Regulation - North America, Production


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NW Bio to expand manufacturing of DCVax products


US biotech firm Northwest Biotherapeutics has entered into a set of agreements for large-scale expansion…

BiotechnologyDCVaxEuropeNorth AmericaNorthwest BiotherapeuticsProductionRegulationUSA

Another ban by US FDA on a Ranbaxy production facility

Another ban by US FDA on a Ranbaxy production facility


As if the Indian drug major has not had enough negative news from the US regulator, the US Food and Drug…

Asia-PacificDaiichi SankyoGenericsIndiaNorth AmericaProductionRanbaxy LaboratoriesRegulationUSA

Joint generic drug inspections initiative announced by FDA and EMA

Joint generic drug inspections initiative announced by FDA and EMA


In a joint statement, the US Food and Drug Administration and the European Medicines Agency revealed…

EuropeGenericsNorth AmericaProductionRegulation

FDA clears Eisai Zonegran facility in UK for US exports

FDA clears Eisai Zonegran facility in UK for US exports


Eisai says the US Food and Drug Administration has approved the US supply of the epilepsy drug Zonegran…

EisaiEuropeNeurologicalNorth AmericaPharmaceuticalProductionRegulationZonegran

Ban on FDA-regulated drugs from Ranbaxy's Mohali plant


There was another blow for India's largest drugmaker Ranbaxy Laboratories (BSE: 500359) yesterday (September…

Asia-PacificDaiichi SankyoGenericsNorth AmericaProductionRanbaxy LaboratoriesRegulation

US payers have more faith in biosimilars from multinationals


US payer's trust in specific biosimilar manufacturers could dictate which companies will be most successful…

BiotechnologyEuropeGenericsNorth AmericaProductionRegulation

Grindeks gains new export opportunities in the USA


Latvian drugmaker JSC Grindeks (GRD1R: RI ) says it has successfully passed a US Food and Drug Administration…

EuropeGenericsGrindeksNorth AmericaProductionRegulation

Waiver from European Commission to help exporting for US pharmaceutical manufacturers


The US Food and Drug Administration announced on Friday (June 21) that the USA is now a "listed country"…

EuropeGenericsNorth AmericaPharmaceuticalProductionRegulation

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

Canada strengthens drug safety with GMP now to apply to all APIs


Canada's Health Minister Leona Aglukkaq this week announced that Canada's Food and Drug Regulations have…

GenericsNorth AmericaPharmaceuticalProductionRegulation

FDA sends CRL rejecting Allergan's migraine drug Levadex on quality issues


US drugmaker Allergan (NYSE: AGN) said yesterday (April 16) that the US Food and Drug Administration…

AllerganLevadexNeurologicalNorth AmericaPharmaceuticalProductionRegulation

GlaxoSmithKline cleared for $91M flu vaccine plant in USA; Gets CRL on Q-Plan H5N1


UK pharma giant GlaxoSmithKline (LSE: GSK) and The Texas A&M University System (TAMUS) say that the US…

GlaxoSmithKlineNorth AmericaPharmaceuticalProductionQ-Plan H5N1RegulationVaccines

Public Citizen slams FDA over lax oversight of "compounding pharmacies"


Strengthened enforcement over compounding pharmacies that act as drug manufacturers would help alleviate…

GenericsNorth AmericaPharmaceuticalProductionRegulation

Tackling opioid drug abuse through new delivery methods and post-marketing studies


The opioid pain management market will continue to evolve over the coming years with new products and…

NeurologicalNorth AmericaPharmaceuticalProductionRegulation

Another stumbling block for Impax Pharma's Rytary


Impax Pharmaceuticals, the branded products division of Impax Laboratories (Nasdaq: IPXL), revealed on…

GlaxoSmithKlineImpax LaboratoriesNeurologicalNorth AmericaPharmaceuticalProductionRegulationRytary

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

PharmaJet links with Australia's CSL for needle-free flu vaccine delivery


USA-based PharmaJet has entered into a collaboration with Australia's largest biotech firm CSL Limited…

AfluriaAnti-viralsCSL LimitedHomeNorth AmericaPharmaJetProductionRegulation

FDA approves Novartis' Flucelvax, first seasonal flu vaccine using cell culture technology


The US Food and Drug Administration yesterday approved Swiss drug major Novartis' (NOVN: VX) Flucelvax,…

FlucelvaxNorth AmericaNovartisPharmaceuticalProductionRegulationVaccines

Canadian government moves to strengthen drug safety


Canadian Minister of Health Leona Aglukkaq this week announced that Canada's Food and Drug Regulations…

North AmericaPharmaceuticalProductionRegulation

ViroPharma gets FDA backing for industrial scale Cinryze manufacturing


US biotech firm ViroPharma (Nasdaq: VPHM) says that the US Food and Drug Administration has approved…

BiotechnologyCinryzeNorth AmericaProductionRegulationReproductiveViroPharma



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