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


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


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


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


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


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


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


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


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


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


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


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


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


High expectations for new US biosimilars following FDA guidance documents


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


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


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


FDA advisory backs Pfizer's tofacitinib for RA


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


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


NICE recommends Roche's Tarceva for NSCLC


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


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


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


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


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


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

AdasuveAlexza PharmaceuticalNeurologicalNorth AmericaPharmaceuticalRegulation

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