Regulation

Filter

Current filters:

None

Popular Filters

2176 to 2200 of 2582 results

Shire to acquire FerroKin BioSciences; drops Replagal BLA

16-03-2012

Ireland-headquartered Shire (LSE: SHP) said yesterday that it has signed an agreement to acquire privately-held…

FerroKin BioSciencesMergers & AcquisitionsNorth AmericaOncologyPharmaceuticalRare diseasesRegulationReplagalShire

Esbriet offers additional benefit, says German G-BA

16-03-2012

USA-based InterMune (Nasdaq: ITMN) says that the German Federal Joint Committee (G-BA) has announced…

EsbrietEuropeInterMunePharmaceuticalPricingRegulationRespiratory and Pulmonary

Positive NICE news for Gilenya for MS and Incivo for hep C

16-03-2012

There was good news from the UK drugs watchdog the Institute for Health and Clinical Excellence (NICE)…

Anti-viralsEuropeGilenyaIncivoJanssen-CilagJohnson & JohnsonNeurologicalNovartisPharmaceuticalPricingRegulation

Likelihood of big uptake of biosimilars by 2020 questioned

15-03-2012

The engine of the biosimilar sector is the same as with small molecule drugs, patent expiry. On this…

BiotechnologyGenericsGlobalMarkets & MarketingPatentsRegulation

NICE recommends NHS use of Pradaxa

15-03-2012

In final guidance published today (March 15), the UK drug watchdog the National Institute of Health and…

Boehringer IngelheimCardio-vascularEuropePharmaceuticalPradaxaPricingRegulation

Mexico defines orphan drugs, but questions remain; US patent deal

14-03-2012

Earlier this year, on January 31, new provisions of the Mexican General Health Law (GHL) came into force,…

PatentsPharmaceuticalRegulationSouth America

Alkermes pulls MAA for Megestrol product

13-03-2012

The European Medicines Agency says it has been formally notified by the Irish subsidiary of US drugmaker…

AlkermesAnti-viralsEuropeMegestrolOncologyPharmaceuticalRegulation

EU Commission medicines availability proposals viewed by Finnish pharma

13-03-2012

The amendments envisaged in the European Union legislation could accelerate the price and reimbursability…

EuropePharmaceuticalPricingRegulation

AstraZeneca sues US FDA over Seroquel decision

13-03-2012

Anglo-Swedish drug major AstraZeneca (LSE: AZN) announced this morning that it has filed a law suit against…

AstraZenecaLegalNeurologicalNorth AmericaPharmaceuticalRegulationSeroquelSeroquel XR

German pharma criticizes new AMNOG vetting procedure

13-03-2012

Until recently, pharmaceutical companies could set prices for new drugs in Germany. But now their "monopoly…

EuropePharmaceuticalPricingRegulation

UK NICE asks Bayer for Xarelto cost-effectiveness data

13-03-2012

UK health care price watchdog the National Institute for Health and Clinical Excellence (NICE), which…

BayerCardio-vascularEuropePharmaceuticalPricingRegulationXarelto

ThromboGenics confident as it plans for ocriplasmin launch

12-03-2012

Belgian biopharma firm ThromboGenics (Euronext Brussels: THR) says that, over the past 12 months, it…

BiotechnologyFinancialocriplasminOphthalmicsRegulationResearchThromboGenics

Sihuan Pharma heart drug IND accepted in China

12-03-2012

Leading China-based cardio-cerebral vascular drug firm Sihuan Pharmaceutical Holdings (HKEx: 0460) says…

Asia-PacificCardio-vascularMarkets & MarketingPharmaceuticalRegulationSihuan Pharmaceuticaltylerdipine

Boca generic version of Tapazole cleared by FDA

12-03-2012

Florida, USA-based privately-held Boca Pharmacal said on Friday that it has received approval from the…

Boca PharmacalGenericsKing PharmaceuticalsMetabolicsNorth AmericaRegulationTapazole

New pathway proposed for antibiotic approval in USA

09-03-2012

The US Congress will consider a new drug approval pathway to encourage development of critically needed,…

Antibiotics and Infectious diseasesNorth AmericaPharmaceuticalRegulationResearch

NICE backs Merck & Co hep C drug Victrelis

09-03-2012

UK drug watchdog the National Institute for Health and Clinical Excellence (NICE) has today (March 9)…

Anti-viralsEuropeMerck & CoPharmaceuticalPricingRegulationVictrelis

Australia latest to approve Bayer's Eylea

08-03-2012

The Australian Therapeutic Goods Administration (TGA) has approved Eylea (aflibercept) Injection for…

Asia-PacificBayerEyleaOphthalmicsPharmaceuticalRegeneronRegulation

US FDA delays Eisai's Dacogen for AML; accepts perampanel NDA

08-03-2012

The US Food and Drug Administration has issued a Complete Response Letter to Japanese drug major Eisai…

Astex PharmaceuticalsDacogenEisaiNeurologicalNorth AmericaOncologyperampanelPharmaceuticalRegulation

Gilead's Quad non-inferior to Atripla for HIV; Truvada objections

08-03-2012

US biotech firm Gilead Sciences (Nasdaq: GILD) yesterday announced full Phase III clinical trial results…

Anti-viralsAtriplaBiotechnologyGilead SciencesNorth AmericaQuadRegulationResearchTruvada

FDA nod for Discovery Labs Surfaxin for RDS

07-03-2012

US specialty drugmaker Discovery Laboratories (Nasdaq: DSCO) saw its shares rocker 30% to $4.88 in after-hours…

Discovery LaboratoriesNorth AmericaPharmaceuticalRegulationRespiratory and PulmonarySurfaxin

2176 to 2200 of 2582 results

Back to top