HL Life Sciences

@HLLifeSciences

With 500 life sciences lawyers across the globe, we understand the issues you face in the countries you do business in and help you stay ahead of the curve.

Vrijeme pridruživanja: siječanj 2015.

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  1. 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.

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  2. 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 agreements.

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  3. On January 30, announced the new Healthy Adult Opportunity initiative. One significant result of the initiative is that it will allow states to limit under without reducing manufacturer rebate obligations.

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  4. 4. velj

    In its proposed Notice of Benefit and Payment Parameters for 2021, proposes changes to existing policy governing how manufacturer coupons accrue with respect to non-grandfathered plan enrollees’ annual limit on cost-sharing.

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  5. 4. velj

    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!

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  6. 4. velj

    FDA’s Center for Biologics Evaluation and Research finalized six guidances and issued a new draft guidance, which provides FDA’s thinking on determining “sameness” of gene therapy products for orphan-drug designation and exclusivity.

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  7. 4. velj

    . finalized its proposal to expand national of FDA-approved or -cleared using next generation sequencing for patients with breast or ovarian cancer at any stage.

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  8. 3. velj

    Read our most recent and relevant resources for the and industry in the February edition of our monthly newsletter.

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  9. 3. velj

    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.

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  10. 2. velj

    Congratulations to our client on it's groundbreaking approval by the for PALFORZIA™, the first approved therapy for peanut allergy!

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  11. 31. sij

    We are happy to share that our German team has been recognized as Tier 1 for and by . Tanja Eisenblaetter & Joerg Schickert were named as leading lawyers, & Arne Thiermann was recognized as a next generation lawyer.

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  12. 31. sij

    Our Medical Device and Technology Regulatory team co-authored a comprehensive analysis of U.S. and development, premarket clearance/approval requirements, and postmarket compliance.

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  13. 30. sij

    . published three regulations formally classifying certain image analyzers and related software, including computer-assisted/aided detection, as class II subject to 510(k) premarket notification with special controls.

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  14. 29. sij

    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 office.

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  15. 29. sij

    In 2019, FDA issued 3 warning and 7 untitled letters to companies for promotional materials that allegedly misbranded products. The letters show the Agency’s focus on advertisements that fail to warn of serious risks.

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  16. 23. sij

    . has committed early patient access to new . 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.

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  17. 23. sij

    In our 2020 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.

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  18. 23. sij

    "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.

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  19. 23. sij

    Brian Curran & Anne Salladin spoke to about the impact of & 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.

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  20. 21. sij

    Join our team at and 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.

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