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

26-08-2011

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

26-08-2011

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

26-08-2011

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

25-08-2011

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

25-08-2011

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

25-08-2011

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

EuropeFinancialGenericsLegalPharmaceuticalRegulation

US govt tightens financial conflict of interest rules for medical researchers

25-08-2011

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

24-08-2011

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

Anti-viralsAstraZenecaFluMistPharmaceuticalResearchVaccines

AstraZeneca breast cancer drug Faslodex not good use of NHS resources, says NICE draft guidance

24-08-2011

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

AstraZenecaEuropeFaslodexOncologyPharmaceuticalPricingRegulation

Changing the mood of Brazilian antidepressant market; fake Levitra

24-08-2011

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

23-08-2011

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

23-08-2011

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

23-08-2011

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

22-08-2011

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

21-08-2011

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

BiotechnologyEuropePharmaceuticalRegulation

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

21-08-2011

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

Asia-PacificGenericsHealthcarePharmaceuticalPoliticsRegulation

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

19-08-2011

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

BayerEuropeLevitraMarkets & MarketingPharmaceuticalRegulationSativex

Gentium withdraws US NDA for defibrotide

19-08-2011

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

18-08-2011

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

Anti-viralsPharmaceuticalResearchVaccines

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

18-08-2011

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

North AmericaOncologyPharmaceuticalRegulationRochevemurafenibZelboraf

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