OxyDial的动态

GC Biopharma is excited to announce the submission of a Phase 1/2 IND application to the US FDA for LA-GLA, our innovative treatment for Fabry disease being developed with Hanmi Pharmaceuticals. LA-GLA represents a groundbreaking advancement as the world's first once-monthly subcutaneous injection for Fabry disease, designed to replace the current bi-monthly IV enzyme replacement therapy. This new treatment aims to offer a more convenient and effective alternative to existing methods. In May, LA-GLA received Orphan Drug Designation (ODD) from the FDA. Our non-clinical studies demonstrated its potential to improve renal dysfunction, vasculopathy, and neuropathy. Drawing on our extensive experience and expertise in treating lysosomal storage disorders, we are committed to advancing innovative solutions for patients with Fabry disease. #FabryDisease #TreatmentUpdate #LysosomalStorageDisorders #INDApplication

Government Must Empower NICE - National Institute for Health and Care Excellence to Unlock Access to Life-Saving Medicines for Severe Conditions The NICE - National Institute for Health and Care Excellence has decided to maintain its current valuation methods for medicines, despite concerns that patients with severe conditions are missing out on critical treatments. The Association of the British Pharmaceutical Industry (ABPI), led by Paul Catchpole, urges the government to reform funding constraints imposed by the 2024 Voluntary Scheme for Branded Medicines Pricing and Access, which they argue is restricting access to innovative therapies. While NICE - National Institute for Health and Care Excellence plans to reassess public opinion on medicine valuation, The Association of the British Pharmaceutical Industry (ABPI) is concerned that the two-year timeline will delay necessary reforms, leaving patients without access to potentially life-saving treatments. For more details please click the link! https://lnkd.in/duJjR_Ep #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical?

Shortages of medicines in Europe are increasingly frequent due to various factors. While antibiotics and pediatric drugs often make headlines, shortages also extend to treatments for cardiovascular diseases, CNS, and oncology. Over the past 10 years, the number of withdrawn generic products increased by 12%, while the number of new generic products decreased by 3%. To tackle this, the European Commission published a list of critical medicines considering 2 factors – the seriousness of the disease and number of alternative therapies available. The pharmaceutical industry faces challenges without the ability to adjust prescription drug prices. Generics stimulate access, for which they need legal clarity and predictability to ensure an immediate launch after the expiry of exclusivity. Long-term solutions require supportive policies to maintain a healthy pharmaceutical industry and safeguard people's health. For more information go to: https://bit.ly/49Yv8Yr #tevapharmaceuticals #tevapharm #production #euproduction #manufacturing #shortages #cns #cardio #inflation?#generics

CMS PHARMA DRUG PRICE NEGOTIATIONS UPDATE: CMS offers Pharma more time and opportunities to submit counteroffers during price talks that may finalize in 2025. In August, the federal government?announced?the lower negotiated prices for 10 medications, which include therapies for Type 2 diabetes, blood clots and heart failure. The new prices — which are?estimated?to reduce healthcare costs by $7.5 billion — will go into effect Jan. 1, 2026. For the next phase, CMS will select up to 15 medications to undergo negotiations for lower list prices to take effect Jan. 1, 2027. Multiple cancer therapies are?predicted?to be chosen, and CMS will announce the selected drugs by February. In contrast to the first round of negotiations, CMS will hold up to 15 patient-focused roundtables and one town hall that weighs the clinical considerations, according to a 313-page?final guidance published Oct. 2nd. #CMS #PHARMA #NEGOTIATIONS #UPDATE #AHCA

The U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for #LNZ100 (aceclidine 1.75% ophthalmic solution) for the treatment of #Presbyopia. #LNZ100 is a single-use, once-daily eye drop containing aceclidine, a small molecule acetylcholine receptor agonist that causes miosis. The NDA is supported by data from the #CLARITY phase 3 program, which included patients aged 45 to 75 years with a refractive range of -4.0D SE (spherical equivalent) to +1.0D SE. The #CLARITY1 trial (https://bit.ly/48y4wNV Identifier: NCT05656027) compared the efficacy and safety of LNZ100 with brimonidine 0.08%, while #CLARITY2 (https://bit.ly/48y4wNV Identifier: NCT06045299) compared LNZ100 with placebo. “With the acceptance of our New Drug Application for LNZ100, we are pleased to be one step closer towards potential approval and look forward to continuing to collaborate with the FDA to deliver the first once-daily, well-tolerated and rapid acting eye drop for the treatment of presbyopia to the 128 million individuals living with blurry near vision in the United States,” said Eef Schimmelpennink, President and Chief Executive Officer of LENZ Therapeutics. Read more: https://bit.ly/4fy7hRL #NewDrugApplication #Aceclidine #EyeDrop #EyeHealth #EyeCare #Ophthalmology #ClinicalTrial #Ophthalmologist #EyeDoctor

The US FDA New Drug Approvals in April 2024 PharmaShots, your go-to media platform for life science news, brings a condensed report highlighting new drug approvals in April 2024. Stay Tuned for more updates! #regulatory #usfda #pharma #healthcareindustry #approvals #newmolecularentities #biologic #pharmashots

CANbridge Pharmaceuticals Inc. (SEHK:1228) announced that the last patient in the CAN103 Phase 2 trial, involving treatment-na?ve patients aged 12 or above with Gaucher disease (GD) Types I and III, has now completed the final visit. In October 2023, the core part of the CAN103 Phase 2 trial reached full enrollment. Phase 2 is a randomized, double-blind, dose comparison study designed to evaluate the efficacy, safety, and pharmacokinetics of CAN103 in newly treated GD patients, followed by an extension period. This trial serves as a potential registrational trial for CAN103. #GaucherDisease #ClinicalTrials #EnzymeReplacementTherapy #HealthcareInnovation #RareDiseases #MedicalResearch #QimingPortfolio #QimingHealthcare Read More: https://lnkd.in/gnBKJeg4

Takeda’s resurrection of the once-rejected #Eohilia appears to be paying off, with a survey of physicians?finding?the launch is in line with the rollout of Dupixent and is delaying the use of Regeneron and Sanofi’s big blockbuster drug.?? The FDA rejected Eohilia, also called TAK-721 , in the chronic inflammatory disease eosinophilic esophagitis in 2021. Spherix Global Insights surveyed 75 U.S. physicians who treat #eosinophilic #esophagitis was found trial rates to be comparable to DUPIXENT? (dupilumab) HCP, which won FDA approval in the setting in 2022, at a similar point in its launch. More than half of the physicians had prescribed Eohilia and “the breadth of patient initiations” for Takeda’s drug surpassed that of #Dupixent, Spherix said. Projecting out to six months after launch suggests a user base comparable to that of Dupixent. Spherix expects Takeda’s market share to increase by fourfold. The forecasts reflect the potential for Eohilia to fill a gap in the toolkit for treating eosinophilic esophagitis

The GLP-1 panic is alive and well Yesterday, Eli Lilly said its GLP-1-targeting medicine met its primary goal in mid-stage study enrolling patients with MASH, the obesity-related liver disease formerly known as NASH. And then biotech companies working in MASH, including one weeks away from an expected FDA approval, fell by double digits. The news is that tirzepatide, which Lilly sells as Mounjaro and Zepbound, led to resolution of MASH for 74% of patients in a Phase 2 trial. Lilly said the drug also had a “clinically meaningful” effect on liver fibrosis, one of the hallmarks of MASH, but the company did not say whether that difference met the threshold of statistical significance. What’s curious is how this datapoint could so dramatically affect the fortunes of a company like Madrigal Pharmaceuticals, which lost as much as 17% of its value yesterday. Madrigal’s drug, up for approval on March 14, has demonstrated a significant improvement in liver fibrosis in a Phase 3 study. There’s a compelling theory that medicines like Zepbound and Wegovy, by virtue of their ability to reduce body weight, will shrink the market for MASH therapies by preventing patients from developing the disease in the first place. But until one of them can demonstrate a reduction in fibrosis, there will almost certainly be demand for drugs like Madrigal’s. https://lnkd.in/e9MVqrcQ

Big news in the pharmaceutical industry! Alvotech and Teva Announce US Approval of Simlandi? Exciting news for the healthcare community! Alvotech and Teva recently announced the US approval of Simlandi?, the first high-concentration, citrate-free biosimilar to Humira. This development has the potential to: -Increase access to affordable treatment options?for patients with various conditions, including rheumatoid arthritis, psoriasis, and Crohn's disease. -Offer healthcare providers more flexibility in treatment choices. Stay up-to-date on the latest advancements in the pharmaceutical industry with RxSlides' LinkedIn regular posts ?? You can explore related RxSlides medical PowerPoint templates on... ?Adalimumab?https://lnkd.in/d4mkDCFp Ustekinumab?https://lnkd.in/dbHr6ZUR We invite you to repost this news post and contribute to a comprehensive understanding of recent advancements in the pharmaceutical landscape. you can read the full article about this news from this link: https://lnkd.in/eHf3yzB2 #rxslides?#pharmanews?#adalimumab?#Alvotech?#Teva?#powerpoint?#Medical?#medicaltraining?#immunology