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2307 to 2331 of 2588 results

French government delists certain Ipsen products

29-01-2012

French drugmaker Ipsen (Euronext: IPN) announced the French government’s decision to no longer reimburse…

EuropeGingko bilobaIpsenMarkets & MarketingNeurologicalPharmaceuticalRegulation

Department of Justice seeks permanent injunction against Ranbaxy

27-01-2012

The US Department of Justice, on behalf of the Food and Drug Administration, has filed a consent decree…

Asia-PacificGenericsLegalNorth AmericaRanbaxy LaboratoriesRegulation

Overview of biologic regulations in India

26-01-2012

Currently, all biologics in India, including innovative and copy biologics are approved as new drugs,…

Asia-PacificBiotechnologyGenericsRegulation

US FDA mixed views on Vytorin and Zetia

26-01-2012

US drug giant Merck & Co (NYSE: MRK) yesterday received Food and Drug Administration approval to update…

Cardio-vascularMerck & CoNephrology and HepatologyNorth AmericaPharmaceuticalRegulationVytorinZetia

Expanded use for Merck Serono’s Rebif in EU

25-01-2012

Merck Serono, the Switzerland-based division of Germany’s Merck KGaA (MRK: DE), says that that the…

EuropeMerck KGaAMerck SeronoNeurologicalPharmaceuticalRebifRegulation

Some advantages seen for Sanofi’s Jevtana by Germany’s IQWiG

25-01-2012

In an early benefit assessment, the German Institute for Quality and Efficiency in Health Care (IQWiG)…

EuropeJevtanaOncologyPharmaceuticalPricingRegulationSanofi

Genzyme Framingham plant now cleared by US and EU regulators

24-01-2012

French drug major Sanofi (Euronext: SAN) said yesterday that the US Food and Drug Administration has…

BiotechnologyFabrazymeGenzymePharmaceuticalRare diseasesRegulationSanofi

Germany’s IQWiG sees added benefits for Incivo

24-01-2012

In an early benefit assessment pursuant to Germany’s Act on the Reform of the Market for Medicinal…

Anti-viralsEuropeIncivekIncivoJanssenJohnson & JohnsonPharmaceuticalPricingRegulationVertex

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

2307 to 2331 of 2588 results

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