Pharmaceutical - Antibiotics and Infectious diseases, North America

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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

Severe diarrheal illness in children linked to antibiotics prescribed in US doctor’s offices; study

10-03-2014

The majority of pediatric Clostridium difficile infections, which are bacterial infections that cause…

Antibiotics and Infectious diseasesHealthcareNorth AmericaPharmaceutical

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

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

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

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

FDA accepts priority review of Durata NDA for Dalvance

FDA accepts priority review of Durata NDA for Dalvance

27-11-2013

Shares of Durata Therapeutics leapt 13.4%, following the news that the New Drug Application for its investigational…

Antibiotics and Infectious diseasesCubicinDalvanceDurata TherapeuticsNorth AmericaPharmaceuticalRegulation

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

US infectious disease specialists’ prescribing choices for GNIs

US infectious disease specialists’ prescribing choices for GNIs

09-10-2013

A majority of US surveyed infectious disease specialists are willing to prescribe novel antibiotics if…

Antibiotics and Infectious diseasesMarkets & MarketingNorth AmericaPharmaceuticalPricing

FDA issues new Boxed Warning on Pfizer antibacterial

FDA issues new Boxed Warning on Pfizer antibacterial

28-09-2013

The US Food and Drug Administration is warning that an additional analysis shows an increased risk of…

Antibiotics and Infectious diseasesNorth AmericaPfizerPharmaceuticalRegulationTygacil

ICAAC: Tetraphase's experimental synthetic tetracycline effective against gonorrhea, intra-abdominal infection and UTIs

16-09-2013

Eravacycline, an experimental agent synthesized from tetracycline, is undergoing Phase III efficacy…

Antibiotics and Infectious diseasesNorth AmericaPharmaceuticalResearchTetracyclineTetraphase Pharmaceuticals

ICAAC: Experimental derivative of spectinomycin could help fill gap for new TB treatment

16-09-2013

An agent referred to as spectinamide 1599, which is a genetically-altered form of a former gonorrhea…

Antibiotics and Infectious diseasesNorth AmericaPharmaceuticalResearch

Bayer in settlement over Cipro pricing

04-09-2013

A partial settlement has been reached in a US class action law suit involving the prescription antibiotic…

Antibiotics and Infectious diseasesBayerCiproGenericsLegalNorth AmericaPharmaceuticalPricing

Theravance reintroduces Vibativ in USA

14-08-2013

US drug developer Theravance (Nasdaq: THRX) says it has commenced shipments of Vibativ (telavancin) into…

Antibiotics and Infectious diseasesAstellas PharmaMarkets & MarketingNorth AmericaPharmaceuticalProductionTheravanceVibativ

Warning over Janssen's Nizoral tablets

30-07-2013

The US Food and Drug Administration is taking action over anti-fungal Nizoral (ketoconazole) oral tablets…

Antibiotics and Infectious diseasesJanssen PharmaceuticaNizoralNorth AmericaPharmaceuticalRegulation

Briefs: Boehringer files Pradaxa for DVT and PE; Astellas' Mycamine pediatric approval; Simcere divests Boda

25-06-2013

Family-owned German drug major Boehringer Ingelheim has submitted an application to the European Medicines…

Antibiotics and Infectious diseasesAstellas PharmaBoehringer IngelheimCardio-vascularEuropeJilin BodaMergers & AcquisitionsNorth AmericaPharmaceuticalRegulationSimcere PharmaceuticalYidashen

Briefs: Added use for Theravance's Vibativ; approval sought for ViiV dolutegravir; FDA accepts Pfizer sNDA for Xeljanz

23-06-2013

USA-based Theravance (Nasdaq: THRX) says that the US Food and Drug Administration has approved the firm's…

Anti-Arthritics/RheumaticsAnti-viralsAntibiotics and Infectious diseasesBiotechnologydolutegravirNorth AmericaPfizerPharmaceuticalRegulationTheravanceVibativViiV HealthcareXeljanz

$200+ billion annual opportunity in USA from using medicines more responsibly, IMS finds

20-06-2013

Avoidable costs of more than $200 billion are incurred each year in the US health care system as a result…

Antibiotics and Infectious diseasesDiabetesFinancialGenericsHealthcareNorth AmericaPharmaceutical

FDA grants "Breakthrough Therapy" status for Alexion's asfotase in HPP; issues CRL for Valeant's efinaconazole

28-05-2013

US drugmaker Alexion Pharmaceuticals (Nasdaq: ALXN) says that the Food and Drug Administration has granted…

Alexion PharmaceuticalsAntibiotics and Infectious diseasesasfotase alfaefinaconazoleNorth AmericaPharmaceuticalRare diseasesRegulationValeant Pharmaceuticals

Breakthrough status for Pfizer's palbociclib; Merck & Co Noxafil NDA accepted

11-04-2013

Global pharma behemoth Pfizer (NYSE: PFE) is the latest to gain a "Breakthrough Therapy" designation…

Antibiotics and Infectious diseasesMerck & CoNorth AmericaNoxafilOncologypalbociclibPfizerPharmaceuticalRegulation

1 to 25 of 46 results

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