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Congratulations to Lina Kontos for being promoted to partner! Lina advises medical device companies on FDA regulatory issues, with a focus on the premarket clearance and approval of new products. http://bit.ly/39clOR6 pic.twitter.com/Td8Tn0WAFW
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The Court of Justice of the European Union issued its decision on a request for preliminary ruling submitted by the UK Competition Appeal Tribunal in a case concerning the balances and limits between legitimate and anti-competitive
#settlement agreements. http://bit.ly/39cgi0U pic.twitter.com/bpxhDlWQvi
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On January 30,
@CMSGov announced the new Healthy Adult Opportunity initiative. One significant result of the initiative is that it will allow states to limit#drugcoverage under#Medicaid without reducing manufacturer rebate obligations. http://bit.ly/36XAwd3 pic.twitter.com/5BFgfA2KS5
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In its proposed Notice of Benefit and Payment Parameters for 2021,
@CMSGov proposes changes to existing policy governing how#pharmaceutical manufacturer coupons accrue with respect to non-grandfathered#health plan enrollees’ annual limit on cost-sharing. http://bit.ly/2tq8ZTQ pic.twitter.com/D3fNTAz8JN
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We are happy to share that Margaux J. Hall was promoted to partner. Margaux's practice is at the forefront of health reform in federal health care programs and focuses on drug pricing. Congratulations, Margaux! http://bit.ly/2SgwWpg pic.twitter.com/oRacpQm3wv
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FDA’s Center for Biologics Evaluation and Research finalized six
#genetherapy guidances and issued a new draft guidance, which provides FDA’s thinking on determining “sameness” of gene therapy products for orphan-drug designation and exclusivity. http://bit.ly/36SS4a9 pic.twitter.com/Uh63CTHP6r
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@CMSGov finalized its proposal to expand national#coverage of FDA-approved or -cleared#laboratorytests using next generation sequencing for patients with breast or ovarian cancer at any stage. http://bit.ly/392LUFS pic.twitter.com/3tBVLfIrG6
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Read our most recent and relevant resources for the
#LifeSciences and#HealthCare industry in the February edition of our monthly newsletter. http://bit.ly/392yOIU pic.twitter.com/d0vLyQ8vIj
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Congratulations to Carrie DeLone for her promotion to partner! Clients look to Carrie for guidance in areas of complex civil litigation matters, with a particular focus on class actions. http://bit.ly/2GRuHU0 pic.twitter.com/8YheUOFMta
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Congratulations to our client
@aimmune on it's groundbreaking approval by the@US_FDA for PALFORZIA™, the first approved therapy for peanut allergy! https://bit.ly/2SazXYb pic.twitter.com/7mWdHLQNfM
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We are happy to share that our German team has been recognized as Tier 1 for
#Healthcare and#LifeSciences by@thelegal500. Tanja Eisenblaetter & Joerg Schickert were named as leading lawyers, & Arne Thiermann was recognized as a next generation lawyer. http://bit.ly/2uQB2MC pic.twitter.com/hPDwB27ADs
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Our Medical Device and Technology Regulatory team co-authored a comprehensive analysis of U.S.
#medicaldevice and#diagnostics development, premarket clearance/approval requirements, and postmarket compliance. http://bit.ly/2UcejoP pic.twitter.com/6PcVeYLyin
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@US_FDA published three regulations formally classifying certain#radiological image analyzers and related software, including computer-assisted/aided detection, as class II#medicaldevices subject to 510(k) premarket notification with special controls. http://bit.ly/2S4oHwe pic.twitter.com/goSmOSLGOp
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We are pleased to announce that Maria Durant has been named Office Managing Partner, and Greg Noonan is the Office Administrative Partner for the firm's
#Boston office. http://bit.ly/2uJozKu pic.twitter.com/vdCtyGedsJ
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In 2019, FDA issued 3 warning and 7 untitled letters to
#pharma companies for promotional materials that allegedly misbranded#prescriptiondrug products. The letters show the Agency’s#enforcement focus on advertisements that fail to warn of serious risks. http://bit.ly/2U7ufZI pic.twitter.com/DpgAR2SPn6
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@EMA_News has committed early patient access to new#medicines. To help you understand the EMA's approach to early access schemes, our team has created a guide that provides a comparison of EMA and U.S. early access rules. http://bit.ly/2RQczz4 pic.twitter.com/c2lBySvUFa
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In our 2020
#FalseClaimsAct Guide, we provide our current analyses of trends in FCA enforcement. By looking back at the events of 2019 and looking forward to what lies ahead, we aim to help you navigate the frequently turbulent waters of FCA enforcement. http://bit.ly/2GnG6dL pic.twitter.com/zvSSYxI4yh
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"For innovative drugs, patent extension means a longer period of market exclusivity, which brings China on par with the U.S. and Europe,” said Xin Tao in this Bloomberg article.
#China#Pharmaceuticals@business http://bloom.bg/38wvoxK pic.twitter.com/VwkEF02AXH
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Brian Curran & Anne Salladin spoke to
@bloomberglaw about the impact of#CFIUS & the Foreign Investment Risk Review Modernization Act on data-heavy companies in the insurance & health sectors, as well as startup tech companies & early stage tech companies. http://bit.ly/2TOYTa0 pic.twitter.com/2AHSiNCr1P
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Join our team at
#PLW2020 and#WSCS20 to discuss strategies for companies with 361 HCT/Ps and HCT/Ps transitioning to BLAs to engage with FDA on a regulatory approach that will be optimal for patients, FDA, and industry.#CellTherapy http://bit.ly/2RzT79s pic.twitter.com/as9czLRluf
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