By Katie Palmer and Lizzy Lawrence Last week at Beth Israel Deaconess Medical Center, medical residents got a chance to test GPT-4 on a patient case, a workshop the hospital’s training physicians hope can help prepare the next generation of medical minds for the technology. “It’s going to be utterly, utterly transformative, and medical education is not ready,” said Adam Rodman, a clinical reasoning researcher who co-directs the iMED initiative at Beth Israel. “And the people who have realized what a big deal it is are all kind of freaking out.” Read the on-the-ground dispatch from Katie and STAT’s Brittany Trang. Inside the lab, researchers are highlighting the kind of problems those residents could run into using the tool. A recent preprint shows that GPT-4 displays subtle, but systemic racial and gender bias when it’s put to a number of clinical tasks. Read more from Katie. Reference: https://www.statnews.com/
Pictured: Merck Research Laboratories headquarters in Silicon Valley/iStock, Michael Vi Merck’s anti-PD-1 blockbuster Keytruda (pembrolizumab) aced one of its primary efficacy metrics in the Phase III KEYNOTE-A18 study, the company announced Wednesday. Though its news release was sparse with specific data from the study, Merck said that an independent Data Monitoring Committee found that Keytruda with chemoradiotherapy led to a significant and clinically meaningful improvement in progression-free survival (PFS), as compared with chemoradiotherapy alone. “[T]hese results reinforce our research efforts in earlier stages of disease where there is a greater potential for better outcomes,” Gursel Aktan, vice president of global clinical development at Merck Research Laboratories, said in a statement. KEYNOTE-A18, also known as ENGOT-cx11/GOG-3047, is a randomized and double-blinded trial enrolling 980 patients with newly diagnosed, locally advanced cervical cancer. To be eligible, patients must also be classified as high-risk, defined as having stage 1B2 to 2B and lymph ...
Pictured: Gavel on desk/Courtesy, iStock Astellas and Johnson & Johnson have filed lawsuits against the Medicare program, challenging the constitutionality of the Inflation Reduction Act’s drug pricing provisions. These legal actions add to a growing wave of litigation from drugmakers seeking to block the implementation of the Medicare Drug Price Negotiation Program. The IRA, designed to address rising healthcare costs and make medications more affordable for Americans, has faced significant opposition from the pharmaceutical industry. Friday, Astellas filed a lawsuit challenging the program, arguing that it violates the Fifth Amendment by unlawfully depriving them of their intellectual property rights. The pharma claimed that the IRA’s provisions, which allow Medicare to negotiate drug prices directly with manufacturers, amount to an unconstitutional confiscation of their patented drugs. Tuesday, J&J also filed a lawsuit against the Biden administration over the Medicare Drug Price Negotiation Program. The company asserted in its filing that the program is ...
Medicaid managed care organizations deny prior authorization requests at high rates, according to a recent report by the Office of Inspector General. Of the 115 MCOs the OIG analyzed, 12 had prior authorization denial rates above 25%. Medicaid Managed Care Organizations (MCOs) denied one out of eight prior authorization requests in 2019, according to a new report from the Office of Inspector General (OIG). The OIG review included seven MCO parent companies that operated 115 MCOs across 37 states and covered 29.8 million people in 2019. The organization received a congressional request to review MCOs and their prior authorization practices. “Medicaid managed care organizations play an increasingly important role in ensuring that people with Medicaid have access to medically necessary, covered services,” the OIG stated. “In recent years, allegations have surfaced that some MCOs inappropriately delayed or denied care for thousands of people enrolled in Medicaid, including patients ...
The US Federal Trade Commission (FTC) has requested more information and documentary material regarding Pfizer’s proposed $43bn acquisition of Seagen. The second request is a standard review procedure by which the FTC and the Antitrust Division of the US Department of Justice investigate mergers and acquisitions. If a second request is submitted, the law forbids merging companies from completing a transaction until they have substantially complied with the additional investigatory request. The Pfizer/Seagen agreement, which was originally announced in March this year, would mark a significant boost to the US pharma’s oncology pipeline. At the time of the announcement, Pfizer’s oncology portfolio included 24 approved drugs, while Seagen’s included Adcetris for lymphomas, Padcev for bladder cancers, Tivdak for cervical cancer, and Tukysa for breast and colorectal cancers. The deal would also grant Pfizer access to Seagen’s drug development pipeline as well as its proprietary ...
Pfizer on Wednesday said its experimental vaccine targeting the potentially deadly bacterial disease Group B Streptococcus returned strong mid-stage clinical trial results, a promising step as the drug inches toward potential approval. Pfizer is among several drugmakers racing to develop the world’s first shot targeting Group B strep disease, which is linked to nearly 150,000 infant deaths worldwide each year, especially in lower-income countries. The Food and Drug Administration in September granted breakthrough therapy designation to Pfizer’s vaccine, which is intended to expedite the development and review of the shot. Pfizer’s single-dose shot generated antibodies that may provide infants with meaningful protection against the disease, according to the data released Wednesday from a phase two clinical trial. The jab is administered to expectant mothers, who pass vaccine-induced antibodies to their fetuses. One of the company’s vaccines targeting respiratory syncytial virus also uses that maternal vaccination method. ...
Pieris Pharmaceuticals will be laying off 70% of its workforce as part of a corporate restructuring following the termination of its collaboration with British pharmaceutical company AstraZeneca. After encountering challenges such as the termination of patient recruitment in a Phase IIa asthma trial of the drug elarekibep, AstraZeneca decided to end its R&D partnership with Pieris, per the 18 July announcement. The company has returned elakeribep and terminated the existing discovery program. The two companies announced their collaboration to develop inhaled engineered proteins in May 2017. As part of the agreement, AstraZeneca has agreed to fund all clinical development and commercialisation programmes of the lead candidate, elarekibep. Also known as PRS-060, elarekibep is a type of engineered protein that targets interleukin-4 receptor alpha, which is based on Pieris’ Anticalin platform. The companies also agreed to develop four additional treatments based on the platform for different targets ...
A new study led by Indiana University School of Medicine researchers shows primary care clinicians who receive specialized training can make accurate autism diagnoses for over 80 percent of young children referred with developmental delays, providing compelling evidence that community-based models of autism evaluation are a potential solution for improving access to this needed service. They recently published their findings in Pediatrics. One in 36 children are now diagnosed with autism, according to the latest 2023 report from the Centers for Disease Control. In many regions of the county, waitlists for autism diagnostic evaluations often exceed a year and families regularly travel long distances to access the limited number of specialists who are qualified to perform these evaluations. Rebecca McNally Keehn (PhD, assistant professor of pediatrics and lead author of the study) said, “The bottleneck families experience in their road to an accurate diagnosis is a public ...
The European Commission, the Heads of Medicines Agencies (HMA), and the European Medicines Agency (EMA) have issued recommendations to prevent shortages of antibiotics. Drug shortages have become the norm in recent years, with the US Food and Drug Administration (FDA) reporting 295 active shortages in the last quarter of 2022 and the EMA reporting that a shortage of cardiovascular medications is expected to continue until next year. The EMA has said that the EU has an adequate supply of oral antibiotics for the treatment of respiratory infections, if the demand remains comparable to previous years, as per a 17 July press release. Nonetheless, the agency has issued several recommendations to ensure robust preparedness. It has also announced plans to engage with marketing authorisation holders to increase production and continue to monitor supply and demand without resorting to stockpiling. In addition, the agency wants to increase ...
Alnylam Pharmaceuticals’ investigational RNAi therapeutic has shown promise in patients with early-onset Alzheimer’s disease, according to phase 1 results presented by the company at this year’s Alzheimer’s Association International Conference (AAIC). Interim results from the early-stage study showed that a single injection of ALN-APP, which is designed to switch off the production of amyloid precursor protein (APP) in the central nervous system, was able to rapidly reduce levels of the protein, with clinical effect sustained over six months. ALN-APP is being developed in collaboration with Regeneron Pharmaceuticals for both Alzheimer’s disease and the related disorder cerebral amyloid angiopathy (CAA) and is now the first investigational RNAi therapeutic to demonstrate gene silencing in the human brain. “We’ve known for decades that mutations that increase APP production, or alter its proteolysis, cause early-onset Alzheimer’s disease, early-onset CAA or both,” said Dr Sharon Cohen, neurologist and medical director, Toronto ...
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