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US FDA modifies dosing for ESA’s Aranesp, Epogen and Procrit on cardiovascular risks


The US Food and Drug Administration on Friday recommended more conservative dosing guidelines for erythropoiesis-stimulating…

AmgenAranespBiotechnologyEpogenJohnson & JohnsonNorth AmericaOncologyPharmaceuticalProcritRegulation

Thumbs down from EMA for Amsterdam Molecular’s Glybera


Dutch human gene therapy firm Amsterdam Molecular Therapeutics (Euronext: AMT) says it has received a…

Amsterdam MolecularBiotechnologyEuropeGlyberaRare diseasesRegulation

Sanofi Pasteur gets WHO prequalification for Typhim Vi; opens R&D unit in Canada


Sanofi Pasteur, the vaccines division of French drug major Sanofi (Euronext: SAN) has been granted World…

FinancialPharmaceuticalRegulationResearchSanofiSanofi PasteurTyphimVaccines

CSL Biotherapies gets official warning letter from US FDA


The US Food and Drug Administration issued a formal warning letter to Australia’s largest biotech…

AfluriaAsia-PacificBiotechnologyCSL BiotherapiesCSL LimitedNorth AmericaRegulationVaccines

Merck KGaA drops plans for oral MS drug cladribine, leaving field clear for Gilenya


German drug major Merck KGaA (MRK: DE) said yesterday that, following feedback from regulatory authorities,…

CladribineGilenyaMarkets & MarketingMerck KGaANeurologicalNovartisPharmaceuticalRegulation

EU clears anti-JC virus risk labeling for Biogen and Elan’s Tysabri


US biotech firm Biogen Idec (Nasdaq: BIIB) and Ireland-based Elan (NYSE: ELN) said yesterday that the…

Biogen IdecBiotechnologyElanEuropeNeurologicalRegulationTysabri

US FDA approves ProStrakan’s Rectiv for anal fissures pain


Scotland-based ProStrakan, now a subsidiary of Japan’s Kyowa Hakko Kirin (TYO: 4151) as the result…

Gastro-intestinalsKyowa Hakko KirinNorth AmericaPharmaceuticalProStrakanRectivRectogesicRegulation

EU generic drugmakers launch code of conduct on MAA slots


The European Generic medicines Association (EGA) says it has officially launched a code of conduct on…


Eli Lilly gets EU approval for long-acting diabetes drug Bydureon


In what was excellent news for all three companies following rejections of the drug by US regulators,…

AlkermesAmylinBydureonDiabetesEli LillyEuropePharmaceuticalRegulation

Pfizer’s Lyrica meets endpoint in Ph III study of central neuropathic pain after spinal cord injury


Global drugs behemoth Pfizer (NYSE: PFE) says its blockbuster neuropathic pain drug Lyrica (pregabalin)…


US FDA views ways to improve consumer understanding of Rx drug ads


Findings from three studies conducted by the US Food and Drug Administration confirm that the way information…

Markets & MarketingNorth AmericaPharmaceuticalRegulation

Australia and New Zealand resurrect plans for joint Therapeutic Products Agency; Medicines Australia views impact


The governments of Australian and New Zealand have agreed to proceed with a joint scheme for regulation…


Pfizer and Acura’s tamper resistant opioid Oxecta gets US FDA approval


After a significant delay, drugs behemoth Pfizer (NYSE: PFE) and partner Acura Pharmaceuticals (Nasdaq:…

Acura PharmaceuticalsNeurologicalNorth AmericaOxectaPfizerPharmaceuticalRegulationRemoxy

Bristol-Myers Squibb gets EU approval for Nulojix for kidney transplant rejection


The European Commission yesterday granted marketing authorization for US drug major Bristol-Myers Squibb’s…

Bristol-Myers SquibbEuropeImmunologicalsNulojixPharmaceuticalRegulation

New global strategy to help ensure safety and quality of imported products unveiled by US FDA


The US Food and Drug Administration has unveiled a new strategy to meet the challenges posed by rapidly…

GlobalMarkets & MarketingNorth AmericaPharmaceuticalRegulation

EMA and US FDA get first parallel QbD application; FDA beats EMA on cancer drug appros


The European Medicines Agency (EMA) and the US Food and Drug Administration have agreed to accept the…

EuropeNorth AmericaOncologyPfizerPharmaceuticalRegulation

Unanimous FDA advisory support for Regeneron wet-AMD drug Eylea/VEGF Trap-Eye


As was largely expected following positive briefing papers from the US Food and Drug Administration earlier…

BayerBiotechnologyEyleaOphthalmicsPharmaceuticalRegeneronRegulationVEGF Trap-Eye

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