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Medicaid MCOs Denied 1 out of 8 Prior Authorization Requests in 2019

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 ...
- Source: drugdu
- 133
- July 21, 2023
GSK-Funded Report on Adult Vaccination Rates Finds Major Global Declines in Recent Years

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 ...
- Source: drugdu
- 208
- July 21, 2023
US FTC Requests More Information on Pfizer’s Proposed $43bn Seagen Acquisition

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 ...
- Source: drugdu
- 222
- July 21, 2023
Pfizer Group B Strep Vaccine for Infants Returns Encouraging Mid-Stage Trial Results

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. ...
- Source: drugdu
- 111
- July 21, 2023
Pieris Pharma Lays off 70% of Workforce Amid Company Restructuring

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 ...
- Source: drugdu
- 93
- July 21, 2023
QuidelOrtho Test Could Miss Heart Attacks, Drawing Class I recall

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 ...
- Source: drugdu
- 126
- July 20, 2023
EAE Hub Model Reduces Barriers to Early Autism Diagnosis

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 ...
- Source: drugdu
- 136
- July 20, 2023
Johnson & Johnson Becomes 4th Drugmaker to File Suit Against IRA’s Drug Price Negotiations

Johnson & Johnson has hopped on the litigation bandwagon, becoming the fourth large drugmaker to sue the U.S. government over drug price negotiations in the Inflation Reduction Act (IRA).In U.S. District Court in New Jersey, J&J claimed (PDF) that price negotiations by Medicare would violate the First and Fifth Amendments of the U.S. Constitution. Merck, Bristol Myers Squibb and Astellas have made the same argument in separate lawsuits. Last week in federal court in Washington, D.C., Merck applied more pressure, filing for a decision in its case without a trial. The U.S. Chamber of Commerce and industry association PhRMA have also filed suits with similar claims. “The government is forcing (J&J) to provide its innovative, patented medicines on pricing terms that by law must be significantly below market prices,” J&J said in a release. “This would upend the current self-sustaining cycle of pharmaceutical innovation that provides patients with access ...
- Source: drugdu
- 279
- July 20, 2023
EU Prepares for the Winter With Plans to Avoid an Antibiotic Shortage

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 ...
- Source: drugdu
- 100
- July 20, 2023
Alnylam Presents Promising Results for RNAi Therapeutic in Alzheimer’s Disease at AAIC

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 ...
- Source: drugdu
- 122
- July 20, 2023

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