Search Results for “Clinical Trial” – Page 79 – media

Gene Therapy and a New Medicine Delivery Approach Signal Progress for Cystic Fibrosis Patients

It’s time to build the infrastructure needed to scale up inhaled gene therapies targeting cystic fibrosis, and to bolster investment that supports several key program components. By JOAN LAU Thanks to simultaneous achievements in gene therapy and medicine delivery platforms, new solutions to intractable problems are bringing us to a real watershed moment in the treatment of respiratory disease. This synchronicity of science and tech advancements is no accident; along with colleagues in my own and other organizations, I have been working for the past several years on the medical and technological leaps that together signal hope for respiratory-disease patients with unmet need. This is especially true for those with cystic fibrosis (CF), for whom the standard of care is in urgent need of update. And now that we have the science and the technology in place, we must push to scale-up efforts; patients are waiting. Right now, CF patients ...
- Source: drugdu
- 92
- December 21, 2023
Chiesi Rare Skin Disease Drug Acquired in Billion Dollar Deal Wins FDA Approval

Chiesi Group’s Filsuvez is the second drug to win FDA approval for epidermolysis bullosa and the first for junctional EB, a more severe form of the rare skin disease. The birch tree bark-derived drug is from Chiesi’s $1.25 billion Amryt Pharma acquisition. By FRANK VINLUAN The rare inherited disorder epidermolysis bullosa, or EB, leads to skin so fragile that it tears like tissue paper. The resulting wounds and blisters are slow to heal and prone to infection. On Tuesday, the FDA approved a Chiesi Group drug developed to promote faster wound healing in EB patients. Privately held Chiesi will market its new drug as Filsuvez, the same brand name for the product in Europe, where it won its first regulatory approval last year. The FDA decision for this topical gel covers the treatment of patients age six months and older. EB stems from a mutation to the gene that codes ...
- Source: drugdu
- 96
- December 21, 2023
Smartwatches prove effective in detecting heart arrhythmias in children

A recent study published in the journal Communications Medicine discusses how smartwatches can facilitate the diagnosis of arrhythmias in children. Background Smartwatches and other wearable devices are becoming increasingly popular and allow users to constantly monitor their health, leading to their value for medical diagnosis becoming well-recognized. While the utility of these devices for adults has been widely researched, including for cardiac health monitoring and reducing the time needed to detect symptomatic rhythms, little is known about how they can be used to monitor child health indicators. Palpitations and abnormalities in cardiac rhythms are a leading cause of referrals in pediatric cardiology. However, existing non-invasive methods like patch rhythm monitors are not always effective in diagnosing arrhythmias, as symptoms often present infrequently, and children cannot wear monitors for as long as adults. Invasive methods such as implantable loop monitors (ILR) allow long-term monitoring. However, this approach may not be ideal ...
- Source: drugdu
- 105
- December 20, 2023
Point Bio Prostate Cancer Therapy Meets Phase 3 Goal, But Results Still Disappoint

Despite achieving its Phase 3 study’s main goal, the results for Point Biopharma’s therapy are short of what Novartis radiopharmaceutical Pluvicto achieved in a similarly designed clinical trial. Nevertheless, the data readout should clear the way for Eli Lilly to complete its $1.4 billion acquisition of Point. By FRANK VINLUAN A Point Biopharma Global cancer therapy key to a $1.4 billion Eli Lilly M&A deal has met the main goal of its pivotal clinical trial in prostate cancer. But the results raise questions about how well the drug will match up against a radiopharmaceutical marketed by Novartis. The Point drug, PNT2002, is also a radiopharmaceutical. It offers targeted delivery of a radioactive particle by linking it to a ligand that targets PSMA, a protein abundant on the surface of prostate cancer cells. The open-label Phase 3 study evaluated the Point radiopharmaceutical in patients with cases of prostate cancer that has ...
- Source: drugdu
- 92
- December 20, 2023
Innovent Announces Publication of Mazdutide (IBI362) Phase 2 Full Results in Chinese Patients with Overweight or Obesity in Nature Communications

ROCKVILLE, U.S. and SUZHOU, China, Dec 18, 2023，— Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, metabolic, autoimmune, ophthalmology and other major diseases, announces that results of a Phase 2 clinical trial of mazdutide (Innovent R&D code: IBI362), a glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist, in Chinese patients with overweight or obesity were published in Nature Communications. Professor Linong Ji, the leading principal investigator of the study, Peking University People’s Hospital, stated, “As a chronic disease with complex underlying causes, obesity is one of the leading risk factors of type 2 diabetes, fatty liver, cardiovascular and cerebrovascular diseases, joint diseases, sleep apnea in addition to cancers. Obesity requires increased public awareness of long-term treatment and management with effective and science-backed approaches. China has the largest obese population; however, no safe and efficacious ...
- Source: drugdu
- 117
- December 20, 2023
FDA Approves Padcev/Keytruda Combo for Locally Advanced, Metastatic Urothelial Cancer

Pharmaceutical Executive Editorial Staff In clinical trials, Padcev (enfortumab vedotin-ejfv) plus Keytruda (pembrolizumab) produced a statistically significant improvement in survival compared to platinum-based chemotherapy alone in patients with locally advanced or metastatic urothelial cancer. Image credit: Olivier Le Moal | stock.adobe.com The FDA has approved Padcev (enfortumab vedotin-ejfv; Astellas Pharma and Seagen [now owned by Pfizer]) plus Keytruda (pembrolizumab; Merck) for patients with locally advanced or metastatic urothelial cancer (la/mUC).1 The FDA previously granted the application with priority review and breakthrough designation. The efficacy of the combination was evaluated in the open-label, randomized EV-302/KN-A39 (NCT04223856) trial, which enrolled 886 patients with la/mUC who received no prior systemic therapy for advanced disease. Patients were randomly assigned 1:1 to receive either Padcev with Keytruda or platinum-based chemotherapy consisting of gemcitabine with either cisplatin or carboplatin. The trial’s major efficacy outcomes were overall survival (OS) and progression-free survival (PFS) as assessed by blinded ...
- Source: drugdu
- 92
- December 19, 2023
GLP-1 agonists can blunt obesity-associated health problems

Science has named the development of glucagon like peptide-1 (GLP-1) agonists and this year’s discovery that these drugs can blunt obesity-associated health problems as its 2023 Breakthrough of The Year. Although obesity’s causes span genetic, physiological, environmental, and social factors, as a medical problem, obesity’s risks can be life-threatening – including heart disease, diabetes, arthritis, liver disease, and certain cancers. Drug treatments for obesity have had “a sorry past, one often intertwined with social pressure to lose weight and the widespread belief that excess weight reflects weak willpower,” writes Jennifer Couzin-Frankel in the Breakthrough news feature. However, a new class of drug therapies for weight loss has emerged and is showing promising results. Originally developed to treat diabetes nearly 20 years ago, the excitement surrounding GLP-1 drugs to treat obesity has recently exploded. And this year, two landmark clinical trials that showed in large numbers that GLP-1 agonists produced meaningful ...
- Source: drugdu
- 117
- December 18, 2023
Abbisko Therapeutics Announces that U.S. FDA Has Granted Fast Track Designation for Its CSF-1R Inhibitor Pimicotinib(ABSK021)

Abbisko Therapeutics Co., Ltd.(Abbisko Therapeutics) today announced that its CSF-1R inhibitor pimicotinib(ABSK021) has been granted the fast track designation (FTD) by the U.S. FDA for the treatment of tenosynovial giant cell tumor (TGCT) patients that are not amenable to surgery. Previously, pimicotinib was granted the breakthrough therapy designation (BTD) by the U.S. FDAfor TGCT in January, 2023.The grant of FTD and BTD will accelerate the global development and commercialization of pimicotinib. Fast Track is a policy designed to facilitate the development and expedite the review of drugs in order to treat serious conditions and fulfill unmet medical needs. Its purpose is to get important new drugs to patients earlier. Moreover, the FTD enables companies to maintain more frequent communications and meetings with the U.S.FDA. The drug also becomes eligible for accelerated approval and priority review by the U.S.FDA. In early December, Abbisko entered into an agreement with Merck KGaA, Darmstadt, ...
- Source: drugdu
- 98
- December 17, 2023
Blood Tests Used to Hunt for Cancer DNA May Help Detect Cancers Faster

For a long time, visible signs of tumor growth on scans were the benchmark for initiating cancer treatment. However, the emergence of precision oncology tools, including circulating tumor DNA sequencing, is changing this approach. These advancements allow for earlier cancer detection and adaptation of treatment strategies to combat mutations that cause resistance to current therapies. They also offer the potential for less toxic alternatives to chemotherapy. New research led by a clinical scientist at UC Davis Health (Sacramento, CA, USA) highlights the benefits of using blood tests to search for cancer DNA. This method can speed up cancer detection and inform the use of targeted treatments. Cancer DNA circulating in a patient’s blood can be identified from a simple blood draw. This DNA is then sequenced to determine its genetic structure, helping to classify the cancer based on the findings in the blood sample. Unlike traditional tissue biopsies, which are ...
- Source: drugdu
- 84
- December 16, 2023
Bristol Myers Squibb to Pay Up to $8.4 Billion to Codevelop Antibody-Drug Conjugate With SystImmune

Pharmaceutical Executive Editorial Staff Bristol Myers Squibb will pay $800 million upfront to SystImmune for the rights to codevelop and sell a potentially first-in-class bispecific antibody-drug conjugate that has shown promise treating non-small cell lung cancer and breast cancer. Bristol Myers Squibb (BMS) has reached an agreement with SystImmune for the rights to codevelop and sell a potentially first-in-class EGFRxHER3 bispecific antibody-drug conjugate (ADC) in a deal that could exceed $8 billion. As part of the agreement, BMS will pay $800 million upfront to SystImmune and up to $500 million in contingent near-term payments.1 Should certain developmental, regulatory, and sales performance milestones be achieved, SystImmune would be eligible for additional payments that would bring the total for the agreement to approximately $8.4 billion.1 “Our collaboration with SystImmune allows us to strengthen our leadership in oncology and is consistent with our strategy to diversify beyond immuno-oncology to transform patient care,” said ...
- Source: drugdu
- 127
- December 14, 2023

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