PharmaFocus Today – Page 321 – media

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
- 149
- 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
- 301
- 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
- 104
- 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
- 128
- July 20, 2023
Sanofi and Scribe Announce in Vivo Genetic Therapy Partnership Worth Over $1.2bn

Sanofi and Scribe Therapeutics have announced an expanded collaboration agreement worth over $1.2bn to advance in vivo genetic medicines for sickle cell and other genomic diseases. The agreement follows the launch of the companies’ existing partnership focused on developing ex vivo editing of natural killer cell therapies for cancer. Under the latest deal, Sanofi will gain an exclusive licence to use Scribe’s CRISPR X-Editing genome editing technologies to develop in vivo therapies. In exchange, Scribe will receive a $40m upfront payment and will also be eligible for more than $1.2bn based on the successful completion of certain development and sales milestones. Sanofi will largely be responsible for any resulting candidates, but Scribe will have the opportunity to opt into sharing the development costs and profits on one future programme in the US. Christian Mueller, global head of Genomic Medicine Unit at Sanofi, said: “We’re ...
- Source: drugdu
- 114
- July 20, 2023
Pfizer Inks Potential $7B Deal with Flagship to Deepen Pipeline

Pfizer is looking to enrich its pipeline with up to 10 new innovative medicines by partnering with startup creator Flagship Pioneering, the companies announced Tuesday. Under the terms of the agreement, Pfizer and Flagship will each contribute an upfront investment of $50 million. The collaboration will leverage Flagship’s rich ecosystem of biotechnology platforms and more than 40 human health companies. Pfizer and Flagship will explore up to 10 single-asset programs, which Pfizer will fund and have the option to acquire. Flagship and its companies will be eligible to receive up to $700 million in milestones and royalties for each program that hits the market, giving Tuesday’s deal a maximum potential value of $7 billion. This partnership will bring together expertise from Pfizer and Flagship “to maximize discovery and development potential from inception to impact,” Paul Biondi, executive partner at Flagship and president of Pioneering Medicines, said in a statement. ...
- Source: drugdu
- 112
- July 20, 2023
Neumora Races Toward Phase III with New Driver in the Hot Seat

Pictured: A silhouette of a woman sitting on the floor with her head in her hands/iStock, simpson33 Neumora Therapeutics is making big moves this week. On Tuesday the young biotech announced the initiation of a Phase III program for its potential depression treatment along with a new CEO to lead the way. The nearly two-year-old startup posted statistically significant results for treating moderate-to-severe major depressive disorder (MDD) in its Phase II trial of navacaprant, a kappa opioid receptor (KOR) antagonist. Initiated by BlackThorn Therapeutics prior to its acquisition by Neumora, the trial was amended to include those more serious MDD patients, the population in which it appears to be most effective. In moderate-to-severe patients, navacaprant had statistically significant results in lowering patients’ 17-item Hamilton Rating Scale for Depression score by 3 points at week 4 and 2.8 points by week 8. Across all patients, which included mildly depressed patients, navacaprant did not achieve ...
- Source: drugdu
- 122
- July 20, 2023
An AI System to Figure Out When to Trust AI-based Medical Diagnoses

Performance of CoDoC in breast cancer prediction compared to that of a standalone predictive AI system and clinical readers. Credit: Nature Medicine (2023). DOI: 10.1038/s41591-023-02437-x A team of AI and medical specialists working with or for Google Research and Google DeepMind, has developed an AI based system designed to judge the confidence level of existing AI systems used for analyzing medical scans as a means of improving analysis of diagnostic tools, such as mammograms or chest X-rays. In their paper, published in the journal Nature Medicine, the group describes how they built the system and how well it worked when tested. Fiona Gilbert, with the University of Cambridge’s Clinical School of Medicine, has published a News & Views piece in the same journal issue outlining the work done by the team on this new effort. Over the past several years, as AI applications have become more refined, the medical establishment has embraced the ...
- Source: drugdu
- 121
- July 20, 2023
Pfizer, Flagship Team Up in $100M R&D Pact — 10 New Drugs for Unmet Needs

Pfizer and Flagship Pioneering are partnering in a drug research alliance leveraging the capabilities of the more than 40 biotech startups in the venture capital firm’s portfolio. The new partners aim to develop drugs for unmet needs, including those in broad patient populations. Pharmaceutical companies frequently strike deals with smaller biotech companies as a way to build up their drug pipelines, and Pfizer is no exception. But in a twist to this strategy, the pharma giant is now turning to Flagship Pioneering, the venture capital firm whose highest profile creation might be the messenger RNA company Moderna. The alliance announced Tuesday calls for Flagship and Pfizer to each invest $50 million up front. The cash will go toward the R&D of 10 single-asset programs. Flagship does not create single-asset companies. The startups that spring from its labs are all formed around platform technologies, each with the capability of yielding ...
- Source: drugdu
- 139
- July 20, 2023
Pukang Biotechnology Completes Phase IV Clinical Trial of Hepatitis A Vaccine

Recently, Zhejiang Pukang Biotechnology Co., Ltd. has completed the Phase IV clinical trial titled “Single-Arm, Multi-Center Evaluation of the Safety and Immunogenicity of Freeze-Dried Live Attenuated Hepatitis A Vaccine in Chinese Children Aged 18-24 Months” and received the final report. This Phase IV clinical study, involving a large sample size of 10,000 cases across multiple centers, aimed to observe the safety and immunogenicity of the freeze-dried live attenuated Hepatitis A vaccine in the real world. The study results show that after a single dose of the vaccine, the AEFI incidence rate in the 18-24 month-old children was 0.34%, with no serious AEFI reported, and an antibody seroconversion rate of 98.91%. This confirms the vaccine’s good safety and immunogenicity profile, providing richer data support for its widespread application. The freeze-dried live attenuated Hepatitis A vaccine (H2 strain), developed and produced by Zhejiang Pukang Biotechnology Co., Ltd., simulates ...
- Source: drugdu
- 153
- July 20, 2023

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