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Developing new drugs is a time-consuming and costly endeavor. CapsCanada’s FM-CAPS® Clinical Trial Capsules reduce your development costs by speeding your time-to-market. - Learn more: https://hubs.ly/Q02CHVPJ0 - #CapsCanada #clinicaltrials #newdrug #newdrugformulations #fmcaps #capsules

During #DIA2024, I was honored to sit down with Dr. Peter Marks and get his thoughts on how the industry is fairing 2024, as well as his vision for the future. ➡️ Watch the Full Interview: https://lnkd.in/ga_z9spj #regulatory #clinicaltrials #rarediseases #AI #FDA #globalcollaboration .

A new weekly injectable weight-loss drug, pemvidutide, from Altimmune, showed impressive results in a Phase II clinical trial, with patients losing about 75% fat and only 25% muscle. This stands out compared to existing GLP-1 drugs, offering the potential to mimic exercise effects without physical activity. Other drugmakers are likewise exploring solutions to prevent muscle loss.</div><div class="read-more"><a href="" class="more-link">Continue reading</a>https://lnkd.in/eVUrjtsB

Interesting read! https://lnkd.in/dW2b-SM3 With potential amendments to the regulation that may allow substitution of biosimilars at pharmacy level, it only seems natural that the activity in the biosimilars arena will increase, and accordingly, we should expect more activity at the PTAB. IPRs have certainly been a better strategy for biosimilars than small molecule generics. But then, there is also the PREVAIL Act that was introduced in both the House and Senate last summer, and that could try to derail the use of IPRs. All in all, lots to look out for and change strategies accordingly.

In March, the Medical Device Coordination Group (MDCG) published its new document: “Guidance on the Content of the Clinical Investigation Plan for Clinical Investigations of Medical Devices” 📋📊 The MDCG 2024-3 guidance aids sponsors in crafting their CIP by providing detailed descriptions of the information expected in each CIP section. This preemptively addresses potential inquiries from competent authorities during the assessment of clinical investigation applications. 🔍 You can access the complete guidance document here 👇 https://lnkd.in/dedMGjT3 #ClinicalResearch #Innovation #HealthcareSolutions #BiTrial #clinicaltrial #medicalsupport #clinicalmonitoring #fullservicecro #cro #pharma #biotech #hungariancro #crohungary #mdcgguidance #medicalguidance #clinicalinvestigation

Happy to share my latest article, "From Prodrug to Multimatrix: Recent Advancements in Colon-Specific Drug Delivery Systems," now published in Sciences of Pharmacy. Available on: https://lnkd.in/g5DniyYU #Colon_Specific_Drug #CSDDS #Drug_Delivery #Prodrug #Multimatrix #3D_bicompartmental_device #MMX_Technology #Phloral_technology

💰 HOW you take a psychedelic can be a huge moneymaker... Since pharmaceutical companies can't patent magic mushrooms, they are developing ways people can take psychedelics. And I know I might sound a tad snarky, but the reality is that a regulated market that allows for consistent dosing is important. Not everyone is in the psychedelic community and knows how to grow their own mushrooms or dose themselves.  For example, Concept Matrix Solutions (CMS) just secured a patent from the U.S. Patent Office for their "Oral Soft Gel Capsule Containing Psychedelic Compound."  The patented soft gel capsules improve the rate and extent of absorption of psychedelic compounds, meaning patients can experience more consistent and effective dosing. Capsules are easy to swallow, discreet, and designed to protect the active compound from degradation, ensuring a longer shelf life and maintained potency. Chief Technology Officer, Rob Davidson said, "This new delivery method represents a significant advancement in psychedelic medicine. By improving bioavailability and ease of use, we believe our soft gel capsules will help more patients benefit from the therapeutic potential of psychedelics." Full PR piece 🔗 in the comments.  #mdma #psychedelictherapy Write what the most important point of this article is.

Developing drugs includes risk. With the average drug taking over ten years to produce, precise planning and preparation can seriously decrease the risk of failure. Or, where risk is unavoidable, it can help create smaller margins of error. Through solid form screening, PBPK modeling, and route scouting, our new e-book explains how advanced analytical tools can help de-risk your drug development projects and prepare you for a better understanding of how a drug might behave through its development. To download the e-book for free, click here https://lnkd.in/gHARb38r #AHealthierWorld #SmallMolecules #PharmacueticalManufacturing #ArtificialIntelligence #Innovation

Visit us today until Thursday at DIA Europe 2024 Brussels, The Yseop team is at Booth #D4! #DIA #RegulatoryAffairs #MedicalWriting #MedicalWriter #Innovation #Pharma #ClinicalTrials #Lifesciences #DrugDevelopment #GenAI #GenerativeAI

In our January Rx IP Update, Smart & Biggar’s life sciences team highlighted a few updates:   ⚖ Twice is not nice – second notice of allegation may be abusive 💊 U.S. FDA authorizes Florida plan to import drugs in bulk from Canada ⚖ Federal Court finds PMPRB reasonably concluded Galderma’s patent claiming 0.3% adapalene “pertained to” 0.1% adapalene DIFFERIN  ⚖ LUMIGAN RC formulation patent found valid and infringed 💊 PMPRB releases CompassRx Annual Public Drug Plan Expenditure Report (2021/22) 💊 Permanent regulatory framework now broadened beyond COVID-19 medical devices Editors: Nancy Pei, Urszula Wojtyra Contributors: Andrea Berenbaum, Malcolm Harvey, Lynn Ing, Adam Lakusta, Urszula Wojtyra and Ryan Wong   #RxIPUpdate #LifeSciences https://lnkd.in/edc7N93