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 ...
Glioblastoma (histology slide). Credit: Wikipedia/CC BY-SA 3.0 “Don’t eat me,” is how one might translate the signal that the cancer cells in a glioblastoma send to the macrophages (white blood cells specialized in removing dead and dying cellular matter) in the brain. Immunotherapy attempts to enable these cells to eradicate the abnormal cells, but so far, it has met with little success when it comes to glioblastomas. Researchers led by Professor Gregor Hutter from the Department of Biomedicine at the University and University Hospital Basel have recently used patient data, experiments with mice, and samples from human tumors to study one of these “don’t eat me” signals and its inhibitory effect. Their findings, which may pave the way for effective immunotherapies for glioblastomas, are now being published in Science Translational Medicine. The signal is based on sugar molecules called sialic acid glycans on the surface of the cancer cells. These sugar molecules are ...
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 ...
While vaccines for COVID-19 have certainly enjoyed the spotlight in recent years, rates of uptake for other shots have sharply declined.That’s the finding of a new analysis funded by GSK in collaboration with the IQVIA Institute for Human Data Science and the Global Coalition on Aging (GCOA). All told, about 100 million fewer doses than anticipated of some adult vaccines, other than those targeting COVID-19, were administered between 2021 and 2022, the team found. To reach this number, the group weighed vaccine use in the last two years versus trends in global vaccine adoption from 2013 to 2020. In fact, just 16.2 doses of some vaccines were doled out globally per 100 adults in 2022. Meanwhile, COVID-19 vaccines saw overwhelming success with 132 doses delivered for every 100 adults in the same year, according to the report. “While significant strides in vaccine development have delivered vaccines to ...
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 ...
Dive Brief QuidelOrtho’s recall of a test to detect heart attacks was labeled Class I by the Food and Drug Administration, the most serious type of recall, the agency said in a Monday notice. The San Diego-based diagnostic manufacturer flagged a problem with the tests in late May after receiving reports that the tests showed lower than expected troponin levels, which could result in delayed or missed diagnosis of a heart attack. The recall affects nearly 7,800 tests, and QuidelOrtho is instructing clinicians to immediately discontinue using the product, and instead use a different test or send patients to another testing site. Dive Insight Quidel’s Triage Cardiac Panel is intended to help diagnose heart attacks. The test uses a blood sample, and can deliver results in about 20 minutes, according to the company’s website. It is important to detect heart attacks quickly to ...
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 ...
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