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US House of Representatives passes the American Research & Competitiveness Act

US House of Representatives passes the American Research & Competitiveness Act

10-05-2014

By a vote of 274 to 131, US House of Representatives passed legislation (the American Research and Competitiveness…

BiotechnologyFinancialLegalResearchUSA

Proposed new bill would create new patent term extension for certain biologics patents in USA

Proposed new bill would create new patent term extension for certain biologics patents in USA

26-03-2014

Earlier this week in the USA, legislation was introduced allowing new sponsors to gain intellectual property…

BiotechnologyLegalNorth AmericaPatentsPoliticsUSA

US Court upholds damages award in Actelion/Asahi litigation

14-03-2014

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

ActelionAsahi KaseiBiotechnologyfasudilFinancialLegalNorth AmericaRespiratory and PulmonaryUSA

Idenix Pharma files law suits against Gilead in Europe over sofosbuvir

Idenix Pharma files law suits against Gilead in Europe over sofosbuvir

14-03-2014

US drugmaker Idenix Pharmaceuticals says it has filed patent infringement law suits against biotech firm…

Anti-viralsBiotechnologyGilead SciencesIdenix PharmaceuticalsLegalNorthern EuropePatentssofosbuvirSovaldi

Amarin files suit against AstraZeneca over Epanova

Amarin files suit against AstraZeneca over Epanova

05-03-2014

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

28-02-2014

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

19-02-2014

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

07-02-2014

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

BiotechnologyCelgeneLegalMarkets & MarketingNorth AmericaOncologyRevlimidThalomidUSA

PDL BioPharma settles litigation with Genentech and Roche

03-02-2014

US drugmaker PDL BioPharma has entered into an agreement with Genentech and its parent, Swiss drug major…

BiotechnologyFinancialGenentechLegalOncologyOphthalmicsPDL BioPharmaRoche

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

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

10-01-2014

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

ActelionBiotechnologyLegalNorth AmericaRespiratory and PulmonaryTracleerUSA

Sobi terminates deal with Rare Disease Therapeutics for Orfadin distribution

Sobi terminates deal with Rare Disease Therapeutics for Orfadin distribution

20-12-2013

Nordic biotech firm Swedish Orphan Biovitrum (STO: SOBI) has terminated its distributor agreement with…

BiotechnologyLegalLicensingNorthern EuropeOrfadinRare Disease TherapeuticsSobi

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

04-12-2013

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

BiotechnologyLegalNorth AmericaPatentsPolitics

New legislation for regenerative medicine in Japan

New legislation for regenerative medicine in Japan

22-11-2013

The Japanese legislature (Diet) has approved new legislation targeted at regenerative medicine therapies.…

Asia-PacificBiotechnologyCytori TherapeuticsLegalRegulationResearch

Pennsylvania legislation calls for patient and physician notification on biological substitution

Pennsylvania legislation calls for patient and physician notification on biological substitution

14-11-2013

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

BiosimilarsBiotechnologyLegalNorth AmericaRegulation

California Governor rejects Biosimilars Bill

14-10-2013

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

05-09-2013

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

29-08-2013

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

08-08-2013

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

05-08-2013

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

22-07-2013

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

16-07-2013

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

14-06-2013

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

BiotechnologyGeneticsLegalMyriad GeneticsNorth AmericaPatents

PDL files for arbitration for alleged royalties underpayments by Genentech

11-06-2013

USA-based PDL BioPharma (Nasdaq: PDLI) revealed today (June 11) that it has filed a Notice of Arbitration…

BiotechnologyFinancialGenentechLegalPDL BioPharmaPharmaceuticalRoche

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

06-06-2013

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

BiotechnologyGenericsLegalMarkets & MarketingNorth AmericaRegulation

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