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By integrating digitization and machine learning, there is an opportunity to deliver personalized care to all patients and scale precision dosing with minimal physician involvement, maximizing the effectiveness and accessibility of these drugs. appeared first on MedCity News.
Graphite Bio voluntarily paused a Phase 1/2 test of its gene-edited therapy for sickle cell disease after the first patient in the study developed a serious blood complication. The setback will also delay plans to reach the clinic with another genetic medicine in its pipeline.
Corticosteroids are a standard first-line treatment for Duchenne muscular dystrophy, but these drugs have many sideeffects. FDA approval of Italfarmaco’s Duvyzat is the first nonsteroidal drug to pass the agency’s regulatory bar for treating this rare disease.
For patients who may be unable to afford the high cost of GLP-1 obesity drugs or are worried about the sideeffects, it’s important for healthcare providers to offer education on herbal alternatives and consider these as part of the broader treatment conversation. appeared first on MedCity News.
Liver complications are a known sideeffect risk of Zolgensma and other genetic medicines that are delivered by engineered viruses. The two deaths reported following treatment with Novartis’s Zolgensma mark the first fatal cases of acute liver failure associated with the gene therapy.
The product, produced by biopharma company PTC Therapeutics, is approved for patients 18 months and over. Upstaza is administered through a minimally invasive neurosurgical stereotactic procedure used to treat several neurological disorders in paediatric and adult patients. Upstaza clinical trials.
billion buyout of Principia Biopharma has run into trouble, after the FDA placed it on partial clinical hold while a safety signal is investigated. One of the main assets of Sanofi’s $3.7 The hold on dosing applies to subjects in the trials who have received the drug for less than 60 days.
The Italian biopharma said it had decided to press ahead with the new study after assessing results from 100 patients with TRS in open-label studies who received the glutamate modulator drug as an add-on to their current therapy for more than six months. in the evenamide group.
The Swiss biotech is seeking a priority review for vamorolone, which was licensed from US biotech ReveraGen BioPharma in 2020 after Santhera its former DMD therapy candidate idebenone failed clinical testing and was abandoned. “We look forward to working closely with US regulators to advance vamorolone towards approval,” he added.
The companies aim to bring patients drugs that offer the benefit of psychedelics but with a better sideeffect profile. AbbVie’s alliance with Gilgamesh Pharmaceuticals is pursuing next-generation psychiatric medications.
Patients can look forward to electronic assistance that can return their voice or other lost abilities. When entering a patient’s conditions into the chatbot, it responds with a list of recommended drugs. It also flags possible sideeffects and interactions between drugs.
billion deal, in which Eli Lilly agreed to acquire two of POINT Biopharma Global’s late-stage radioligand therapies for oncological indications. These diagnostics have significantly progressed based on rigorous Phase III trial designs and because of the impact these diagnostics have had on patient management.
Obtaining the preferences of patients and their caregivers is not a new concept in healthcare. Increasingly, however, industry guidance documents utilize the term ‘patient preference’ in relation to new drug development and benefit-risk assessment. Health technology assessment (HTA) bodies also have some appetite for this information.
The US regulator has placed oral BTK inhibitor orelabrutinib on partial clinical hold, meaning new patients cannot be enrolled into clinical trials and patients treated with the drug for 70 days or less must discontinue treatment. billion buyout of Principia Biopharma.
In our latest podcast, Ideas to Innovation, we speak with Dr. Grace Lomax, the clinical director at Patient Connect, part of Clarivate. In 2017, the same year the SDGs came into effect, the United Nations found that less than half of the global population was covered by essential health services. Dr. Grace Lomax.
Only 5% of patients ranked pharma companies as the most trusted player in the healthcare space, according to a 2021 survey of 500 patients from Accenture. But 71% also want publicly shared information about how patients’ perspectives were incorporated into the development of products and services. Noël Moossa.
In recent years, the biopharma market has become progressively complex. Payers must take into consideration not only the clinical efficacy of a drug, but also its safety profile, sideeffects, and cost-effectiveness, among other factors. Scientific advice is a mechanism to reduce that challenge—so take it.”.
In this issue, we take a closer look at adherence and compliance regarding patients and medications along with their involvement with pharmaceutical companies. What strategies are most effective in improving patient adherence to prescribed medication regimens, and how can pharmaceutical companies support these strategies?
Myovant Sciences has rejected an acquisition offer from Sumitovant Biopharma and its wholly owned subsidiary, Sumitomo Pharma. Most currently available therapeutic options for endometriosis often have a diminished efficacy over time and result in negative sideeffects such as menopausal-like sideeffects and bone mineral density (BMD) loss.
However, due to conjugation instability and unfavorable safety profiles of currently available ADCs, we can still do more to ensure ADCs are more broadly available and amenable options for the patients who need them. Cellectis is pioneering the concept of off-the-shelf and ready-to-use gene-edited CAR T-cells to treat cancer patients.
Speciality pharmacies play a crucial role in medication dosing, disease and sideeffects management, and patient care. The expert services rendered by them help in improving patient outcomes, minimising costs of the healthcare system, improving medicinal adherence and persistency and saving clinicians’ time.
All of these systems operate under the “master-slave” concept, which involves a surgeon sitting behind a console, away from the patient, who manipulates the mechanical arms of the robot via some kind of joystick-like device.
Dr Baghirzade continued, highlighting that since a particular defining moment for the industry in the late 90s, which resulted in an unfortunate patient fatality, “there is a lot more focus on safety” in gene therapy clinical trials today. She also touched on production costs being irrecoverable—there is a high cost per patient.
May 9, 2023 Since the Orphan Drug Act was passed in 1983, the number of products being researched and approved for rare and orphan diseases has increased dramatically, offering hope and life-saving treatments for the millions of patients affected by these often under-served conditions.
Drug candidates have a high rate of failure, as only 10% of de-novo drugs put through clinical trials finally obtain market approval, with the highest rate of attrition occurring at phase I and II of clinical trials (assessing safety, tolerability, dosage, efficacy, and sideeffects).
Biopharma Akeso Inc. state the therapy could help reduce sideeffects and safety concerns. At the American Society of Clinical Oncology (ASCO) 2022, Phase II study results showed ivonescimab demonstrated an overall response rate (ORR) for patients with NSCLC who failed EGFR-TKI’s of 68.4 Under the agreement, Akeso Inc.
New Developments for TB In a recent Phase I clinical trial (NCT03722472), researchers have been able to test the first thermostable TB vaccine in patients. In this trial, patients were given a thermostable version of the vaccine or a non-thermostable vaccine in two treatment regimens.
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