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Germany’s IQWiG views Xofigo, Kadcyla and Eviplera

03-04-2014

In an early benefit assessment under the Act on the Reform of the Market for Medicinal Products, the…

Anti-viralsBayerEvipleraGermanyGilead SciencesKadcylaNorthern EuropeOncologyPharmaceuticalPricingRegulationRocheXofigo

US FDA clears Xolair for chronic idiopathic urticaria

23-03-2014

Swiss drug major Novartis says the US Food and Drug Administration has approved Xolair (omalizumab) for…

BiotechnologyDermatologicalsGenentechNorth AmericaNovartisRegulationRocheUSAXolair

UK’s NICE does U-turn on Pfizer’s Inlyta for advanced kidney cancer

UK’s NICE does U-turn on Pfizer’s Inlyta for advanced kidney cancer

04-03-2014

UK drug watchdog the National Institute for Health and Care Excellence (NICE) this morning published…

InlytaNorthern EuropeOncologyPharmaceuticalPricingRegulationRocheUK

UK’s NICE consults on updating guidance for Tarceva and Iressa

UK’s NICE consults on updating guidance for Tarceva and Iressa

04-02-2014

The UK’s National Institute for Health and Care Excellence (NICE) said this morning that it is reviewing…

AstraZenecadocetaxelIressaOncologyPharmaceuticalRegulationRocheTarcevaUK

UK’s NICE gives green light to Roche’s MabThera for GPA and MPA

UK’s NICE gives green light to Roche’s MabThera for GPA and MPA

24-01-2014

UK drugs watchdog the National Institute for Health and Care Excellence (NICE) today approved the use…

EuropeImmunologicalsMabTheraPharmaceuticalPricingRegulationRocheUK

Breakthrough year for unmet diseases, as FDA backs 37 designations in 2013

Breakthrough year for unmet diseases, as FDA backs 37 designations in 2013

17-01-2014

Since the US Food and Drug Administration’s breakthrough therapy designation (BTD) was put into effect…

GazyvaGilead SciencesImbruvicaJohnson & JohnsonPharmaceuticalRegulationRocheSovaldiUSA

Celltrion’s trastuzumab biosimilar, Herzuma, approved in South Korea

16-01-2014

South Korean biopharmaceutical firm Celltrion has received approval for its cancer treatment biosimilar…

Asia-PacificBiosimilarsCellTrionGenericsHerceptinHerzumaOncologyRegulationRoche

UK MPs express concerns on clinical trial data transparency and Tamiflu stockpiling

UK MPs express concerns on clinical trial data transparency and Tamiflu stockpiling

06-01-2014

The UK House of Commons Public Accounts Committee is calling for all data on drugs being prescribed in…

Anti-viralsNorthern EuropePharmaceuticalRegulationResearchRocheTamifluUK

IQWiG view on Roche’s Zelboraf unchanged despite new data

IQWiG view on Roche’s Zelboraf unchanged despite new data

18-12-2013

The German Institute for Quality and Efficiency in Health Care (IQWiG) has reassessed Swiss drug major…

EuropeOncologyPharmaceuticalPricingRegulationRocheZelboraf

New Zealand funding plans for Tarceva and Revolade

New Zealand funding plans for Tarceva and Revolade

09-12-2013

Following a consultation, New Zealand’s Pharmaceutical Management Agency PHARMAC said this morning…

Asia-PacificGlaxoSmithKlineHematologyNew ZealandOncologyPharmaceuticalPricingRegulationRevoladeRocheTarceva

Mylan-Biocon Herceptin biosimilar gets first Indian approval

Mylan-Biocon Herceptin biosimilar gets first Indian approval

26-11-2013

US generic major Mylan says that its partner, India-based biotechnology firm Biocon has received approval…

Asia-PacificBioconBiosimilarsGenericsHerceptinHertrazMylan LaboratoriesOncologyRegulationRoche

EMA Committee backs Novo Nordisk’s NovoRapid PumpCart

EMA Committee backs Novo Nordisk’s NovoRapid PumpCart

22-11-2013

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a…

DiabetesEuropeNovo NordiskNovoRapidPharmaceuticalRegulationRoche

Roche’s Kadcyla approved in the EU for advanced HER2-positive breast cancer

Roche’s Kadcyla approved in the EU for advanced HER2-positive breast cancer

20-11-2013

Swiss drug major Roche says that Kadcyla (ado-trastuzumab emtansine or T-DM1), the latest targeted medicine…

EuropeKadcylaOncologyPharmaceuticalRegulationRoche

EMA finds no new safety concerns following Roche pharmacovigilance inspection

EMA finds no new safety concerns following Roche pharmacovigilance inspection

19-11-2013

The European Medicines Agency has finalized a thorough review of all medicines manufactured by Swiss…

EuropePharmaceuticalRegulationRoche

IQWiG says no added benefit for Roche’s Erivedge has been proven

IQWiG says no added benefit for Roche’s Erivedge has been proven

18-11-2013

In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products…

ErivedgeEuropeOncologyPharmaceuticalPricingRegulationRoche

Report: Tarceva and Iressa favored by European oncologists for NSCLC

Report: Tarceva and Iressa favored by European oncologists for NSCLC

04-11-2013

Oncologists across the top five European countries are prescribing Roche's Tarceva or AstraZeneca's Iressa…

AstraZenecaEuropeIressaOncologyPfizerPharmaceuticalPricingRegulationRocheTarcevaXalkori

Roche’s Gazyva gains FDA approval of CLL

Roche’s Gazyva gains FDA approval of CLL

04-11-2013

The US Food and Drug Administration late Friday approved Roche’s Gazyva (obinutuzumab), also known…

Biogen IdecBiotechnologyGazyvaGenentechMabTheraNorth AmericaobinutuzumabOncologyRegulationRituxanRoche

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

UK NICE final draft guidance on treatment for chronic hepatitis C

UK NICE final draft guidance on treatment for chronic hepatitis C

11-10-2013

The UK drugs watchdog the National Institute of Health and Care Excellence this morning confirmed its…

Anti-viralsEuropeMerck & CoPegasysPharmaceuticalPricingRegulationRocheViraferon

UK’s NICE thumbs up for Roche drug in rare autoimmune disease in draft guidance

UK’s NICE thumbs up for Roche drug in rare autoimmune disease in draft guidance

03-10-2013

The UK’s drugs watchdog, the National Institute for Health and Care Excellence (NICE) has published…

EuropeMabTheraOncologyPharmaceuticalPricingRegulationRoche

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

CHMP positive decision for Kadcyla, and approval in Japan

20-09-2013

The cancer drug Kadcyla (trastuzumab emtansine) has today received a positive opinion from the European…

Asia-PacificEuropeImmunoGenKadcylaOncologyPharmaceuticalRegulationRoche

US FDA approves first generic Xeloda for colorectal and breast cancers

17-09-2013

The US Food and Drug Administration approved the first generic version of Swiss drug major Roche's (ROG:…

capecitabineGenericsNorth AmericaOncologyRegulationRocheTeva Pharmaceutical IndustriesXeloda

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