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Evoke Pharma (NASDAQ:EVOK) CEO Dave Gonyer joined Steve Darling from Proactive to share news the company has achieved a significant milestone with the listing of its recently issued U.S. patent related to GIMOTI in the U.S. Food and Drug Administration's publication, commonly known as the "Orange Book." This development is of great importance as patents listed in the Orange Book cover #drugs that the FDA has approved and deemed safe and effective for public use. The patent, titled "Nasal Formulations of Metoclopramide," pertains to a collection of nasal solutions of metoclopramide and outlines its characteristics when formulated. This newly listed patent in the FDA's Orange Book carries a patent term extending until 2029. Its inclusion adds an additional layer of patent protection for GIMOTI, complementing the three prior patents listed. Watch at #Proactive #ProactiveInvestors https://lnkd.in/d67HgJZd #NASDAQ #EVOK

#quality and functionality of #excipients are critical to the development of #medicines with increased efficacy.

Just finished a graphical abstract for a DMT #transdermal patch. Our results show extended release with a low (sub-psychedelic) dose without head-twitch effects. The bioavailability of this transdermal route was outstanding for a molecule with so-called "poor druggability." Hopefully this sheds more light into optimized formulations and non-invasive drug delivery options for drugs like #DMT. #sciencesunday

Drug dosing complexities impact efficacy and safety. Key factors that contribute to variability in exposure and hence response can be investigated using PBPK modeling. In a recent #ASCPT article, Certara’s Karen Rowland Yeo, Eva Gil Berglund, and Genentech’s Yuan Chen highlight PBPK’s pivotal role in tailored dosing, regulatory acceptance, and diversity in trials. Explore the full article for insights into the future of PBPK modeling in drug development. https://ow.ly/jaGs50RN4QJ #PBPKModeling #DrugDevelopment #ClinicalTrials #Inclusivity #RegulatoryScience #Certara

CDER Science, Research Efforts that Support Generics Detailed in 2023 Annual Report: The collaborative efforts that advance the development of more generic drugs is the work of CDER’s science and research program whose 2023 annual report provides details on the efforts behind the issuance of 244 new and revised product specific guidances (PSG), including 174 for complex products. #fda #financial #lifesciences

#TechnoteTuesday Do you need to analyze a high volume of drug candidates during early drug development? CE-SDS is a widely used method for drug purity, integrity, and stability analysis. However, the current single-capillary system presents a bottleneck. But don't worry, with a multi-capillary system, separations are sped up to 1.5x faster than the gold standard CE-SDS workflow. This means you can analyze 192 reduced samples in 14 hours with high data quality. Learn more about the "Lightning capillary electrophoresis sodium dodecyl sulfate (CE-SDS) workflow for high-throughput analysis of biotherapeutics" in today's Technote by Zhichang Yang, Marcia Santos, Tingting Li, Mario A Pulido, Jane Luo, Sahana Mollah, and their team. #BioPhase8800 #FastGlycan #RNA9000 #mabs #development #drugdevelopment #drugdiscovery #sciex #CapillaryElectrophoresis #GenomeLabGeXP #SciexforScience #genetherapy #rnatherapeutics #PA800Plus #immunotherapy #clinicaltrials #safety

Very meaningful keynote speech about the state of the generics and biosimilars industries by AAM board chair Christine Baeder at AAM’s GRx+Biosims conference. Generic drug shortages of life saving drugs are unacceptable. Christine emphasized the market needs redundancy of supply and economics to recoup the cost at the least. Policy makers and regulators have to act. Biosimilars incentives are lacking in the pharmacy benefit space. Christine spoke about the adalimumab example, the largest off patent event there ever was in the US, where we do not see any meaningful biosimiliar uptake. Policy makers have to act to support the uptake and sustainability of biosimilars. #GRx+Biosims #AAM #Teva #4GRANTED

🙌 🙌 Welcome to read the #HighlyCitedPaper A review of "Recent Advancements in the Development of Nanocarriers for #Mucosal Drug Delivery Systems to Control Oral Absorption" by Hideyuki Sato et al. Paper link: https://shorturl.at/qZ3KZ

  TIME IS TICKING ⏳: THIS IS YOUR FINAL CHANCE TO LEARN THE MOST ADVANCED APPROACH FOR DRUG DISCOVERY AND DEVELOPMENT....   Solid drug development should result in high-quality tablets that are safe and effective for the intended patients. However, tablet formulation must be able to overcome many challenges such as: 💭 Undesirable tablet tastes and odors. 💭 Protection from contamination. 💭 Preventing the drug from being dissolved in stomach acid. 💭 Improving overall drug appearance and.... 💭 Implementing a delayed drug release. To overcome these challenges, this webinar will be focusing on the drug development path starting from pre-formulation through to clinical studies.   Robert Feltz and Vinay S Patil will present effective, specific, safe, and well tolerated drugs which can improve patients’ lives.   Mark your calendars for the 21st of May 2024, and register below today.   #Pharma #Drugdevelopment #Webinar #clinicalstudies https://lnkd.in/dGkfcrF5

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.