Regulation - Anti-Arthritics/Rheumatics

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New treatment funded for severe gout in New Zealand

21-05-2014

Patients with severe gout will soon have a new treatment option as New Zealand’s Pharmaceutical Management…

AdenuricAnti-Arthritics/RheumaticsfebuxostatFinancialMenariniNew ZealandPharmaceuticalRegulation

Janssen pulls EU application for IV Simponi

19-05-2014

Janssen Biologics, a European subsidiary of US health care giant Johnson & Johnson, says it has withdrawn…

Anti-Arthritics/RheumaticsBiotechnologyEuropeJanssenJohnson & JohnsonRegulationSimponi Injection

Roche gains EU approval for new RoActemra formulation

Roche gains EU approval for new RoActemra formulation

28-04-2014

Swiss drug major Roche revealed this morning that the subcutaneous formulation of RoActemra (tocilizumab)…

Anti-Arthritics/RheumaticsEuropePharmaceuticalRegulationRoActemraRoche

UK’s NICE does not recommend Janssen’s Stelara for psoriatic arthritis

UK’s NICE does not recommend Janssen’s Stelara for psoriatic arthritis

28-03-2014

Final draft guidance from the UK health care costs watchdog the National Institute for Health and Care…

Anti-Arthritics/RheumaticsJanssenJohnson & JohnsonNorthern EuropePharmaceuticalPricingRegulationStelara InjectionUK

Brazil’s Cristalia gains ANVISA approval for production of biosimilar drugs

24-03-2014

The Brazilian drugmaker Cristalia has just taken another step towards its goal of producing biosimilar…

Anti-Arthritics/RheumaticsBiosimilarsBiotechnologyBrazilCristaliaEnbrelHerceptinMetabolicsNorditropinOncologyProductionRegulationSouth America

Celgene’s Otezla is first oral therapy OKed by FDA for adults with active psoriatic arthritis

23-03-2014

The US Food and Drug Administration on Friday approved US biotech firm Celgene’s Otezla (apremilast),…

Anti-Arthritics/RheumaticsapremilastBiotechnologyCelgeneNorth AmericaOtezlaRegulationUSA

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

Actavis challenges Multaq and Colcrys patents

02-03-2014

Ireland-headquartered generic drugmaker Actavis revealed on Friday (February 28) that French pharma giant…

ActavisAnti-Arthritics/RheumaticsCardio-vascularColcrysGenericsLegalMultaqNorth AmericaPatents & Trade marksRegulationSanofiTakeda PharmaceuticalsUSA

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

EMA pharmacovigilance unit calls for suspension of Protelos/Osseor

EMA pharmacovigilance unit calls for suspension of Protelos/Osseor

10-01-2014

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended…

Anti-Arthritics/RheumaticsEuropeOsseorPharmaceuticalProtelosRegulationServierWomen's Health

UK’s NICE draft guidance negative on Stelara for psoriatic arthritis

UK’s NICE draft guidance negative on Stelara for psoriatic arthritis

27-12-2013

UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has opened a consultation…

Anti-Arthritics/RheumaticsEuropeJanssenJohnson & JohnsonPharmaceuticalPricingRegulationStelara InjectionUK

Rapid uptake of rheumatoid arthritis biosimilars expected in Brazil and Mexico

19-12-2013

Biosimilars will be quickly acquired and used in public health institutions in the treatment of patients…

Anti-Arthritics/RheumaticsBiosimilarsBrazilGenericsMarkets & MarketingRegulationSouth America

Report: Approval of first biosimilar MAb in Europe has major implications for 2014 and beyond

Report: Approval of first biosimilar MAb in Europe has major implications for 2014 and beyond

07-12-2013

Key clinical, corporate and regulatory events affecting the biosimilar industry have been identified…

Anti-Arthritics/RheumaticsBiosimilarsCellTrionEuropeGenericsHospiraInflammatory diseasesInflectraMarkets & MarketingRegulationRemsima

Health Canada clears AbbVie’s Humira for UC

Health Canada clears AbbVie’s Humira for UC

28-11-2013

In what is now the eighth indication in Canada for its top-selling drug Humira (adalimumab), US drugmaker…

AbbVieAnti-Arthritics/RheumaticsGastro-intestinalsHumiraNorth AmericaPharmaceuticalRegulation

EMA Pharmacovigilance unit updates on Iclusig, diacerein and acipimox

EMA Pharmacovigilance unit updates on Iclusig, diacerein and acipimox

09-11-2013

At its November 4-7 meetings, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee…

acipimoxAnti-Arthritics/RheumaticsAriad PharmaceuticalsCardio-vasculardiacereinEuropeIclusigOncologyPharmaceuticalRegulation

Genentech’s SC Actemra approved by US FDA for severe RA

Genentech’s SC Actemra approved by US FDA for severe RA

22-10-2013

Genentech has announced that the US Food and Drug Administration has approved a subcutaneous formulation…

ActemraAnti-Arthritics/RheumaticsGenentechNorth AmericaPharmaceuticalRegulationRoche

US FDA approved auto-injector Otrexup from Antares Pharma for RA

US FDA approved auto-injector Otrexup from Antares Pharma for RA

15-10-2013

Antares Pharma has announced the approval of Otrexup (methotrexate) injection by the US Food and Drug…

Antares PharmaAnti-Arthritics/RheumaticsBiotechnologyNorth AmericaOtrexupRegulation

UCB’s Cimzia granted additional indication by US FDA

UCB’s Cimzia granted additional indication by US FDA

30-09-2013

UCB revealed today that the US Food and Drug Administration has approved its currently marketed drug…

Anti-Arthritics/RheumaticsCimziaNorth AmericaPharmaceuticalRegulationUCB

US FDA warns of hepatitis B reactivation risk with Arzerra and Rituxan

US FDA warns of hepatitis B reactivation risk with Arzerra and Rituxan

26-09-2013

The US Food and Drug Administration has approved changes to the prescribing information of the immune-suppressing…

Anti-Arthritics/RheumaticsArzerraBiogen IdecGlaxoSmithKlineNorth AmericaOncologyPharmaceuticalRegulationRituxanRoche

Johnson & Johnson's Stelara gains FDA approval for psoriatic arthritis

24-09-2013

Janssen Research & Development announced that the US Food and Drug Administration has approved Stelara…

Anti-Arthritics/RheumaticsBiotechnologyJanssen BiotechNorth AmericaRegulationStelara Injection

EGA welcomes first biosimilar MAb approvals in Europe

12-09-2013

Following the European Medicines Agency's CHMP recommendation, the European Commission (EC) has just…

Anti-Arthritics/RheumaticsBiotechnologyGenericsPricingRegulation

EU approval for Ilaris in active systemic juvenile idiopathic arthritis

03-09-2013

Following a positive recommendation from the European Medicines Agency's Committee for Medicinal Products…

Anti-Arthritics/RheumaticsEuropeIlarisNovartisPharmaceuticalRegeneronRegulation

German pharma watch dog finds benefits for biologicals in RA

30-08-2013

The German Institute for Quality and Efficiency in Health Care (IQWiG) examined nine biotechnologically…

Anti-Arthritics/RheumaticsBiotechnologyCimziaEnbrelEuropeHumiraKineretMabTheraOrenciaPharmaceuticalPricingRegulationRemicadeRoActemraSimponi Injection

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