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  • Blog: ALTIUS Blogs“100g of mealworm please!” – First insect approved under the Novel Foods RegulationPosted on May 11, 2021 by
    On 3 May 2021, the EU Member states approved “dried yellow mealworms” as a novel food under EU Regulation 2015/2283. According to the applicant, mealworms can be used in a broad range of food products, such as bread, cookies, or pasta. A Commission implementing regulation will follow soon, which marks the final step and formally authorises the novel food. Mealworms are the first insect species to secure clearance as a novel food but more are likely to follow.Insects require authorisation under the EU Novel Foods Regulation EU Regulation 2015/2283 requires food business operators to seek autho...
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  • Blog: Waller Law BlogCMS issues FY 2022 Prospective Payment System Proposed RulePosted on May 6, 2021 by
    CMS has issued the Prospective Payment System Proposed Rule for fiscal year 2022.
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  • Blog: Patent 213Stanford’s Method for Inferring Haplotype Phase is Not Patent EligiblePosted on April 6, 2021 by Andrew Tuggle and Jessica L. Zurlo
    Stanford University applied for a U.S. patent for statistical methods of predicting haplotype phase. In 2019, the Patent Trial and Appeal Board rejected the application as ineligible subject matter. Last week, a panel of the U.S. Court of Appeals for the Federal Circuit affirmed. The opinion is interesting for being related to two, often separate...
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  • Blog: Homeostasis: Dykema Health Care Law BlogLong Term Care Facilities Should Prepare for County Investigations Into COVID DeathsPosted on March 30, 2021 by Gerald L. Aben
    Earlier this month, Peter Lucido, the Macomb County Prosecutor, who was also a former Republican State Senator and State Senate Majority Whip, announced a plan to investigate COVID-19 deaths in Macomb County nursing homes to determine whether Executive Order 2020-50, which was issued in April 2020 by Governor Gretchen Whitmer, and is no longer in effect, was responsible for those deaths. Prosecutor Lucido made a form available to families of former nursing home residents to collect information from the facility and then share with Macomb County law enforcement officials.  Read M...
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  • Blog: Biologics BlogFederal Circuit Upholds Jury Award, Weighs in on Willfulness Standard, in Adynovate® DisputePosted on March 29, 2021 by
    According to the Federal Circuit, $173 million was the right damages award for almost three years of patent infringement resulting from Baxalta’s sale of its biologic product Adynovate® (Antihemophilic Factor (Recombinant), PEGylated).  In Bayer Healthcare LLC v. Baxalta Inc., et al., Nos. 2019-2418, 2020-1017 (Fed. Cir. 2021), the circuit court upheld an award to Bayer [...]
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  • Blog: Chemical Law & Prop 65 BlogMajor Changes Coming to Prop 65 “Short-Form” WarningsPosted on February 1, 2021 by
    By: Anne Marie Ellis, John Epperson, Peter McGaw
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