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Genentech files NDA for cobimetinib with Zelboraf in advanced melanoma

Genentech files NDA for cobimetinib with Zelboraf in advanced melanoma

15-12-2014

Genentech, the US biotech subsidiary of Swiss Pharma major Roche Group, has submitted a New Drug Application…

BiotechnologycobimetinibExelixisGenentechOncologyRegulationRocheUSAZelboraf

Roche's Gazyvaro and Bayer’s Adempas approved by Scottish Medicines Consortium

Roche's Gazyvaro and Bayer’s Adempas approved by Scottish Medicines Consortium

08-12-2014

The Scottish Medicines Consortium has decided to grant access to Gazyvaro (obinutuzumab), manufactured…

AdempasBayerCardio-vascularGazyvaroOncologyPharmaceuticalRegulationRoche

NICE reverses October decision and approves Roche's Gazyvaro

NICE reverses October decision and approves Roche's Gazyvaro

02-12-2014

The UK’s National Institute for Health and Care Excellence (NICE) has reversed its decision on Gazyvaro…

GazyvaroOncologyPharmaceuticalRegulationRocheUK

Yet another indication for Roche’s blockbuster Avastin from FDA

16-11-2014

The US Food and Drug Administration on Friday approved Avastin (bevacizumab) solution for intravenous…

AvastinBiotechnologyEli LillyGemzarGenentechOncologyRegulationRocheUSA

Polyphor’s POL7080 receives QIDP designation from the FDA

12-11-2014

Privately-held Swiss pharma firm Polyphor says that the US Food and Drug Administration has designated…

Antibiotics and Infectious diseasesPharmaceuticalPOL7080PolyphorRegulationRocheUSA

FDA oncologists welcome policy to speed approval of life-saving breast cancer drugs

FDA oncologists welcome policy to speed approval of life-saving breast cancer drugs

10-11-2014

Two key figures at the US Food and Drug Administration’s Center for Drug Evaluation and Research have…

OncologyPerjetapertuzumabPharmaceuticalRegulationRocheUSA

French regulator requests information from Roche on off-label use of Avastin for wet-AMD

French regulator requests information from Roche on off-label use of Avastin for wet-AMD

07-11-2014

The French pharma regulator, l’Agence nationale de sécurité du médicament et des produits de santé…

AvastinFranceOphthalmicsPharmaceuticalRegulationRoche

Data uncertainties mean NICE does not recommend Roche leukemia drug

Data uncertainties mean NICE does not recommend Roche leukemia drug

03-10-2014

In yet another rejection of the company’s cancer drugs, the UK drugs watchdog, the National Institute…

GazyvaroOncologyPharmaceuticalPricingRegulationRocheUK

UK’s NICE proposes to recommend GSK’s Tafinlar for melanoma

UK’s NICE proposes to recommend GSK’s Tafinlar for melanoma

18-09-2014

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

GlaxoSmithKlineOncologyPharmaceuticalPricingRegulationRocheTafinlarUKZelboraf

Compromised vials of Roche's MabThera found in Germany

Compromised vials of Roche's MabThera found in Germany

15-09-2014

Swiss drug major Roche has said that compromised vials of its arthritis and cancer drug MabThera had…

GermanyHerceptinLegalMabTheraOncologyPharmaceuticalProductionRegulationRoche

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

Roche’s Avastin gets FDA approval for use with chemotherapy in cervical cancer

Roche’s Avastin gets FDA approval for use with chemotherapy in cervical cancer

15-08-2014

Swiss drug major Roche has received approval from the US Food and Drug Administration for its drug Avastin…

AvastinCervical cancerOncologyPharmaceuticalRegulationRocheSwitzerland

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

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