other offices across the country.”
Michon Lindstrom, a spokesperson for Kentucky Secretary of State Michael Adams, said in a statement that a threat was sent to secretaries of state across the country as a “mass email.” Lindstrom said the building was evacuated between 9 a.m. and 9:30 a.m. local time before reopening at noon.
The threat did not specifically mention certain secretaries, but Lindstrom told the The Lexington Herald-Leader that the email said bombs had been placed in state capitol buildings.
Another threat was reported at the Georgia state capitol, according to Gabriel Sterling, the chief operating officer for Georgia Secretary of State Brad Raffensperger.
“Starting 2024 with a bomb threat at the Georgia State Capitol. Delayed opening until the all clear is given,” Sterling posted on X. “Avoid the area for now.”
The Georgia Department of Public Safety later said a search was conducted, and an all-clear was given.
The department said an a statement it determined the bomb threat was not credible and was a hoax email sent to an employee Wednesday morning. The building opened just before 9 a.m. local time.
Mississippi Department of Public Safety spokesperson Bailey Martin confirmed a lockdown was underway Wednesday morning in Jackson due to a bomb threat sent to the state capitol building, according to multiple local news outlets. According to a statement posted on the Legislature site, “standard emergency procedures” were being followed.
Martin said in a statement to The Hill that the department concluded that there was no threat of explosives found in the building after a search.
“The Mississippi Department of Public Safety has successfully cleared the Mississippi State Capitol. The building was thoroughly searched, and no explosives or suspicious equipment were found,” Martin said. “This is an ongoing investigation and there is no further threat to the Capitol or surrounding buildings.”
Sgt. Jay Nelson of the Montana Highway Patrol (MTP) confirmed that a bomb threat targeting the Montana state capitol was received at 8:30 a.m. MTP troopers evacuated the building and the explosive detection K9 team swept the building.
A reporter for the Helena Independent Record posted on X that staff at the state capitol had been evacuated to nearby state buildings.
A sweep was completed and no credible threat was found, the Montana Department of Administration General Services said, adding the building had reopened to the public.
The Hill has reached out to Secretary of State Christi Jacobsen’s office for more information.
Connecticut State Capitol Police Lt. Gregory Wimble told The Hill that the state capitol was forced to evacuate just before 8 a.m. Wednesday morning after numerous employees received an email warning them about a bomb threat in the building. He said officers and an explosive-detecting dog were sent in to search the building and found nothing suspicious.
He said the building was cleared shortly before 10 a.m. and that officials will be working with state, local and federal partners to investigate the incident.
In Michigan, State Police said the state capitol building in Lansing would be closed for the rest of the day as a result of a bomb threat, according to a social media post. Police said an email was sent to a general account for the state capitol at about 7:45 a.m. local time on Wednesday.
It also said it was “aware of similar threats” sent around the country. Police said that they determined there “was no threat” but that the building will remain closed.
Long COVID Has Caused Thousands of US Deaths: New CDC Data
While COVID has now claimed more than 1 million lives in the United States alone, these aren't the only fatalities caused at least in part by the virus. A small but growing number of Americans are surviving acute infections only to succumb months later to the lingering health problems caused by long COVID.
Much of the attention on long COVID has centered on the sometimes debilitating symptoms that strike people with the condition, with no formal diagnostic tests or standard treatments available, and the effect it has on quality of life. But new figures from the US Centers for Disease Control and Prevention (CDC) show that long COVID can also be deadly.
More than 5000 Americans have died from long COVID since the start of the pandemic, according to new estimates from the CDC.
This total, based on death certificate data collected by the CDC, includes a preliminary tally of 1491 long COVID deaths in 2023 in addition to 3544 fatalities previously reported from January 2020 through June 2022.
Guidance issued in 2023 on how to formally report long COVID as a cause of death on death certificates should help get a more accurate count of these fatalities going forward, said Robert Anderson, PhD, chief mortality statistician for the CDC.
"We hope that the guidance will help cause of death certifiers be more aware of the impact of long COVID and more likely to report long COVID as a cause of death when appropriate," Anderson said. "That said, we do not expect that this guidance will have a dramatic impact on the trend."
There's no standard definition or diagnostic test for long COVID. It's typically diagnosed when people have symptoms at least 3 months after an acute infection that weren't present before they got sick. As of the end of last year, about 7% of American adults had experienced long COVID at some point, the CDC estimated in September 2023.
The new death tally indicates long COVID remains a significant public health threat and is likely to grow in the years ahead, even though the pandemic may no longer be considered a global health crisis, experts said.
For example, the death certificate figures indicate:
- COVID-19 was the third leading cause of American deaths in 2020 and 2021, and the fourth leading cause of death in the United States in 2023.
- Nearly 1% of the more than one million deaths related to COVID-19 since the start of the pandemic have been attributed to long COVID, according to data released by the CDC.
- The proportion of COVID-related deaths from long COVID peaked in June 2021 at 1.2% and again in April 2022 at 3.8%, according to the CDC. Both of these peaks coincided with periods of declining fatalities from acute infections.
"I do expect that deaths associated with long COVID will make up an increasingly larger proportion of total deaths associated with COVID-19," said Mark Czeisler, PhD, a researcher at Harvard Medical School who has studied long COVID fatalities.
Months and even years after an acute infection, long COVID can contribute to serious and potentially life-threatening conditions that impact nearly every major system in the body, according to the CDC guidelines for identifying the condition on death certificates.
This means long COVID may often be listed as an underlying cause of death when people with this condition die of issues related to their heart, lungs, brain or kidneys, the CDC guidelines noted.
The risk for long COVID fatalities remains elevated for at least 6 months for people with milder acute infections and for at least 2 years in severe cases that require hospitalization, some previous research suggested.
As happens with other acute infections, certain people are more at risk for fatal case of long COVID. Age, race, and ethnicity have all been cited as risk factors by researchers who have been tracking the condition since the start of the pandemic.
Half of long COVID fatalities from July 2021 to June 2022 occurred in people aged 65 years and older, and another 23% were recorded among people aged 50-64 years old, according a report from CDC.
Long COVID death rates also varied by race and ethnicity, from a high of 14.1 cases per million among America Indian and Alaskan natives to a low of 1.5 cases per million among Asian people, the CDC found. Death rates per million were 6.7 for White individuals, 6.4 for Black people, and 4.7 for Hispanic people.
The disproportionate share of Black and Hispanic people who developed and died from severe acute infections may have left fewer survivors to develop long COVID, limiting long COVID fatalities among these groups, the CDC report concluded.
It's also possible that long COVID fatalities were undercounted in these populations because they faced challenges accessing healthcare or seeing providers who could recognize the hallmark symptoms of long COVID.
It's also difficult to distinguish between how many deaths related to the virus ultimately occur as a result of long COVID rather than acute infections. That's because it may depend on a variety of factors, including how consistently medical examiners follow the CDC guidelines, said Ziyad Al-Aly, MD, chief of research at the Veterans Affairs, St. Louis Health Care System and a senior clinical epidemiologist at Washington University in St. Louis.
"Long COVID remains massively underdiagnosed, and death in people with long COVID is misattributed to other things," Al-Aly said.
An accurate test for long COVID could help lead to a more accurate count of these fatalities, Czeisler said. Some preliminary research suggests that it might one day be possible to diagnose long COVID with a blood test.
"The timeline for such a test and the extent to which it would be widely applied is uncertain," Czeisler noted, "though that would certainly be a gamechanger."
Pediatric Obesity Specialists Struggle to Get GLP-1 Agonists
While adults, many of whom don't meet the clinical definition of obesity, scramble to procure glucagon-like peptide 1 (GLP-1) agonists for weight loss, pediatric obesity specialists said their young patients who could benefit more over the long term often are unable to access the potentially life-altering medications.
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