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New Ph III data support early 2014 filing for Cubist’s ceftolozane/tazobactam

New Ph III data support early 2014 filing for Cubist’s ceftolozane/tazobactam

17-12-2013

US drugmaker Cubist Pharmaceuticals saw its shares jump 8.3% to $68 in premarket trading yesterday, when…

Antibiotics and Infectious diseasesceftolozoneCubist PharmaceuticalsEuropeNorth AmericaPharmaceuticalRegulationResearchtazobactam

BioAlliance Pharma pursues development plan for Loramyc in Japan through partner Sosei

13-03-2013

French orphan oncology and supportive care specialist BioAlliance Pharma (Euronext Paris: BIO) says its…

Antibiotics and Infectious diseasesAsia-PacificBioAlliance PharmaLoramycOravigPharmaceuticalRegulationResearchSosei

Merck & Co gets all clear to continue Vytorin study; FDA warns on Pfizer's Zithromax

13-03-2013

US pharma giant Merck & Co said yesterday that the Data Safety Monitoring Board (DSMB) of the IMPROVE-IT…

Antibiotics and Infectious diseasesCardio-vascularMerck & CoNorth AmericaPfizerPharmaceuticalRegulationResearchVytorinZithromax

GlaxoSmithKline amends accord with Isis Pharma; gets FDA panel backing for raxibacumab

06-11-2012

USA-based Isis Pharmaceuticals (Nasdaq: ISIS) says it has agreed to amend the clinical development plan…

Antibiotics and Infectious diseasesBiotechnologyFinancialGlaxoSmithKlineIsis PharmaceuticalsISIS-TTR.RXLicensingNorth AmericaPharmaceuticalRare diseasesraxibacumabRegulationResearch

News briefs: TB drug developments at Jansen and AstraZeneca; NPS/Amgen deal amended

03-07-2012

US health care giant Johnson & Johnson's (NYSE: JNJ) Janssen Research & Development unit has submitted…

AmgenAntibiotics and Infectious diseasesAstraZenecabedaquilineBiotechnologyCellworkscinacalcetJanssenJohnson & JohnsonLicensingMetabolicsNPS PharmaceuticalsPharmaceuticalRegulationResearch

News briefs: GlaxoSmithKline and Bayer

24-05-2012

UK pharma giant GlaxoSmithKline (LSE: GSK) has said it would not proceed with its $2.59 billion hostile…

Antibiotics and Infectious diseasesBayerGlaxoSmithKlineMergers & AcquisitionsOncologyPharmaceuticalregorafenibRegulationResearch

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

EU Commission unveils 12 concrete actions against antimicrobial resistance for the next five years

17-11-2011

With about 25,000 patients dying per year in the European Union from infections caused by drug resistant…

Antibiotics and Infectious diseasesEuropePharmaceuticalRegulationResearch

GlaxoSmithKline warned by US FDA over cGMP violations at UK plant; positive malaria vaccine news

20-10-2011

UK pharma giant GlaxoSmithKline ILSE: GSK) has received a warning letter from the US Food and Drug Administration…

Antibiotics and Infectious diseasesGlaxoSmithKlinePharmaceuticalRegulationResearchVaccines

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