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FDA lifts hold on Insmed Arikace trial

23-01-2012

USA-based biopharma company Insmed’s (Nasdaq CM: INSM) shares leapt 33.7% to $5.08 on Friday, after…

ArikaceBiotechnologyInsmedNorth AmericaPharmaceuticalRegulationRespiratory and Pulmonary

EMA starts review of Gilenya; guidance on biosimilar interferon beta

23-01-2012

The European Medicines Agency has begun a review of the benefits and risks of Swiss drug major Novartis’…

BiotechnologyEuropeGenericsGilenyainterferon betaNeurologicalNovartisPharmaceuticalRegulation

FDA updates Tysabri label relating to anti-JCV

23-01-2012

The US Food and Drug Administration on Friday approved a product label change for Tysabri (natalizumab),…

Biogen IdecBiotechnologyElanNeurologicalNorth AmericaPharmaceuticalRegulationTysabri

EMA panel backs Novartis Cushing’s disease drug; Glivec label change

23-01-2012

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended…

EuropeGlivecNovartisOncologypasireotidePharmaceuticalRare diseasesRegulationSignifor

FDA Advisory thumbs down for Columbia and Watson product

23-01-2012

US drugmakers Columbia Laboratories (Nasdaq: CBRX) and Watson Pharmaceuticals (NYSE: WPI) confirmed on…

Columbia LaboratoriesCrinoneNorth AmericaPharmaceuticalRegulationReproductiveWatson PharmaceuticalsWomen's Health

Merck & Co gets positive CHMP opinion for Remicade in new indication

22-01-2012

US drug giant Merck & Co (NYSE: MRK) says that announced that the European Medicines Agency’s Committee…

EuropeGastro-intestinalsMerck & CoPharmaceuticalRegulationRemicade

Additional indication for Otsuka’s Abilify in Japan

22-01-2012

Japanese drugmaker Otsuka Pharmaceutical (TYO: 4768) said last week that it has received new regulatory…

AbilifyAsia-PacificNeurologicalOtsukaPharmaceuticalRegulation

Eisai gets Lunesta approval in Japan, launches Fostoin

20-01-2012

Japanese drug major Eisai (TYO: 4523) this week received approval from Japan's Ministry of Health, Labor…

Asia-PacificEisaiFostoinLunestaMarkets & MarketingNeurologicalNobelpharmaPharmaceuticalRegulation

FDA backs Gilead’s Viread for children

20-01-2012

The US Food and Drug Administration has approved US biotech firm Gilead Sciences (Nasdaq: GILD) Viread…

Anti-viralsBiotechnologyGilead SciencesNorth AmericaPharmaceuticalRegulationViread

Which of 2012's launches will be future blockbusters?

20-01-2012

A review of the year's biggest product launches - based on analyst forecasts - reveals a bumper crop…

BiotechnologyFinancialPharmaceuticalRegulation

FDA’s CRL on dapagliflozin calls for more clinical data

19-01-2012

In what comes as no surprise given a negative vote by an Food and Drug Administration advisory panel…

AstraZenecaBristol-Myers SquibbdapagliflozinDiabetesNorth AmericaPharmaceuticalRegulation

Bayer’s Xarelto OKed in Japan; promising regorafenib data

19-01-2012

Bayer Healthcare, a unit of Germany’s Bayer AG (BAY: DE), had a couple of good news item to report…

BayerCardio-vascularOncologyOnyx PharmaceuticalsPharmaceuticalregorafenibRegulationResearchXarelto

BTG’s Voraxaze gains first approval, in USA

19-01-2012

The US Food and Drug Administration has approved UK headquartered BTG International’s (LSE: BGC)…

BiotechnologyBTGNephrology and HepatologyNorth AmericaOncologyRegulationVoraxaze

Adequate global standards for registry reports required, say IQWiG staffers

17-01-2012

Different formats are available for reporting the results of clinical trials. In an article just published…

BiotechnologyEuropePharmaceuticalRegulationResearch

German pharma hails successful 2011; views AMNOG

16-01-2012

The German pharmaceutical industry can be proud of its progress last year, said Birgit Fischer, director…

EuropeMarkets & MarketingPharmaceuticalPricingRegulation

FDA completes work on three drug user fee programs

16-01-2012

The US Food and Drug Administration has completed its recommendations for three user fee programs that…

BiotechnologyFinancialGenericsNorth AmericaPharmaceuticalRegulation

“Black box” warning for Seattle Genetics’ Adcetris

16-01-2012

US biotech Seattle Genetics (Nasdaq: SGEN) saw its shares fall 5.2% to $17.49 on Friday, after the company…

AdcetrisBiotechnologyNorth AmericaOncologyRegulationSeattle Genetics

A lot of user fee issues in USA

15-01-2012

2012 has only just begun, but the US Congress, the Food and Drug Administration and several health care…

BiotechnologyGenericsNorth AmericaPharmaceuticalPoliticsRegulation

FDA gives Hemispherx time to respond to CRL

12-01-2012

Shares of USA-based Hemispherx Biopharma (NYSE Amex: HEB) rose 14% to $0.24 on Wednesday, after the company…

AmpligenHemispherx BioPharmaImmunologicalsNorth AmericaPharmaceuticalRegulation

2376 to 2400 of 2606 results

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