Regulation - Vaccines


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Boehringer and Lilly’s Trajenta approved for type 2 diabetes in Europe


Following a positive European Medicines Agency advisory committee recommendation two is months ago, Independent…

Boehringer IngelheimDiabetesEli LillyEuropePharmaceuticalRegulationTradjentaTrajenta

US FDA approves Shire’s Firazyr to treat acute attacks of hereditary angioedema


After a near unanimous recommendation from an advisory panel earlier this year (The Pharma Letter June…

FirazyrNorth AmericaPharmaceuticalRare diseasesRegulationShire

United Thera’s oral PAH drug treprostinil fails in Ph III study


US biotech firm United Therapeutics (Nasdaq: UTHR) says that preliminary results from its FREEDOM-C(2)…

BiotechnologyRegulationResearchRespiratory and PulmonaryTreprostinilUnited Therapeutics

Shire drops Dermagraft for venous leg ulcers, after Ph III failure


Ireland-headquartered drugmaker Shire (LSE: SHP) says that Advanced BioHealing (ABH), the USA-based regenerative…

Advanced BioHealingBiotechnologyDermagraftDermatologicalsPharmaceuticalRegulationResearchShire

Allergan gets US FDA nod for Botox to treat form of urinary incontinence


There was a boost for US specialty drug firm Allergan (NYSE: AGN) yesterday when the company revealed…

AllerganBotoxNeurologicalNorth AmericaPharmaceuticalRegulation

Spain hopes to save 2.4 billion euros by ordering doctors to Rx generics


As part of moves to reduce the nation’s budget deficit, Spain’s socialist government has passed…


US govt tightens financial conflict of interest rules for medical researchers


The US Department of Health and Human Services this week issued an updated Final Rule on conflict of…

FinancialNorth AmericaPharmaceuticalRegulationResearch

Trudeau Institute discovers how FluMist elicits protection


New research from the USA-based Trudeau Institute may help to explain why live attenuated influenza vaccine…


AstraZeneca breast cancer drug Faslodex not good use of NHS resources, says NICE draft guidance


An independent committee of experts that develops guidance on behalf of the UK drugs watchdog the National…


Changing the mood of Brazilian antidepressant market; fake Levitra


The Vice President of Brazil’s Superior Court of Justice (STJ), Minister Felix Fischer, has restored…

BayerGenericsLevitraLexaproLundbeckNeurologicalPharmaceuticalRegulationReproductiveSouth America

USA’s Public Citizen calls for strongest warnings on PPIs, saying they are over-Rxed


In a petition sent to the US Food and Drug Administration yesterday, consumer advocacy group Public Citizen…

Gastro-intestinalsNorth AmericaPharmaceuticalRegulation

US FDA fast-tracks Bayer and Algeta’s prostate drug Alpharadin


Germany’s Bayer (BAY: DE) said this morning that its investigational compound Alpharadin (radium-223…

AlgetaAlpharadinBayerNorth AmericaOncologyPharmaceuticalRegulation

Regulatory updates for Incivek, Xgeva and Corlux in North America


In a batch of regulatory news released yesterday, Vertex Pharmaceuticals (Nasdaq: VRTX) said that Health…

AmgenAnti-viralsCorcept TherapeuticsCorluxIncivekNorth AmericaPharmaceuticalRare diseasesRegulationVertexXgeva

CEL-SCI gets FDA warning letter about web site statements on Multikine


US drug developer CEL-SCI Corp (NYSE AMEX: CVM) says it received a warning letter received from the Division…

CEL-SCI CorpMarkets & MarketingMultikineNorth AmericaOncologyPharmaceuticalRegulation

New validation criteria for electronic submissions from Sept 1, 2011, says EMA


In a web site posting, the European Medicines Agency is informing pharmaceutical companies that a new…


Australia’s generics firms also welcome Senate report on government administration of the PBS


Following the release of the Australia’s Senate Finance and Administration References Committee…


Bayer reprimanded for breaches of the ABPI Code by tweeting on Rx drugs


The UK Prescription Medicines Code of Practice Authority (PMCPA) has reprimanded Bayer Healthcare, a…

BayerEuropeLevitraMarkets & MarketingPharmaceuticalRegulationSativex

Gentium withdraws US NDA for defibrotide


Italian drug developer Gentium SpA (Nasdaq: GENT) saw its shares price plunge 29% to $6.22 on the Nasdaq…

Cardio-vasculardefibrotideGentiumNorth AmericaPharmaceuticalRegulationSigma Tau

AIDS researchers isolate new potent and broadly effective antibodies against HIV


A team of researchers at and associated with the International AIDS Vaccine Initiative (IAVI), The Scripps…


Roche’s Zelboraf and companion diagnostic for late-stage melanoma cleared in USA


Swiss drug major Roche (ROG: SIX) yesterday received US Food and Drug Administration approval for Zelboraf…

North AmericaOncologyPharmaceuticalRegulationRochevemurafenibZelboraf

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