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US Court upholds damages award in Actelion/Asahi litigation

14-03-2014

Switzerland-based Actelion says that the California Supreme Court has denied the firm’ petition for…

ActelionAsahi KaseiBiotechnologyfasudilFinancialLegalNorth AmericaRespiratory and PulmonaryUSA

Generic drugs slow pharma spending growth in Canada

Generic drugs slow pharma spending growth in Canada

13-03-2014

Last year, C$29.3 billion ($26.47 billion) was spent on prescription drugs in Canada, but the annual…

CanadaFinancialGenericsMarkets & MarketingNorth AmericaPharmaceutical

PhRMA links up on national campaign to help increase clinical trials diversity

PhRMA links up on national campaign to help increase clinical trials diversity

13-03-2014

The Pharmaceutical Research and Manufacturers of America (PhRMA) and the National Minority Quality Forum…

North AmericaPharmaceuticalResearchUSA

Pfizer to appeal Court decision on Celebrex reissue patent

Pfizer to appeal Court decision on Celebrex reissue patent

13-03-2014

US pharma behemoth Pfizer confirmed today that the US District Court for the Eastern District of Virginia…

Anti-Arthritics/RheumaticsCelebrexLegalNorth AmericaPatentsPfizerPharmaceuticalUSA

USA’s HHS establishes new network to perform clinical studies

USA’s HHS establishes new network to perform clinical studies

13-03-2014

The USA’s Department of Health and Human Services has established a network of five clinical research…

HealthcareNorth AmericaPharmaceuticalResearchUSA

Geron nosedives on FDA clinical hold for blood disorders drug imetelstat

Geron nosedives on FDA clinical hold for blood disorders drug imetelstat

12-03-2014

USA-based Geron Corp saw its shares plunge 59% to $1.79 when the company revealed that it had received…

BiotechnologyGeron CorpimetelstatNorth AmericaOncologyRegulationResearchUSA

Mallinckrodt gains FDA approval for Xartemis XR

Mallinckrodt gains FDA approval for Xartemis XR

12-03-2014

The US Food and Drug Administration has approved Ireland-headquartered specially drugmaker Mallinckrodt’s…

DepomedMallinckrodtNeurologicalNorth AmericaPharmaceuticalRegulationUSAXartemis XR

Teva agrees $27.6 million settlement with US Justice Dept

Teva agrees $27.6 million settlement with US Justice Dept

12-03-2014

US subsidiaries of Israeli generics giant Teva Pharmaceutical Industries have agreed to pay the US government…

ClozapineFinancialGenericsIvaxLegalNeurologicalNorth AmericaTeva Pharmaceutical IndustriesUSA

US CMS withdraws contentious Medicare Part D proposals

11-03-2014

The US Centers for Medicare & Medicaid Services (CMS) has halted movement on several proposals in its…

HealthcareNorth AmericaPharmaceuticalPoliticsUSA

KYTHERA regains rights to ATX-101 outside USA and Canada from Bayer

KYTHERA regains rights to ATX-101 outside USA and Canada from Bayer

11-03-2014

US biotech firm KYTHERA Biopharmaceuticals says it has re-acquired all rights outside of the USA and…

ATX-101BayerDermatologicalsKYTHERA BiopharmaceuticalsLicensingNorth AmericaPharmaceutical

FDA accepts Lundbeck NDA for IV carbamazepine

FDA accepts Lundbeck NDA for IV carbamazepine

10-03-2014

The US subsidiary of Danish CNS specialist Lundbeck says that the Food and Drug Administration has accepted…

CarbamazepineCarbellaFinancialLigand PharmaceuticalsLundbeckNeurologicalNorth AmericaPharmaceuticalRegulationUSA

US researchers report blood test that can predict Alzheimer’s

10-03-2014

A blood test that can accurately predict the onset of Alzheimer's disease has been reported by, US researchers.…

NeurologicalNorth AmericaPharmaceuticalResearchUSA

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 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

Amarin files suit against AstraZeneca over Epanova

Amarin files suit against AstraZeneca over Epanova

05-03-2014

US biotech firm Amarin revealed in a Stock Exchange Commission submission that it has filed a complaint…

AmarinAstraZenecaBiotechnologyCardio-vascularEpanovaLegalNorth AmericaOmthera PharmaceuticalsPatentsUSAVascepa

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

RedHill Biopharma and IntelGenx respond to CRL on rizatriptan

04-03-2014

Emerging Israeli biotech firm RedHill Biopharma, together with Canadian drug delivery specialist IntelGenx,…

BiotechnologyIntelGenxNeurologicalNorth AmericaRedHill BiopharmaRegulationUSA

Teva gains approval for generic Evista in the USA

Teva gains approval for generic Evista in the USA

04-03-2014

Israel-based Teva Pharmaceutical Industries says it has received approval from the US Food and Drug Administration…

Anti-Arthritics/RheumaticsEli LillyEvistaGenericsNorth AmericaRegulationTeva Pharmaceutical IndustriesUSA

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

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