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US FDA reviews NDAs faster than EU and Canadian regulators, contends new study

16-05-2012

a new study published on-line yesterday in the prestigious New England Journal of Medicine, the US Food…

BiotechnologyNorth AmericaPharmaceuticalRegulation

UK's NICE does U-turn, recommending Zytiga as Janssen cuts price

16-05-2012

UK drugs watch dog the National Institute for Health and Clinical Excellence (NICE) has reversed an earlier…

EuropeJanssenJohnson & JohnsonOncologyPharmaceuticalPricingRegulationZytiga

Biovest to file for EU approval of BiovaxID, a personalized cancer vaccine

16-05-2012

USA-based Biovest International (OTCQB: BVTI), a majority-owned subsidiary of Accentia Biopharmaceuticals…

BiovaxIDBiovest InternationalEuropeOncologyPharmaceuticalRegulationVaccines

US FDA fast-tracks Achillion's hepatitis C drug candidate

15-05-2012

USA-based Achillion Pharmaceuticals (Nasdaq: ACHN) says it has received Fast Track designation from the…

Achillion PharmaceuticalsAnti-viralsNorth AmericaPharmaceuticalRegulation

Expropriation in the Hungarian pharmacy sector reviewed

14-05-2012

The change of regime in Hungary in 1989 brought the much expected changes in the field of the retail…

EuropeMarkets & MarketingPharmaceuticalRegulation

FDA advisory thumbs up for Gilead's once-daily Quad for HIV

14-05-2012

There was more good news for Gilead Sciences (Nasdaq: GILD), the world's largest maker of HIV drugs,…

Anti-viralsBiotechnologyGilead SciencesNorth AmericaPharmaceuticalQuadRegulation

Cell Therapeutics' Pixuvri cleared in EU for NHL

14-05-2012

US biotech firm Cell Therapeutics (Nasdaq and MTA: CTIC) last week received conditional marketing authorization…

BiotechnologyCell TherapeuticsEuropeOncologyPharmaceuticalPixuvriRegulation

UK's Proximagen boosted by US lorcaserin news with respect to its own obesity drug candidate

14-05-2012

UK-based biotechnology firm Proximagen (AIM: PRX) saw its shares leap 20.1% to 257.5 pence, on the back…

BiotechnologyMetabolicsProximagenRegulationResearch

UK's NICE negative on Sanofi's Jevtana, but backs Botox for migraine

11-05-2012

Confirming previous negative guidance (The Pharma Letter January 12), UK drugs watchdog the National…

AllerganBotoxEuropeJevtanaNeurologicalOncologyPharmaceuticalPricingRegulationSanofi

US FDA warns on safety of Celgene's Revlimid; new Ph III trial results

11-05-2012

The US Food and Drug Administration this week issued a notification of an increased risk of second primary…

BiotechnologyCelgeneOncologyRegulationResearchRevlimid

High expectations for new US biosimilars following FDA guidance documents

10-05-2012

In light of the upcoming FDA guidance for biosimilar approval, Novation, health care supply chain expertise…

BiotechnologyGenericsNorth AmericaPricingRegulation

US drug sponsors' regulatory experience was mixed during PDUFA IV, says Tufts CSDD

10-05-2012

Drug sponsors experienced a mixed regulatory burden under the Food and Drug Administration Amendments…

BiotechnologyNorth AmericaPharmaceuticalRegulation

Impact of Japanese drug price reductions, by P Reed Maurer

10-05-2012

Outside observers have long predicted the mandated price reductions of drugs will kill the Japanese pharmaceutical…

Asia-PacificPharmaceuticalPricingRegulation

FDA advisory backs Pfizer's tofacitinib for RA

10-05-2012

The US Food and Drug Administration's Arthritis Advisory Committee yesterday voted eight to two to recommend…

Anti-Arthritics/RheumaticsNorth AmericaPfizerPharmaceuticalRegulationtofacitinib

Move towards better detection and EU-wide withdrawal of dangerous medicines

10-05-2012

The adverse effects of medicinal products will be better monitored in future, to prevent the recurrence…

EuropePharmaceuticalPoliticsRegulationServier

NICE recommends Roche's Tarceva for NSCLC

10-05-2012

Having received further previously requested data from Swiss drug major Roche (ROG: SIX), the UK drugs…

EuropePharmaceuticalPricingRegulationRocheTarceva

Sandoz to emphasize need for consistent regulatory standards across all biologics at FDA hearings

10-05-2012

Germany-based Sandoz, the generics unit of Swiss drug major Novartis (NOVN: VX) announced that Mark McCamish,…

BiotechnologyGeneralNorth AmericaNovartisRegulationResearchSandoz

Spanish reforms and generics hit Almirall's 1st-qtr; Sativex progress

09-05-2012

Spain's leading drugmaker Almirall (ALM: MC) has reported a 5.9% decrease in sales for the first quarter…

AlmirallEuropeFinancialGW PharmaceuticalsNeurologicalPharmaceuticalRegulationSativex

Sunshine Act data collection delayed to January 2013, says USA's CMS

08-05-2012

In a web site posting last week, The US Center for Medicare and Medicaid Services (CSM) announced that…

BiotechnologyNorth AmericaPharmaceuticalPoliticsRegulation

FDA again rejects Alexza's Adasuve, citing manufacturing deficiencies

07-05-2012

California, USA-based Alexza Pharmaceuticals (Nasdaq: ALXA) revealed last week that it has received another…

AdasuveAlexza PharmaceuticalNeurologicalNorth AmericaPharmaceuticalRegulation

2310 to 2334 of 2674 results

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