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🌐 #TuesdayTip for Updating AMCP Dossiers 🌐 As digital therapeutics (DTx) increasingly integrate into healthcare management, it's crucial not to overlook them in your dossier submissions. With the upcoming AMCP dossier format updates, ensuring that your DTx products are well-represented and compliant with new guidelines is essential. Remember, your dossier should clearly outline the technical specifications, platform compatibility, and any third-party validations of your DTx solutions. This not only meets the new AMCP standards but also enhances the credibility of your submissions. Stay ahead by adapting early to these changes! #DigitalTherapeutics #AMCP2024 #HealthcareInnovation #MedicalWriting

📣 Exciting News from ZYUS Life Sciences #ZYUS is pleased to announce receipt of the final clinical study report and positive results respecting its Phase 1, first-in-human (“FIH”) Clinical Trial for its lead drug product candidate, Trichomylin® softgels. Positive Phase 1 results and supportive pre-clinical data will assist ZYUS in its ongoing Phase 2 clinical development of Trichomylin softgels and further strengthens ZYUS’ commitment to secure regulatory approvals and ultimately bring this innovative therapy to patients suffering from chronic pain. 💊 #ZYUSLifeSciences #HealthcareInnovation #CannabinoidTherapies #ClinicalTrialResults #MedicalResearch #InnovativeMedicine #BestinClass #FirstinClass #PharmaceuticalInnovation #Lifesciences #ChronicPain #FixedDoseCombonation https://lnkd.in/gQ9mp282

Reflecting on SRP-001's FDA Fast Track Designation: A Month Later A month ago, we shared the exciting news that SRP-001 received Fast Track designation (FTD) from the U.S. FDA for treating acute pain. Today, we reflect on this milestone and its implications for our ongoing efforts. SRP-001, a novel non-opioid analgesic, stands out for its unique mechanism of action in the midbrain's periaqueductal grey (PAG) region. It offers a promising alternative in pain management without the typical liver and kidney toxicities. The FTD accelerates the development and review process for drugs addressing serious conditions with unmet medical needs. FTD includes benefits like more frequent interactions with the FDA, potential eligibility for Accelerated Approval or Priority Review, and the Rolling Review of the New Drug Application (NDA) option. As we continue to advance SRP-001 through the development pipeline, we remain committed to bringing this innovative treatment to patients as swiftly and safely as possible. The FTD is not just a regulatory achievement but a catalyst in our journey to redefine the safer treatment of pain. See the news: https://lnkd.in/eyc7Zd3Q #FDA #FDAFastTrack #PainReliefInnovation #DrugDevelopment #Innovation #Biotech

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The future of cancer detection is bright.

Check out NPLB's latest Blog Post: 5 ways President Biden's #SOTU and Sen. Britt's response could advance biotech affordability & innovation for all of US: 1. Fix #IRA's small molecule penalty 2. Recognize true value of medicines to patients and society 3. Ensure Rx savings are for people, not PBMs 4. Extend IRA's $2K OOP Rx cap for all ACA plans 5. Treat US Biotech as a national defense priority https://lnkd.in/ez-pi_5z

The #FDA has approved our Investigational New Drug (IND) application for a clinical trial to assess LP-310 in patients with symptomatic oral lichen planus. This demonstrates Lipella’s ability to significantly advance our value proposition by adding a new clinical-stage asset to our pipeline. https://bit.ly/3S5OEMu $LIPO #investors #stockstowatch #stocksinfocus #daytraders #orallichenplanus https://bit.ly/3S5OEMu

💥There were 9 Key Digital Therapeutics (DTx) Developments in April 2024 🌅See infographic slide below with the summaries, along with therapeutic area and news category key 🧠4 in Mental Health and 💗3 in Cardiovascular show these areas are still dominating the development focus ✅4 approvals (3 FDA and one in India) #DigitalHealth #DTx

We are thrilled to announce our latest article in #Pharmaceutics: "Innovative Approaches to Optimize Clinical Transporter Drug-Drug Interaction Studies." Dive into groundbreaking research by Sabina Paglialunga, Natacha Benrimoh, and Aernout van Haarst from Celerion that tackles the complexities of transporter DDIs using innovative methodologies. Read now: https://lnkd.in/eZgEMSFT #DDI #DrugDevelopment #Pharmacokinetics #ClinicalResearch

📢 Check out our latest review article on Transporter DDI studies!