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New legislation for regenerative medicine in Japan

New legislation for regenerative medicine in Japan


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


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

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

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 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

"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

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

Bipartisan Bill to strengthen testing of pediatric drugs launched in USA


US Representative Mike Rogers (Republican, Michigan) this week introduced bipartisan legislation with…

BiotechnologyLegalNorth AmericaPharmaceuticalRegulationResearch

US TREAT Act poised to revolutionize the biotechnology industry


In recent years, smaller biotechnology companies have received less funding from venture capitalists…

BiotechnologyFinancialLegalNorth AmericaRegulation

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