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Novartis gets win with Afinitor in Europe

Efforts by Novartis to defend its blockbuster cancer drug Afinitor against competitors got a boost from European regulators, who approved it for use on certain types of advanced gastrointestinal and lung neuroendocrine tumors.

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EU approves first gene therapy for children

The world’s first life-saving gene therapy for children, developed by GlaxoSmithKline and Italian scientists, was approved for sale in Europe.

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Europe gives green light to first gene therapy for children

The world’s first life-saving gene therapy for children, developed by Italian scientists and GlaxoSmithKline, has been recommended for approval in Europe, boosting the pioneering technology to fix faulty genes.   The European Medicines Agency (EMA) said on Friday it had endorsed the therapy, called Strimvelis, for a tiny number of children with ADA Severe Combined […]

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Europe launches new fast approval scheme for promising drugs

European regulators launched a new scheme on Monday to speed the approval of promising new drugs that address unmet medical needs by offering enhanced support to medicine developers as they work on clinical trials.   The European Medicines Agency’s (EMA) initiative called PRIME, which stands for PRIority MEdicines, is the latest example of regulators on […]

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Swedish industry wants European medicines agency if UK quits EU

Sweden should become the new home of the European Medicines Agency (EMA) if Britons vote to leave the European Union in a June referendum, according to the head of the Swedish pharmaceutical association. The agency, which approves medicines for all EU countries, has been based in London since it started in 1995. However, a so-called […]

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Gilead’s HIV drug gets closer to getting Europe approval

Gilead Sciences Inc’s experimental cocktail to treat HIV received a green light from European regulators on Friday, boosting the chances of the drug being formally approved by the European Commission. The European Medicines Agency issued a positive opinion on the treatment, Descovy, a combination of emtricitabine and tenofovir alafenamide. Both drugs stop HIV from multiplying. […]

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EU agency accepts Sandoz application for pegfilgrastim biosimilar

The European Medicines Agency (EMA) has accepted an application to review Sandoz’s biosimilar to Amgen’s EU-licensed Neulasta (pegfilgrastim), a recombinant human granulocyte colony-stimulating factor, Sandoz parent Novartis said on Thursday. Sandoz is seeking approval for the same indication as the reference product, it added in a statement. The U.S. Food and Drug Administration in November […]

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Xarelto trial results reaffirmed despite faulty device

Europe’s drug regulator said on Friday the defective blood clotting test device used in a key trial for the approval of Bayer’s top-selling anti-clotting drug Xarelto did not distort the study’s main findings.   “Xarelto can continue to be used as before, in line with the current prescribing information,” the European Medicines Agency (EMA) said […]

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Samsung Bioepis’ Enbrel drug copy gets EU approval

Samsung Bioepis Co Ltd said on Sunday it had received European Commission approval for its copy of the blockbuster biotech arthritis drug Enbrel. The drug, known scientifically as etanercept, will be sold in Europe by U.S. biotechnology group Biogen and rolled out gradually across all 28 European Union member states as well as Norway, Iceland […]

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pSivida Files Early with European Regulator for Eye Care Device, Possibly to FDA As Well

December 29, 2015By Mark Terry, BioSpace.com Breaking News Staff   Watertown, Mass.-based pSivida Corp. (PSDV) announced yesterday that it plans to file with the European Union (EU) for marketing approval for its Medidur sustained release drug delivery product to treat chronic non-infectious uveitis of the posterior segment of the eye. Only last week, on Dec. […]

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