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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

PDL files for arbitration for alleged royalties underpayments by Genentech


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

BiotechnologyFinancialGenentechLegalPDL BioPharmaPharmaceuticalRoche

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

Italy's antitrust body investigating Roche and Novartis for alleged cartel


The Italian antitrust authority has opened a cartel investigation of Swiss drug majors Novartis (NOVN:…


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

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

European Parliament approves unitary patent rules


Following the historic vote yesterday in the European Union Parliament to approve the unitary patent…


Alnylam and Tekmira restructure relationship and settle all litigation in $65 million deal


USA-based Alnylam Pharmaceuticals (Nasdaq: ALNY) says it has restructured its relationship with Canadian…

Alnylam PharmaceuticalsBiotechnologyFinancialLegalLicensingPharmaceuticalTekmira Pharmaceuticals

"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

New US bill would provide exclusivity add-on for significant drug combos


Legislation co-sponsored in the USA by Representatives Brian Bilbray (Republican, California), Carolyn…

BiotechnologyLegalNorth AmericaPharmaceuticalRegulation

US House and Senate reconcile PDUFA reauthorization legislation


The US Congress has released a reconciled Prescription Drug User Fee Act (PDUFA) reauthorization bill…

BiotechnologyLegalNorth AmericaPharmaceuticalPoliticsRegulation

US Senate passing of FDA Safety and Innovation Act lauded by biotech and pharma industry


The US Senate approved the Food and Drug Administration Safety and Innovation Act (FDASIA), which includes…

BiotechnologyFinancialLegalNorth AmericaPharmaceuticalPoliticsRegulation

Pharma companies "must be held fully accountable for defrauding US government," says Public Citizen


Public Citizen strongly supports a measure proposed by US Senator Bernie Sanders (Independent, Vermont)…

BiotechnologyLegalMarkets & MarketingNorth AmericaPharmaceuticalPolitics

US Senators Burr and Coburn introduce legislation to reform FDA


US Senators Richard Burr (Republican, North Carolina) and Tom Coburn (Republican, Oklahoma) this week…

BiotechnologyLegalNorth AmericaPharmaceuticalPoliticsRegulation

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