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Undervaluing new medicines threatens patient wellbeing and economic growth; report

Undervaluing new medicines threatens patient wellbeing and economic growth; report

14-03-2014

Innovative medicines and other new therapies have extended life expectancy by some 10 years since the…

HealthcareNorthern EuropePharmaceuticalPricingRegulationUK

UK plans for early access to medicines scheme

UK plans for early access to medicines scheme

14-03-2014

Severely ill patients in the UK, and those with rare debilitating conditions, could be given new medicines…

HealthcareNorthern EuropePharmaceuticalRegulationUK

Sun Pharma latest Indian generic drugmaker to fall foul of US FDA

Sun Pharma latest Indian generic drugmaker to fall foul of US FDA

14-03-2014

Even as India-based drug majors Ranbaxy and Wockhardt reel under the impact of US Food and Drug Administration…

Asia-PacificGenericsIndiaProductionRegulation

NICE says better information needed on Celgene’s MM drug

NICE says better information needed on Celgene’s MM drug

14-03-2014

The UK drugs watchdog, the National Institute for Health and care Excellence (NICE) says that, based…

BiotechnologyCelgeneNorthern EuropeOncologyPricingRegulationRevlimidUK

Taiwan’s TaiGen Biotech receives domestic marketing approval for Taigexyn

13-03-2014

Taiwan-based drug developer TaiGen Biotechnology says that the Taiwan Food and Drug Administration has…

Antibiotics and Infectious diseasesAsia-PacificBiotechnologyRegulationTaiGen BiotechTaigexyn

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

AstraZeneca’s diabetes drug Xigduo launched in UK

AstraZeneca’s diabetes drug Xigduo launched in UK

11-03-2014

Anglo-Swedish drug major AstraZeneca’s type 2 diabetes drug Xigduo is now available in the UK.

AstraZenecaDiabetesPharmaceuticalRegulationUKXigduo

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 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

Keryx Biopharma files for EU approval of Zerenex

Keryx Biopharma files for EU approval of Zerenex

10-03-2014

US drugmaker Keryx Biopharmaceuticals has submitted a Marketing Authorization Application to the European…

EuropeKeryx BiopharmaceuticalsNephrology and HepatologyPharmaceuticalRegulationZerenex

Ranbaxy recalls Lipitor generic over dose error

Ranbaxy recalls Lipitor generic over dose error

10-03-2014

India’s largest drugmaker Ranbaxy Laboratories (BSE: 500359) has recalled more than 64,000 bottles…

Atorvastatin CalciumCardio-vascularIndiaLipitorPharmaceuticalRanbaxy LaboratoriesRegulationUSA

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

Highlights from the Pharmacovigilance Risk Assessment Committee meeting

Highlights from the Pharmacovigilance Risk Assessment Committee meeting

09-03-2014

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) gave recommendations…

diacereindomperidoneEuropeGastro-intestinalsNeurologicalPharmaceuticalRegulationzolpidem

Ph III study for Jakavi meets endpoint in patients with polycythemia vera

Ph III study for Jakavi meets endpoint in patients with polycythemia vera

07-03-2014

Swiss pharma major Novartis today announced positive results from a pivotal Phase III trial of Jakavi…

IncyteJakaviNovartisOncologyPharmaceuticalRare diseasesRegulationResearch

Streamlined PBS pricing processes to improve access to medicines in Australia

Streamlined PBS pricing processes to improve access to medicines in Australia

07-03-2014

From April 1, the Australian government will implement a new streamlined process to reduce the time taken…

Asia-PacificAustraliaPharmaceuticalPricingRegulation

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

Boehringer Ingelheim presents new data for HCV/HIV candidate faldaprevir

Boehringer Ingelheim presents new data for HCV/HIV candidate faldaprevir

06-03-2014

German family-owned pharma major Boehringer Ingelheim announced positive results from STARTVerso 4 in…

Anti-viralsBoehringer IngelheimfaldaprevirPharmaceuticalRegulationResearch

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

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

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