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Proactive measures to protect your patents include: Regular patent portfolio reviews Monitoring competitor activities Maintaining detailed lab notebooks and documentation Implementing strong trade secret protections By staying vigilant, you can often prevent infringement before it occurs or strengthen your position if litigation becomes necessary.
The NHC supports the efforts to reduce out-of-pocket costs for Medicare beneficiaries and appreciates CMS’ work to establish a process that seeks to incorporate patient perspectives into drugpricing policy. This will allow other stakeholders (e.g.,
AbbVie, Teva Pharmaceutical, and AstraZeneca left over a span of five months following the passage of the drug-pricing reform law pushed by Democrats last year. Financial interests were often not clearly disclosed in NICE documents.
The downfall of Aduhelm, the first new treatment for Alzheimer’s disease in two decades, is largely the story of a drug company choosing to maximize its potential profits at the expense of patients and taxpayers, according to a congressional investigation that cites thousands of pages of internal Biogen documents.
I am pleased to announce our new 2021 Economic Report on U.S. Click here to download a free report overview (including key industry trends, the Table of Contents, and a List of Exhibits) New Drug Channels Institute Study: The Latest Trends for U.S. The 2021 Economic Report on U.S. The full document clocks in at 412 pages.
The top 13 players reported more than 10% revenue growth, with BioNTech (3,834.4%), Moderna (2,199.1%), Pfizer (95.2%) and Regeneron Pharmaceuticals (89.1%) reporting a more than 80% year-on-year (YoY) revenue growth from 2020 to 2021, according to GlobalData’s Pharma Intelligence Centre Companies Database. AbbVie reported a 22.7%
Why DrugPrices Are Rising? Newly developed drugs can be expensive to produce. During patent exclusivity, prices are set higher to offset the high research and development cost (up to billions of dollars). Additionally, many middlemen are involved in the drug supply chain , each taking a cut of the profits.
Overall, while the NHC appreciates CMS’ intent to streamline the data submission process and make it more accessible, we encourage ongoing dialogue and adjustments to ensure that the process remains patient-centered, efficient, and capable of capturing the full spectrum of information necessary to inform meaningful drugprice negotiations.
A 2021 survey of US physicians representing 12 therapeutic areas revealed that 57% of them would be more likely to prescribe an interchangeable biosimilar, and 59% reported that an interchangeable designation makes them more comfortable with a pharmacy-level substitution of that biosimilar in place of the prescribed originator medicine.
General Comments The NHC appreciates CMS’ commitment to actively engaging with stakeholders, including patients, consumer advocates, and health experts, in implementing the Medicare DrugPrice Negotiation Program (DPNP). This includes collecting data on utilization management practices, formulary changes, and patient experiences.
The alleged actions violated the Hatch-Waxman Act, formally known as the “DrugPrice Competition and Patent Term Restoration Act of 1984,” which allows generic manufacturers to market their generic versions of previously approved generic medications. 2021 was a year of continued innovation and change in the Biopharmaceutical industry.
This article appears in our digital magazine, Deep Dive: Market Access 2021. Long headquartered in London, the EU drug regulator is now severed from the country both physically and systematically, with its base now in Amsterdam and the UK now assessing drugs through its own regulatory agency, MHRA.
Anyway – on to the current issue of the Digest (which is the 2021 Digest that summarizes data from 2020 operations). It’s a well-thought through survey document, but I still have uncertainties about how to answer some of the questions – a part asks how many prescriptions were filled with brands and how many with generics.
From the post: The HHS Budget in Brief document describes the policy objective simply enough: “ Permit Biosimilar Substitution without Prior FDA Determination of Interchangeability” and clarifies that this means “deem all approved biosimilars to be interchangeable with their respective reference products”.
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