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Pfizer reports positive top-line data for Trumenba Phase II study in adolescents

Pfizer reports positive top-line data for Trumenba Phase II study in adolescents

24-02-2015

US pharma giant Pfizer has announced positive top-line results of a Phase II study of Trumenba (meningococcal…

Antibiotics and Infectious diseasesPfizerPharmaceuticalResearchTrumenbaUSA

FDA's anti-infective committee recommends Astellas' Cresemba

FDA's anti-infective committee recommends Astellas' Cresemba

23-01-2015

The US Food and Drug Administration’s Anti-Infective Drugs Advisory Committee has voted unanimously…

Antibiotics and Infectious diseasesAstellasCresembaPharmaceuticalRegulationUSA

BioCryst's Rapivab approved by FDA to treat influenza

BioCryst's Rapivab approved by FDA to treat influenza

23-12-2014

USA-based BioCryst Pharmaceuticals has received approval from the US Food and Drug Administration for…

Antibiotics and Infectious diseasesBioCryst PharmaceuticalsperamivirPharmaceuticalRegulationUSA

FDA approves new antibacterial drug Zerbaxa

20-12-2014

The US Food and Drug Administration has approved Cubist Pharmaceuticals’Zerbaxa (ceftolozane/tazobactam)…

Antibiotics and Infectious diseasesCubist PharmaceuticalsMerck & CoPharmaceuticalRegulationUSAZerbaxa

FDA approves Alcon’s Xtoro to treat swimmer’s ear

FDA approves Alcon’s Xtoro to treat swimmer’s ear

18-12-2014

The US Food and Drug Administration today approved Xtoro (finafloxacin otic suspension), a new drug used…

Acute otitis externaAlcon LaboratoriesAntibiotics and Infectious diseasesHealthNovartisPharmaceuticalRegulationUSAXtoro

Janssen commits $30 million to USAID agreement to fight antibiotic-resistant bacteria

Janssen commits $30 million to USAID agreement to fight antibiotic-resistant bacteria

12-12-2014

US health care giant Johnson & Johnson’s subsidiary Janssen has made an agreement with the United States…

Antibiotics and Infectious diseasesJanssenPharmaceuticalResearchUSA

FDA advisory panel backs Actavis’ ceftazidime-avibactam

06-12-2014

Ireland-headquartered generic drugs major Actavis says that the Anti-Infective Drugs Advisory Committee…

ActavisAntibiotics and Infectious diseasesAstraZenecaceftazidime-avibactamPharmaceuticalRegulationUSA

FDA approves Sanofi’s Priftin for latent TB

FDA approves Sanofi’s Priftin for latent TB

03-12-2014

French pharma major Sanofi says that the US Food and Drug Administration has approved Priftin (rifapentine),…

Antibiotics and Infectious diseasesPharmaceuticalPriftinRegulationSanofiUSA

Polyphor’s POL7080 receives QIDP designation from the FDA

12-11-2014

Privately-held Swiss pharma firm Polyphor says that the US Food and Drug Administration has designated…

Antibiotics and Infectious diseasesPharmaceuticalPOL7080PolyphorRegulationRocheUSA

Safety trials under way for GSK and Canadian Public Health Agency's Ebola vaccines

Safety trials under way for GSK and Canadian Public Health Agency's Ebola vaccines

27-10-2014

Safety trials are currently under way in two of the most advanced Ebola candidates, and the World Health…

Antibiotics and Infectious diseasesGSKPharmaceuticalResearchUKUSA

Tekmira shares jump as US FDA and Health Canada expand access to Ebola drug

Tekmira shares jump as US FDA and Health Canada expand access to Ebola drug

23-09-2014

Shares of Tekmira Pharmaceuticals have rocketed after the US Food and Drug Administration authorized…

Antibiotics and Infectious diseasesCanadaEbolaFDAHealthPharmaceuticalRegulationTekmira PharmaceuticalsTKM-EbolaUSA

Six hospital-acquired pneumonia drugs in late-stage development could generate $3.8bn by 2020

Six hospital-acquired pneumonia drugs in late-stage development could generate $3.8bn by 2020

09-09-2014

Six drugs currently in Phase III studies to treat hospital-acquired pneumonia would generate a total…

AmikacinAntibiotics and Infectious diseasesAstraZenecaBayerceftazidime-avibactamceftolozaneCubist PharmaceuticalsGSKHospital-acquired pneumoniaPharmaceuticalResearchUSA

FDA accepts Actavis’ NDA for ceftazidime-avibactam

FDA accepts Actavis’ NDA for ceftazidime-avibactam

05-09-2014

Ireland-headquartered generic drugs major Actavis today confirmed that the US Food and Drug Administration…

ActavisAntibiotics and Infectious diseasesceftazidime-avibactamPharmaceuticalRegulationResearchUSA

Debiopharm receives Qualified Infectious Disease designation for Debio 1450 from FDA

Debiopharm receives Qualified Infectious Disease designation for Debio 1450 from FDA

04-09-2014

Swiss independent pharma company Debiopharm has received Qualified Infectious Disease Product designation…

AntibioticsAntibiotics and Infectious diseasesBacterial diseasesDebio 1450DebiopharmMethicillin-resistant Staphylococcus aureusPharmaceuticalRegulationStaphylococcaceaeUSA

Tetraphase reports positive oral dosing data in Phase III of eravacycline

Tetraphase reports positive oral dosing data in Phase III of eravacycline

03-09-2014

US pharma company Tetraphase Pharmaceutical has announced positive top-line data from the lead-in portion…

Antibiotics and Infectious diseasesComplicated urinary tract infectionseravacyclineLevofloxacinPharmaceuticalResearchTetraphase PharmaceuticalsUS Food and Drug AdministrationUSA

Globavir to seek approval and launch of novel Ebola treatment by year-end

Globavir to seek approval and launch of novel Ebola treatment by year-end

19-08-2014

Privately-held US biotech firm Globavir Biosciences said yesterday that it intends to develop its lead…

Antibiotics and Infectious diseasesGBV006Globavir BiosciencesMarkets & MarketingPharmaceuticalRegulationRest of the WorldTropical diseasesUSA

FDA approves The Medicines Company's Orbactiv for use in ABSSSIs

FDA approves The Medicines Company's Orbactiv for use in ABSSSIs

07-08-2014

The Food and Drug Administration has approved The Medicines Company’s Orbactiv (oritavancin) for injection…

Antibiotics and Infectious diseasesOrbactivoritavancinPharmaceuticalRegulationThe Medicines CompanyUSA

Biota tanks as flu drug candidate disappoints

Biota tanks as flu drug candidate disappoints

04-08-2014

USA-based Biota Pharmaceuticals saw its shares slump 29% to a record low of $2.29 on Friday, after the…

Anti-viralsAntibiotics and Infectious diseasesBiota PharmaceuticalsFinancialPharmaceuticalResearchUSA

GlobalData says UK fears over antibiotic resistance is

GlobalData says UK fears over antibiotic resistance is "valid conclusion"

04-07-2014

Earlier this week, UK Prime Minister David Cameron revealed the formation of an independent review panel…

Antibiotics and Infectious diseasesEuropePharmaceuticalResearchUSA

Transcept and Paratek join forces in reverse takeover

Transcept and Paratek join forces in reverse takeover

01-07-2014

US pharma company Transcept Pharmaceuticals and privately-held biopharmaceutical company Paratek Pharmaceuticals…

Antibiotics and Infectious diseasesMergers & AcquisitionsParatek PharmaceuticalsPharmaceuticalTranscept PharmaUSA

FDA calls for additional Ph III study for Basilea’s ceftobiprole

FDA calls for additional Ph III study for Basilea’s ceftobiprole

26-06-2014

Swiss drugmaker Basilea Pharmaceutica saw its shares drop as much as 12% yesterday, after it revealed…

Antibiotics and Infectious diseasesBacteriaBasilea PharmaceuticaceftobiproleHealth Medical PharmaHealth Medical PharmaisavuconazoleMedicinePharmaceuticalRegulationTreatment of pneumoniaUSA

Cubist’s Sivextro gets FDA approval for serious skin infections

Cubist’s Sivextro gets FDA approval for serious skin infections

22-06-2014

The US Food and Drug Administration has approved Cubist Pharmaceuticals’ Sivextro (tedizolid phosphate)…

Antibiotics and Infectious diseasesCubist PharmaceuticalsPharmaceuticalRegulationSivextroUSA

FDA accepts Cubist’s ceftolozane/tazobactam NDA with Priority Review

FDA accepts Cubist’s ceftolozane/tazobactam NDA with Priority Review

20-06-2014

The US Food and Drug Administration has accepted Cubist Pharmaceuticals’ New Drug Application for its…

Antibiotics and Infectious diseasesceftolozaneCubist PharmaceuticalsPharmaceuticalRegulationtazobactamUSA

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