PharmaFocus Today – Page 86 – media

FDA Approves Regeneron and Sanofi’s Kevzara to Treat Patients with Active Polyarticular Juvenile Idiopathic Arthritis

Don Tracy, Associate Editor Approval for Kevzara was based on controlled studies, pharmacokinetic data from adults with rheumatoid arthritis, and pediatric-specific studies on pharmacokinetics. The FDA has approved Regeneron’s and Sanofi’s approved Kevzara (sarilumab) for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients weighing over 138 lbs. According to a joint press release, the approval was based on results of controlled studies and pharmacokinetic data from adults with rheumatoid arthritis (RA), as well as pediatric-specific studies on pharmacokinetics, pharmacodynamics, dosing, and safety.1 “Polyarticular juvenile idiopathic arthritis can be a painful disease for children where multiple joints are impacted by this chronic inflammation,” said George D. Yancopoulos, MD, PhD, board co-chair, president, chief scientific officer, Regeneron, in a press release. “Not only are their daily lives impacted, but their futures can be disrupted without adequate treatment. The approval of Kevzara in polyarticular juvenile idiopathic arthritis provides these vulnerable ...
- Source: drugdu
- 133
- June 13, 2024
Ipsen, Genfit Drug That Missed in MASH Wins FDA Approval in a Much Rarer Liver Disease

Iqirvo failed as a treatment for the fatty liver disease MASH, but the drug is now FDA approved in primary biliary cholangitis. An Intercept Pharmaceuticals drug already treats this rare liver disease and Gilead Sciences is poised to compete with its PBC drug approaching an FDA decision this summer. By Frank VinluanA rare liver disease that can progress to organ failure now has a new FDA-approved therapy, a drug from Ipsen that brings a novel approach to treating the chronic condition. The Ipsen drug, elafibranor, treats primary biliary cholangitis (PBC). The regulatory decision announced late Monday makes the drug just the third approved therapy for the chronic liver disorder, but competition in this indication is heating up. Paris-based Ipsen will market its new product under the brand name Iqirvo. PBC is an autoimmune condition in which bile and toxins build up in the liver, leading to inflammation and damage to ...
- Source: drugdu
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- June 13, 2024
Dana-Farber Cancer Institute and OncoHost partner for renal cell carcinoma research

The Dana-Farber Cancer Institute and OncoHost have partnered to research and identify biomarkers for renal cell carcinoma (RCC), a form of kidney cancer. The collaboration aims to create a proteomic plasma profile by providing OncoHost with materials using Dana-Farber’s repository of patient plasma samples and clinical data. According to Cancer Research UK, kidney cancer is the sixth most common cancer in the UK, accounting for 4% of all new cancer cases. RCC occurs when malignant cells are found in the lining of tubules in the kidney and there is currently no blood test available for these patients to help make personalised treatment recommendations, explained Wenxin Xu, physician, Dana-Farber and assistant professor of medicine at Harvard Medical School. For most RCC patients, immune-checkpoint inhibitor therapy (ICI) has been used to treat the disease. However, ICIs may not benefit all patients and can cause immune-related adverse events (irAEs). The PROPHETIC trial will ...
- Source: drugdu
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- June 13, 2024
New paediatric blood test to prevent sudden death from hereditary heart condition

Hypertrophic cardiomyopathy is a rare condition that affects up to 1,000 children in the UK Researchers from University College London (UCL) and Great Ormond Street Hospital have developed a new blood test that could identify children with a potentially fatal, hereditary heart condition. The research, co-funded by LifeArc and Action Medical Research, was published in the journal Circulation: Genomics and Precision Medicine. In the UK, up to 1,000 children are living with hypertrophic cardiomyopathy (HCM), a rare hereditary condition that causes the thickening of the heart muscle. Over time, the heart can no longer take in or pump out enough blood to supply the body’s needs, which can cause sudden death in children and young people. Results from the study showed that the new test successfully acted as a marker for HCM. Juan Pablo Kaski, professor of paediatric inherited cardiovascular medicine, UCL Institute of Cardiovascular Science and consultant cardiologist at ...
- Source: drugdu
- 121
- June 13, 2024
AbbVie’s Telisotuzumab Vedotin (Teliso-V) Included in CDE’s List of Breakthrough Therapeutic Varieties

Recently, the Center for Drug Evaluation (CDE) of the State Drug Administration formally included AbbVie’s clinically developed sterile lyophilized powder for infusion, Telisotuzumab Vedotin (Teliso-V), into the list of breakthrough therapeutic drug varieties for the treatment of advanced/late stage c-Met protein (OE) with high expression of c-Met protein (OE) with disease progression occurring during or after platinum-based drug therapy. metastatic epidermal growth factor receptor (EGFR) wild-type (WT) non-squamous (NSq) non-small cell lung cancer (NSCLC) patients. About Telisotuzumab Vedotin (Teliso-V) Teliso-V is an investigational first-in-class antibody-coupled drug (ADC) targeting the c-MET protein in patients with tumors overexpressing c-Met, a receptor tyrosine kinase that is overexpressed in many solid tumors, including NSCLC. Its efficacy safety as monotherapy in previously treated patients with c-Met overexpressing NSCLC will be further evaluated in the randomized Phase 3 study TeliMET NSCLC-01 (Study M18-868) For more information on the Teliso-V clinical trial, please visit https://clinicaltrials.gov/. Currently, there ...
- Source: drugdu
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- June 13, 2024
2024 ASCO | Benmelstobart monotherapy research results in gynecologic oncology and other areas updated

The 2024 American Society of Clinical Oncology (ASCO) Annual Meeting was held in Chicago from May 31 to June 4, local time. Chiatai Tianqing’s recently launched Class 1 innovative biologic Benmelstobart announced a number of research results at the meeting, covering the fields of digestive and gynecological oncology. Benmelstobart monoclonal antibody is an innovative humanized anti-PD-L1 monoclonal antibody with a new sequence, which was just approved for marketing in May 2024. The first approved indication is for the first-line treatment of patients with extensive-stage small-cell lung cancer (ES-SLC) in combination with amilotinib hydrochloride capsule, carboplatin and etoposide. Endometrial cancer is one of the most common gynecologic malignancies and its incidence is on the rise worldwide. Most patients with endometrial cancer are diagnosed at an early stage and have a good overall prognosis, with a 5-year survival rate of 95%. Once localized spread or distant metastasis occurs, the 5-year survival rate ...
- Source: drugdu
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- June 13, 2024
Abbott ramps up over-the-counter CGM race with new sensors

Dive Brief Abbott said Monday it will launch two over-the-counter continuous glucose monitors after receiving clearance from the Food and Drug Administration. One product is the company’s Lingo device, sold as a wellness product for people who do not have diabetes. The other is Abbott’s new Libre Rio device, which is intended for adults with Type 2 diabetes who do not use insulin, posing a direct challenge to Dexcom’s Stelo device. After Lingo was cleared last week, RBC Capital Markets analyst Shagun Singh wrote the over-the-counter nod could offer a more than $1 billion sales opportunity for Abbott. Dive Insight Abbott had discussed plans to bring Lingo to the U.S. after releasing it in the U.K. last year. The device, which can be worn on the upper arm for 14 days, tracks glucose to help people understand how their bodies react to different foods, exercise and stressors. Abbott received FDA ...
- Source: drugdu
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- June 12, 2024
Noninvasive Technology Detects Rare Cancer Cells in Blood

Historically, analyzing circulating tumor cells (CTCs) required invasive methods like blood draws, which often missed rare CTCs or multicellular CTC clusters (CTCCs) known for their high metastatic potential. Now, a groundbreaking technology offers a new way for researchers to monitor and understand the spread of cancer within the body. A collaborative effort between researchers at Northeastern University (Boston, MA, USA) and Dartmouth College (Hanover, NH, USA) has led to the development of an innovative device known as “diffuse in vivo flow cytometry” (DiFC). This technology facilitates the noninvasive detection and counting of rare cancer cells circulating in the bloodstream. By utilizing highly scattered light to probe large blood vessels, DiFC overcomes the shortcomings of traditional tests to enable the noninvasive analysis of larger peripheral blood volumes and detection of rare cancer cells. The team’s pioneering two-color DiFC system can simultaneously identify two distinct populations of cancer cell in real time ...
- Source: drugdu
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- June 12, 2024
FDA Approves GSK’s Arexvy to Prevent Respiratory Syncytial Virus in Adults Aged 50-59 with Increased Risk

Don Tracy, Associate Editor Arexvy receives expanded indication to include adults aged 59 years and younger to prevent RSV lower respiratory tract disease. GSK’s Arexvy (RSV Vaccine, Adjuvanted) has been approved by the FDA for an expanded indication to prevent respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in adults aged 50-59 years with an increased risk. The approval for this age group was based on encouraging results from a Phase III trial (NCT05590403) that evaluated the immune response and safety of Arexvy in adults aged 50-59, including those with underlying medical conditions. Arexvy was previously approved for adults aged 60 years and older for the same purpose in May 2023. Additionally, the Advisory Committee on Immunization Practices (ACIP) recommended its use through shared clinical decision-making.1 “[This] approval reflects the importance of broadening the benefits of RSV immunization to adults aged 50-59 who are at increased risk. For those ...
- Source: drugdu
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- June 12, 2024
Skye Bioscience Falls Short in Glaucoma Trial, But It’s Full Steam Ahead for Obesity Program

Skye Bioscience’s nimacimab blocks CB1, the same receptor targeted by an obesity drug candidate now in the hands of Novo Nordisk. But Skye contends its Phase 2-ready antibody drug has several advantages over the small molecule that joined Novo’s pipeline in a deal valued at $1 billion. By Frank VinluanDespite some evidence that cannabis reduces intraocular eye pressure from glaucoma, the ophthalmology community hasn’t embraced its use. One reason cited: The short duration of effect means a patient must smoke or ingest a lot of marijuana to maintain its effect throughout the day. Skye Bioscience’s ambitions to bring glaucoma patients these therapeutic benefits in a twice-daily eye drop have missed the mark. The clinical-stage company is now turning its focus to another drug that targets the same receptor in a different way for a different indication — weight loss. In doing so, Skye aims to show it can compete with ...
- Source: drugdu
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- June 12, 2024

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