Regulation - Pharmaceutical, Anti-Arthritics/Rheumatics

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UK's NICE does not recommend Pfizer's Xiapex for Dupuytren's contracture

UK's NICE does not recommend Pfizer's Xiapex for Dupuytren's contracture

07-11-2014

The UK’s National Institute for Health and Care Excellence is consulting on provisional recommendations…

Anti-Arthritics/RheumaticsPfizerPharmaceuticalRegulationUKXiapex

AbbVie gains expanded approval for Humira by FDA

AbbVie gains expanded approval for Humira by FDA

06-10-2014

US drugmaker AbbVie has received approval from the US Food and Drug Administration for an extension of…

AbbVieAnti-Arthritics/RheumaticsHumiraPharmaceuticalRegulationUSA

Roche’s RoActemra gains EU approval for use in early RA

Roche’s RoActemra gains EU approval for use in early RA

08-09-2014

The European Commission has approved Swiss pharma major Roche’s RoActemra (tocilizumab) for use in…

ActemraAnti-Arthritics/RheumaticsEuropeInterleukin 6PharmaceuticalRegulationRoActemraRoche

Scottish Medicines Consortium approves Roche's subcutaneous RoActemra for NHS use

Scottish Medicines Consortium approves Roche's subcutaneous RoActemra for NHS use

11-08-2014

The Scottish Medicines Consortium has approved the prescribing on the National Health Service of Roche’s…

Anti-Arthritics/RheumaticsImmunologyImmunosuppressantsNHSPharmaceuticalRegulationRoActemraRocheTocilizumabUK

Pfizer granted European approval for Enbrel in early-stage inflammatory joint disease

Pfizer granted European approval for Enbrel in early-stage inflammatory joint disease

06-08-2014

US pharma giant Pfizer has been granted a license extension by the European Commission for Enbrel (etanercept)…

Anti-Arthritics/RheumaticsArthritisChronic, lifelong inflammatory diseaseEnbrelPfizerPharmaceuticalRegulationSpondyloarthropathyUSA

Medac’s Rasuvo approved for RA while Antares’ injunction is denied

Medac’s Rasuvo approved for RA while Antares’ injunction is denied

14-07-2014

USA-based Medac Pharma, a wholly-owned subsidiary of privately-held German firm medac GmbH, says that…

Antares PharmaAnti-Arthritics/RheumaticsLegalMedac PharmaPharmaceuticalRasuvoRegulationUSA

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

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

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

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

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

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

US FDA accepts Pennsaid 2% NDA for review

22-08-2013

The US Food and Drug Administration has accepted for filing US drugmaker Mallinckrodt's (NYSE: MNK) New…

Anti-Arthritics/RheumaticsGenericsMallinckrodtNorth AmericaNuvo ResearchPennsaidPharmaceuticalRegulation

Two CHMP positives for Novartis

29-07-2013

There was a flow of positive news from the European Medicines Agency on Friday (July 26) for Swiss drug…

Anti-Arthritics/RheumaticsEuropeIlarisNovartisPharmaceuticalRegulationRespiratory and PulmonaryUltibro BreezhalerVectura

Disappointment for Pfizer on negative CHMP view for Xeljanz

26-07-2013

There was disappointment for US pharma behemoth Pfizer (NNYSE: PFE), when the European Medicines Agency's…

Anti-Arthritics/RheumaticsEuropePfizerPharmaceuticalRegulationXeljanz

Nuvo's partner Mallinckrodt to resubmit osteoarthritis treatment to US FDA

24-07-2013

Canada's Nuvo Research (TSX: NRI) says that its licensing partner Mallinckrodt (NYSE: MNK) has successfully…

Anti-Arthritics/RheumaticsCovidienMallinckrodtNorth AmericaNuvo ResearchPennsaidPharmaceuticalRegulation

Simponi ARIA cleared by US FDA

19-07-2013

US health care giant Johnson & Johnson's (NYSE: JNJ) Janssen Biotech subsidiary has received US Food…

Anti-Arthritics/RheumaticsBiotechnologyJanssen BiotechJohnson & JohnsonNorth AmericaPharmaceuticalRegulationSimponi ARIA

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