The FDA’s inquiry revolves around reports indicating a possible link between certain CAR-T cell treatments and the development of T cell malignancies in patients undergoing these immunotherapies. This investigation sheds light on a critical aspect of CAR-T cell therapy safety and will require a closer examination of its implications for patient care and regulatory oversight.

C himeric antigen receptor T-cell (CAR T) therapy showed tremendous potential in treating hematological malignancies such as leukemia in recent years; however, it is linked with serious adverse effects that can be lifethreatening, such as severe cytokine release syndrome (CRS), explains Zhenyu Wei, PhD candidate. Past research indicated between 54% and 91 % of patients may manifest CRS during treatment, and if CRS is grade 3 or greater, it is considered serious. To help predict the occurrence and development of severe CRS, Wei and colleagues analyzed clinical data with artificial intelligence in a study published in Frontiers in Immunology. Although CAR T cell therapy has been used in about 4% of people living with leukemia, that percentage is expected to rise with the FDA approvals of six CAR T therapies since 2017. Also, studies have shown that CAR T therapy leads to significant clinical benefits for patients with leukemia with poor prognosis.

The researchers found that in the base-case analysis, the increase in median overall survival was four and one months for axi-cel and liso-cel, respectively. The incremental cost-effectiveness ratio was $684,225 and $1,171,909, respectively, per quality-adjusted life year (QALY) for axi-cel and liso-cel; the corresponding incremental net monetary benefit was −$107,642 and −$102,477. In sensitivity analysis, to be cost-effective with a willingness-to-pay threshold of $200,000 per QALY, the cost of CAR-T would need to be reduced to $321,123 and $313,730 for axi-cel and liso-cel, respectively. During a five-year period, implementation in high-risk patients would increase U.S. health care spending by about $6.8 billion.

The work is based on an invention by Minglin Ma of Cornell who conceived of a detachable polymer thread containing thousands of islet cells covered by a thin hydrogel covering that could be inserted into a patient's belly without inducing an immune reaction. Shapiro was already working on a diabetes skin implant with similar qualities and upon stumbling on Ma’s work had the idea of combining the two approaches. This proved very successful. “And indeed it worked! By combining the two, it really did improve the skin site for engrafting cells without the need for anti-rejection drugs. The data are very compelling,”.

The results suggest the existence of a batch-dependent safety signal for the BNT162b2 vaccine, and more studies are warranted to explore this preliminary observation and its consequences.

The platform employs clinical-grade AI to provide comprehensive patient medication information, with the aims of reducing manual data entry, enhancing patient safety and saving time for clinicians and pharmacists. It also offers prescription price transparency, enabling healthcare providers to access patients’ pharmacy benefits and out-of-pocket costs.

Patient adherence to the technologies associated with remote data collection is crucial for the success of RPM and clinical trials. Reliable data collection hinges on patients following the directions for using RPM devices to fully maximize their potential. And the older the age group, the bigger the challenge with technology.

It's been proven vitiligo, the autoimmune skin depigmentation condition, can be treated through hospital-based phototherapy, but recent studies show that self-treating, home-based therapy's adherence to treatment is significantly better. While phototherapy has been shown to have a positive effect on vitiligo as it works to reduce or prevent the destruction of skin cells, treatment done in the hospital can be long-term and require a number of visits.

Treatment adherence in pediatric patients with atopic dermatitis (AD) patients is key to seeing clearer skin in most cases. Steve Feldman, MD, PhD, professor at Wake Forest University School of Medicine in Winston-Salem, North Carolina, is presenting adherence strategies on an panel alongside AD treatment experts Peter Lio, MD, Medical Dermatology Associates of Chicago, and Amy Paller, MD, Northwestern University Feinberg School of Medicine, on July 14 from 11:15-11:45 am during the 2023 Society for Pediatric Dermatology Meeting in Asheville, North Carolina.

Becton, Dickinson and Co. (BD) and Biocorp are working together to use connected technology to track patient adherence with self-administered drug therapies, including biologics. The two companies plan to couple Biocorp’s Injay technology with BD’s UltraSafe Plus Passive Needle Guard used with prefillable syringes. Biocorp’s Injay technology, which is designed to “capture and transmit injection events using Near Field Communication (NFC) technology.

Medication is a staple of modern medicine, with almost 50% of adults in the United States taking at least one prescription medication. Despite this, pharmaceutical companies have not won over public trust. A recent study found that only 48% of participants expressed trust in pharmaceutical companies. This lack of trust in such a crucial industry can lead to decreased compliance, poor treatment adherence, and negative health outcomes for patients.

According to the study, simulated spaceflight conditions, particularly exposure to GCR, led to impairments in non-adrenergic non-cholinergic (NANC) nerve-mediated relaxation in the dIPA and CC tissues. These impairments suggested a potential pathway for erectile dysfunction in astronauts during deep space exploration missions.

Un large sourire s'affiche sur le visage de Vanina, 54 ans, lorsqu'elle évoque sa participation à l'essai clinique mené au CHU de Nantes. « Maintenant, j'ai peut-être une chance de vieillir », souffle-t-elle. Depuis cinq ans, cette mère de deux garçons se bat contre un myélome multiple, un cancer rare du sang.

Scientists at St. Jude validated a cellular immunotherapy target called 78-kDa glucose-regulated protein (GRP78) in proof-of-principle experiments. The group also discovered a resistance mechanism whereby some tumors trick the cancer-killing immune cells into expressing GRP78, thereby turning off the immune cells or causing them to be killed, too. The research, which has implications for developing immunotherapy for the broad range of difficult-to-treat brain and solid tumors expressing GRP78, was published today in Cell Reports Medicine.

Bayer’s plans to turn asundexian into a 5 billion euro ($5.5 billion) a year medicine have taken a hit. The factor XIa inhibitor had “inferior efficacy” to Bristol Myers Squibb and Pfizer’s Eliquis in a phase 3 trial, prompting Bayer to stop the study early while continuing to advance the asset in another indication. Biopharma companies have identified factor XIa inhibition as a possible way to stop the formation of blood clots in veins without raising the risk of bleeding. Disentangling thrombosis from hemostasis could provide the efficacy of drugs such as Eliquis without the downsides. For Bayer, that prospect opens up a way to offset the upcoming loss of patent protection on Xarelto, a drug it sells with Johnson & Johnson.

Coating the inner barrel surface of a syringe with silicone has long been a necessary method to reduce the injection force required to administer drugs. However, silicone can interact with some drugs and even harm them. In contrast with other technologies designed to mitigate the risks associated with silicone-based coatings, syriQ BioPure® silicone-free prefillable syringes feature a glass barrel and plunger free of silicone. Enhanced by the absence of silicone, the proven quality level of syriQ BioPure® silicone-free opens up new possibilities for the storage and administration of silicone-sensitive drugs in prefillable syringes, saving time for clinicians and improving safety for patients.

AstraZeneca has launched a new company to allow CROs and fellow Big Pharmas to pay to access its tried-and-tested digital solutions for running clinical trials. The standalone company, called Evinova, is launching with 300 team members selected from across AstraZeneca and spread among nine countries. The international reach reflects the fact that the Evinova tech has already been road-tested in AstraZeneca-sponsored trials conducted in over 40 countries.

Sexual health is no stranger to public opinion. With the concern for birth control a pressing topic amongst the likes of healthcare professionals, democratic lawmakers and most importantly, women, the conversations surrounding contraceptives have been gaining prevalence in modern-day society. And this only marks a big step for the future of health and safety regarding the female body, as transparency surrounding female health begins to strip back such taboo topics.

Armed with $100 million in new funding, digital health startup Forward is betting that people will buy telehealth from its “CarePod” kiosks for $99 a month.

In patients with subclinical atrial fibrillation (AF) detected by implanted devices such as pacemakers or loop recorders, oral anticoagulation with apixaban resulted in a lower risk of stroke or systemic embolism than aspirin, but a higher risk of major bleeding in the ARTESIA study.