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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

UK’s Summit sets up operations in the USA

UK’s Summit sets up operations in the USA

17-06-2014

UK drug discovery firm Summit, which is focused on therapies for Duchenne muscular dystrophy and Clostridium…

Antibiotics and Infectious diseasesBoardroomManagementPharmaceuticalRare diseasesResearchSummit PharmaceuticalsUSA

Drug pricing power led by hepatitis C, diabetes and cancer

Drug pricing power led by hepatitis C, diabetes and cancer

13-06-2014

Hepatitis C, diabetes and cancer are sustaining high pricing power through innovation according to Morningstar's…

AbbVieAntibiotics and Infectious diseasesBiogen IdecCopaxoneDiabetesGenericsGilead SciencesMerck & CoOncologyPharmaceuticalPricingTecfideraTeva Pharmaceutical IndustriesUSA

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

Astellas settles with US DoJ over Mycamine marketing

Astellas settles with US DoJ over Mycamine marketing

17-04-2014

The US subsidiary of Japanese drug major Astellas Pharma will pay $7.3 million to resolve allegations…

Antibiotics and Infectious diseasesAstellas PharmaLegalMarkets & MarketingMycamineNorth AmericaPharmaceuticalUSA

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

Medimetriks licenses ozenoxacin, a novel antibacterial, from Ferrer

24-03-2014

US specialty drug firm Medimetriks Pharmaceuticals has entered into a licensing agreement with Ferrer,…

Antibiotics and Infectious diseasesFerrer InternacionalLicensingMedimetriks PharmaceuticalsNorth AmericaOzenoxacinPharmaceuticalUSA

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

AbbVie presents positive Phase III results in patients with chronic hepatitis C

AbbVie presents positive Phase III results in patients with chronic hepatitis C

04-03-2014

The first detailed results from US drugmaker AbbVie’s pivotal Phase III study, PEARL-III, have been…

AbbVieAntibiotics and Infectious diseasesPharmaceuticalResearchUSA

Astellas amends license deal for isavuconazole with Basilea

01-03-2014

Japanese drug major Astellas Pharma has amended the license, co-development and co-promotion agreement…

Antibiotics and Infectious diseasesAstellas PharmaBasilea PharmaceuticaCanadaisavuconazoleLicensingNorth AmericaPharmaceuticalUSA

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

MedImmune joins research collaboration with the University of California

MedImmune joins research collaboration with the University of California

17-02-2014

MedImmune, the global biologics research and development arm of Anglo-Swedish drug major AstraZeneca,…

Antibiotics and Infectious diseasesCardio-vascularInflammatory diseasesMedImmuneMetabolicsNeurologicalOncologyPharmaceuticalResearchRespiratory and PulmonaryUSA

AbbVie’s hepatitis C Phase III trials all record top results

AbbVie’s hepatitis C Phase III trials all record top results

04-02-2014

US drugmaker AbbVie has announced the completion of its Phase III clinical program and released results…

AbbVieAntibiotics and Infectious diseasesPharmaceuticalResearchUSA

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

AbbVie reports 96% response in Phase III hepatitis C study

AbbVie reports 96% response in Phase III hepatitis C study

10-12-2013

US drugmaker AbbVie (NYSE: ABBV)has released Phase III results for the investigational three direct-acting-antiviral…

AbbVieAnti-viralsAntibiotics and Infectious diseasesPharmaceuticalResearchUSA

AbbVie releases positive Phase III results for oral hepatitis C program

AbbVie releases positive Phase III results for oral hepatitis C program

18-11-2013

US drugmaker AbbVie has released the first Phase III results for the investigational three direct-acting-antiviral…

AbbVieAntibiotics and Infectious diseasesNorth AmericaPharmaceuticalResearchUSA

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