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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

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

EMA completes review of polymyxins and issues updated guidance

EMA completes review of polymyxins and issues updated guidance

24-10-2014

The European Medicines Agency has completed its review of polymyxin-based medicines and issued its recommendations…

Antibiotics and Infectious diseasesColistimethateEuropePharmaceuticalRegulation

Amgen working on alternative methods for Mapp's Ebola vaccine; Canada sends vaccine vials to WHO

Amgen working on alternative methods for Mapp's Ebola vaccine; Canada sends vaccine vials to WHO

20-10-2014

USA-based Amgen, the world’s leading independent biotech firm, has indicated that it plans to work…

AmgenAntibiotics and Infectious diseasesBiotechnologyCanadaHuman InterestProductionRegulationResearchUSAZMapp

New Zealand's PHARMAC funds four new medicines as part of major agreement with Novartis

New Zealand's PHARMAC funds four new medicines as part of major agreement with Novartis

20-10-2014

New Zealand's Pharmaceutical Managment Agency PHARMAC has agreed to fund four new medicines for which…

Antibiotics and Infectious diseasesCardio-vascularglycopyrroniumindacaterolNew ZealandNovartisOmalizumabPharmaceuticalRegulationRespiratory and PulmonaryTobramycin

Daiichi Sankyo seeks wider indication for Cravit in Japan

Daiichi Sankyo seeks wider indication for Cravit in Japan

03-10-2014

Japanese drug major Daiichi Sankyo has submitted a supplemental New Drug Application (sNDA) in Japan…

Antibiotics and Infectious diseasesCravitDaiichi SankyoJapanPharmaceuticalRegulation

FDA fast track designation for AstraZeneca’s MEDI3902

FDA fast track designation for AstraZeneca’s MEDI3902

24-09-2014

Anglo-Swedish pharma major AstraZeneca’s global biologics R&D arm, MedImmune has received fast track…

Antibiotics and Infectious diseasesAstraZenecaBiotechnologyMEDI3902MedImmuneRegulationUSA

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

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

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

Cubist Pharmaceuticals voluntarily recalls Cubicin lots in the USA

Cubist Pharmaceuticals voluntarily recalls Cubicin lots in the USA

06-08-2014

American biopharmaceutical company Cubist has issued a voluntary recall of certain lots of Cubicin (daptomycin…

Antibiotics and Infectious diseasesBiotechnologyCubicinCubist PharmaceuticalsPhlebitisRegulationThromboembolismUSA

FTC puts conditions on Akorn’s proposed acquisition of VersaPharm

FTC puts conditions on Akorn’s proposed acquisition of VersaPharm

05-08-2014

The US Federal Trade Commission revealed yesterday that US generics drugmaker Akorn has agreed to sell…

AkornAntibiotics and Infectious diseasesClinical researchGeneric injectable tuberculosisGenericsMergers & AcquisitionsRegulationRifampinUSAVersaPharm

Antiviral gel in condoms to kill HIV approved in Australia

Antiviral gel in condoms to kill HIV approved in Australia

28-07-2014

Australian biotech firm Starpharma says it has achieved a major milestone with the receipt of Conformity…

AnsellAnti-viralsAntibiotics and Infectious diseasesAustraliaBiotechnologyRegulationStarpharmaVivaGel

Astellas submits NDA for isavuconazole to treat deadly fungal infections

Astellas submits NDA for isavuconazole to treat deadly fungal infections

10-07-2014

Japanese drug major Astellas Pharma has submitted a New Drug Application to the US Food and Drug Administration,…

Antibiotics and Infectious diseasesAntifungal therapiesAspergillosisAstellas PharmaBiologyFungal diseasesImmunologicalsInvasive aspergillosisisavuconazoleJapanMycologyPharmaceuticalRegulationZygomycosis

South Africa regulator gives MSF access to cheaper TB drug linezolid

South Africa regulator gives MSF access to cheaper TB drug linezolid

01-07-2014

After a three-year long struggle, humanitarian aid agency Medecins Sans Frontieres has received approval…

Antibiotics and Infectious diseasesGenericsHealthcareLinezolidPfizerRegulationSouth AfricaZyvox

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

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