Search Results for “EC” – Page 336 – media

Benzodiazepine prescribing practices for homeless veterans with mental illness

What question were you investigating? Despite elevated risk for substance use disorder and overdose death in the homeless population, benzodiazepine prescribing for this population has not been examined. Our team therefore set out to answer the questions:  What is the rate of benzodiazepine prescribing to homeless vs. non-homeless veterans with mental illness in the VA system?  Are homeless veterans more likely to receive risky and potentially inappropriate prescriptions? What methods did you use? We used logistic regression to compare likelihood of benzodiazepine prescribing and tests to compare indicators of risky and potentially inappropriate benzodiazepine prescribing patterns for homeless veterans with mental illness and their housed counterparts. Our approach was unique in that it is the first study to attempt to investigate this question. We were able to do so in a large, national VA database, the country’s largest provider of homeless services. What did you find? We found ...
- Source: drugdu
- 106
- November 20, 2023
Inari Medical closes LimFlow acquisition

BY SEAN WHOOLEY The LimFlow System. [Illustration courtesy of LimFlow] Inari Medical (Nasdaq: NARI)+ announced that it completed its acquisition of chronic limb-threatening ischemia (CLTI) treatment maker LimFlow. The Irvine, California–based company earlier this month announced plans to acquire LimFlow for up to $415 million. The deal came just weeks after Paris-based LimFlow won FDA premarket approval (PMA) for its breakthrough CLTI treatment. Inari Medical intends to pay a total upfront consideration of $250 million in cash at closing. Contingent consideration of up to $165 million in additional cash payments hinges on certain commercial and reimbursement milestones. Inari Medical expects to pay those tranches out between 2025 and 2027. The company said it funded the acquisition at close from existing cash resources. LimFlow designed its system for transcatheter arterialization of deep veins. It diverts blood from a diseased tibial artery to a tibial vein to deliver oxygen to a patient’s ...
- Source: drugdu
- 99
- November 20, 2023
Q&A With Dr. Mike McCullar, CEO of RegCell

Mike Hollan McCullar discusses his new role as CEO of RegCell. Dr. Mike McCullar CEO RegCell Pharmaceutical Executive: How did you end up as CEO? Dr. Mike McCullar: Prior to joining RegCell as CEO and president, I was a toxicologist by training. I was fortunate to work in multiple operating roles over the years. I ended up working in Japan for a decade, and I was approached by a leading Japanese venture fund and asked if could help them start to migrate leading Japanese companies to the US. RegCell was one of those companies, and I felt it had the potential to have the best-in-class platform in terms of how we think about treating autoimmune disorders. It’s been an interesting journey so far. PE: What are the companies plans for the coming year? McCullar: What we’re focused on right now is launching a first in-human clinical trial. That takes quite ...
- Source: drugdu
- 109
- November 20, 2023
World’s first CRISPR-based gene therapy approved for sickle cell anaemia

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has granted conditional marketing authorisation to Vertex Pharmaceuticals and CRISPR Therapeutics’ Casgevy (exagamglogene autotemcel), marking the world’s first approval of a CRISPR-based gene editing therapy. Casgevy has been approved to treat patients with sickle cell disease with recurrent vaso-occlusive crises and transfusion-dependent beta-thalassemia aged 12 years or older, for whom a human leukocyte antigen (HLA) matched related hematopoietic stem cell donor is not available. Also known as exa-cel, Casgevy is currently being evaluated by the US Food and Drug Administration (FDA). The Prescription Drug User Fee Act (PDUFA) target action date for the drug is set for 8 December in severe sickle cell disease and 30 March 2024 in beta-thalassemia, as per a 16 November press release. Casgevy is a genetically modified autologous CD34+ cell population that contains clustered regularly interspaced short palindromic repeats (CRISPR) edited human haematopoietic stem and progenitor ...
- Source: drugdu
- 103
- November 20, 2023
BMS strengthens NSCLC market share with ROS1 drug Augtyro

The US Food and Drug Administration (FDA) has approved Bristol Myer Squibs’ (BMS) Augtyro (repotrectinib) for adults with non-small cell lung cancer (NSCLC). Augtyro is an orally administered tyrosine kinase inhibitor (TKI) designed to selectively bind to active kinase formations in ROS1-positive NSCLC and suppress uncontrolled cell proliferation and tumor growth caused by ROS1 oncogenic fusions. It is the only FDA-approved TKI for ROS1-positive NSCLC. The FDA approval was based on data from the ongoing Phase I/II TRIDENT-1 (NCT03093116) trial, which is evaluating repotrectinib in 500 patients with advanced solid tumours characterized by ALK, ROS1, or NTRK1-3 fusions. The Phase I portion assessed the safety, tolerability, and pharmacokinetics of repotrectinib. Patients previously treated with a TKI and no chemotherapy demonstrated an overall response rate (ORR) of 38% and a median DOR of 14.8 months. Patients with no prior treatment with a TKI had an ORR of 79% and a median ...
- Source: drugdu
- 100
- November 20, 2023
FDA approves study of Versameb’s mRNA therapy in urinary incontinence

Swiss company Versameb will initiate a clinical trial investigating a messenger ribonucleic acid (mRNA) to treat stress urinary incontinence, after receiving clearance from the US Food and Drug Administration (FDA). The FDA approved the company’s investigational new drug (IND) application for a Phase IIa trial of VMB-100 – an intramuscularly locally delivered, sequence-engineered mRNA. The study is scheduled to start in the first half of 2024. Versameb’s candidate encodes human insulin-like growth factor-1 (IGF-1). According to Versameb, preclinical studies have shown that VMB-100 can induce the expression of IGF-1 in human muscle cells, and the candidate accelerated the regeneration of the urinary sphincter muscle and restored urinary sphincter function in animal models of stress urinary incontinence, after a single dose of treatment. Stress urinary incontinence is a condition where there is an involuntary leakage of urine due to a weakened urinary sphincter muscle. It is a condition that particularly affects ...
- Source: drugdu
- 170
- November 20, 2023
Kite and Arcellx expand strategic collaboration

Gilead company Kite has expanded its existing partnership with Arcellx for the latter’s CART-ddBCMA candidate to include lymphomas. The parties entered an international strategic deal in December 2022 to jointly develop and market a CART-ddBCMA candidate for relapsed or refractory multiple myeloma. Kite has now exercised its licence option for ACLX-001, an ARC-SparX programme of Arcellx in multiple myeloma. Arcellx is entitled to receive an equity investment of $200m in exchange for 3,242,542 shares of its common stock. The funding will offer 13% ownership of Arcellx to Gilead. Arcellx is also eligible to receive $85m in upfront non-dilutive cash payment, separately from milestone payments in the future. The deal will close by the end of 2023. A BCMA-specific CAR-modified T-cell therapy of Arcellx, CART-ddBCMA is currently in a Phase II clinical trial. Kite executive vice-president Cindy Perettie stated: “We are pleased to see the momentum with the CART-ddBCMA multiple myeloma ...
- Source: drugdu
- 155
- November 20, 2023
Almirall and Absci announce $650m AI drug discovery partnership for dermatological diseases

Almirall and Absci have announced a drug discovery partnership aimed at developing and commercialising artificial intelligence (AI)-designed treatments for dermatological diseases, with the deal worth over $650m. The collaboration will combine Almirall’s dermatological capabilities with Absci’s Integrated Drug Creation platform, which the generative AI company says “unlocks the potential to accelerate time to clinic and increase the probability of success by simultaneously optimising multiple drug characteristics important to both development and therapeutic benefit”. Under the terms of the agreement, Absci will apply its de novo generative AI technology to create and commercialise therapeutic candidates for two dermatological targets. In addition to product royalties, Absci is eligible to receive up to approximately $650m in upfront fees, research and development (R&D) and post-approval milestone payments across the two programmes if all milestones are successfully completed. Dr Karl Ziegelbauer, Almirall’s executive vice president of R&D and chief scientific officer, said: “Almirall chose Absci ...
- Source: drugdu
- 96
- November 18, 2023
New genetic variants linked to prostate cancer in men with African ancestry

Researchers from the Institute of Cancer Research (ICR) and the University of Southern Carolina’s Keck School of Medicine in the US have identified new genetic variants that link to men with African ancestry’s risk of developing prostate cancer. Results from the study could help explain why men of African descent have a greater risk of developing the condition. Published in Nature Genetics, researchers compiled DNA from over 944,000 men of European, African, Asian and Hispanic ancestry – over 150,000 of whom had prostate cancer. Approximately 19,391 of the samples were from men with prostate cancer of African ancestry, offering insight into why they are twice as likely to develop the condition compared to white European men. As a whole, researchers identified 187 new genetic variants linked to men’s risk of developing prostate cancer. Across the UK, more than 52,000 men are diagnosed with prostate cancer every year. The condition affects ...
- Source: drugdu
- 206
- November 18, 2023
FDA Approves Bristol Myers Squibb’s Augtyro for Non-Small Cell Lung Cancer

Pharmaceutical Executive Editorial Staff Repotrectinib (Augtyro) is a next-generation, potential best-in-class tyrosine kinase inhibitor approved to treat locally advanced or metastatic ROS1-positive non-small cell lung cancer. The FDA has approved Bristol Myers Squibb’s repotrectinib (Augtyro) to treat locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).1 Repotrectinib is a next-generation, potential best-in-class tyrosine kinase inhibitor (TKI) that targets ROS1- or NTRK-positive locally advanced or metastatic solid tumors. The drug was designed to improve the durability of response and with favorable properties that improve intracranial activity. “While progress has been made in the treatment of NSCLC over the past decade, there is still a need to address this particularly difficult-to-treat form of the disease with innovative science and a targeted approach,” Samit Hirawat, MD, executive vice president, chief medical officer, Global Drug Development, Bristol Myers Squibb, said in a press release.1 “As the only approved next-generation TKI for ROS1 positive ...
- Source: drugdu
- 172
- November 18, 2023

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