Regulation - Pharmaceutical, Eli Lilly

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Tentative FDA approval for Lilly and Boehringer Ingelheim's Basaglar

Tentative FDA approval for Lilly and Boehringer Ingelheim's Basaglar

19-08-2014

The US Food and Drug Administration yesterday granted tentative approval for Basaglar (insulin glargine…

AbasriaBasaglarBiosimilarsBoehringer IngelheimDiabetesEli LillyInsulin Glargine [rDNA origin] InjectionLantusPharmaceuticalRegulationUSA

Canadian health authorities approve Abraxane plus gemcitabine for metastatic pancreatic cancer

Canadian health authorities approve Abraxane plus gemcitabine for metastatic pancreatic cancer

06-08-2014

Health Canada has approved US biotech company Celgene’s Abraxane, and gemcitabine, marketed by US drug…

AbraxaneCanadaCancerCelgene Corp.Eli Lillygemcitabine HclMetastatic pancreatic cancerOncologyOrganofluoridesPharmaceuticalRegulation

US FDA approves Jardiance for adults with type 2 diabetes

US FDA approves Jardiance for adults with type 2 diabetes

02-08-2014

The US Food and Drug Administration on Friday approved Jardiance (empagliflozin) tablets as an adjunct…

Boehringer IngelheimDiabetesEli LillyEuropeGermanyJardiancePharmaceuticalRegulationUSA

UK's NICE changes guidance to recommend Eli Lilly’s Efient for blood clots

UK's NICE changes guidance to recommend Eli Lilly’s Efient for blood clots

23-07-2014

The National Institute for Health and Care Excellence (NICE), the UK’s health care guidance body, has…

Acute coronary syndromesCardio-vascularEfientEli LillyPharmaceuticalprasugrelRegulationUK

Six new drugs recommended for approval by EMA’s CHMP

Six new drugs recommended for approval by EMA’s CHMP

27-06-2014

At its end-June meetings, the European Medicines Agency’s Committee for Medicinal Products for Human…

AbasriaAnti-viralsBristol-Myers SquibbCardio-vascularDaklinzaDiabetesEli LillyEuropeFreseniusGE HealthcarePharmaceuticalRegulationTriumeqVelphoroVifor PharmaVizamyl

UK’s NICE draft guidance recommends Lilly’s Efient

UK’s NICE draft guidance recommends Lilly’s Efient

20-06-2014

UK health care watchdog the National Institute for Health and Care Excellence (NICE) has today published…

Cardio-vascularEfientEli LillyPharmaceuticalPricingRegulationUK

Boehringer and Lilly re-file empagliflozin NDA with FDA

Boehringer and Lilly re-file empagliflozin NDA with FDA

19-06-2014

The US subsidiary of German family-owned drugmaker Boehringer Ingelheim and pharma major Eli Lilly have…

Boehringer IngelheimDiabetesEli LillyempagliflozinPharmaceuticalRegulationUSA

Boehringer and Lilly’s diabetes drug Jardiance gains EU approval

23-05-2014

German family-owned pharma major Boehringer Ingelheim and US partner Eli Lilly have received Marketing…

Boehringer IngelheimDiabetesEli LillyempagliflozinEuropeJardiancePharmaceuticalRegulation

UK NICE recommends Giotrif and Velcade, but says “no” to added use of Alimta

23-04-2014

People in England and Wales with lung cancer whose tumors test positive for a mutation will now have…

AlimtaBoehringer IngelheimEli LillyGiotrifJohnson & JohnsonNorthern EuropeOncologyPharmaceuticalPricingRegulationUKVelcade

Lilly's Cyramza first FDA-approved drug for advanced gastric cancer after prior chemo

22-04-2014

The US Food and Drug Administration has approved pharma major Eli Lilly’s Cyramza (ramucirumab) as…

CyramzaEli LillyNorth AmericaOncologyPharmaceuticalRegulationUSA

NDA filing for empagliflozin and linagliptin combo accepted by FDA

NDA filing for empagliflozin and linagliptin combo accepted by FDA

14-04-2014

The US Food and Drug Administration has accepted the filing of the New Drug Application for the investigational…

Boehringer IngelheimDiabetesEli LillyempagliflozinJardiancelinagliptinNorth AmericaPharmaceuticalRegulationTradjentaUSA

EMA/CHMP recommends empagliflozin for approval for type 2 diabetes

23-03-2014

German family-owned drug major Boehringer Ingelheim and partner Eli Lilly of the USA have announce a…

Boehringer IngelheimDiabetesEli LillyempagliflozinEuropeJardiancePharmaceuticalRegulation

FDA issues CRL on empagliflozin, noting manufacturing deficiencies

FDA issues CRL on empagliflozin, noting manufacturing deficiencies

05-03-2014

There was disappointment today for US drug major Eli Lilly and family-owned German pharma firm Boehringer…

Boehringer IngelheimDiabetesEli LillyempagliflozinNorth AmericaPharmaceuticalProductionRegulationUSA

Negative NICE appraisal for Eli Lilly’s Alimta as maintenance therapy

27-02-2014

UK health care guidance body the National Institute for Health and Care Excellence (NICE) has published…

AlimtaEli LillyNorthern EuropeOncologyPharmaceuticalPricingRegulationUK

FDA investigating risk of stroke, heart attack and death with testosterone products

FDA investigating risk of stroke, heart attack and death with testosterone products

03-02-2014

The US Food and Drug Administration said on Friday that it is investigating the risk of stroke, heart…

AbbVieActavisAndrodermAndroGelAxironEli LillyMen's HealthNorth AmericaPharmaceuticalRegulationResearchTestosteroneUSA

New Zealand views access to sugammadex and atomoxetine and baclofen injection funding

02-12-2013

New Zealand’s Pharmaceutical Management Agency PHARMAC is seeking feedback on the following proposals…

Asia-PacificBridionEli LillyLioresal IntrathecalMerck & CoNeurologicalNew ZealandPharmaceuticalRegulationStrattera

Third NICE consultation on Eli Lilly’s Alimta in the UK

Third NICE consultation on Eli Lilly’s Alimta in the UK

27-11-2013

The UK’s drugs watchdog the National Institute of Health and Care Excellence (NICE) is holding a third…

AlimtaEli LillyOncologyPharmaceuticalRegulationUK

NICE holds second consultation on Alimta for lung cancer maintenance

20-08-2013

The UK's drugs watchdog the National Institute of Health and Care Excellence (NICE) is holding a second…

AlimtaEli LillyEuropeOncologyPharmaceuticalRegulation

EU regulator finds no added pancreatic risks for GLP-1 diabetes drugs

26-07-2013

Having finalized a review of glucagon-like peptide 1 (GLP-1)-based diabetes therapies, the European Medicines…

AstraZenecaBoehringer IngelheimBristol-Myers SquibbBydureonDiabetesEli LillyEuropeJanuviaMerck & CoNovo NordiskOnglyzaPharmaceuticalRegulationTradjentaVictoza

FDA approves Boehringer and Lilly's Tradjenta and Jentadueto labeling to reflect pancreatitis risk

21-06-2013

German family-owned Boehringer Ingelheim and US partner Eli Lilly (NYSE: LLY) revealed yesterday (June…

Boehringer IngelheimDiabetesEli LillyJentaduetoNorth AmericaPharmaceuticalRegulationTradjenta

FDA probes two deaths possibly linked to Lilly's antipsychotic Zyprexa Relprevv

19-06-2013

The US Food and Drug Administration yesterday (June 18) revealed it is investigating two unexplained…

Eli LillyNeurologicalNorth AmericaPharmaceuticalRegulationZyprexa

Daiichi Sankyo files for Japanese approval of Prasugrel

18-06-2013

Japanese drug major Daiichi Sankyo (TYO: 4568) says that it has submitted a New Drug Application to the…

Asia-PacificCardio-vascularDaiichi SankyoEffientEli LillyPharmaceuticalprasugrelRegulation

NICE final draft guidance on Eli Lilly's Alimta negative

13-06-2013

UK drugs watch dog the National Institute for Health and Care Excellence (NICE) this morning (June 13)…

AlimtaEli LillyEuropeOncologyPharmaceuticalPricingRegulation

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