You won't want to miss the upcoming webinar on the HEAL #Pain Therapeutics Development Program (#PTDP). Monday July 29, 2024 3:00 PM ET. This webinar will inform and provide participants with an opportunity to ask questions about PTDP and the #NIH funding announcement, RFA-NS-24-019 whose purpose is to support #preclinical optimization and development of safe, effective, and #nonaddictive small molecule and biologic therapeutics to treat pain. The goal of PTDP is to accelerate promising early therapeutic molecules and facilitate their readiness for the Early Phase Pain Investigation Clinical Network (EPPIC-Net) or other Phase II clinical studies. Link to register for the webinar: https://lnkd.in/g4ftETip
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Ensure your #mRNA vaccine & therapeutic products analytical development success! 🚀 We hope to see you at the mRNA-Based Therapeutics Summit in Boston (July 29-31). Find out how Intertek experts can support your mRNA therapeutics development from early-stage characterization to late-stage development and commercialization! Please stop by our booth or contact us to schedule a meeting: Diogo Rodrigues and Mairita Ntoulovi. 🌍 Event: 4th Annual mRNA-Based Therapeutics Summit 📅 When: July 29-31, 2024 📍 Where: Boston, MA #mRNATherapeutics #mRNATherapeuticsSummit #mRNABasedTherapeuticsSummit
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Candel Therapeutics’ Pancreatic Ductal Adenocarcinoma Treatment Granted FDA Fast Track Status The FDA has granted Fast Track Designation to Candel Therapeutics' CAN-2409 along with valacyclovir for the treatment of pancreatic ductal adenocarcinoma (PDAC). CAN-2409 is an adenoviral construct that converts prodrugs into a toxic form, leading to tumor cell death and a CD8+ T cell-mediated response. A study showed that the combination of CAN-2409 and valacyclovir resulted in a significantly higher survival rate compared to the control group. Currently, a Phase II trial is investigating the use of CAN-2409 with valacyclovir as neoadjuvant therapy for PDAC. For more details please click the link! https://lnkd.in/d3qTWYk8 #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical
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Chief & Director, Cellular Therapy Program. Associate Professor, Children's National & GWU | Cell Therapy Expert | Speaker | Leader
Great to see some positive news in the allogeneic CAR T space. Especially for a disease like Multiple Myeloma where commercial companies have struggled to meet demand. Also interest to see prominent use of a non-viral gene delivery platform, which I think we'll see more of very soon. #CART #celltherapy #genetherapy.
More positive #CARTcellTherapy news for #MultipleMyeloma patients as Poseida Therapeutics, Inc. and Roche's allogeneic product advances in clinical setting with a reported 91% ORR in 23 patients. (From geneng news) https://lnkd.in/guDcJxjP
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🌟 HIRC Insight Series 🌟 It is very encouraging to see the FDA's commitment to advancing treatments for rare diseases. This initiative marks a significant step forward in developing potentially life-changing therapies for patients with rare conditions. The next step is getting these treatments to the patients who need them. HIRC's new research with payers and specialty pharmacies assists manufacturers’ commercialization and market access efforts pertaining to rare disease portfolios. For more information visit: https://lnkd.in/gzUDFA4j #HIRCInsightSeries #HIRC #RareDisease #FDA #ClinicalTrials #STARTProgram #InnovativeTherapies #HealthcareAdvancement #Pharma #PharmaTrends #Pharmaceuticals #PharmaIndustry #PharmaNews #PharmaData #PharmaResearch #Healthcare #LifeSciences #Specialtypharmacy #Specialtypharmaceuticals #Orphandrugs #Genetherapy
On May 29, 2024, FDA notified selected participants of their acceptance into the Support for clinical Trials Advancing Rare disease Therapeutics (START) Pilot Program: https://lnkd.in/eFNrXnCV Announced in September 2023, the pilot is an FDA initiative to help further accelerate the development of novel drug and biological products for rare diseases.
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With nearly 7,000 rare diseases affecting over 30 million Americans, the FDA's new START Pilot Program will be pivotal for the future treatment of these diseases and improving the lives of patients. Looking to gain insights on market access for rare diseases? HIRC's research with payers and specialty pharmacies supports manufacturers in commercialization and market access efforts. Click here: https://lnkd.in/erYKHcqf #HIRCInsightSeries #HIRC #RareDiseases #FDA #ClinicalTrials #STARTProgram #InnovativeTherapies #HealthcareAdvancement #Pharma #PharmaTrends #Pharmaceuticals #PharmaIndustry #PharmaNews #PharmaData #PharmaResearch #Healthcare #LifeSciences #Specialtypharmacy #Specialtypharmaceuticals #Orphandrugs #Genetherapy
On May 29, 2024, FDA notified selected participants of their acceptance into the Support for clinical Trials Advancing Rare disease Therapeutics (START) Pilot Program: https://lnkd.in/eFNrXnCV Announced in September 2023, the pilot is an FDA initiative to help further accelerate the development of novel drug and biological products for rare diseases.
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In a press release and call to investors today, March 19, 2024, Design Therapeutics, Inc. provided an update on the progress of GeneTAC™ program in FA. “Our lead program in FA has a new drug product, DT-216P2, that we have designed to have an improved pharmacokinetic and injection site safety profile, which positions us to resume clinical development for this debilitating, degenerative, neuro-muscular genetic disease. This work builds on encouraging data in FA patients from our previous clinical trial." - Pratik Shah, Ph.D., chairperson and chief executive officer of Design Therapeutics Design is advancing DT-216P2 for FA, with plans to complete GLP studies by year-end 2024 to start patient trials in 2025. Click here to read the full press release: https://bit.ly/4cmnatS or to access the presentation to investors: https://bit.ly/3IHQhdB
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This is a major milestone for the Click Therapeutics, Inc. team and for our wholly-owned Click asset, CT-132, an investigational prescription digital therapeutic intended for the preventive treatment of migraine. The results from the Reduction in Monthly Migraine Days (ReMMi-D) study of CT-132 reaffirm our ongoing commitment to developing novel #DigitalTherapeutics that address areas of high unmet needs for patients, especially in chronic or persistent conditions like episodic migraine. We look forward to bridging gaps in treatment for migraine sufferers, providing new treatment options, and delivering improved outcomes for patients. #ClickTherapeutics #HealthcareInnovation #MigraineResearch
Today, Click Therapeutics announced meeting the primary endpoint in the ReMMi-D, Reduction in Monthly Migraine Days study, a randomized, double-blind and sham-controlled study evaluating the effectiveness and safety of CT-132, an investigational prescription digital therapeutic for the preventive treatment of migraine. Results from the study are further supported by a bridging study in 110 patients on calcitonin gene-related peptide (CGRP) inhibitors, along with an integrated efficacy analysis of both studies. Click looks forward to advancing CT-132, which previously received FDA Breakthrough Device Designation, through regulatory clearance with the goal of providing a new evidence-based treatment option for patients with episodic migraine. Read the full release: https://lnkd.in/g-8w5P2R
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Board Member/ VC Partner/ Strategic Advisor (Focus on PDTx, Digital Health, Precision Medicine) ex Pharma Executive, Human Geneticist
Thank you David Benshoof Klein and Click Therapeutics, Inc. For this impressive clinical milestone to support the more than one billion people worldwide living with migraine that now have a best in class therapeutic option (first PDTx for migraine), a new modality of medicine to manage their condition without side effects. And thank you for your relentless efforts to tackle the biggest challenges in healthcare and advance the emergence of this new class of medicine, prescription software as therapeutics across many diseases and unmet needs. Amazing strides! #healthinnovation, #HealthTech, #prescriptiondigitaltherapeutics, #evidencebasedmedicine,
Today, Click Therapeutics announced meeting the primary endpoint in the ReMMi-D, Reduction in Monthly Migraine Days study, a randomized, double-blind and sham-controlled study evaluating the effectiveness and safety of CT-132, an investigational prescription digital therapeutic for the preventive treatment of migraine. Results from the study are further supported by a bridging study in 110 patients on calcitonin gene-related peptide (CGRP) inhibitors, along with an integrated efficacy analysis of both studies. Click looks forward to advancing CT-132, which previously received FDA Breakthrough Device Designation, through regulatory clearance with the goal of providing a new evidence-based treatment option for patients with episodic migraine. Read the full release: https://lnkd.in/g-8w5P2R
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Your one-stop-shop for many things mRNA🤝 ...Don't just take our word for it - check out what some of our expert speakers have to say about the 4th mRNA-Based Therapeutics Summit this July! Get your copy of the three-day program here, jam-packed with four tracks' worth of mRNA content: https://ter.li/s9qfa7 #mRNA #mRNATherapeutics #mRNAVaccines #RNA #WorldRNA #mRNASummit
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I am so very proud of the Click Therapeutics, Inc. team ❤️ Today we announce meeting the primary endpoint in the ReMMi-D, Reduction in Monthly Migraine Days pivotal study, which evaluated the effectiveness and safety of CT-132, our prescription digital therapeutic for the preventive treatment of migraine. Migraine affects 39 million in the U.S. and more than a billion people worldwide (American Migraine Foundation). As a chronic and disabling condition, migraine is more than just a headache. Migraine can interfere with your education, your work, your social life and personal activities. Despite the availability of acute and preventive migraine medications, there remains a significant unmet need in migraine management as patients continue to experience frequent and debilitating attacks, even when using these drugs as prescribed. Click has designed CT-132 to fill this gap in care, providing patients with a new evidence-based and high-quality treatment option, intended to provide added benefit on top of a patient’s existing migraine medication. Next up: our team is eager to continue to advance this asset with FDA Breakthrough Device Designation through the regulatory clearance process in order to enable patient access to a new preventive migraine treatment. #ClickTherapeutics #HealthcareInnovation
Today, Click Therapeutics announced meeting the primary endpoint in the ReMMi-D, Reduction in Monthly Migraine Days study, a randomized, double-blind and sham-controlled study evaluating the effectiveness and safety of CT-132, an investigational prescription digital therapeutic for the preventive treatment of migraine. Results from the study are further supported by a bridging study in 110 patients on calcitonin gene-related peptide (CGRP) inhibitors, along with an integrated efficacy analysis of both studies. Click looks forward to advancing CT-132, which previously received FDA Breakthrough Device Designation, through regulatory clearance with the goal of providing a new evidence-based treatment option for patients with episodic migraine. Read the full release: https://lnkd.in/g-8w5P2R
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