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New Approaches In Cancer Drug Development - Healthcare

One of the features that excites me about representing life sciences and other technology innovators is the impact they can have on our society.

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CRISPR Gene Editing For Sickle Cell Disease: A New Era Of Hope - Healthcare

We live in an extraordinary time. It's a time where technology in life sciences is peeling back the curtain on the underlying causes of disease.

Emmanuelle-charpentier , Jenifer-doudna , Crowley-law , Vertex-pharmaceuticals , Mondaq , Crispr-gene-editing-for-sickle-cell-diseasea-new-era-of-hope , Food , Rugs , Ealthcare , Ife-sciences , Healthcare , Life-sciences

FDA Approves Florida's Application To Import Drugs From Canada - Healthcare

On January 5, 2024, the Food and Drug Administration (FDA) authorized the state of Florida's proposal under the Section 804 Importation Program (SIP) for a period of two years.

Canada , Florida , United-states , American , Canadian , Canadians , Drug-administration , Health-canada , Importation-program , Biden-administration , Affordable-health-coverage

Orphan Drugs To The Rescue - Life Sciences, Biotechnology & Nanotechnology

It's dedicated to creating treatments for rare diseases. These drugs are designated as 'orphan' because, without government assistance...

United-states , European-union , European-union-commission , Medicines-agency , International-cooperation , International-expansion , Orphan-drug-act , Crowley-law , Mondaq , Orphan-drugs-to-the-rescue , Food

FDA Releases Its Scientific Support For Rescheduling Marijuana To Schedule III -

On Jan. 12, 2024, the U.S. Department of Health and Human Services (HHS) officially released unredacted documents detailing the U.S. Food and Drug Administration's (FDA) reasons for recommending...

Washington , United-states , Drug-administration , Us-department-of-health , Drug-enforcement-administration , Controlled-substances-act , Internal-revenue-code , Mondaq , Fda-releases-its-scientific-support-for-rescheduling-marijuana-to-schedule-iii , Cannabis-amp-hemp , Food

USPTO Issues

The USPTO has issued "Guidelines for Assessing Enablement in Utility Applications and Patents in View of the Supreme Court Decision in Amgen Inc. et al. v. Sanofi et al."

Trademark-office , Supreme-court-decision-in-amgen-inc , Supreme-court , Amgen , Utility-applications , Supreme-court-decision , Wands-factors-remain-probative , Federal-circuit , Amgen-federal-circuit , Amgen-federal , Mondaq

The Interplay: Key Decisions At The Intersection Of Antitrust & Life Sciences - January 2024 - Antitrust, EU Competition

n December 15, 2023, the Fifth Circuit vacated the FTC's order that Illumina unwind its acquisition of Grail—a developer of a multi-cancer early detection (MCED) test. All MCED...

California , United-states , New-york , Long-island , Louisiana , Court-rejects-challenge-to-united-healthcare , Academy-of-allergy , Court-certifies-two-classes-in-invisalign , Company-of-new-york-inc , Health-insurance-companies-successfully-defend , Technology-inc

AI And IP: Considerations For Medtech - Life Sciences, Biotechnology & Nanotechnology

Increasingly, artificial intelligence (AI) tools like ChatGPT and GitHub Copilot are reshaping corporate operations. They can boost efficiency, particularly in software development and content creation.

Food-drug-administration , European-union , Digital-health-innovation-action-plan , Github-copilot , Drug-administration , Medical-device , General-data-protection , Mondaq , Food-and-drug-administration-fda- , Ntellectual-property-ip- , Rtificial-intelligence-ai-

Recent Settlement Highlights Increased Focus On Clinical Research Enforcement And Risks For Clinical Trial Billing - Healthcare

On January 4, the H. Lee Moffitt Cancer Center & Research Institute Hospital Inc. of Florida (Moffitt) agreed to pay US$19.5 million to resolve its civil liability under the False Claims Act (FCA) related to alleged conduct occurring from May 11, 2014 through May 10, 2020.

Florida , United-states , Arung-rao , H-lee-moffitt-cancer-center-research , Institute-hospital-inc , Arnold-porter , Drug-administration , Moffitt-cancer-center , Institute-hospital , False-claims-act , Medicaid-services-national-coverage-determination

U.S. Life Sciences Regulatory And Compliance Outlook 2024 (Part I): FDA Enforcement And Litigation (Podcast) - Healthcare

Join Ropes & Gray's life sciences attorneys for a podcast series exploring regulatory, compliance, and enforcement changes emanating from Washington, D.C. and the potential impact on life sciences companies in 2024.

India , Texas , United-states , China , Washington , Greg-levine , Beth-weinman , Us-senate , House-committee , Department-of-health , Regulatory-affairs , Supreme-court