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Kadcyla’s rejection confirms that NICE must change the way it considers cancer treatment, says analyst

Kadcyla’s rejection confirms that NICE must change the way it considers cancer treatment, says analyst

13-08-2014

“The National Institute for Health and Care Excellence’s recent rejection of Kadcyla, Roche’s latest…

KadcylaOncologyPharmaceuticalPricingRegulationRocheUK

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

Genentech files sBLA for Lucentis for diabetic retinopathy

09-08-2014

Genentech, the biotech subsidiary of Swiss pharma major Roche, has submitted a supplemental Biologics…

BiotechnologyGenentechLucentisOphthalmicsRegulationRocheUSA

NICE disappointed by Roche’s decision on Kadcyla pricing

NICE disappointed by Roche’s decision on Kadcyla pricing

08-08-2014

UK health care cost watchdog the National Institute for Health and Care Excellence (NICE) said this morning…

Breast cancerCancerKadcylaNational Health ServiceOncologyPharmaceuticalPricingRegulationRocheUK

Patient involvement pilot for orphan drugs launches in Canada

Patient involvement pilot for orphan drugs launches in Canada

07-08-2014

Canada’s Minister of Health, Rona Ambrose, says that the government has launched a pilot project targeting…

CanadaHealth CanadaPharmaceuticalRare diseasesRegulationResearchRocheTreatment of chronic lymphocytic leukemia

NICE comes back with different views on Tarceva and Iressa for NSCLC

NICE comes back with different views on Tarceva and Iressa for NSCLC

07-08-2014

UK health costs watchdog the National Institute for Health and Care Excellence (NICE) is consulting again…

AstraZenecaIressaOncologyPharmaceuticalPricingRegulationRocheTarcevaUK

EU approves Roche’s Avastin for platinum-resistant recurrent ovarian cancer

EU approves Roche’s Avastin for platinum-resistant recurrent ovarian cancer

06-08-2014

The European Commission has approved the use of Swiss pharma major Roche’s blockbuster cancer drug…

AvastinEuropeOncologyPharmaceuticalRegulationRocheTreatment for women with recurrent ovarian cancer

New blood cancer injection given green light by UK regulators

New blood cancer injection given green light by UK regulators

05-08-2014

Patients in the UK with one of the most common forms of blood cancer can now benefit from a new injection.…

Andrew DaviesLymphomaMabTheraNHSOncologyPharmaceuticalRegulationRituximabRocheUK

Roche’s Gazyvaro granted European Commission approval for leukemia

Roche’s Gazyvaro granted European Commission approval for leukemia

29-07-2014

Swiss drug major Roche has announced that its drug Gazyvaro (obinutuzumab) has been approved by the European…

ChemistryEuropeEuropean CommissionGazyvaroOncologyPharmaceuticalPreviously untreated lymphocytic leukemiaRegulationRoche

EUCOPE slams French plans to cut spending through off-label drugs

EUCOPE slams French plans to cut spending through off-label drugs

12-07-2014

The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) says it is very concerned about legislative…

AvastinEuropeFranceLegalOphthalmicsPharmaceuticalRegulationRoche

France adopts draft law on off-label use of drugs

France adopts draft law on off-label use of drugs

09-07-2014

The French National Assembly yesterday voted on the draft law proposal, which would potentially allow…

AvastinDraft law proposalEuropeFranceLegalOphthalmicsPharmaceuticalRegulationRoche

Japan first to approve Roche’s lung cancer drug alectinib

Japan first to approve Roche’s lung cancer drug alectinib

04-07-2014

The Japanese Ministry of Health, Labor and Welfare has approved Swiss pharma major Roche’s alectinib…

alectinibJapanOncologyPharmaceuticalRegulationRoche

Added indications recommended by EMA/CHMP

Added indications recommended by EMA/CHMP

27-06-2014

Along with backing for approval for six news drugs issued at the late June meeting of the European Medicines…

AvastinBayerBristol-Myers SquibbCardio-vascularEliquisEuropeEyleaKalydecoOncologyOphthalmicsPfizerPharmaceuticalRare diseasesRegulationRocheVertex Pharmaceuticals

Drug policy expert calls for “nip in the bud” for AMD therapy drug substitute

Drug policy expert calls for “nip in the bud” for AMD therapy drug substitute

16-06-2014

Steven Bradshaw, a UK-based drug policy expert and former ophthalmologist, is disappointed at the news…

AvastinEuropeItalyLucentisOphthalmicsPharmaceuticalRegulationRoche

Italian legislation undermines EU regulatory framework by endorsing off-label drug use for economic reasons

Italian legislation undermines EU regulatory framework by endorsing off-label drug use for economic reasons

11-06-2014

The European Federation of Pharmaceutical Industries and Associations says it is concerned about a decision…

AvastinEuropeFinancialItalyNovartisOphthalmicsPharmaceuticalRegulationRoche

CHMP recommends approval of Roche’s Gazyvaro for CLL

25-05-2014

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP)had recommended…

EuropeGazyvaroobinutuzumabOncologyPharmaceuticalRegulationRoche

Biocad’s AcellBia is first MAb biosimilar approved by Russia’s Ministry of Health

15-05-2014

A biosimilar of Swiss drug major Roche’s MabThera (rituximab), to be marketed under the trade name…

AcellBiaBiocadBiosimilarsGenericsMabTheraOncologyRegulationRocheRussia

Roche may lose $240 million contract in Russia to Biocad biosimilar

Roche may lose $240 million contract in Russia to Biocad biosimilar

07-05-2014

Swiss drug major Roche may lose an important $240 million contract in Russia for the supply of its anti-cancer…

AcellBiaBiocadBiosimilarsBiotechnologyMabTheraMarkets & MarketingOncologyRegulationrituximabRoche

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 rejects use of Roche’s Kadcyla for breast cancer on NHS

23-04-2014

UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has today issued preliminary…

KadcylaNorthern EuropeOncologyPharmaceuticalPricingRegulationRocheUK

EMA says that vials of falsified Herceptin have been identified

EMA says that vials of falsified Herceptin have been identified

16-04-2014

The European Medicines Agency says it has been informed that vials of Swiss drug major Roche’s blockbuster…

EuropeHealthcareHerceptinOncologyPharmaceuticalRegulationRoche

EMA concludes inquiry into Roche infringement procedure

EMA concludes inquiry into Roche infringement procedure

14-04-2014

The European Medicines Agency says it has concluded its inquiry into alleged non-compliance with pharmacovigilance…

EuropePharmaceuticalRegulationRoche

UK’s NICE reverses negative decision on Roche’s Tarceva for NSCLC

04-04-2014

Following a consultation period, the UK drug watchdog the National Institute for Health and Care Excellence…

Northern EuropeOncologyPharmaceuticalPricingRegulationRocheTarcevaUK

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

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