DrugPatentWatch Pharmaceutical Drug Patent Intelligence’s Post

Three of the 32 small molecules that secured FDA Novel Drug Approvals in 2023 traversed Sai’s labs during their discovery, development and manufacturing stages. And this is not an exception. We have been part of the journey of over 10% of all small molecule approvals in each of the last four years, demonstrating a consistency in the quality of science we do, and our resolve to support innovators bring new medicines to life. We remain committed to this journey of innovation, collaboration, and scientific excellence to make it better together. #sailifesciences #pharma #lifesciences #smallmolecules #drugapproval #drugdiscovery #drugdevelopment

The FDA 505b2 Pathway was born out of the Hatch-Waxman Amendments in 1984, and has completely revamped the drug approval process. It's like a secret weapon that allows companies to tap into third-party studies, saving both application time and costs. This 505b2 Pathway is no ordinary route; it's a hybrid of the 505b1 and 505j. Imagine the possibility of bidding farewell to nonclinical studies, reducing risks, enjoying a streamlined application process, and faster development: https://lnkd.in/dYfY8uSq #pharmaceutical #3dprinting #3dprintingtechnology #medicalinnovation #medicaltechnology #medicaltech

FDA Orange Book: A Visual Exploration of Patent and Data Exclusivity Data for drug products. Strategies for making the best use of "board tools" already available to combine and visualize large amounts of complex data for patent strategies. #pharmaceuticalindustry #drugdevelopment #drugapproval #fda #dataanalytics #exclusivity #patentsearch #patentcliff #researchinnovation #innovation

ICH M13A: First ICH Guideline for Bioequivalence Learning Objectives: • Provide an overview of the M13 guideline series • Provide an overview of the final M13A guideline and major changes from the draft guideline • Provide an update on the FDA planning on the implementation of M13A for generic drug applications #ICH # Bioequivalnce # guidelines

In the article "Old Drugs, New Tricks: Repurposing Through 505(b)(2) Submissions," published in Intellectual Property and Technology Law Journal, Sterne Kessler Directors Gaby L. Longsworth and Dennies Varughese, Pharm.D., Esq., with the assistance of Summer Associates Hannah Jankunis and Matthew Swazer discuss the various FDA drug approval pathways available. https://lnkd.in/enbpAVv3 Specifically, they discuss how drug companies are turning to 505(b)(2), which is a hybrid between a de novo NDA and an ANDA, allowing drug developers to avoid some of the time and costs associated with extensive preclinical and clinical safety and efficacy testing. Read the article to learn about the use of 505(b)(2). #ANDA #Patent #DrugDevelopment

Did you know that once a drug receives FDA approval, its research and development often slows down? It's a common misconception that approval marks the peak of a drug's journey. In reality, it’s the opposite. When the drug eventually turns generic, it's now more affordable and accessible than ever. Yet paradoxically, this is when R&D typically comes to a standstill. As someone whose life was saved by an old, generic drug, I am deeply invested in this topic. We should be maximizing these opportunities, not diminishing them. At Every Cure we are on a mission to shift the narrative and focus on how we can leverage these accessible drugs to their fullest potential. What are your thoughts on how we can reinvigorate R&D for generic drugs to enhance their impact and accessibility? #drugdevelopment #drugdiscovery #pharma #drugdelivery #drugrepurposing

From the emergence of specialty drugs to the effect of patent expirations, here are 8 developing trends in the pharmacy benefits sphere that employers should be aware of. Dive deeper into the topic within our whitepaper 🔗 https://lnkd.in/eyppjZCu #pharmacybenefits #JGSInsurance #InsuranceIsntBoring

From the emergence of specialty drugs to the effect of patent expirations, here are 8 developing trends in the pharmacy benefits sphere that employers should be aware of. Dive deeper into the topic within our whitepaper 🔗 https://lnkd.in/eyppjZCu #pharmacybenefits #AHTInsurance

What are the 8 evolving trends in pharmacy benefits you need to know? Read more in our whitepaper 🔗 https://lnkd.in/eyppjZCu #TheBaldwinGroup #pharmacy #employeebenefits

Thoughts on this? >> Pfizer and BioNTech say GSK's Covid patent suit is 'groundless' >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #healthcare #biotech #pharmaceutical #pharma #productmarketing