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BIO urges Indiana Governor to sign Bill on interchangeable biologic medicines


US trade group the Biotechnology Industry Organization (BIO) and the Indiana Health Industry Forum (IHIF)…

BiosimilarsGenericsLegalNorth AmericaRegulationUSA

AHF claims victory over FDA on Gilead’s PrEP


The USA-based AIDS Healthcare Foundation (AHF) says it has won another key legal victory late last week…

Anti-viralsBiotechnologyGilead SciencesLegalNorth AmericaRegulationTruvadaUSA

Proposed US legislation on biosimilars welcomed by BIO and WBBA

Proposed US legislation on biosimilars welcomed by BIO and WBBA


The USA’s Biotechnology Industry Organization (BIO) and the Washington Biotechnology & Biomedical Association…

BiosimilarsGenericsLegalNorth AmericaRegulationUSA

Actavis confirms challenge of Lilly’s Axiron patent

Actavis confirms challenge of Lilly’s Axiron patent


US generics major Actavis confirms that it has filed an Abbreviated New Drug Application with the US…

ActavisAxironEli LillyGenericsLegalMen's HealthNorth AmericaPatentsRegulation

Pennsylvania legislation calls for patient and physician notification on biological substitution

Pennsylvania legislation calls for patient and physician notification on biological substitution


The US state of Pennsylvania’s Senate Public Health and Welfare Committee has approved Senate Bill…

BiosimilarsBiotechnologyLegalNorth AmericaRegulation

California Governor rejects Biosimilars Bill


The Governor of the US state of California, Jerry Brown, on Saturday (October 11) vetoed proposed legislation…

BiosimilarsBiotechnologyLegalNorth AmericaRegulation

US Appeals Court lifts temporary injunction on Hanmi Nexium generic NDA


AstraZeneca said that the US Court of Appeals for the Federal Circuit (CAFC) lifted a temporary injunction…

AstraZenecaEsomeprazole MagnesiumGastro-intestinalsHanmi PharmaceuticalLegalNexiumNorth AmericaPharmaceuticalRegulation

Final approval for California's SB 598 Biosimilars Bill


A bill updating US State of California's pharmacy substitution law to allow greater patient access to…

BiotechnologyGenericsLegalNorth AmericaRegulation

California Assembly passes controversial biosimilars bill


In the USA this week, the California Assembly has passes legislation that would allow pharmacists to…

BiotechnologyGenericsLegalNorth AmericaPoliticsRegulation

AHF claims victory over FDA in HIV prevention drug case


The USA-based AIDS Healthcare Foundation (AHF) says it won a key legal victory in a push for drug safety…

Anti-viralsBiotechnologyGilead SciencesLegalNorth AmericaPharmaceuticalRegulationTruvada

Actavis confirms Vimpat patent challenge and gets OK for generic Opana


US generics major Actavis (NYSE: ACT) confirmed on Friday (July 12) that it has filed an Abbreviated…

ActavisEndo Health SolutionsGenericsLegalNeurologicalNorth AmericaOpana ERPatentsRegulationUCBVimpat

New Florida law takes a major step in promoting access to biologic medicines


Legislation amending the US state of Florida's existing prescription drug substitution law has the potential…

BiotechnologyGenericsLegalMarkets & MarketingNorth AmericaRegulation

US DoJ says Ranbaxy pleads guilty and agrees to pay $500 million in settlements


In the largest drug safety settlement to date with a generic drug manufacturer, Ranbaxy USA, a subsidiary…

Asia-PacificDaiichi SankyoFinancialGenericsLegalNorth AmericaProductionRanbaxy LaboratoriesRegulation

Florida joins growing list of US states blocking some Biosimilars Bills provisions


Last Friday, the US state of Florida joined several states, most recently Indiana, in refusing to enact…

BiotechnologyGenericsLegalNorth AmericaRegulation

Florida Biosimilars Bill seeks to notify patients and doctors of changes to prescriptions


The US State of Florida Senate Committee on Health Policy has passed Senate Bill (SB) 732. Under this…

BiotechnologyGenericsLegalNorth AmericaRegulation

Mixed industry views on Virginia's law on biosimilar substitutions


A new law in the US state of Virginia signed into law last week by Governor Bob McDonnell - designed…

BiotechnologyGenericsLegalNorth AmericaPoliticsRegulation

US Supreme Court to rule on liability of generic drugmakers


The US Supreme Court on Tuesday heard arguments on whether Americans who suffer side effects caused by…

GenericsLegalMutual PharmaceuticalNorth AmericaRegulationsulindac

US Senator Grassley urges White House to finish Sunshine Act regulations


US Senator Chuck Grassley (Republican, Iowa) is urging the White House to finalize the Physician Payments…

BiotechnologyLegalNorth AmericaPharmaceuticalRegulation

Landmark US court ruling reverses conviction on off-label drug promotion


The US Court of Appeals for the Second Circuit (based in New York City) on December 3 issued a long-awaited…

Jazz PharmaceuticalsLegalMarkets & MarketingNorth AmericaPharmaceuticalRegulationXyrem

"New" CDER Exclusivity Board focuses on clarity and consistency of exclusivity decisions


The US Food and Drug Administration recently announced that the agency has established within the Center…

BiotechnologyLegalNorth AmericaPatentsPharmaceuticalRegulation

Watson gets FDA final approval for generic Actos; negative news on Prochieve appeal


US generic drugmaker Watson Pharmaceuticals (NYSE: WPI) said on Friday that it has launched a generic…

ActosDiabetesGenericsLegalMylan LaboratoriesNorth AmericaProchieveRegulationReproductiveTakeda PharmaceuticalsWatson Pharmaceuticals

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