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FDA Issues Final Rule On Regulation Of Laboratory Developed Tests - Life Sciences, Biotechnology & Nanotechnology

On April 29, 2024, the U.S Food and Drug Administration (FDA) announced its final rule on Laboratory Developed Tests (LDTs).

Drug administrationGoodwin life sciences regulatory compliance teamLaboratory developedLaboratory developed testsFederal foodCosmetic actLife sciences regulatoryCompliance teamFda issues final rule on regulation of laboratory developed testsLife sciencesFood and drugs lawLife sciencesIotechnology amp nanotechnology

Alvotech Announces Positive Topline Results From Confirmatory Clinical Study For Its Proposed Golimumab Biosimilar - Life Sciences, Biotechnology & Nanotechnology

On April 23, 2024, Alvotech announced "positive topline results from a confirmatory clinical study for AVT05," Alvotech's proposed golimumab biosimilar to Janssen Biotech, Inc.'s.

United statesFoley lardnerSarah hoganStephen pageGina bertoliniSheppard mullin richter hamptonColumbus regional healthcare system incCalifornia office of health care affordabilityUs department of justiceHealth careSubcommittee on primary healthAmerican health law associationLife sciencesAkin gump strauss hauer feldSenate healthHuman service office

Navigating The Potential Implications For Global Life Sciences Companies Of The Evolving GDPR Enforcement Landscape - Data Protection

On April 10, 2024, the European Parliament (EP) voted on its amendments to the European Commission's (EC) July 4, 2023 proposal for a GDPR Enforcement Regulation (the Proposal).

European parliamentEuropean commissionImpact on global life sciences companiesGeneral data protection regulationData protection authoritiesGlobal life sciencesMoving target that demands closeNavigating the potential implications for global life sciences companies of evolving gdpr enforcement landscapeLife sciencesLife sciencesIotechnology amp nanotechnologyData protection

Alvotech And Teva s Selarsdi™ (ustekinumab-aekn), Biosimilar To Stelara® Approved By FDA - Life Sciences, Biotechnology & Nanotechnology

According to an April 2024 press release, Alvotech and Teva's Selarsdi™ (ustekinumab-aekn) was approved by the FDA on April 16 as a biosimilar of Janssen / Johnson & Johnson's Stelara® (ustekinumab).

United statesGina bertoliniStephen pageFoley lardnerSarah hoganSheppard mullin richter hamptonAmerican health law associationAkin gump strauss hauer feldUs department of justiceColumbus regional healthcare system incHealth careSubcommittee on primary healthSenate healthCalifornia office of health care affordabilityLife sciencesHuman service office

USPTO Proposes Significant Fee Increases Impacting Patent Prosecution Practices - Patent

The USPTO is soliciting comments regarding its proposed fee increases for fiscal year 2025. Written comments must be received on or before June 3, 2024, to ensure consideration.

United statesHeidi lunasinVickig nortonBryanc smithHuman servicesProperty practice groupLife sciencesDepartment of healthConsideration programFederal registerNon provisional applicationsContinuation in part applicationsEarliest priorityUndiscounted non provisionalApplicant provided itemsFinal consideration program

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