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US Court upholds damages award in Actelion/Asahi litigation


Switzerland-based Actelion says that the California Supreme Court has denied the firm’ petition for…

ActelionAsahi KaseiBiotechnologyfasudilFinancialLegalNorth AmericaRespiratory and PulmonaryUSA

Amarin files suit against AstraZeneca over Epanova

Amarin files suit against AstraZeneca over Epanova


US biotech firm Amarin revealed in a Stock Exchange Commission submission that it has filed a complaint…

AmarinAstraZenecaBiotechnologyCardio-vascularEpanovaLegalNorth AmericaOmthera PharmaceuticalsPatentsUSAVascepa

Amarin calls on FDA to extend Vascepa exclusivity by five years


US biotech firm Amarin has filed with a federal court requesting it to order the US Food and Drug Administration…

AmarinBiotechnologyCardio-vascularGlaxoSmithKlineLegalLovazaNorth AmericaUSAVascepa

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

Whistleblower law suit against Celgene unsealed

Whistleblower law suit against Celgene unsealed


A US federal court yesterday unsealed a whistleblower/false claims law suit brought against US biotech…

BiotechnologyCelgeneLegalMarkets & MarketingNorth AmericaOncologyRevlimidThalomidUSA

Tracleer “whistleblower” case by the US Department of Justice dismissed

Tracleer “whistleblower” case by the US Department of Justice dismissed


In connection with a qui tam proceeding ("whistleblower case"), Swiss biotech firm Actelion previously…

ActelionBiotechnologyLegalNorth AmericaRespiratory and PulmonaryTracleerUSA

USA’s BIO expresses serious concerns on Innovation Act, HR 3309


The US trade group Biotechnology Industry Organization (BIO) has expressed grave concerns relating to…

BiotechnologyLegalNorth AmericaPatentsPolitics

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

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

Pharma associations strongly support Senate bill on FDA User Fees sequestration exemptions


In the USA last week, Mark Pryor (Democrat, Arkansas), chairman of the Senate Appropriations Subcommittee…

BiotechnologyFinancialGenericsLegalNorth AmericaPharmaceuticalPolitics

Bipartisan Bill exempting FDA user fees from sequestration introduced in USA


A bipartisan group of US House of Representatives Members last week introduced the FDA Safety Over Sequestration…

BiotechnologyFinancialLegalNorth AmericaPharmaceuticalPolitics

US Court denies re-hearing of Arzerra patent case


Danish drugmaker Genmab (OMX: GEN) says that the US Court of Appeals for the Federal Circuit has declined…

ArzerraBiogen IdecBiotechnologyGenentechGenmabGlaxoSmithKlineLegalNorth AmericaOncologyPatentsPharmaceutical

US Supreme Court issues mixed ruling on DNA patents


The US Supreme Court yesterday (June 13) delivered its unanimous decision regarding the Association for…

BiotechnologyGeneticsLegalMyriad GeneticsNorth AmericaPatents

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

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

Amgen to pay $24.9 million to resolve false claims on Aranesp marketing


USA-based Amgen (Nasdaq: AMGN), the world's largest independent biotech company, has agreed to pay the…

AmgenAranespBiotechnologyFinancialLegalNorth America

Appeals Court rules against EMD Serono over Rebif deal with Pfizer


Germany's Merck KGaA (MRK: DE) says that a Pennsylvania appeals court has ruled against Merck in deciding…

BiotechnologyEMD SeronoLegalMarkets & MarketingMerck KGaANeurologicalNorth AmericaPfizerPharmaceuticalRebif

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 government takes steps to expose financial ties between drugmakers and doctors


After more than a year of prodding from the Senate Special Committee on Aging, the USA's federal government…

BiotechnologyFinancialLegalNorth AmericaPharmaceuticalResearch

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