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US lawmakers question price of Gilead’s Sovaldi

US lawmakers question price of Gilead’s Sovaldi


Three leading US Congressmen have written to John Martin, chief executive of US biotech firm Gilead Sciences,…

Anti-viralsBiotechnologyGilead SciencesNorth AmericaPoliticsPricingRegulationSovaldiUSA

OncoMed CEO presses for better environment for biopharma innovation, at House hearings


The case for encouraging biopharma innovation was presented yesterday at the US House Committee on Oversight…

BiotechnologyNorth AmericaOncoMed PharmaceuticalsPoliticsRegulationResearch

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

California Assembly passes controversial biosimilars bill


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

BiotechnologyGenericsLegalNorth AmericaPoliticsRegulation

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

HAI Europe questions pharma commitment to clinical trial data transparency, claiming leaked documents suggest otherwise


Consumer advocacy Health Action International (HAI) Europe says it welcomes any initiative that grants…

BiotechnologyEuropeNorth AmericaPharmaceuticalPoliticsRegulationResearch

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 FY 2014 budget continues push to curb patent settlements, shorten biologics exclusivity; a lawyer's view


At first look, the US Food and Drug Administration appears to have fared rather well under President…

BiotechnologyGenericsNorth AmericaPatentsPoliticsRegulationResearch

President Obama's 2014 budget proposal a mixed bag for pharma


US President Barack Obama $3.77 trillion budget proposal for fiscal 2014 delivers mixed news for the…

BiotechnologyFinancialHealthcareNorth AmericaPharmaceuticalPolitics

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 biotech giants lobbying to block biosimilars, NTY claims


Some of the USA's biggest biotechnology companies are lobbying intensively to limit generic competition…

AmgenBiotechnologyGenentechGenericsNorth AmericaPoliticsRegulation

Canadian Senate committee finds faults in current clinical trials system


The absence of a standardized approach to research ethics review significantly impacts the time required…

BiotechnologyNorth AmericaPharmaceuticalPoliticsRegulationResearch

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 legislation could block public access to drug safety information, claim consumer groups


A provision in the Food and Drug Administration Reform Act that would block public access to potentially…

BiotechnologyNorth 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

Foreign efforts to lure US biopharmaceutical companies


Despite increasing budget pressures, countries around the world are making substantial investments in…

BiotechnologyFinancialGlobalNorth AmericaPharmaceuticalPoliticsResearch

Sunshine Act data collection delayed to January 2013, says USA's CMS


In a web site posting last week, The US Center for Medicare and Medicaid Services (CSM) announced that…

BiotechnologyNorth AmericaPharmaceuticalPoliticsRegulation

BIO asks US House Committee on Ways and Means to extend critical tax provisions; backs Obama Bioeconomy Blueprint


US trade group the Biotechnology Industry Organization (BIO) has submitted a statement for the record…

BiotechnologyFinancialNorth AmericaPolitics

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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