Bioactive glasses, doped with gallium developed to create a potential treatment for bone cancer
Lab tests have a 99 percent success rate of killing cancerous cells
Method could also regenerate diseased bones.
Bioactive glasses, a filling material which can bond to tissue and improve the strength of bones and teeth, has been combined with gallium to create a potential treatment for bone cancer.
Tests in labs have found that bioactive glasses doped with the metal have a 99 percent success rate of eliminating cancerous cells and can even regenerate diseased bones.
In laboratory tests 99% of osteosarcoma (bone cancer) cells were killed off without destroying non-cancerous normal human bone cells. The researchers also incubated the bioactive glasses in a simulated body fluid and after seven days they detected the early stages of bone formation.
Osteosarcoma is the mostly commonly occurring primary bone cancer and despite the use of chemotherapy and surgery to remove tumours survival rates have not improved much since the 1970s. Survival rates are dramatically reduced for patients who have a recurrence and primary bone cancer patients are more susceptible to bone fractures.
Despite extensive research on different types of bioactive glass or ceramics for bone tissue engineering, there is limited research on targeted and controlled release of anti-cancer agents to treat bone cancers.
Professor Martin said: “There is an urgent need for improved treatment options and our experiments show significant potential for use in bone cancer applications as part of a multimodal treatment.
“We believe that our findings could lead to a treatment that is more effective and localised, reducing side effects, and can even regenerate diseased bones.
“When we observed the glasses, we could see the formation of a layer of amorphous calcium phosphate/ hydroxy apatite layer on the surface of the bioactive glass particulates, which indicates bone growth.” The glasses were created in the Aston University labs by rapidly cooling very high temperature molten liquids (1450o C) to form glass. The glasses were then ground and sieved into tiny particles which can then be used for treatment.
In previous research the team achieved a 50 percent success rate but although impressive this was not enough to be a potential treatment. The team are now hoping to attract more research funding to conduct trials using gallium.
Dr Lucas Souza, research laboratory manager for the Dubrowsky Regenerative Medicine Laboratory at the Royal Orthopaedic Hospital, Birmingham worked on the research with Professor Martin. He added: “The safety and effectiveness of these biomaterials will need to be tested further, but the initial results are really promising. “Treatments for a bone cancer diagnosis remain very limited and there’s still much we don’t understand. Research like this is vital to support in the development of new drugs and new methodologies for treatment options.”
More women chose to have their tubes tied after Roe v. Wade was overturned in 2022, a new study shows, and the biggest increases were in states that ban abortion.
A research letter published Wednesday in JAMAopens in a new tab or window examined insurance claims data from 2021 and 2022 for around 4.8 million women who got tubal ligations, which are surgeries to close the fallopian tubes so the patient can no longer get pregnant. The data came from 36 states and Washington, D.C., and researchers categorized these places as "banned," "limited," or "protected," based on their abortion policies.
In the 18 months before the Dobbs decision in late June 2022opens in a new tab or window, tubal ligations remained stable in all three groups of states. But in the latter half of 2022, the procedure rose in all three groups. Researchers also looked at sustained change in the numbers over time, finding that tubal ligations rose by 3% each month in banned states.
It's "not entirely surprising" given the changes to abortion laws, said Xiao Xu, PhD, lead author of the research letter and associate professor of reproductive sciences at Columbia University's Vagelos College of Physicians and Surgeons.
The research letter adds to other findings about a rise in sterilization procedures after Roe was overturned, including a study from researchers published in April in JAMA Health Forumopens in a new tab or window that found an abrupt increase in tubal ligations among women ages 18-30 and vasectomies among men in that age group.
"It looks like the data they used were able to break things down by state, which is nice and something we were unable to do with the data we used," said Jacqueline Ellison, PhD, an author of the April study who works at the University of Pittsburgh's School of Public Health.
Clayton Alfonso, MD, recalled seeing a rise in tubal ligations in his ob/gyn practice at Duke University in North Carolina, "especially closer to the Dobbs decision."
Patients who didn't want more -- or any -- children were worried about contraceptives failing and becoming pregnant unexpectedly, said Alfonso, who wasn't involved in either study. Patients told him they would rather be sterilized in case they weren't able to get an abortion.
North Carolina banned most abortions after 12 weeksopens in a new tab or window of pregnancy in 2023. Alfonso said the number of patients seeking tubal ligations has fallen a bit, which he suspects happened when people became more certain about local laws.
He also said he'd like to see research on what happens past 2022, given the "ever-evolving landscape." Xu said her team is interested in doing such a study when the data become available.
Democratic vice presidential nominee, Minnesota Gov. Tim Walz, has come under fire for appointinga Chinese lawyer with longstanding ties to a CCP-friendly political factionto a key state advisory board.
The lawyer, Chang Wang, was first appointed by Walz in May 2020 to the Council on Asian Pacific Minnesotans, which advises the governor, legislature, and other state agencies on promoting "economic, social, legal and political equality" for Asian Pacific Minnesotans. As of now, Wang is the interim chair of the council, with his term set to expire in January 2025. According to the council's annual report, it spent over half a million dollars of taxpayer money in 2023 according to the Daily Caller.
According to the report, Wang has ties to the China Association for Promoting Democracy (CAPD), a political party in China that operates under the strict supervision of the CCP - which the Caller uncovered through "a review of Chinese government announcements, archived University of Minnesota records and Chinese-language publications written by Wang himself."
CAPD is one of the handful of alternative Chinese political parties allowed to operate in the communist nation. Like China’s other minor parties, CAPD is “loyal” to the CCP and continues “to function within the structure of the Chinese People’s Political Consultative Conference (CPPCC),” which is the country’s top political advisory body, according to the Federal Research Division of the Library of Congress.
CAPD is allowed to operate in China based upon their organization’s stated promise to “rally closely around” the CCP’s Central Committee and play a role as advisors and assistants to the CCP, according to Xinhua, China’s official news agency. -Daily Caller
According to the Federal Research Division of the Library of Congress, CAPD's operational status is based on its "stated promise to 'rally closely around' the CCP’s Central Committee and play a role as advisors and assistants to the CCP," as reported by Xinhua, China’s official news agency.
Records show that Wang, since joining the Minnesota state council, has been recognized by the Chinese government multiple times. For example, the Chinese government granted him a title and even accepted a policy research proposal he submitted. When asked about his relationship with CAPD, Wang replied in an email to the DCNF - saying: "My elderly parents are my only ties to China." Meanwhile, Wang’s profile on the University of Minnesota’s website appears to have scrubbed his CAPD affiliation, though an archived version contains it.
Wang has also disclosed in the past that his parents were "senior scientists" at "Academia Sinica," the former name of the Chinese Academy of Sciences (CAS). CAS reports directly to China's State Council, and "much of its work contributes to products for military use," according to the U.S. Department of Defense. Steve Yates, China Policy Initiative chair at the America First Policy Institute and a former Chinese language analyst for the National Security Agency, pointed out the significance of this connection: "For someone to have two parents in that entity, it basically is the equivalent of being not just a made man, but a made family."
Further complicating the matter, Wang has stated that he works as a senior associate professor of law at the Beijing-based China University of Political Science and Law, and the university's website still lists him as faculty.
Walz’s connections with China and its political structures have been a focus of Republican lawmakers. Kentucky Rep. James Comer, for example, sent a letter to FBI Director Christopher Wray requesting information about "any Chinese entity or individual with whom Mr. Walz may have engaged or partnered."
Walz's history with China is extensive. He has traveled to the country approximately 30 times and even worked for Macau Polytechnic University while serving in Congress, as noted in Comer’s letter. Previous media reports have also unearthed past comments from Walz that appear to praise Chinese communism. For instance, Walz reportedly told high school students in 1991 that communism "means that everyone is the same and everyone shares."
More recently, the DCNF reported that Walz has attended several events organized by members of a Minnesota nonprofit affiliated with a CCP influence and intelligence agency. Members of the nonprofit and related organizations even held a fundraiser for Walz’s gubernatorial reelection in 2022. Yates, commenting on the appointment of Wang, questioned, "You would think that there would be some screening. Of what possible value-add is someone with ties to that entity in China to the citizens of the United States or to Minnesota, and why would a governor with a generation of experience coming and going to the People’s Republic of China want someone from that world having privileged access to advise leaders in Minnesota on any issue?"
Despite the word "democracy" in its name, CAPD is described as "a political party that accepts the leadership of the CCP and cooperates with the CCP as a participant in socialism with Chinese characteristics." Its members are mainly intellectuals working in academia, science, media, and related fields. As Yates points out, "When you are engaging entities from communist countries that have the word ‘democracy’ in them, you have a near 100% chance that they’re not really about democracy. You’re talking about organizations that are meant to interact with people and groups in the Free World on behalf of the ultimate authority in the PRC: the CCP."
John Dotson, deputy director of the Global Taiwan Institute, echoed similar concerns: "CAPD is one of what the CCP calls the ‘eight democratic parties’ that operate alongside the ruling CCP, in the effort to provide a veneer of pluralism to the [Chinese] system." Dotson further emphasized, "Anyone who is a member of one of the ‘eight democratic parties’ should be understood as a CCP member, subject to Party directives, etcetera."
The DCNF uncovered Wang’s CAPD membership through a review of multiple archived profiles in both English and Chinese. One archived version of Wang’s 2022 bio on the University of Minnesota’s China Center website identified him as "one of the twenty-five members serving on the Central Civil and Judiciary Committee of China Association For Promoting Democracy, the third largest political party in mainland China." However, between January and July 2023, references to Wang's membership in CAPD were removed from his China Center bio. The China Center did not respond to the DCNF’s requests for comment. Meanwhile, CAPD’s Chinese-language website still lists Wang as a member of its Central Civil and Judiciary Committee and identifies him as a professor at the Institute of Comparative Law at China University of Political Science and Law.
Tremfya’s ulcerative colitis approval on Wednesday comes as Johnson & Johnson’s blockbuster immunotherapy Stelara continues to face growing competition from biosimilars.
The FDA on Wednesday approvedJohnson & Johnson’s therapeutic antibody Tremfya (guselkumab) for the treatment of adult patients with moderate to severe active ulcerative colitis.
According to the pharma, Tremfya is now the first and only fully-human, dual-acting monoclonal antibody for ulcerative colitis (UC). Tremfya not only blocks IL-23 to dampen the inflammatory response but also targets the CD64 receptor on cells that secrete IL-23, such as activated macrophages and monocytes.
Christopher Gasink, J&J’s vice president for medical affairs, gastroenterology and autoantibody, in a statement said that the approval gives UC patients a new treatment option that provides “meaningful improvements in symptoms” as well as the “promise of remission.” J&J is also seeking approval for Tremfya in Crohn’s disease.
Tremfya is already approved for the treatment of moderate-to-severe plaque psoriasis and psoriatic arthritis.
Backing Wednesday’s approval are findings from the Phase IIb/III QUASAR study, a randomized, double-blinded and parallel-group study that tested 200-mg and 100-mg doses of Tremfya in patients who had previously shown suboptimal response—or were otherwise intolerant to—conventional therapies, including biologics and JAK inhibitors.
Results showed that 50% of patients given 200 mg of Tremfya every four weeks achieved clinical remission at 44 weeks, compared with only 19% on placebo. Those who received the lower 100-mg dose every eight weeks had a clinical remission rate of 45%. The treatment effects for both dose groups were statistically superior to placebo, according to J&J.
Endoscopic remission at one year was likewise significantly better for the 200-mg and 100-mg Tremfya doses, with respective rates of 34% and 35%, versus 15% in the placebo arm. QUASAR also “reinforced the well-established safety profile” of Tremfya, the company said.
The findings continue “to raise the bar for efficacy in the treatment of this inflammatory bowel disease,” according to Gasink.
Wednesday’s approval adds to J&J’s efforts to protect its bottom line from growing biosimilar competition for its blockbuster immunotherapy Stelara (ustekinumab). First approved in 2009 for moderate-to-severe plaque psoriasis, Stelara quickly became one of J&J’s top-performing assets, winning additional indications in ulcerative colitis and Crohn’s disease, among others.
In 2023, Stelara sales jumped 11.7% year-over-year to $10.9 billion. However, the recent expiration of one of its key patent protections has opened the door to biosimilar competitors to enter the market. In November 2023, Amgen won approval for its interchangeable Stelara copycat Wezlana (ustekinumab-auub) for several inflammatory conditions. Teva and Alvotech followed suit in April 2024 with a regulatory victory for Selarsdi (ustekinumab-aekn), set to launch in early 2025.
Compounding J&J’s Stelara challenges is a recent announcement from Cigna’s Evernorth Health Services that it would offer patients an interchangeable biosimilar at $0 out-of-pocket cost starting next year.
Sanofi will join Big Pharma peers Novartis, BMS and Eli Lilly in radioligands, striking a $110 million licensing deal with RadioMedix and Orano Med to develop AlphaMedix for neuroendocrine tumors.
Sanofi has become the next Big Pharma company to challenge Novartis in the field of radiopharmaceuticals, inking a $110 million licensing deal to work with RadioMedix and Orano Med on a neuroendocrine tumor candidate.
The three-way deal will see Sanofi pay out €100 million ($110 million) upfront, with €220 million ($242.5 million) in sales milestones, plus royalties, according to a Thursday press release. RadioMedix is a U.S.-based biotech developing radiopharmaceuticals for PET imaging and targeted alpha therapy for unmet needs in cancer. Orano Med is a French company developing radioligand therapies.
The focus of the deal is AlphaMedix, a targeted radioligand therapy that uses lead-212Pb to target cancer. Truist Securities noted that pharmas have been zeroing in on Lead as the next big thing in radioligand therapy. The potential advantages include a short half-life and clearance, delivery of potent alpha emission and more abundant source material, according to Truist analysts.
With that said, Truist warned that investors are concerned about a lack of clarity around distribution logistics for the one-time delivery of the therapy and potential safety concerns.
Under the deal, Sanofi will be responsible for commercialization while Orano Med will conduct manufacturing. AlphaMedix is currently in a Phase II trial for gastroenteropancreatic neuroendocrine tumors (GEP-NETs), according to RadioMedix’s pipeline.
Sanofi is the latest Big Pharma to enter the radioligand space. The clear front runner is Novartis, which has two therapies already approved with Pluvicto for prostate cancer and Lutathera for GEP-NETs.
AstraZeneca, Bristol Myers Squibb and Eli Lilly have all struck major deals over the past year to enter the space. The largest was BMS’s $4.1 billion acquisition of RayzeBio in December 2023.
Lilly has done both a licensing deal with Aktis Oncology and a full buyout of Point BioPharma for $1.4 billion to get in on the action.
Novartis began its journey into radioligands in 2017 with the acquisition of Advanced Accelerator Application for $3.9 billion, followed by the $2.1 billion buyout of EndoCyte in October 2018 and then Mariana Oncology for $1 billion upfront and $750 million in milestones in May .
With a Friday advisory committee meeting looming, the sole indication for Intercept Pharmaceuticals’ Ocaliva appears to be at risk as the regulator flags issues regarding its post-marketing results.
The FDA could pull the accelerated approval for Intercept Pharmaceuticals’ Ocaliva (obeticholic acid) for primary biliary cholangitis, as the agency cites problems with post-marketing data ahead of an advisory committee meeting.
The regulator will convene its Gastrointestinal Drugs Advisory Committee on Friday to discuss the matter.
In the meantime, the FDA’s internal staffers released a briefing document outlining the agency’s concerns regarding Ocaliva. In one of its confirmatory trials, dubbed 747-302, Ocaliva “failed to demonstrate efficacy” on the primary composite endpoint of liver transplantation, death and other liver-related outcomes. The study focused on primary biliary cholangitis (PBC) patients with chronic disease.
The FDA’s analysis of 747-302’s data also showed that Ocaliva led to “unfavorable trends” in liver transplantation and mortality.
An observational cohort study with real-world evidence that Intercept submitted to bolster Ocaliva’s case also “did not demonstrate clinical benefit” compared to PBC patients who were not being treated with Ocaliva.
The third study under contention is another post-marketing confirmatory trial dubbed 747-401, which was designed to evaluate the pharmacokinetic and pharmacodynamic profiles of Ocaliva in PBC patients with Child-Pugh classes B and C. However, while the study was ongoing, the FDA flagged reports of hepatotoxicity associated with Ocaliva, which led to substantial changes in the drug’s boxed warning and safety labels.
“As a result of this regulatory action, Trial 747-401 was terminated because OCA was now contraindicated for the entire study population,” the FDA staffers wrote in the briefing document. Some patients in the747-302 study also had to drop out because of this labelling adjustment, though the regulator contends that “it reached study closure and achieved the target number of events” for an analysis of its efficacy endpoint.
The advisory committee will deliberate on whether the findings from the observational study and the 747-302 trial are enough to confirm the clinical benefit of Ocaliva in PBC, or if Intercept needs to run additional studies. Given its safety signals, the panel will also discuss whether Ocaliva’s clinical benefits outweigh its risks.
Ocaliva is a farnesoid X receptor agonist that works by preventing the build-up of bile acid in the liver. The FDA granted it accelerated approval in 2016 for PBC. Intercept has tried and twice failed to secure approval in metabolic dysfunction-associated steatohepatitis (MASH)—the first in June 2020 and then again in June 2023—which forced the company to abandon its MASH program and lay off one-third of its staff.
General Motors is in talks to buy electric vehicle batteries that would use technology from China's CATL and be assembled at a new plant in the United States, a person briefed on the matter confirmed on Thursday.
Crosstown rival Ford Motor already plans to license CATL technology to produce low-cost lithium-iron batteries at a battery plant it is building in Michigan under a plan announced in February 2023.
But U.S. lawmakers including Intelligence Committee vice-chair Marco Rubio have raised concerns about Ford's plan.
In GM's case, the proposed plant would be funded and operated by Japanese consumer electronic firm TDK Corp, Bloomberg News reported, and is expected to be located in the south of the United States and to create more than 1,000 jobs.
Talks are still ongoing and many details are still unclear, the source told Reuters, with no final deal expected immediately. A deal could help GM produce lower-cost batteries and by assembling them in the United States, avoid new U.S. tariffs.
"Our EV strategy is focused on designing products that continue to lower cost, improve performance and localize production. Battery technology is a key enabler of that strategy. We won’t comment on speculation," GM said.
CATL did not immediately respond to a request for comment.
Automakers face tens of billions of dollars in capital costs to build new EVs and batteries, as they race to put out greener vehicles that comply with stringent emissions regulations amid heavy competition around the globe.
Industry officials previously said that if Ford was allowed to proceed with its CATL deal, other automakers would quickly follow suit so they could also cut costs.
Earlier, GM and Hyundai Motor announced that they have agreed to explore future collaboration across key strategic areas including potential joint vehicle development, supply chains and clean-energy technologies.
