The FDA has granted a fast track designation to 225Ac-FL-020, an investigational PSMA-targeting radionuclide drug conjugate for mCRPC. https://lnkd.in/ereb53yc
Urology Times’ Post
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#sBLA for #Epcoritamab in R/R #Follicular #Lymphoma Earns FDA Priority Review:- •The FDA has granted priority review to a supplemental biologics license application (#sBLA) for #epcoritamab-bysp (#Epkinly) as a treatment for adult patients with #relapsed/refractory #follicular #lymphoma following at least 2 prior lines of therapy, according to a press release from #Genmab and #AbbVie.
sBLA for Epcoritamab in R/R Follicular Lymphoma Earns FDA Priority Review
cancernetwork.com
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UK Infuses £13M into Diverse Range of Manufacturing Ventures Amgen faces a pivotal moment with its KRAS inhibitor Lumakras as uncertainties linger over its compatibility with PD-1 inhibitors and the defense of its accelerated approval. An FDA advisory committee meeting is scheduled for October 5th to discuss transitioning Lumakras' accelerated approval to full endorsement. Debates center on Lumakras' efficacy, with Phase 3 CodeBreaK 200 trial results showing modest benefits compared to CodeBreaK 100. Safety concerns regarding liver toxicity and competition with Mirati's Krazati add complexity. As the meeting approaches, the future of Lumakras hangs in the balance, drawing attention from the biopharmaceutical community and raising suspense over its fate in NSCLC treatment. If you're interested in continuing to read the full story and want to stay updated with the Latest Pharma News in USA, visit Pharmtales. #pharma #pharmaceutical #pharmtales #latestnews #pharmanews #pharmaceuticalindustry #fda #pharmaceuticalcompanies #Lumakras #KRAS https://lnkd.in/dA22b9PR
FDA Convenes Advisors to Assess Full Approval Prospects for Amgen’s Lumakras Amid KRAS Uncertainties
https://pharmtales.com
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At some point, people should start coming to us exposing who these subpar contract manufacturers are. It's not just bad for the client biopharma company's business, it's bad for patients, especially when you have a potential first-in-class medicine delayed like this because of some shortfalls at a manufacturing plant. Daiichi Sankyo, Merck, FDA #DaiichiSankyo #Merck #MSD #ADC #antibodydrugconjugate #HER3 #CRL #FDA #NSCLC #EGFR #lungcancer #lungcancertreatment
Daiichi's lung cancer ADC rejected by FDA in blow to first project under Merck partnership
fiercepharma.com
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𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗨𝗽𝗱𝗮𝘁𝗲𝘀! ✅ The European Commission has approved Merck Group's #Keytruda ✅ AstraZeneca has picked up an FDA priority review for the #Tagrisso and chemotherapy combo ✅ Novavax has encountered a setback in its attempt to win market authorization for its updated COVID-19 vaccine in Europe ✅ Orasis Pharmaceuticals, a Florida-based ophthalmic pharmaceutical company, has secured an FDA approval for its #Qlosi to treat presbyopia ✅ Takeda's antibody-drug conjugate (ADC) Adcetris has picked up an approval from the European Commission. #regulatoryaffairs #pharma #biotech #approvals #fda #ema #EU #US #oncology #presbyopia #combinationtherapy #ADC #opthalmology #MAA #marketingauthorisations
Regulatory tracker: Merck's Keytruda picks up 2 new approvals in Europe
fiercepharma.com
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We look forward to progressing our Phase 2 clinical trial in acute ischaemic stroke patients in Q1 2024! If you missed our latest announcement, have a read of the latest article by Stockhead below! #ASX #AGN #stroke #clinicaltrial #strokeawareness
Argenica Therapeutics is progressing its Phase 2 clinical trial in acute ischaemic stroke patients, with the manufacturing of its ARG-007 drug substance now complete. Argenica Therapeutics #ad #ASX
Argenica on track to commence patient dosing for Phase 2 stroke clinical trial in Q1 - Stockhead
https://stockhead.com.au
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Dive into this week's edition of FirstWord Pharma's Friday Five for an insightful glance into the pharmaceutical industry's latest. Here’s a sneak peek: 🎉 UCB's twin triumphs with FDA approvals, paving the way despite initial hiccups. 🔬 Early info leaks ahead of the ESMO Congress, teasing some promising advancements in cancer treatment. 💰 Novo Nordisk's venture into the hypertension space, marking a significant stride in its portfolio. Stay tuned for our comprehensive analysis shedding light on prescribing trends, market access issues and expert opinions on the unfolding scenarios. Plus, catch up with FirstWord's Simon King at the ESMO Congress! #PharmaNews #FDAApprovals #ESMOCongress #NovoNordisk #UCB #Analysis #FridayFive #pharmaceuticals #Ardelyx #mergersandacquisitions #clinicalresearch #clinicaltrials #Merck #Keytruda #ckd #NSCLC #FridayFive https://lnkd.in/ebYs3_Gf
Friday Five (20 Oct 2023) – UCB’s twin triumphs, early ESMO info, Novo’s blood pressure buy … and more
ml.firstwordpharma.com
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Exciting news from Viridian Therapeutics, Inc.! The company is gearing up to kick off two phase 3 clinical trials, REVEAL-1 and REVEAL-2, for VRDN-003, an anti-IGF-1R antibody, in August 2024. These trials will focus on treating moderate-to-severe thyroid eye disease (TED). VRDN-003, designed for subcutaneous administration as infrequently as every eight weeks, aims to enhance patient access and adherence to treatment. REVEAL-1 and REVEAL-2 will involve around 84 and 126 patients, respectively, evaluating the proportion of patients achieving a minimum 2mm improvement in proptosis at week 24. With topline results expected in the first half of 2026, if successful, Viridian plans to file a Biologics License Application by the end of 2026. The company envisions launching VRDN-003 with an autoinjector pen for easy administration, believing it could set a new standard in TED treatment and improve outcomes for patients. To learn more about Viridian's groundbreaking trials and VRDN-003, 𝐜𝐥𝐢𝐜𝐤 𝐡𝐞𝐫𝐞: https://lnkd.in/dnaDkaM8 #ViridianTherapeutics #ClinicalTrials #HealthcareInnovation Atanas Atanasov Laura A Epelbaum 🦁
Viridian Therapeutics Launches Two Phase 3 Trials: TED
https://www.clinicaltrialvanguard.com
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First phase 3 results from CARTITUDE-4: Cilta-cel versus standard of care (PVd or DPd) in lenalidomide-refractory multiple myeloma. Ide-cel or Standard Regimens in Relapsed and Refractory Multiple Myeloma
While expressing optimism about the potential of new treatments from Bristol Myers Squibb and Johnson & Johnson to secure FDA approval in earlier lines of treatment for multiple myeloma, experts questioned aspects of the treatment paradigm. #fda #pharma #biospace https://hubs.li/Q02nWcKb0
FDA Adcomm to Tackle Complexity of CAR-T for Multiple Myeloma | BioSpace
biospace.com
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💊𝗕𝗹𝗼𝗴𝗴𝗲𝗿 #ConnectingInforming #DrugDiscoverytoDrugDelivery 💻𝗩𝗶𝗱𝗲𝗼 𝗖𝗼𝗻𝘁𝗲𝗻𝘁 𝗖𝗿𝗲𝗮𝘁𝗼𝗿 YouTube: RSK Life Science Media 📈𝗖𝗼𝗻𝘀𝘂𝗹𝘁𝗮𝗻𝘁-LinkedIn/Marketing/Media/Events, Brand Champion
#Article: When #MadrigalPharmaceuticals’ #Rezdiffra was approved last month as the first-ever treatment for #metabolicdysfunctionassociatedsteatohepatitis, experts hailed the drug as an “important first.” However, the consensus among experts is that Rezdiffra is just the beginning for a disease that has been notoriously difficult to treat. Metabolic dysfunction-associated steatohepatitis (#MASH) is inflammation of the liver caused by excess fat cells, which can lead to progressive fibrosis and cirrhosis of the liver. “[Rezdiffra] is the first oral drug that’s been demonstrated to show reversal of fibrosis in Phase III clinical studies,” said Lawrence M. Blatt, CEO of Aligos Therapeutics, which is also developing a candidate for MASH. “If you look at the magnitude of the impact of Madrigal’s drug, it’s good for patients,” he told BioSpace. “I don’t want to downplay what they’ve achieved . . . but there’s a lot of room for improvement.” About a quarter of patients treated with Rezdiffra have an improvement in fibrosis, he noted. “That leaves 75% of patients with the need for better therapies.” A day before Rezdiffra’s approval, Ionis Pharmaceuticals, Inc. announced that its own #MASHcandidate hit the primary endpoint in a #PhaseIItrial, showing significant improvement in steatohepatitis without worsening fibrosis, according to the company. And this is only the tip of the iceberg. Here, BioSpace looks at five mid- to late-stage investigational MASH drugs. Read more from #Biospace's Heather McKenzie👇🏼 https://lnkd.in/eZFepwAH
5 Promising MASH Therapies That Could Follow Madrigal’s Rezdiffra | BioSpace
biospace.com
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Building on the very promising data from the early-stage trial, Faron Pharmaceuticals Limited (AIM:FARN, OTC:FPHAF) has launched the phase II evaluation of BEXMAB focusing on people with myelodysplastic syndromes (MDS) resistant to standard treatments. MDS is a group of bone marrow disorders that result in an inability to produce enough healthy blood cells. The trial will test two dosages. Guided by feedback from the US Food and Drug Administration (FDA) it will work with 3 milligrams per kilogram and 6 milligrams per kilogram of bexmarilimab. Thirty-two patients who have not responded to hypomethylating agents (HMAs), a common MDS treatment, will be enrolled. More at #Proactive #ProactiveInvestors #AIM #OTC #FARN #FPHAF #FaronPharmaceuticals #MDS #myelodysplastic http://ow.ly/AvG31050l5s
Faron Pharma kicks off phase II evaluation of promising bone marrow cancer candidate
proactiveinvestors.co.uk
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