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As demand for these therapies continues to surge, particularly with the emergence of biosimilars, the necessity for strict quality controls during development and manufacturing becomes paramount. These attributes not only determine a drug’s safety and efficacy but also influence its regulatory approval and post-market success.
As pharma companies grapple with mounting pressure from regulators, payers, and evolving market dynamics, the CSO model offers a compelling alternative to traditional, fully in-house sales forces. These markets are characterized by stringent pricing regulations and decentralized healthcare systems, making localized sales expertise essential.
Naomis insights and experience will solidify an already strong team of lawyers and regulatory experts helping our clients navigate the drug approval process, noted Director James Valentine. We were sad when he left to gain valued experience as a federal prosecutor but are absolutely thrilled and honored to welcome him back.
Agreement includes commercializing biosimilar candidate of ophthalmology drug ranibizumab (Lucentis ® ) in Europe, Canada, Israel and global markets. Bioeq has in-licensed the exclusive global commercialization rights to FYB201 from the German biosimilardeveloper Formycon AG. Source link: [link].
This proposal is clearly intended to address difficulties in formulating generic drugs with the same quantity and quality of inactive ingredients as required by regulation for certain dosage forms. “FDA FDA believes this change would effectuate timelier and more cost-efficient generic drugdevelopment.”
Sandoz strengthens pipeline expansion through partnership to develop and manufacture multiple biosimilars Sandoz, a global leader in off-patent (generic and biosimilar) medicines, today announced a multi-year partnership with Just – Evotec Biologics, the Seattle-based subsidiary of Evotec SE.
However, ensuring that these structures comply with applicable tax laws and regulations is essential to avoid potential legal and reputational risks. The IP surrounding Trodelvy , including patents covering the drug's composition, manufacturing process, and clinical use, was a significant valuation component.
Start Up and Generic Pharmaceutical Drug and Biologic Companies have high quality, affordable products and biosimilars that improve the quality of life for their patients. has over 30 years of management, full spectrum Regulated Life Sciences, RA, QA, EU-MDR, QMS, PMS, CSV/CSA, and R&D experience. Spanogle, Ph.D.
What will the orphan drug market exclusivity haircut mean for industry? Just over a month ago, the European Commission released its proposal for the new pharmaceutical directive and regulation. Other orphan drugs, which, by definition, address an unmet medical need, “only” receive 9 years of market exclusivity.
What We Expect the FDA to do in August and September 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.
What We Expect the FDA to do in July 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.
FDA has made good progress on these initial goals, providing updates on the first four on the Digital Health Technologies (DHTs) for DrugDevelopment website. Earlier this year, FDA published the Framework for the Use of Digital Health Technologies in Drug and Biological Product Development (DHT Framework).
Lenz, Principal Medical Device Regulation Expert — Following up on our first post discussing Digital Health Technologies (DHTs) ( here ), this post will focus on development and qualification of DHTs for use in clinical trials for drugdevelopment. By Adrienne R.
The LMG awards are reflective of HPM’s excellence across several of our core life sciences practices, from controlled substances work to drugdevelopment, to Hatch-Waxman, to drug pricing, to medical device regulation. is the largest dedicated food and drug law firm in the country.
The FTD is designed to make important new drugs accessible to patients faster. About Junshi Biosciences
Founded in December 2012, Junshi Biosciences (HK: 1877; SH: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics.
The phrase in subsection (ii) “authorized for investigation as a new drug” is generally accepted to mean that an IND is in effect. Under FDA’s interpretation, it is impossible to determine whether there is a non-public IND prior to starting work on developing an ingredient as a dietary supplement.
Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. However, as with any such undertaking, there are substantial risks and uncertainties in the process of drugdevelopment and commercialization.
What We Expect the FDA to do in June 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. An updated Unified Agenda: The Unified Agenda is the U.S.
What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.
October 1, 2023 [link] Regulations Expected to be Published in Q3These are taken from the most recent version of the White House’s Unified Agenda. Specifically, this ANPRM seeks comments, research, information, data, and responses from certain categories of stakeholders that can inform the Agency’s modernization of FDA’s recall regulation.
Under the FDA’s Good Guidance Practices regulation at 21 CFR 10.115 , the agency is required to annually publish “a list of possible topics for future guidance document development or revision during the next year.” Our review found that CDER is planning several notable new guidances, including one on artificial intelligence.
What we expect European regulators to do in July 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.
In other cases, the FDA is under no obligation to release a document at any time, but is instead developing the document on its own accord. We have tried to sort guidance documents by topic area. If you’re looking for something specific, we recommend using the search function in your browser (Ctrl-F) to look for keywords of interest.
The increasing costs associated with in-house drugdevelopment have prompted biotech and pharmaceutical companies to increasingly outsource to contract research organization s (CROs) for assistance. This approach replaces paper sources, supports productivity-enhancing workflows, and ensures compliance with relevant regulations.
Prior analyses indicate that recessions can affect drug demand for myriad reasons, including lower utilization of patented biologics and branded drugs, as well as an uptick in utilization of biosimilars and generics. The drugdevelopment industry is undoubtedly in a season of change.
What We Expect the FDA to do in May and June 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.
156 for certain FDA-regulated products, we know what you were thinking. 156(d) (and the PTO’s PTE regulations at 21 C.F.R. That regulation is pretty clear. Karst — After waiting with bated breath for more than a week since posting spicy Part 1 and Part 2 of our three-part series on recent U.S. 27, 1995); aff’d , 109 F.3d
As we have done in the past for the initial and each quinquennial reauthorization of the drug and medical device user fee laws—in 1992 , 1997 , 2002 , 2007 , 2012 , and 2017 —Hyman, Phelps & McNamara, P.C. The memorandum summarizes each section of FUFRA and analyzes the new law’s potential effects on the FDA-regulated industry.
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The Economics of Drug Access The economics of drug access is a complex interplay of factors, including research and development (R&D) costs, manufacturing and distribution costs, intellectual property rights (IPR), pricing policies, and healthcare financing mechanisms.
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Co-founded and led by CEO Cameron Owen, rBio is a biotech company making a significant impact in the biosimilar insulin market. With a commitment to making insulin biosimilars more affordable and accessible, rBio is addressing a critical need for patients across the globe.
Marks promotion to Counsel reflects the value that he brings to the firm and his clients based on expansive and diverse experiences in the drugdevelopment arena, commented HPM Director James Valentine. She already has broad-based exposure to a variety of FDA regulated products.
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