Regulation - Pharmaceutical, Antibiotics and Infectious diseases

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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

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

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

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

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

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

FDA approves Durata’s Dalvance to treat skin infections

26-05-2014

The US Food and Drug Administration last Friday approved Durata Therapeutics’ Dalvance (dalbavancin),…

Antibiotics and Infectious diseasesDalvanceDurata TherapeuticsPharmaceuticalRegulationUSA

Otsuka wins EU approval for Deltyba in MDR-TB

30-04-2014

Japanese drugmaker Otsuka Pharmaceutical says that the European Commission has granted a marketing authorization…

Antibiotics and Infectious diseasesDeltybaEuropeOtsukaPharmaceuticalRegulation

Global Fund taps pharmaceutical expertise in China

02-04-2014

The Global Fund is deepening its partnership with China by tapping the expertise of Chinese pharmaceutical…

Anti-viralsAntibiotics and Infectious diseasesChinaGlobalMarkets & MarketingPharmaceuticalProductionRegulation

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