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FDA calls on Genzyme to re-file Lemtrada sBLA


French drug major Sanofi (Euronext: SAN) revealed yesterday that its US biotech subsidiary has received…

BayerBiotechnologyGenzymeLemtradaNeurologicalNorth AmericaPharmaceuticalRegulationSanofi

Synergy Pharma gains rights to shingles drug from Bristol-Myers


US biopharma firm Synergy Pharmaceuticals (Nasdaq: SGYP) has signed an asset purchase agreement with…

Anti-viralsBiotechnologyBristol-Myers SquibbFV-100Mergers & AcquisitionsSynergy Pharmaceuticals

EMA recommendations to deal with sterility concerns for DepoCyte


The European Medicines Agency last Friday agreed a number of precautionary measures to deal with manufacturing…

DepoCyteEuropeMundipharmaOncologyPacira PharmaceuticalsPharmaceuticalRegulationSigma Tau

Claris to go it alone in USA


Claris Lifesciences, a leading Indian injectable generic pharmaceuticals maker, has said that, following…

Claris LifesciencesGenericsLicensingMarkets & MarketingNorth AmericaPfizerRegulation

PhRMA disputes Indian claims relating to cancer drug shortages


In a recent interview with Times of India, a trade association that represents several major generic…

Asia-PacificGenericsNorth AmericaPatentsPharmaceuticalPolitics

Bayer and J&J's Xarelto aids survival after heart attack


A major subgroup analysis from the ATLAS ACS 2-TIMI 51 study of 7,817 patients with acute coronary syndrome…

BayerCardio-vascularJohnson & JohnsonPharmaceuticalResearchXarelto

NICE issues draft guidance on Boehringer's Actilyse


UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) issued draft guidance…

ActilyseBoehringer IngelheimCardio-vascularEuropePharmaceuticalRegulation

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