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FDA accepts Lundbeck NDA for IV carbamazepine

FDA accepts Lundbeck NDA for IV carbamazepine


The US subsidiary of Danish CNS specialist Lundbeck says that the Food and Drug Administration has accepted…

CarbamazepineCarbellaFinancialLigand PharmaceuticalsLundbeckNeurologicalNorth AmericaPharmaceuticalRegulationUSA

New data shows FDA’s proposed generic labeling rules would add to health costs

New data shows FDA’s proposed generic labeling rules would add to health costs


The US Food and Drug Administration’s Proposed Rule on prescription drug labeling would add $4 billion…

FinancialGenericsNorth AmericaRegulationUSA

US global share of biomedical research spending declines, as Asia gains


The USA’s global share of biomedical research spending fell from 51% in 2007 to 45% in 2012, while…

Asia-PacificChinaFinancialNorth AmericaPharmaceuticalRegulationResearchUSA

2013 FDA approval rates suggest record year for post-launch success


A focus on hard to treat or specialist diseases is set to result in record post-launch sales for new…

Biogen IdecFinancialGilead SciencesNorth AmericaPharmaceuticalRegulationsofosbuvirTecfidera

Curis plunges on negative CUCD-427 news; 3rd-qtr loss down


Oncology focussed US biotech firm Curis saw its shares sink 21% to $3.08, after it revealed receipt of…

BiotechnologyCUCD-427CurisFinancialNorth AmericaOncologyRegulationResearch

US FDA jacks up FY 2014 generic drug user fees


In a Federal Register notice, the US Food and Drug Administration has announced the rate for the Abbreviated…

FinancialGenericsNorth AmericaRegulation

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 DoJ says Ranbaxy pleads guilty and agrees to pay $500 million in settlements


In the largest drug safety settlement to date with a generic drug manufacturer, Ranbaxy USA, a subsidiary…

Asia-PacificDaiichi SankyoFinancialGenericsLegalNorth AmericaProductionRanbaxy LaboratoriesRegulation

US FDA adds new indication for Shire's ADHD drug Vyvanse; 1st-qtr results


Ireland-headquartered Shire (LSE: SHP) says that the US Food and Drug Administration has approved its…

FinancialNeurologicalNorth AmericaPharmaceuticalRegulationShireVyvanse

Merck & Co submits ragweed AIT BLA to the FDA


US pharma giant Merck & Co (NYSE: MRK) has submitted a Biologics License Application (BLA) to the US…

ALK AbelloFinancialImmunologicalsMerck & CoNorth AmericaPharmaceuticalRegulation

Chelsea Thera to re-file Northera NDA with existing data; Celgene share buyback


Chelsea Therapeutics International (Nasdaq: CHTP) saw its shares more than double to $1.61 in pre-market…

BiotechnologyCardio-vascularCelgeneChelsea TherapeuticsFinancialNorth AmericaNortheraRegulation

Briefs: Sanofi to up stake in Regeneron; Bayer files for riociguat approval


US biotech Regeneron Pharmaceuticals (Nasdaq: REGN) saw its shares rise 4.8% to $173.84 in early trading…

BayerBiotechnologyEuropeFinancialMergers & AcquisitionsNorth AmericaPharmaceuticalRegeneronRegulationRespiratory and PulmonaryriociguatSanofi

US FDA details Generic Drug User Fee for APIs and finished dosage form facilities for FY2013


In a federal Register posting, the US Food and Drug Administration has announced the rate for the generic…

FinancialGenericsNorth AmericaProductionRegulation

Eight US FDA approvals in December boost 2012 to banner year for new drugs


The US Food and Drug Administration approved eight new drugs in December pushing the year's total to…

BiotechnologyFinancialNorth AmericaPharmaceuticalRegulation

Extraneous clinical data collection costs drug developers $4-$6 billion a year, says Tufts CSDD


One out of every five procedures performed during later stage clinical trials collects extraneous data…

BiotechnologyFinancialNorth AmericaPharmaceuticalRegulationResearch

USA's PDUFA V sets new course for regulatory science, say BIO and PhRMA


With the implementation of the USA's Prescription Drug User Fee Act (PDUFA V) on Monday, trade groups…

BiotechnologyFinancialNorth AmericaPharmaceuticalRegulation

Legislative fix would allow FDA to collect GDUFA user fees


Legislation allowing the US Food and Drug Administration to collect several user fees under the Generic…

FinancialGenericsNorth AmericaRegulation

Resubmission of aripiprazole NDA accepted; AstraZeneca bond issue


Danish CNS-focused drugmaker Lundbeck (LUND: DC) and Japanese partner Otsuka Pharmaceutical (TYO: 4668)…

aripiprazole depotAstraZenecaFinancialLundbeckNeurologicalNorth AmericaOtsukaPharmaceuticalRegulation

US health care reform looks to squeeze players up and down the value chain


This summer's landmark Supreme Court decision to uphold the USA's Patient Privacy and Affordable Care…

BiotechnologyFinancialHealthcareNorth AmericaPharmaceuticalRegulationResearch

USA's PDUFA V begins with relatively modest changes to user fee rates


In two Federal Register notices published on August 1, the US Food and Drug Administration announced…

BiotechnologyFinancialNorth AmericaPharmaceuticalRegulation

Isis earns $25 million milestone from Genzyme as US FDA accepts Kynamro NDA


The US Food and Drug Administration has accepted for filing the New Drug Application for Kynamro (mipomersen…

BiotechnologyCardio-vascularFinancialGenzymeIsis PharmaceuticalsKynamroNorth AmericaPharmaceuticalRegulationSanofi

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

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