(Reuters) – The U.S. Food and Drug Administration on Saturday granted emergency use authorization to Yale School of Public Health’s saliva test to detect COVID-19, after a trial on National Basketball Association players and staff.
SalivaDirect, the fifth saliva test approved by the FDA for the disease, requires no swab or collection device and uses spit from people suspected of having the coronavirus, the agency said. (bit.ly/3fZyX30)
FDA Commissioner Stephen Hahn called the test “groundbreaking” in its efficiency and in being unaffected by crucial component shortages.
SalivaDirect is seen as a cheap, simpler and less invasive testing method that requires no extraction of nucleic acid and can use several readily available reagents.
The NBA has used the test in a program involving asymptomatic players, coaches and staff from various teams, after partnering with Yale in June, the school said (bit.ly/3iOlYmf) in a separate statement.
“We simplified the test so that it only costs a couple of dollars for reagents, and we expect that labs will only charge about $10 per sample,” Nathan Grubaugh, assistant professor at Yale School of Public Health, said.
One of the goals of the research team was to eliminate the need for expensive saliva collection tubes, and a separate study found that the virus is stable in saliva for prolonged periods at warm temperatures, and that preservatives or special test tubes were not necessary, Yale said.
The FDA said the test could lower the risk to healthcare workers from collecting samples as it is self-collected under the observation of a healthcare professional.
Reporting by Bhargav Acharya in Bengaluru; Editing by Richard Chang and Will Dunham
NYC biotech LB Pharmaceuticals eyes $75M for new take on decades-old schizophrenia drug
As Karuna Therapeutics wraps up its FDA approval request for what could be the first new type of schizophrenia drug in decades, another East Coast biotech…
As Karuna Therapeutics wraps up its FDA approval request for what could be the first new type of schizophrenia drug in decades, another East Coast biotech is raising $75 million to test an adjusted version of a decades-old medicine for the disorder next year.
LB Pharmaceuticals has secured about $35 million so far and expects another $40 million in the round, according to an SEC filing on Thursday. Per the financial document, its board includes directors associated with Vida Ventures, Pontifax, Deep Track Capital and TCGX, a crossover firm that has invested in multiple nine-figure biotech financings in recent months, including Carmot Therapeutics, Alkeus and Upstream Bio.
LB declined to comment.
The New York City biotech plans to run a Phase II trial of a chemically differentiated form of amisulpride, a D2 and D3 antagonist that has been available in Europe and more than 50 countries for decades, according to an investor deck from June. Sanofi marketed it as Solian, which generated €135 million in sales in 2002 for the French Big Pharma. It’s since become available as a generic.
LB’s board includes Piero Poli, CEO of Swiss drugmaker Rivopharm, which produces generic amisulpride. In February 2020, Acacia Pharma secured FDA approval for an IV formulation of amisulpride in certain postoperative patients with nausea, marketing it as Barhemsys.
With its methylated version of amisulpride, LB says its oral asset LB-102 has the potential to be more effective at lower doses by improving blood-brain barrier permeability, per the investor deck. Its new chemical structure gives LB-102 IP protection until “at least 2037.” LB has positioned the drug as a blockbuster treatment that could generate $1 billion or more in annual sales, pointing to antipsychotic prescriptions in the EU with an average price of $2,000 per month.
The drug is set to go into Phase II testing in adults with acute schizophrenia in the first quarter of next year, per the June document.
The company expects to enroll about 350 people at 25 sites, testing whether three doses of the drug are better than placebo based on the commonly used schizophrenia clinical trial measure known as PANSS, or Positive and Negative Syndrome Scale. Karuna’s M1/M4-preferring muscarinic agonist KarXT has passed two Phase III trials that use that measure, leading to massive financing hauls for the biotech and Cerevel Therapeutics. Boston-based Karuna plans to submit its approval request to the FDA this quarter. Meanwhile, Sumitomo and Otsuka’s ulotaront failed a Phase III on the PANSS test two months ago.
LB expects the study to focus on in-patients for four weeks. Pending the mid-stage results, the company would likely then take LB-102 into multiple Phase III trials in 2025, with plans to submit an NDA in 2028, per the June presentation. The company sees schizophrenia as the first step, with potential for studies in depression, bipolar depression and other indications.
The drug developer is led by a former family office manager, CEO Zachary Prensky. LB’s medical chief is Anna Eramo, who previously ran clinical and medical affairs at Lundbeck’s US operations and worked on the development of Rexulti, approved for schizophrenia and other indications. Science chief Andrew Vaino and chief financial officer Marc Panoff were previous executives at Retrophin.
Prensky co-founded LB with Vincent Grattan, a pharmacist who came across amisulpride in the 2000s while working on medication managements in multiple prisons. “As many are aware, correctional facilities are de facto mental health hospitals, and I wanted to make sure we were stocking the most reliable medications,” he told Psychiatric News in 2021.depression treatment testing fda medication europe eu
Dana-Farber, Brigham breakup could lead to a ripple effect for CGT clinical trials for cancer
Dana-Farber Cancer Institute announced on Sept. 14 that it is securing a new joint venture with Beth Israel Deaconess Medical Center, marking a breakup…
Dana-Farber Cancer Institute announced on Sept. 14 that it is securing a new joint venture with Beth Israel Deaconess Medical Center, marking a breakup of its decadeslong adult cancer care partnership with Brigham and Women’s Hospital.
The news shocked Brigham, which had been negotiating a partnership extension with Dana-Farber for the past 15 months, according to the Boston Globe.
There are around 20 ongoing cell therapy clinical trials under the Dana-Farber Brigham Cancer Center, which comprises 12 treatment centers with experts from Dana-Farber and Brigham working together. Brigham also has its own gene and cell therapy institute and a lab dedicated to next-generation, genetically-modified CAR-T cell therapies for cancer.
With the Dana-Farber contract set to end in 2028, concerns have been raised about the impact on current cell and gene therapy (CGT) studies and ones that are scheduled to start, due to the complex nature of the treatments involved.
Manufacturing CGTs is a skill- and labor-intensive process. Ori Biotech CEO Jason Foster told Endpoints News that hospitals and research centers often work together to make them on-site for clinical trials, with highly skilled experts from the specialty centers playing a key role. UK-based Ori develops technologies that automates CGT manufacturing.
At Dana-Farber Brigham Cancer Center’s cellular therapies program, cells are processed at an outside commercial facility or at the Connell and O’Reilly Families Cell Manipulation Core Facility.
When such partnerships come to an end, “that kind of [specialist] knowledge loss is something that will impact both the trajectory of [CGT] trials, but also the time it takes to get these products to patients,” Foster added.
These potential negative impacts on trials would only compound preexisting barriers to access to CGTs, including high costs and lengthy manufacturing processes. Estimates suggest that 25% of patients die while waiting for CAR-T treatments, according to ASCO Post.
Lee Buckler, senior vice president of advanced therapies at Blood Centers of America, told Endpoints in an email that collaboration between research institutes and healthcare providers was of significant — if not critical — value to the testing of CGTs.
A Brigham spokesperson said that the hospital is one of the largest recipients of NIH funding and does not expect any changes to trials already under agreement, adding it would continue to be a leader in the CGT space. “We are also planning for a new, state of the art Brigham facility which will include the medical oncology specialty,” the spokesperson said.
Dana-Farber did not respond to Endpoints before deadline.
Problems with CGT trials could be both the cause and the effect of partnership breakdowns. Buckler said that general hospitals are often reluctant to facilitate the kinds of clinical trial protocols associated with innovative CGTs, which may drive research centers to align with partners more willing to prioritize them.
Under the new partnership with Beth Israel, Dana-Farber plans to create a free-standing state-of-the-art cancer hospital, which it said would have the flexibility to “incorporate the innovations and technology in cancer care that Dana-Farber’s and BIDMC’s researchers and clinicians are developing every day.”
But a dedicated cancer hospital is not necessarily better at carrying out CGT trials than a general hospital with a tightly-integrated cancer specialty.
“I’ve seen general hospitals with tremendous capabilities and specific hospitals with tremendous capabilities — it really depends on the particular hospital,” Orgenesis CEO Vered Caplan told Endpoints in an interview. Germantown, MD-headquartered Orgenesis rolls out CGT mobile processing units and labs for cancer treatment to hospitals.
Regardless, the breakup means Dana-Farber must convince patients that its program with Beth Israel will provide at least the same quality care as the Brigham partnership, while Brigham must rebuild its specialist capabilities without Dana-Farber expertise.treatment testing clinical trials therapy uk
Democrat Sen. Bob Menendez, Wife Indicted Over Gold Bar And Other Bribery Schemes
Democrat Sen. Bob Menendez, Wife Indicted Over Gold Bar And Other Bribery Schemes
Sen. Bob Menendez (D-NJ) and his wife Nadine have been indicted…
Sen. Bob Menendez (D-NJ) and his wife Nadine have been indicted in New York for allegedly accepting bribes in relation to an allegedly corrupt relationship they had with three businessmen from their home state. The indictment also charges three businessmen, Wael Hana, Jose Uribe and Fred Daibes.
"Those bribes included cash, gold, payments toward a home mortgage, compensation for a low-or-no-show job, a luxury vehicle, and other things of value," reads the indictment.
Daibes, a developer and former bank chairman, allegedly gave Menendez gold bars valued at approximately $400,000, in exchange for assistance in a case in which he faced federal bank charges.
Instead of facing over 10 years in prison, Daibes, a felon, only ended up serving probation after striking an agreement with the US Attorney's Office in New Jersey.
"For purposes of the Federal Extortion Act, it makes no difference if the senator took an official act so long as he accepted the money and there was knowledge the money was in exchange for that official influence, even if he never carried out what he had promised he would do," according to NBC Legal Analyst Danny Cevallos.
Menendez disclosed that his family had accepted gold bars in 2020. Daibes encountered bank fraud charges that could have netted him up to a decade in prison for lying about a nearly $2 million loan from Mariner's Bank, where Daibes served as chairman.
Last year, however, New Jersey's U.S. Attorney's Office agreed to let Daibes plead guilty to one count and serve probation. They said Daibes had repaid the loan. -Fox News
According to the report, Menendez, 69, is 'close' with US Attorney Philip Sellinger - having supported him for the position, while Sellinger had previously raised funds for Menendez's campaign.
Officials are also looking at whether Menendez, the former Chairman of the powerful Senate Foreign Relations Committee, or his wife, had improperly received gifts from a New Jersey food processor who obtained an exclusive contract with the Egyptian government to certify halal food experts around the world.
Egyptian officials and the New Jersey businessman who received the contract were hosted by Menendez in his office in 2018, according to the Wall Street Journal. A year later, the businessman became the "sole certifier of halal meat exported from the U.S. to Egypt," the outlet noted.
NBC News 4 said the gifts included the usage of a Mercedes and a luxury Washington, D.C., apartment. Investigators are attempting to resolve if Menendez, chair of the Senate Foreign Relations Committee, used his standing to help the man secure the contract. -Fox News
According to the indictment, Menendez provided 'sensitive US Government information to Egypt.'
Indictment says this info wasn't classified, but was "highly sensitive." And it was shared very shortly after Menendez allegedly sought it. pic.twitter.com/GQPqXdLgYB— Aaron Blake (@AaronBlake) September 22, 2023
Menendez and his wife are charged with three counts: conspiracy to commit bribery, conspiracy to commit honest services fraud, and conspiracy to commit extortion under color of official right.
In June of last year, federal agents searched Menendez's New Jersey home, where they found "fruits" of the pair's "corrupt bribery agreement" with the three businessman - including over $480,000 in cash, some of which was stuffed in envelopes, and $70,000 in Nadine Menendez's safe deposit box.
They also found gold bars worth over $100,000, "provided by either Hana or Daibes."
In the months before his office admitted he was under federal investigation, Menendez's wife sold up to $400,000 in gold bars between April 7, 2022 and June 16, 2022.
A press event will be held today at 11:00 a.m. to announce the unsealing of an indictment charging Robert Menendez, U.S. Senator from New Jersey, and his wife, Nadine Menendez, with bribery offenses in connection with their corrupt relationship with three New Jersey businessmen. pic.twitter.com/CLTXnU0mAm— US Attorney SDNY (@SDNYnews) September 22, 2023
If we’ve learned anything from DOJ this year, it’s that if you’re going to take gold or diamonds from foreigners in exchange for official acts, your last name had better be Biden.— Sean Davis (@seanmdav) September 22, 2023
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