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US Congressmen express concerns on FDA’s proposed change to generic drug labeling policy

US Congressmen express concerns on FDA’s proposed change to generic drug labeling policy


US Senator Lamar Alexander (Republican, Tennessee), the senior Republican on the Senate Health Committee,…

GenericsNorth AmericaPoliticsRegulationUSA

No changes in Australian domestic IP warranted, say generic drugmakers

No changes in Australian domestic IP warranted, say generic drugmakers


Members of the generic drugs industry are calling on the Australian government to support efforts to…

Asia-PacificGenericsNorth AmericaPatentsPolitics

MSF warns of US/Indian tension over generic policy discussion

MSF warns of US/Indian tension over generic policy discussion


Humanitarian group Médecins Sans Frontières has warned that India is facing political pressure from…

Anti-viralsAsia-PacificBayerGenericsGleevecHealthcareNexavarNorth AmericaNovartisPolitics

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

Tightening health budgets on both sides of the Atlantic leading to crackdowns on patent settlements, says EIU analyst


Later this month, following an inquiry launched in 2009, the European Commission is expected to impose…

EuropeFinancialGenericsNorth AmericaPatentsPharmaceuticalPoliticsRegulation

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

Mixed views from PhRMA and GPhA on Obama's State of the Union Address


There were mixed reactions from two sides of the US drug industry - research-based and generic drugmakers…

FinancialGenericsHealthcareNorth AmericaPharmaceuticalPolitics

US biotech giants lobbying to block biosimilars, NTY claims


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

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PhRMA disputes Indian claims relating to cancer drug shortages


In a recent interview with Times of India, a trade association that represents several major generic…

Asia-PacificGenericsNorth AmericaPatentsPharmaceuticalPolitics

US House of Reps Passes FDA Reform Act


Just days after the US Senate overwhelming approved the Food and Drug Administration Safety and Innovation…

GenericsLegalNorth AmericaPharmaceuticalPoliticsRegulation

Leahy Bill would boost generic drug safety in USA, says consumer group


A bill giving generic drug manufacturers in the USA the authority to revise labeling for their products…

GenericsNorth AmericaPoliticsRegulation

US House Bill will establish inspection parity, improve US drug supply


Ranking US Congress Member Henry Waxman, Health Subcommittee Ranking Member Frank Pallone, Representative…

GenericsLegalNorth AmericaPharmaceuticalPoliticsRegulation

A lot of user fee issues in USA


2012 has only just begun, but the US Congress, the Food and Drug Administration and several health care…

BiotechnologyGenericsNorth AmericaPharmaceuticalPoliticsRegulation

US Senators question Pfizer deals to limit access to generic Lipitor


Three prominent US Senators have sent letters to pharma behemoth Pfizer (NYSE: PF), as well as three…

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