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UK government looks to speed up access to new medicines

UK government looks to speed up access to new medicines


The UK government has announced a substantial investment package from industry, and that it is to carry…

BiotechnologyPoliticsRegulationUKUnited Kingdom

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

UK report on life sciences calls for greater freedoms for EU member states

UK report on life sciences calls for greater freedoms for EU member states


A new UK report condemns the European Union’s “anti-biotech legislation” which is damaging Europe’s…


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

California Assembly passes controversial biosimilars bill


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

BiotechnologyGenericsLegalNorth AmericaPoliticsRegulation

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

MoCA report a welcome stepping stone, but access to orphan medicines remains unfinished business, say trade groups


The three leading pharma/biotech trade bodies, EuropaBio, the European Federation of Pharmaceutical Industries…

BiotechnologyEuropeHealthcarePharmaceuticalPoliticsRare diseasesRegulation

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

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

UK govt supports regenerative medicines, saying it is a priority area


George Osborne, the UK's Chancellor of the Exchequer, spoke at the Royal Society last Friday of both…


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

EMIG calls for greater clarity on value-based medicines from UK Parliamentary inquiry into NICE


The UK Ethical Medicines Industry Group (EMIG) has welcomed the House of Commons Health Select Committee's…


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

More guidelines needed to grow regenerative medicine market, report finds


Standardized research guidelines are needed to control and encourage the development of gene therapy…


German model for assessment of new medicines slammed by EU pharma leaders


Leading pharmaceutical companies in Europe, represented in the European Federation of Pharmaceutical…


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

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

Biopharmaceuticals "no longer a growth market" in Germany


After years of consistent growth, the German biopharmaceuticals market came to a juddering halt last…

BiotechnologyEuropeMarkets & MarketingPharmaceuticalPoliticsPricingRegulation

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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