Perspectives for the Life Sciences Community
The Industry Edge:
Global Life Sciences Digest
A curated compilation of Sidley updates
and events of interest to our life sciences clients
Sidley Awards & News
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AwardsSidley Recognized as Premier Life Sciences Firm in LMG Life Sciences 2022
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NewsSidley Represents Walgreens Boots Alliance in Its US$1.37 Billion Acquisition of Shields Health Solutions
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NewsSidley Represents LifePoint Health in Multi-Year Strategic Partnership with Google Cloud
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NewsJames Lu Joins Sidley’s Growing Life Sciences, Corporate, and ECVC Practices
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AwardsSidley Awarded “Patent Impact Case of the Year” at LMG Life Sciences Americas Awards 2022
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NewsSidley Represents MicroPort NeuroTech Limited in Successful Hong Kong IPO
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AwardsSidley Duo Named 2022 Private Equity "Leaders of Influence" by Los Angeles Business Journal
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AwardsSidley Wins Two “Firm of the Year” Awards at China Business Law Awards 2022
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AwardsSidley Receives High Praise in Chambers USA 2022
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NewsSidley Secures Appellate Win for Client Nektar Therapeutics
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AwardsSidley Wins “Impact Case of the Year Award” at LMG Life Sciences Awards 2022 EMEA
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NewsSidley Represents amika and Eva NYC Brands in Their Acquisition by Bansk Group
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NewsSidley Represents Underwriters in Bausch + Lomb Dual-Listed IPO
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NewsSidley Represents Myovant Sciences in Exclusive License Agreement with Accord Healthcare, Ltd. to Commercialize ORGOVYX® for Advanced Hormone-Sensitive Prostate Cancer in Europe
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AwardsSidley Shortlisted for Three Awards at LMG Life Sciences Awards EMEA
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NewsSidley Represents Seller of TheraBreath Brand in US$580 Million Sale to Church & Dwight
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AwardsSidley Named “Crisis Management Team of the Year” at 2021 British Legal Awards
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NewsSidley Represents Kiniciti on Its Investment in Ncardia
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NewsSidley Advises IO Biotech in IPO
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AwardsU.S. News – Best Lawyers Honors Sidley as “Law Firm of the Year” in FDA Law
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NewsSidley Advised KKR on Its Investment in Biosynth Carbosynth
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NewsSidley Represents Shanghai MicroPort MedBot (Group) Co., Ltd. in Successful Hong Kong IPO
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AwardsSidley Given Quintet of Awards by LMG Life Sciences Americas
In This Issue
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EventsLife Sciences Regulatory Bootcamp
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Regulatory UpdatesUnprecedented Changes to Medicare Programs Leave Many Questions Unanswered for Pharmaceutical Manufacturers
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Regulatory UpdatesOversight Tools Piloted During COVID-19 Pandemic Are Here to Stay: FDA Issues Draft Guidance on Remote Regulatory Assessments
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Global Drug PricingComment Period Now Open for Proposed Rule Implementing Manufacturer Refunds for Discarded Drugs
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EventsBoston Life Sciences Roundtable
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Regulatory UpdatesFDA Releases Draft Guidance and Urges Industry to Address Concerns Regarding Non-Penicillin Beta-Lactam Drugs Cross-Contamination
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Regulatory UpdatesOIG Approves Manufacturer’s Arrangement to Make Zero-Interest Financing Available to Provider Customers
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EventsDigital Health App'ero and Life Sciences College
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EventsBay Area Lifesciences Roundtable
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EventsRegulatory Reboot: What You Need to Know About Biopharma Regulation in 2022 and Beyond
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Digital HealthDigital Health Industry Take Note: New HIPAA Comment Opportunity and Guidance Addresses Growing Risk of Cybersecurity Attacks
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Global Drug PricingMaine Enacts Canadian Reference Pricing Law
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Regulatory UpdatesOIG Approves Pharmaceutical Manufacturer-Sponsored Genetic Testing and Counseling Arrangement
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Data PrivacyIf Your Company Is GDPR Compliant, Are You Ready for China’s PIPL?
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Regulatory UpdatesShortages of Medicinal Products Tackled by EU Regulators
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Global Drug PricingU.S. Looks to Introduce European-Style Drug Price Controls
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Regulatory UpdatesFour Ways FDA’s New Intended Use Regulations Affect Drug and Medical Device Companies
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Data PrivacyHow To Minimize FCA Cyberfraud Enforcement Risk
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EventsWebinar Series: How the Green Wave Is Set to Reshape Chemical and Consumer Product Regulations Globally
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Global Drug PricingGlobal Drug Pricing Resource Page
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Digital HealthRegulators Offer Fresh Guidance on Using Real-World Data to Support Regulatory Decisions
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EventsFDA’s Intended Use Final Rule: Constitutional Implications and Practical Consequences
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Digital HealthHow Artificial Intelligence Manufacturers Can Protect Themselves Against Future Negligence Claims
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Regulatory UpdatesFive Ways FDA’s New Final Rule on Intended Use Could Affect Consumer Products
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Regulatory UpdatesHHS Announces Withdrawal of Good Guidance Practices and Fairness in Enforcement Rules
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Regulatory UpdatesU.S. Agencies Issue Regulations on No Surprises Act’s Independent Dispute Resolution Process and Good Faith Estimate Requirements
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EventsImplications of FDA’s Final Rule on Intended Use on Safe-Harbored Communications
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Data PrivacySwitzerland Recognizes New EU Standard Contractual Clauses and Issues Guidance on International Data Transfers
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Digital HealthPharmacovigilance Considerations in the Era of Patient Centricity: Data Collected by Apps
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Events6th Annual Bay Area Lifesciences Roundtable
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Global Drug PricingMedicare “Most Favored Nation” Drug Payment Heading to Rescission, Shifting Focus to Potential Alternatives
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Digital HealthSingapore to License Telemedicine Service Providers from 2022
Femtech in the Spotlight:
An Interview with Wolfgang Hackl, Founder and CEO of OncoGenomX
Eva von Mühlenen (Advisor, Geneva) and Josefine Sommer (Senior Managing Associate, Brussels) interviewed Wolfgang Hackl, founder of OncoGenomX, a Femtech startup that guides doctors in the treatment of breast cancer — about regulation, research and development (R&D), and the vast potential of artificial intelligence in the field of health technology for women.