Search Results for “EC” – Page 252 – media

【EXPERT Q&A】What is OTC? What products do FDA need to apply for OTC?

Drugdu.com expert’s response: OTC stands for “Over-the-Counter,” referring to medications that can be purchased without a prescription from a healthcare professional. These medications are typically used to treat common health issues such as headaches, colds, fevers, and mild pains. In the United States, the Food and Drug Administration (FDA) regulates OTC drugs, and certain products require an application for OTC status before they can be sold on the market. Products that need to apply for OTC status according to the FDA include: 1.New Drugs: Drugs that have not been previously marketed require FDA approval before being sold as OTC products, regardless of their composition or effects. 2.Prescription Drugs: Some prescription drugs can apply for OTC status after undergoing clinical studies and safety assessments to demonstrate their safety and effectiveness. 3.Previously OTC Products with Safety Concerns: Certain OTC products may be required by the FDA to halt sales or undergo further ...
- Source: drugdu
- 148
- May 8, 2024
Jacobio Pharma Announced its KRAS G12C inhibitor reached the primary endpoint

BEIJING and SHANGHAI and BOSTON, April 30, 2024 /PRNewswire/ — Jacobio Pharma (1167.HK) announced that the data from the Phase II registrational study of the KRAS G12C inhibitor glecirasib were offically reported at the April ASCO Plenary Series, which was held online. Prof. Yuankai Shi, chief physician of Cancer Hospital Chinese Academy of Medical Sciences, the lead principal investigator of this clinical trial, presented the data in the form of an online oral presentation (Abstract 468214). The efficacy data showed that among second-line non-small cell lung cancer patients receiving monotherapy treatment, the confirmed objective response rate (cORR) was 47.9% (56/117), including 4 patients achieved a complete response (CR) and 36 patients with tumor reduction exceeding 50%. Disease control rate (DCR) was 86.3%. The median progression-free survival (mPFS) was 8.2 months, and median overall survival (mOS) was 13.6 months. The median duration of response (mDoR) has not been reached:6-month and 12-month ...
- Source: drugdu
- 86
- May 6, 2024
Amgen reports a 22% increase in Q1 2024 net revenues

Amgen’s total revenues grew in Q1 2024 to $7.4bn, displaying a 22% increase from earnings reported in the first quarter of last year. The company reported an operating income of $3.1bn, on a non-GAAP [generally accepted accounting principles] basis. The non-GAAP earnings per share (EPS) dipped 1% to $3.96, with the decrease attributed to higher operating and interest expenses that resulted from the acquisition of Horizon Therapeutics. Amgen acquired Horizon for $27.8bn (£22.76bn) following approval from the US Federal Trade Commission (FTC) in October 2023. The revenue growth was driven by a 22% increase in product sales and a 25% volume growth, with ten products achieving double-digit volume growth. Key performers included hyperlipidemia immunotherapy Repatha (evolocumab) and osteoporosis treatment in postmenopausal women Evenity (romosozumab-aqqg), which grew 33% year-over-year (YoY) and 35% YoY respectively in Q1. Amgen also reported an 80% YoY growth for the severe asthma medication Tezspire (tezepelumab-ekko), and ...
- Source: drugdu
- 99
- May 6, 2024
Cambridge researchers use AI to accelerate drug design for Parkinson’s disease

The progressive neurological condition affects more than six million people worldwide Researchers from the University of Cambridge have designed and used an artificial-intelligence (AI)-based approach to advance drug design and accelerate the search for Parkinson’s disease (PD) treatments. Published in the journal Nature Chemical, researchers used AI to identify compounds that block the clumping or aggregation of alpha-synuclein, the key protein that characterises PD. Affecting more than six million people worldwide, PD is a progressive neurological condition that slowly deteriorates parts of the brain. As well as motor symptoms, PD can also affect the gastrointestinal system, nervous system, sleeping patterns, mood and cognition and can contribute to a reduced quality of life and significant disability. Researchers developed and used a machine learning technique to screen a chemical library that contained millions of entries to identify small molecules that bind to the amyloid aggregates and block their proliferation. The process of ...
- Source: drugdu
- 145
- May 6, 2024
Research Shows Generative AI In The EHR Can Work Well, But Only With Human Oversight

As the burden of documentation and various other administrative duties has increased, physician burnout has reached historical levels. In response, EHR vendors are embedding generative AI tools to aid physicians by drafting their responses to patient messages. However, there is a lot that we don’t yet know about these tools’ accuracy and effectiveness. Researchers at Mass General Brigham recently conducted research to learn more about how these generative AI solutions are performing. They published a study last week in The Lancet Digital Health showing that these AI tools can be effective at reducing physicians’ workloads and improving patient education — but also that these tools have limitations that require human oversight. For the study, the researchers used OpenAI’s GPT-4 large language model to produce 100 different hypothetical questions from patients with cancer. The researchers had GPT-4 answer these questions, as well as six radiation oncologists who responded manually. Then, the ...
- Source: drugdu
- 101
- May 6, 2024
Cue Health to cut 230 employees

Dive Brief Cue Health plans to cut 230 employees, or nearly half of its staff, as it looks to reduce costs amid declining COVID-19 test sales. The San Diego-based company grew quickly during the pandemic when it brought in government and private contracts for its point-of-care molecular tests. Now, Cue faces questions about its ability to continue as losses add up and revenue declines. The changes are intended to refocus Cue’s business on its Cue Health Monitoring System, including developing and deploying point-of-care tests, spokesperson Rachel Rudo wrote in an email. “In alignment with this strategy, Cue has significantly reduced, or removed altogether, functions that don’t directly support this strategy,” Rudo said. Dive Insight Cue has gone through several rounds of layoffs as the testing company looks to control costs. In January, the company cut more than 200 positions across two rounds of layoffs, and Cue also slashed hundreds of ...
- Source: drugdu
- 96
- May 6, 2024
Amgen Puts Its Weight Behind Obesity Drug With Potential Edge Over Lilly, Novo Nordisk Meds

Amgen is confident its injectable obesity drug would have a differentiated profile compared to medications now on the market from Novo Nordisk and Eli Lilly and it’s now preparing for Phase 3 testing. But an oral obesity drug in Amgen’s pipeline will not advance beyond Phase 1. By Frank Vinluan Amgen aims to challenge the Novo Nordisk and Eli Lilly duopoly in the market for injectable obesity medications, and the company is now preparing for Phase 3 testing of an injectable drug candidate that would introduce new competition. While executives are not yet sharing specific details of the clinical data that support these plans, Amgen’s drug candidate could have dosing and manufacturing advantages. The update for the drug, maridebart cafraglutide or MariTide (known in earlier stages of development as AMG 133), came with Amgen’s report of financial results for the first quarter of 2024. CEO Robert Bradway said the company ...
- Source: drugdu
- 103
- May 6, 2024
Novartis Set to Acquire Mariana Oncology to Enhance Radioligand Therapy Pipeline

Don Tracy, Associate Editor Deal includes a number of radioligand therapies targeting solid tumors, such as breast, prostate, and lung cancers. Novartis announced that it has acquired Mariana Oncology, a biotech specializing in developing radioligand therapies (RLTs) for cancer treatment. According to the company, the acquisition is expected to enhance Novartis’ existing RLT pipeline and add major research capabilities. These programs target breast, prostate, and lung cancers, and features a leading developmental candidate, MC-339, for small cell lung cancer. As per terms of the agreement, Novartis is expected to make an upfront payment of $1 billion, with further potential payments of up to $750 million upon the completion of pre-specified milestones.1 “The acquisition of Mariana Oncology reflects our commitment to radioligand therapy as one of our company’s key technology platforms and strengthens our leadership in this field,” said Fiona Marshall, president, biomedical research, Novartis, in a press release. “We are ...
- Source: drugdu
- 115
- May 6, 2024
【EXPERT Q&A】What is CAPA for Medical Devices?

Drugdu.com expert’s response: Corrective and Preventive Actions (CAPA) in medical devices refer to a series of measures taken in response to identified issues or defects. CAPA aims to ensure the safety and effectiveness of medical devices and compliance with regulatory requirements. These measures include: 1.Corrective Actions: Steps taken to address existing issues or defects, aimed at eliminating or correcting their root causes to prevent recurrence. This may involve repairs, improvements to product design, or enhancements to manufacturing processes. 2.Preventive Actions: Measures taken to address potential issues or defects, intended to prevent future quality problems. This may include improving product design, updating manufacturing processes, or enhancing training. CAPA is an essential component of the quality management system for medical devices, often detailed in standards such as ISO 13485. Implementing CAPA helps ensure the safety, effectiveness, and quality of medical devices, while also ensuring compliance with regulatory requirements.
- Source: drugdu
- 168
- May 6, 2024
Lupin Digital Health’s Lyfe Platform gets Class C Medical Device License from CDSCO

Lupin Digital Health’s Lyfe platform has received approval as a Class C Medical Device from the Central Drugs Standard Control Organisation (CDSCO). A press statement informed that Lyfe is now India’s first clinically proven remote cardiac rehabilitation program, designed to enhance heart health and quality of life. By providing tailored, accessible solutions in the comfort of patients’ homes, Lyfe empowers individuals to confidently manage their heart health. Rajeev Sibal, President – India Region Formulations, Lupin, stated, “This approval reaffirms our dedication to excellence in cardiac care. We are proud to be at the forefront of digital therapeutics in India, signifying our commitment to supporting cardiologists with patient-centric solutions and improving cardiovascular outcomes.” Elaborating on the significance of receiving this license, Sidharth Srinivasan, CEO, Lupin Digital Health added, “Securing the Class C Medical Device license for Lyfe is a significant achievement. It validates Lyfe as a best-in-class platform to support millions ...
- Source: drugdu
- 77
- May 5, 2024

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