Regulation - Pharmaceutical, Antibiotics and Infectious diseases

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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

Unanimous FDA advisory panel backing for Cubist’s Sivextro

Unanimous FDA advisory panel backing for Cubist’s Sivextro

02-04-2014

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

Antibiotics and Infectious diseasesCubist PharmaceuticalsNorth AmericaPharmaceuticalRegulationSivextrotedizolidUSA

FDA advisory unanimously recommends Durata’s Dalvance

FDA advisory unanimously recommends Durata’s Dalvance

01-04-2014

The US Food and Drug Anti-Infective Drugs Advisory Committee voted 12 to 0 that Durata Therapeutics’…

Antibiotics and Infectious diseasesDalvanceDermatologicalsDurata TherapeuticsNorth AmericaPharmaceuticalRegulationUSA

Clinigen plans to launch Vibativ after lifting of EU marketing authorization suspension

Clinigen plans to launch Vibativ after lifting of EU marketing authorization suspension

18-03-2014

UK specialty pharma company the Clinigen Group today announced that the European Commission has ratified…

Antibiotics and Infectious diseasesClinigen GroupEuropeMarkets & MarketingPharmaceuticalRegulationTelavancin for InjectionUKVibativ

Janssen’s Sirturo gets conditional EU approval for multi-resistant TB

Janssen’s Sirturo gets conditional EU approval for multi-resistant TB

10-03-2014

US health care giant Johnson & Johnson’s European subsidiary Janssen-Cilag has been granted conditional…

Antibiotics and Infectious diseasesEuropeJanssen-CilagJohnson & JohnsonPharmaceuticalRegulationSirturo

FDA approves label changes for Doribax to reflect risks

10-03-2014

The US Food and Drug Administration has approved label changes for the antibacterial Doribax (doripenem)…

Antibiotics and Infectious diseasesDoribaxNorth AmericaPharmaceuticalRegulationShionogiUSA

FDA accepts The Medicines Company's NDA for oritavancin with priority review

FDA accepts The Medicines Company's NDA for oritavancin with priority review

19-02-2014

The US Food and Drug Administration has accepted the filing of The Medicines Company’s New Drug Application…

Antibiotics and Infectious diseasesNorth AmericaoritavancinPharmaceuticalRegulationThe Medicines CompanyUSA

Leading Chinese hepatitis B vaccine makers stop production; Pfizer drug import halted

03-01-2014

China’s Food and Drug Administration announced on January 2 that the country’s three leading manufacturers…

Anti-viralsAntibiotics and Infectious diseasesAsia-PacificBioKangtaiChinaFluconazolePfizerPharmaceuticalRegulationVaccines

Cubist’s tedizolid NDA accepted for priority review in USA

Cubist’s tedizolid NDA accepted for priority review in USA

31-12-2013

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

Antibiotics and Infectious diseasesBayerCubist PharmaceuticalsNorth AmericaPharmaceuticalRegulationtedizolidTrius TherapeuticsUSA

Four medicines recommended for approval by EMA/CHMP

Four medicines recommended for approval by EMA/CHMP

22-12-2013

Following regular monthly meeting of the European Medicines Agency’s Committee for Medicinal Products…

AlconAntibiotics and Infectious diseasesComtriqDermatologicalsEuropeGaldermaJanssen-CilagJohnson & JohnsonMirvasoNovartisOncologyOphthalmicsPharmaceuticalRegulationSirturoTMC Pharma Services

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

GSK’s Synflorix gets additional indication in Europe

GSK’s Synflorix gets additional indication in Europe

05-12-2013

The European Commission has granted marketing authorization for an additional indication for UK pharma…

Antibiotics and Infectious diseasesEuropeGlaxoSmithKlinePharmaceuticalRegulationSynflorix

IFPMA and the Global Fund collaborate to help protect patients from fake medicines

05-12-2013

The International Federation of Pharmaceutical Manufacturers and Associations and the Global Fund to…

Anti-viralsAntibiotics and Infectious diseasesGlobalMarkets & MarketingPharmaceuticalRegulationTropical diseases

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