Search Results for “Clinical Trial” – Page 95 – media

Pfizer Drops Early-Stage Obesity Drug Following Disappointing Phase I Data

By Tristan Manalac Pictured: Pfizer sign on building/Tobias Arhelger/Adobe Stock Pfizer is discontinuing the clinical development of its investigational GLP-1 receptor agonist lotiglipron, which was being developed for obesity and Type 2 diabetes mellitus, the company announced Monday. The decision to cut lotiglipron from Pfizer’s pipeline comes after the company detected heightened concentrations of liver transaminases in patients treated with the investigational drug. Lotiglipron was being evaluated in two Phase I drug-drug interaction studies and one Phase II trial. Pharmacokinetic data from the two Phase I studies also contributed to the candidate’s discontinuation. None of the patients developed liver-related symptoms or similar side effects and neither required medical intervention. Pfizer also did not document signs of liver failure among these patients. The company will present lotiglipron data at an upcoming conference or will submit it for publication in peer-reviewed journals. With lotiglipron’s discontinuation, Pfizer will instead focus on the clinical ...
- Source: drugdu
- 155
- June 28, 2023
Personalized dosing improves outcomes for men with metastatic castration-resistant prostate cancer

By monitoring early-response biomarkers in men undergoing 177Lu-PSMA prostate cancer treatment, physicians can personalize dosing intervals, significantly improving patient outcomes. In a study presented at the Society of Nuclear Medicine and Molecular Imaging 2023 Annual Meeting, early stratification with 177Lu-SPECT/CT allowed men responding to treatment to take a “treatment holiday” and allowed those not responding the option to switch to another treatment. Approved by the U.S. Food and Drug Administration in 2022, 177Lu-PSMA is an effective treatment for metastatic castration-resistant prostate cancer. However, not all men respond equally to treatment, with some responding very well and others progressing early. “Currently, a standardized dosing interval is used for 177Lu-PSMA treatment,” said Andrew Nguyen, MBBS, FRACP, AANMS, senior staff specialist in the Department of Theranostics and Nuclear Medicine at St. Vincent’s Hospital in Sydney, Australia. “However, monitoring early-response biomarkers to adjust treatment intervals may improve patient outcomes.” In the study, researchers sought ...
- Source: drugdu
- 108
- June 28, 2023
Pfizer shelves one oral pill, pivots to another in weight loss drug race

Pfizer has terminated one of its glucagon-like peptide-1 receptor agonist (GLP-1-RA) candidates as the race heats up to market the first oral weight loss drug. The loss of lotiglipron means Pfizer will rest its hopes on its other candidate danuglipron to take on Novo Nordisk and Eli Lilly for the first marketed weight loss pill. The market responded accordingly to Pfizer’s announcement about shelving the program, with shares in the company opening 3% lower on Monday morning compared to pre-announcement market close (23 June). The decision to scrap lotiglipron was due to elevated levels of transaminases seen in two Phase I studies and a currently ongoing Phase II study. Pfizer said no liver-related symptoms or side effects were observed and added that the increase in transaminase levels has not been seen in any of its danuglipron trials. Pfizer has already published results for danuglipron in the Journal of the American ...
- Source: drugdu
- 103
- June 28, 2023
Jazz brings the noise to the FDA with lawsuit over approval of Avadel’s narcolepsy drug Lumryz

After years of using the patent system to delay competition from a rival company and then exhausting that ploy early this year, Jazz Pharmaceuticals is taking a new route—suing the FDA.Jazz is challenging the regulator for approving Avadel Pharmaceuticals’ narcolepsy drug Lumryz, which poses a major threat to Jazz’s blockbuster Xyrem/Xywav franchise. In U.S. district court in Washington, D.C., Jazz claimed that the green light for Lumryz—which was awarded on May 1—was “unlawful.” The Dublin company says that the approval violated the orphan drug exclusivity (ODE) the agency granted to Xywav in 2021. In awarding Lumryz its own ODE, the FDA ruled that Lumryz is superior to Jazz’s offerings, citing its ability to make a major contribution to patient care based on its convenience and additional clinical benefit. While Lumryz is taken once a night, Xywav requires two doses. Both are oral suspension drugs. Jazz maintains that the FDA acted ...
- Source: drugdu
- 118
- June 28, 2023
Biotech AltPep scores around $53m in Series B funding round

US-based amyloid diseases treatment solutions developer AltPep has raised $52.9m in its Series B investment round led by Senator Investment Group. Former investors such as Matrix Capital Management Company and Alexandria Venture Investments, who took part in the firm’s Series A round, joined the latest fundraise along with new backers. The new investors in Series B include Eli Lilly and Company, Partners Investment, and Section 32. As part of the deal, Senator Investment Group’s Rohit Vanjani will join the AltPep board. Besides, Lilly’s senior vice president and chief scientific officer for Neurobiologicals Ronald DeMattos will become a member of the Scientific Advisory Board at AltPep. Vanjani noted: “We believe AltPep is in an excellent position to optimise the value of its unique technology. “With scientific application for both therapeutics and diagnostics in a wide range of amyloid diseases, the potential for the company’s pipeline is vast and extremely promising.” The ...
- Source: drugdu
- 206
- June 27, 2023
analysts

Dive Brief Intuitive Surgical’s minimally invasive bronchoscopy platform Ion may provide “some of the most exciting advancements in robotic technology” in the coming years, according to analysts at BTIG. While Ion contributed an estimated $115 million of the company’s $6.2 billion in revenue last year, the analysts see scope for Intuitive to grow sales by capturing more of the lung biopsy market and expanding into the ablation of tumors. Intuitive competes for the bronchoscopy market with Johnson & Johnson’s Monarch platform. The analysts estimate there are about twice as many Ion systems as Monarch devices in use. Dive Insight Intuitive’s success rests on its da Vinci robotic platform and discussions of the future of the company focus on whether J&J and Medtronic can challenge the dominance of that device, the BTIG analysts said. “Intuitive’s push into robotic bronchoscopy is purposeful, not just simply for the bronchoscopy opportunity, but for its ...
- Source: drugdu
- 100
- June 26, 2023
Study reports drug that significantly reduces bacteria’s ability to develop antibiotic resistance

A team of researchers at Baylor College of Medicine is gaining ground in their search for solutions to the global problem of bacterial antibiotic resistance, which was responsible for nearly 1.3 million deaths in 2019. The team reports in the journal Science Advances a drug that, in laboratory cultures and animal models, significantly reduces the ability of bacteria to develop antibiotic resistance, which might prolong antibiotic effectiveness. The drug, called dequalinium chloride (DEQ), is a proof-of-concept for evolution-slowing drugs. “Most people with bacterial infections get better after completing antibiotic treatment, but there are also many cases in which people decline because the bacteria develop resistance to the antibiotic, which then can no longer kill the bacteria,” said corresponding author Dr. Susan M. Rosenberg, Ben F. Love Chair in Cancer Research and professor of molecular and human genetics, biochemistry and molecular biology and molecular virology and microbiology at Baylor. She also ...
- Source: drugdu
- 97
- June 25, 2023
New study finds that plant extracts used by Indigenous people hold promise in treatment of ataxia

A University of California, Irvine-led team of researchers has discovered that extracts from plants used by the Kwakwaka’wakw First Nations peoples in their traditional botanical medicine practices are able to rescue the function of ion channel proteins carrying mutations that cause human episodic ataxia. The study, “Native American ataxia medicines rescue ataxia-linked mutant potassium channel activity via binding to the voltage sensing domain” was published in June in Nature Communications. “Episodic ataxia 1 (EA1) is a movement disorder caused by inherited mutations in the human KCNA1 gene, which encodes Kv1.1, a voltage-gated potassium channel essential for normal function of the human nervous system,” said Geoffrey W. Abbott, Ph.D., vice dean of basic science research and professor in the Department of Physiology & Biophysics at the UCI School of Medicine. “We found that extracts of stinging nettle, bladderwrack kelp and Pacific ninebark can all correct function of the mutation-carrying proteins causing ...
- Source: drugdu
- 107
- June 23, 2023
Omega-3 fatty acids linked with slower progression of ALS

Consuming omega-3 fatty acids—particularly alpha-linolenic acid (ALA), a nutrient found in foods including flaxseeds, walnuts, and chia, canola and soybean oils—may help slow the progression of disease in patients with amyotrophic lateral sclerosis (ALS), according to a new study led by Harvard T.H. Chan School of Public Health. The study is published on June 21, 2023, in Neurology. “Prior findings from our research group have shown that a diet high in ALA and increased blood levels of this fatty acid may decrease the risk of developing ALS. In this study, we found that among people living with ALS, higher blood levels of ALA were also associated with a slower disease progression and a lower risk of death within the study period,” said lead author Kjetil Bjornevik, assistant professor of epidemiology and nutrition. “These findings, along with our previous research, suggest that this fatty acid may have neuroprotective effects that could ...
- Source: drugdu
- 123
- June 23, 2023
Calliditas files sNDA to US FDA for TARPEYO to treat primary IgAN

Calliditas Therapeutics has submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) for complete approval of TARPEYO (budesonide). The TARPEYO delayed-release capsule is a corticosteroid indicated for reducing proteinuria to treat primary immunoglobulin A nephropathy (IgAN) in adult patients at risk of quick disease progression, generally having a urine protein-to-creatinine ratio greater than or equal to 1.5g/g. The therapy received accelerated approval based on showing a reduction in proteinuria. The submission of sNDA to the regulator was based on the findings obtained from the Phase III NefIgArd clinical trial. The multicentre, randomised, double-blind trial was designed to evaluate the safety and efficacy of TARPEYO 16 mg compared with placebo against a background of optimised RASi (renin–angiotensin system inhibitor) therapy in primary IgA adult patients. TARPEYO showed a highly statistically significant benefit in estimated glomerular filtration rate (eGFR) over a two-year period of treatment. The ...
- Source: drugdu
- 118
- June 23, 2023

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