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Mirati’s Flagship KRAS Inhibitor Krazati Gets Rebuffed in Europe

An approval from the U.S. FDA doesn’t guarantee a green light overseas—a lesson Mirati Therapeutics has learned the hard way after European regulators rebuffed the company’s flagship KRAS inhibitor Krazati. Friday, Mirati revealed that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had spurned the company’s conditional marketing authorization application for Krazati, also known as adagrasib, to treat patients with KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC). In a release, Mirati said it “disagrees with the opinion” and intends to file for a formal re-examination. Once considered an undruggable target, KRAS now has two FDA-approved therapies competing in a potential blockbuster cancer market in the United States. After Amgen won an accelerated nod for its rival KRAS inhibitor Lumakras in May 2021, Mirati entered the fray with Krazati—the biotech’s first commercial product—in December. While Amgen’s drug has suffered a sequential sales decline in the U.S., Mirati’s med recently surprised ...
- Source: drugdu
- 124
- July 25, 2023
ADC Therapeutics Pulls the Plug on Zynlonta Study After Partial FDA Hold

A week after ADC Therapeutics paused its Zynlonta trial to review seven deaths and five other respiratory events in patients who received the drug, the company has scrapped the study altogether following an FDA partial clinical hold. The trial was testing the drug, combined with Roche’s Rituxan, in unfit or frail patients with previously untreated diffuse large B-cell lymphoma (DLBCL). Citing the “challenges of defining the addressable segment” of the difficult-to-treat population, ADC believes the benefit-risk profile “does not support” the continuation of the study, the company said in a release. The call came after a meeting with the FDA, in which the agency slapped a partial hold on enrolling new patients in the trial. However, the agency said patients who are already on the drug and seeing clinical benefits can remain enrolled after reconsenting. After those patients are treated, ADC will take steps to wrap up the trial. ...
- Source: drugdu
- 102
- July 25, 2023
Study Explores the Emergence of Predictive Models in the Hippocampus

Neuroscience studies have found that the brain spontaneously organizes events and life experiences into memories, which can be mentally retrieved and replayed at different points in time. These memories of past events are known to partly shape human perceptions and behavior, for instance highlighting strategies for solving a given problem that have proved to be effective in the past. A key region of the hippocampus, known as the CA1 region, has been hypothesized to support the human ability to retrieve relevant memories to forecast future outcomes, by creating predictive models that roughly represent what could happen in different scenarios. While many neuroscientists have been investigating this hypothesis, the ways in which these models are established and updated over time remain poorly understood. Researchers at The Hospital for Sick Children in Toronto and University of Toronto recently carried out a study aimed at better understanding the formation of these predictive ...
- Source: drugdu
- 144
- July 25, 2023
VR Can Alleviate Brain Tumor Patients’ Anxiety During Treatment, Study Finds

AppliedVR teamed up with the National Cancer Institute to study the feasibility of VR to alleviate anxiety in brain tumor patients undergoing imaging scans. The research partners recently announced interim analysis results from their clinical study — they said that not only would VR intervention be a feasible option to reduce patients’ anxiety, but that patients would report high satisfaction levels as well. Patients diagnosed with brain tumors experience notably higher levels of significant distress compared to other solid tumor patients. This heightened distress can be attributed to the disease’s demanding clinical trajectory, as well as its high symptom burden. On top of these challenges, patients with brain tumors face the additional hardship of undergoing frequent neuroimaging assessments to monitor the progress of their disease, leading to what is often referred to as “scanxiety.” This term refers to the anxiety and stress resulting from the anticipation of these medical scans and their potential ...
- Source: drugdu
- 82
- July 25, 2023
Muscle-Building Supplement May Help Protect Memory and Prevent Alzheimer’s Disease

The secret to protecting your memory may be a staple of a bodybuilder’s diet. RUSH researchers recently discovered that a muscle-building supplement called beta-hydroxy beta-methylbutyrate, also called HMB, may help protect memory, reduce plaques and ultimately help prevent the progression of Alzheimer’s disease. HMB is not a prescription drug or a steroid, but an over-the-counter supplement that is available in sports and fitness stores. Bodybuilders regularly use HMB to increase exercise-induced gains in muscle size and strength while improving exercise performance. HMB is considered safe even after long-term use, with no known side effects. “This may be one of the safest and the easiest approaches to halt disease progression and protect memory in Alzheimer’s disease patients,” said Kalipada Pahan, PhD, the Floyd A. Davis, MD, Professor of Neurology and professor of neurological sciences, biochemistry and pharmacology at RUSH Medical College. Studies in mice with Alzheimer’s disease ...
- Source: drugdu
- 202
- July 24, 2023
Bariatric Surgery Slowdown Nips Intuitive Surgical’s Q2 Procedure Growth

Intuitive Surgical posted strong robotic volume growth in the second quarter and raised its full-year procedure outlook but said patient interest in new weight-loss drugs is curbing demand for bariatric surgeries. The Sunnyvale, California-based robotic surgery leader, on its earnings call Thursday, forecast overall procedure growth in a range of 20% to 22% for the full year, up from the company’s prior forecast of 18% to 21%. In the second quarter, global procedures using Intuitive’s da Vinci surgical robots rose 22%, boosted by demand for general surgery, including hernia repair, colorectal and thoracic procedures, and gynecology and urology procedures. Surgical volumes benefited from higher hospital admissions, especially in the U.S., as healthcare providers catch up with patients whose treatments were delayed during the pandemic, company executives said. “Lower utilization happened over a several-year period, and it will probably take many quarters for it to fully ...
- Source: drugdu
- 143
- July 24, 2023
Pfizer and Flagship Pioneering Sign Drug Discovery Partnership Worth up to $7bn

Pfizer has signed a deal with Flagship Pioneering worth up to $7bn to develop new drug candidates using the venture firm’s large portfolio of biopharma companies. Under the terms of the agreement, Pfizer and Flagship will each invest $50m upfront to develop a new pipeline of up to ten programmes for areas including internal medicine, oncology, infectious diseases, and immunology. The new partners outlined in a statement that the collaboration will focus on addressing unmet needs within Pfizer’s core therapeutic areas, including “broad patient populations and diseases with high potential to benefit from a diverse range of technology platforms and modalities”. Flagship’s drug discovery initiative, Pioneering Medicines, working in collaboration with Pfizer’s research and development leadership, will lead the exploration process. Paul Biondi, president, Pioneering Medicines, and executive partner, Flagship Pioneering, said: “This new partnership brings together the best of our organisations to maximise discovery and ...
- Source: drugdu
- 109
- July 24, 2023
Kenvue Shares Fall Even as J&J Spinoff Beats Estimates in First Quarterly Earnings Since IPO

Kenvue shares fell on Thursday even though the consumer health company beat second-quarter revenue and earnings expectations in the its first quarterly report since it spun out from Johnson & Johnson two months ago. The company, formerly J&J’s consumer health division, also issued an upbeat sales outlook for 2023. Kenvue CEO Thibaut Mongon said during an earnings call that the consumer landscape “continues to be uncertain” and the company expects “market volatility will continue.” But he noted that consumers are still willing to buy “trusted” and “efficacious” health products. Kenvue’s beat was driven by resilient demand for its wealth of widely known brands such as Band-Aid, Tylenol, Listerine, Neutrogena and Aveeno. “This quarter was yet another proof point, showcasing the power of our portfolio,” Mongon said during the call. J&J still owns a 90% stake in Kenvue, meaning it can generally control the direction ...
- Source: drugdu
- 116
- July 24, 2023
J&J’s Darzalex Stays on its Upward Trajectory as Company Adds $1B to Annual Sales Projection

In 2017, when Genmab CEO Jan van de Winkel declared its multiple myeloma drug Darzalex—which is marketed by Johnson & Johnson—had the potential for peak sales of $13 billion, he relented that it was a best-case scenario.Six years later, that best-case scenario appears possible. On Thursday, J&J reported another quarter of strong sales for the monoclonal antibody. Darzalex generated $2.43 billion in the period, a 22% increase from the second quarter of last year. After realizing sales of $6 billion in 2021 and $8 billion last year, Darzalex is on track to approach revenue of $10 billion in 2023. The drug, which was approved in 2015, was boosted in 2020 with the development of Darzalex Faspro, a subcutaneous version of the treatment which allows patients to receive doses in minutes compared to hours for the previous intravenous administration. A year ago, J&J reported that 85% of patients receiving Darzalex were using Faspro. ...
- Source: drugdu
- 114
- July 24, 2023
Sandoz Invests $90m to Build a Biosimilar Centre in Slovenia

Sandoz has invested $90m to build a biopharma development centre in Ljubljana, Slovenia by 2026. The site will serve to develop biosimilar products and is expected to create 200 new jobs. This follows Novartis’ financial report stating $2.4bn in net sales for Sandoz biosimilars in Q2 2023, along with the proposed 100% separation of Sandoz from Novartis to form an independent company by the end of this year. The fully independent Sandoz will be headquartered in Basel, Switzerland, and listed on the SIX Swiss Exchange and American Depositary Receipt (ADR) programme in the US, as per a 1 June press release. To that end, the development centre is the company’s second major investment in Slovenia. In March, the Novartis spin-off announced plans to construct a biologics production plant in Lendava, Slovenia, to support the increasing product demand. According to a press release, Sandoz chief ...
- Source: drugdu
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- July 24, 2023

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