Search Results for “FDA” – Page 95 – media

Tau-Focused Asceneuron Adds $100M as Oral Alzheimer’s Drug Advances to Phase 2 Trial

Novo Holdings led Asceneuron’s $100 million Series C financing. The Merck Serono spinout’s lead program is an oral small molecule designed to prevent aggregation of tau protein in neurodegenerative disorders. By Frank Vinluan Alzheimer’s disease patients can now choose between new two intravenously infused therapies that work by breaking up plaques of amyloid protein in the brain. Asceneuron takes a different approach with oral therapies that address the buildup of tau, a protein that’s also associated with the neurodegenerative disorder. The biotech now has $100 million to advance its lead program to Phase 2 testing. The Series C financing announced Tuesday was led by Novo Holdings, the company that manages the assets of the Novo Nordisk Foundation, the controlling shareholder of metabolic drug giant Novo Nordisk. Using a drug to target and break up pathological proteins associated with Alzheimer’s has been validated by Eisai’s Leqembi, approved by the FDA last year, ...
- Source: drugdu
- 125
- July 18, 2024
AbbVie looks to add an eighth indication for JAK inhibitor Rinvoq

AbbVie is set to expand the indication list for its immunology blockbuster, Rinvoq (upadacitinib). The company has submitted applications to both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to seek approval for the use of Rinvoq as a treatment for giant cell arteritis. Rinvoq blocks the activity of Janus kinase (JAK) enzymes in the JAK-STAT signalling pathway, which plays a role in the release of pro-inflammatory cytokines. It has been approved by the FDA to treat seven autoimmune conditions, namely atopic dermatitis, ankylosing spondylitis, axial spondylarthritis, Crohn’s disease, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis. Rinvoq is one of the top revenue-generating therapies for AbbVie, raking in approximately $4bn in sales last year, per the company’s financials. The therapy’s revenue is expected to soar over the next decade, with Rinvoq expected to pull in over $12bn in sales by 2030, as ...
- Source: https://www.pharmaceutical-technology.com/news/abbvie-looks-to-add-an-eighth-indication-for-jak-inhibitor-rinvoq/
- 80
- July 17, 2024
Multiplex PCR Test Detects Common Viral and Bacterial Causes of Respiratory or Sore Throat Infections in 15 Minutes

The COVID-19 pandemic has created the need for healthcare professionals to employ diagnostic tests as close as possible to the patient and provide rapid actionable results. An increasing number of tests are conducted outside hospital labs directly in Emergency Departments (ED) or at the Point of Care (POC). This market is especially active in the U.S. Now, a fast and innovative syndromic testing solution perfectly matches these new medical needs. bioMérieux’s (Marcy-l’Étoile, France) BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel Mini has obtained U.S. Food and Drug Administration (FDA) Special 510(k) clearance and CLIA-waiver (Clinical Laboratory Improvement Amendments). Designed for use on the BIOFIRE® SPOTFIRE® system, the BIOFIRE® SPOTFIRE® R/ST Panel Mini is a unique multiplex PCR test that detects five of the most common viral and bacterial causes of respiratory or sore throat infections in around 15 minutes. Samples can be taken from a nasopharyngeal swab when a respiratory ...
- Source: https://www.labmedica.com/molecular-diagnostics/articles/294801818/multiplex-pcr-test-detects-common-viral-and-bacterial-causes-of-respiratory-or-sore-throat-infections-in-15-minutes.html
- 69
- July 17, 2024
Positive Data in Pancreatic Cancer Pave Way for Pivotal Test of Revolution Medicines Drug

Revolution Medicines drug RMC-6236 increased progression-free survival in patients with advanced cases of pancreatic ductal adenocarcinoma. With these results, the biotech is preparing for a Phase 3 clinical trial in this indication, the most common type of pancreatic cancer. By Frank Vinluan Pancreatic cancer remains one of the toughest cancers to treat, but Revolution Medicines has data from an early-stage study showing its experimental treatment helped patients live longer without their disease worsening. With these encouraging results, Revolution said Monday it is preparing to proceed to a pivotal clinical trial enrolling patients with advanced cases of the most common type of pancreatic cancer. Revolution develops therapies that target the RAS family of proteins, validated but elusive targets for cancer drug research. Mutations to these proteins lead to the uncontrolled cell growth that happens in a variety of cancers. The most advanced program from Redwood City, California-based Revolution is RMC-6236. This small molecule is ...
- Source: https://medcitynews.com/author/fvinluan/
- 73
- July 17, 2024
Publication in Journal of Translational Medicine Highlighting Henlius’ Dual HER2 Blockade Therapy Mechanism of Action

Recently, Journal of Translational Medicine, a prestigious medical journal, published a research article describing mechanism of action (MOA) of Henlius’ innovative anti-HER2 monoclonal antibody (mAb), HLX22, in dual HER2 blockade therapy. The research analysed the structure foundation and mechanisms of action associated with HLX22, further validating its potential in combination with trastuzumab in the first-line treatment of HER2-positive gastric/gastroesophageal junction (G/GEJ) cancer to benefit more patients worldwide. Trastuzumab, the first HER2-targeted cancer therapy, was introduced in clinical practice and revolutionised the treatment of HER2-positive breast cancer and gastric cancer. Trastuzumab in combination with pertuzumab and docetaxel has also verified their synergistic effect in the treatment of HER2-positive metastatic breast cancer, and the combination regimen is now the standard of care in this indication. However, a phase 3 trial that assessed the efficacy of pertuzumab versus placebo in combination with trastuzumab and chemotherapy in first-line HER2-positive metastatic gastric or G/GEJ cancer ...
- Source: drugdu
- 80
- July 15, 2024
Amylyx Aims to Help Patients With a Novel GLP-1 Drug, But Not the Way You Think

Unlike GLP-1 agonist drugs marketed for weight loss, new Amylyx Pharmaceuticals drug avexitide blocks its target receptor. Amylyx plans to advance this GLP-1 antagonist into Phase 3 testing for post-bariatric hypoglycemia, a rare condition in which blood sugar levels drop precipitously. By Frank VinluanBefore GLP-1 drugs became a wildly popular pharmacologic way to treat obesity, bariatric surgery was a top option for those seeking a medical intervention for losing weight. While this procedure is effective for weight loss, it turns out that changing the structure of the gut can lead to a debilitating disorder in some patients. Amylyx Pharmaceuticals, months removed from a clinical trial failure that shattered its prospects in neurodegeneration, is now planting a flag in metabolic disease with the acquisition of a Phase 3-ready drug for this rare disorder with no FDA-approved therapies. The drug comes from Eiger BioPharmaceuticals, which last month sold off its assets in ...
- Source: drugdu
- 71
- July 12, 2024
Philips recall of imaging coils tied to 12 injuries

Dive Brief Philips has recalled several models of Sense XL Torso coils due to the risk of the devices heating up during MRI scans and burning patients. Philips updated the instructions for six models of Sense XL Torso coils used with 1.5T and 3.0T MRI scanners, according to a recall notice posted Monday by the Food and Drug Administration. The recall does not require products to be removed from facilities or where devices are sold. Twelve reported injuries have been associated with the recall, the FDA said. No deaths were reported. Dive Insight Philips’ latest recall is yet another safety problem for the company, which has spent more than three years managing a recall of over 15 million respiratory devices. The company has had recent issues with imaging machines. In November, Philips recalled certain MRI scanners because of the risk of machines exploding. The FDA said at the time that ...
- Source: drugdu
- 68
- July 11, 2024
Dual HER2 Blockade Therapy Presented on MED and ESMO GI

Recently, results of the phase 2 study of HLX22, an innovative anti-HER2 monoclonal antibody (mAb), in combination with HANQUYOU (HLX02, trastuzumab, trade name: HERCESSI™️ in the U.S., Zercepac® in Europe) and chemotherapy for the first-line treatment of HER2-positive advanced gastric/gastroesophageal junction (G/GEJ) cancer were presented on 2024 ESMO Gastrointestinal Cancers Congress (ESMO GI) and MED, a flagship clinical and translational research monthly journal by Cell Press. The leading principal investigator for this study is Professor Jin Li from Shanghai East Hospital, School of Medicine, Tongji University. The results showed that the addition of HLX22 to HLX02 (trastuzumab) plus chemotherapy as first-line therapy improved efficacy in HER2-positive G/GEJ cancer patients with manageable safety. The results of HLX22-GC-201 were first presented at the 2024 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI). The study data and updated results with another 7.8 months of follow-up were accepted for publication on MED ...
- Source: drugdu
- 60
- July 11, 2024
Eli Lilly Shows Appetite for Oral Immunology Drugs, Swallowing Morphic in $3.2B Deal

Eli Lilly’s Morphic acquisition brings an oral small molecule that blocks the same target as Entvyio, an injectable inflammatory bowel disease drug from Takeda Pharmaceutical. The Morphic deal follows Lilly’s 2023 acquisition of Dice Therapeutics, another company developing oral immunology medications. By Frank VinluanEli Lilly has immunology and inflammation products administered by injection, but the pharmaceutical giant is among the companies interested in bringing patients more convenient pill formulations. Its $3.2 billion acquisition of Morphic comes with a lead drug candidate that’s an oral small molecule in mid-stage development for inflammatory bowel disease. According to deal terms announced Monday, Lilly is paying $57 in cash for each share of Waltham, Massachusetts-based Morphic. That price represents a 79% premium to Morphic’s closing stock price on Friday. The deal, which has been approved by the boards of directors of both companies, is expected to close in the third quarter of this year. ...
- Source: drugdu
- 101
- July 10, 2024
Sanofi & Regeneron Drug Dupixent Gets EMA Approval as the First Biologic COPD Med

European Medicines Agency approval of Dupixent in chronic obstructive pulmonary disease makes the drug the first biologic therapy approved for treating the prevalent respiratory condition. In COPD, Dupixent addresses what’s called type 2 inflammation. By Frank Vinluan Inflammation that develops in chronic obstructive pulmonary disorder stems from different causes. A new regulatory decision in Europe makes Sanofi and Regeneron Pharmaceuticals drug Dupixent the first biologic therapy approved for COPD driven by one particular type of inflammation. The European Medicines Agency (EMA) has approved Dupixent for adults with uncontrolled COPD that is also characterized by raised blood levels of eosinophils, a type of white blood cell. COPD patients typically take multiple medications to manage the chronic condition. The new Dupixent approval, announced just prior to the Independence Day holiday in the U.S., covers use of the injectable drug as an add-on maintenance treatment for patients whose COPD is uncontrolled by available therapies. ...
- Source: drugdu
- 80
- July 9, 2024

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