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FDA probing Regeneron and Sanofi’s investigational drug alirocumab

FDA probing Regeneron and Sanofi’s investigational drug alirocumab

10-03-2014

French drug major Sanofi has revealed in a regulatory filing that the US Food and Drug Administration…

alirocumabCardio-vascularNorth AmericaPharmaceuticalRegeneronRegulationResearchSanofiUSA

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

Endo’s testosterone replacement Aveed gets FDA approval

Endo’s testosterone replacement Aveed gets FDA approval

06-03-2014

Endo International says its operating company Endo Pharmaceuticals has received US Food and Drug Administration…

AveedEndo PharmaceuticalsMen's HealthNorth AmericaPharmaceuticalRegulationUSA

Drug developers circumspect on using social media in clinical research, says Tufts CSDD

06-03-2014

Social media is gaining ground as an important tool to improve the clinical research process through…

North AmericaPharmaceuticalResearchUSA

PhRMA slams US President’s claims that Budget invests in innovation

06-03-2014

Pharmaceutical Research and Manufacturers of America (PhRMA) president and chief executive John Castellani…

GenericsNorth AmericaPatentsPharmaceuticalPoliticsResearchUSA

FDA issues CRL on empagliflozin, noting manufacturing deficiencies

FDA issues CRL on empagliflozin, noting manufacturing deficiencies

05-03-2014

There was disappointment today for US drug major Eli Lilly and family-owned German pharma firm Boehringer…

Boehringer IngelheimDiabetesEli LillyempagliflozinNorth AmericaPharmaceuticalProductionRegulationUSA

Titan Pharma in general agreement with FDA on pathway for Probuphine

Titan Pharma in general agreement with FDA on pathway for Probuphine

04-03-2014

California, USA-based Titan Pharma and its partner, Braeburn Pharmaceuticals, have agreed in principle…

Braeburn PharmaceuticalsNeurologicalNorth AmericaPharmaceuticalProbuphineRegulationResearchTitan PharmaceuticalsUSA

Medicare Part D Rx drug coverage saved $1.5 billion a year in first 4 years

Medicare Part D Rx drug coverage saved $1.5 billion a year in first 4 years

04-03-2014

A new study by the Johns Hopkins Bloomberg School of Public Health and the University of Illinois at…

FinancialHealthcareNorth AmericaPharmaceuticalUSA

Alexza’s partner Teva launches antipsychotic Adasuve in USA

Alexza’s partner Teva launches antipsychotic Adasuve in USA

04-03-2014

US drug developer Alexza Pharmaceuticals says that its marketing partner, Israel-based generic drugs…

AdasuveAlexza PharmaceuticalMarkets & MarketingNeurologicalNorth AmericaPharmaceuticalTeva Pharmaceutical IndustriesUSA

Cumberland Pharma acquires Vaprisol from Astellas

03-03-2014

USA-based Cumberland Pharmaceuticals says it has acquired from the US subsidiary of Japan’s Astellas…

Astellas PharmaCumberland PharmaceuticalsHematologyLicensingNorth AmericaPharmaceuticalUSAVaprisol

US orphan designation for OPKO's longer-acting clotting Factor VIIa-CTP

US orphan designation for OPKO's longer-acting clotting Factor VIIa-CTP

03-03-2014

The US Food and Drug Administration has granted orphan drug designation to US drugmaker OPKO Health’s…

HematologyNorth AmericaOPKO HealthPharmaceuticalRare diseasesUSA

GSK files for US approval for Promacta for severe aplastic anemia

GSK files for US approval for Promacta for severe aplastic anemia

02-03-2014

UK pharma giant GlaxoSmithKline has submitted a supplemental New Drug Application to the US Food and…

GlaxoSmithKlineLigand PharmaceuticalsNorth AmericaOncologyPharmaceuticalPromactaRare diseasesRegulationUSA

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

US orphan status for GW Pharma’s Epidiolex in Lennox-Gastaut syndrome

28-02-2014

UK-based GW Pharmaceuticals says that the Food and Drug Administration has granted orphan drug designation…

epidiolexGW PharmaceuticalsNeurologicalNorth AmericaPharmaceuticalRegulationUSA

Record-breaking recoveries from US DoJ/HHS joint efforts to combat health care fraud

27-02-2014

US Attorney General Eric Holder and Health and Human Services Secretary Kathleen Sebelius have released…

FinancialHealthcareLegalNorth AmericaPharmaceuticalUSA

US FDA approves Anika’s Monovisc for osteoarthritis pain of the knee

26-02-2014

US drugmaker Anika Therapeutics has received marketing approval for Monovisc from the US Food and Drug…

Anika TherapeuticsAnti-Arthritics/RheumaticsDePuyMonoviscNorth AmericaPharmaceuticalRegulationUSA

FDA approves Myalept, the first drug to treat a rare metabolic disease

FDA approves Myalept, the first drug to treat a rare metabolic disease

26-02-2014

The US Food and Drug Administration has approved Myalept (metreleptin for injection) as replacement therapy…

AstraZenecaBristol-Myers SquibbmetreleptinMyaleptNorth AmericaPharmaceuticalRare diseasesRegulationUSA

Iroko Pharma gains FDA approval for low-dose indomethacin drug Tivorbex

25-02-2014

US specialty drugmaker Iroko Pharmaceuticals has received approval from the US Food and Drug has approved…

Iroko PharmaceuticalsNeurologicalNorth AmericaPharmaceuticalRegulationTivorbexUSA

US orphan drug market outlook 2018: Report

25-02-2014

In the largest market for orphan drugs, the USA, there was a shortage of adequate therapies for treating…

Markets & MarketingNorth AmericaPharmaceuticalRare diseasesRegulationUSA

FDA Breakthrough designation for all-oral daclatasvir for chronic hepatitis C

24-02-2014

The US Food and Drug Administration has granted drug major Bristol-Myers Squibb’s investigational DCV…

Anti-viralsBristol-Myers SquibbdaclatasvirNorth AmericaPharmaceuticalRegulationUSA

PhRMA opposes proposed rule on US Medicare Advantage & Part D

PhRMA opposes proposed rule on US Medicare Advantage & Part D

20-02-2014

Pharmaceutical Research and Manufacturers of America (PhRMA) stated yesterday that it is opposed to the…

North AmericaPharmaceuticalPoliticsUSA

FDA and European Medicines Agency strengthen collaboration in pharmacovigilance area

FDA and European Medicines Agency strengthen collaboration in pharmacovigilance area

20-02-2014

The US Food and Drug Administration and the European Medicines Agency have set-up a new “cluster”…

EuropeNorth AmericaPharmaceuticalRegulationUSA

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

Servier Canada collaborates in two research projects

Servier Canada collaborates in two research projects

17-02-2014

Two major projects in clinical research conducted by Canada’s Montreal Heart Institute (MHI) and the…

CanadaCardio-vascularFinancialNorth AmericaPharmaceuticalResearchServier

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