Pharmaceutical - Regulation

Filter

Current filters:

Regulation

Popular Filters

1 to 25 of 2137 results

Bristol-Myers Squibb updates on Opdivo regulatory milestones

30-09-2014

US pharma major Bristol-Myers Squibb has announced multiple regulatory milestones for Opdivo (nivolumab),…

Bristol-Myers SquibbEuropeOncologyOno PharmaceuticalOpdivoPharmaceuticalRegulationUSA

Canada and Europe sometimes years slower than USA in approving cancer

29-09-2014

Access to potentially life-extending cancer drugs varies significantly in different regions of the world,…

CanadaEastern EuropeEuropeOncologyPharmaceuticalRegulationUSA

Added indication for Daiichi Sankyo’s Lixiana in Japan

Added indication for Daiichi Sankyo’s Lixiana in Japan

29-09-2014

The Japanese Ministry of Health, Labor and Welfare has granted approval for domestic pharma major Daiichi…

Cardio-vascularDaiichi SankyoJapanLixianaPharmaceuticalRegulation

US FDA approves Iluvien for diabetic macular edema

US FDA approves Iluvien for diabetic macular edema

28-09-2014

US ophthalmic drug specialist Alimera Sciences says that the US Food and Drug Administration has approved…

Alimera SciencesIluvienMedidurOphthalmicsPharmaceuticalpSividaRegulationTethadurUSA

EMA committee launches pilot project to consult patients on benefits and risk of medicines

EMA committee launches pilot project to consult patients on benefits and risk of medicines

26-09-2014

The European Medicines Agency has launched a pilot project to involve patients in the assessment of the…

Committee for Medicine Products for Human UseEuropeEuropean Medicines AgencyPharmaceuticalRegulation

Boehringer’s Spiriva Respimat OKed by FDA for maintenance treatment of COPD

Boehringer’s Spiriva Respimat OKed by FDA for maintenance treatment of COPD

25-09-2014

German family-owned pharma major Boehringer Ingelheim Pharmaceuticals has received US Food and Drug Administration…

Boehringer IngelheimPharmaceuticalRegulationRespiratory and PulmonarySpirivaUSA

AbbVie's Humira gains added indication from US FDA

AbbVie's Humira gains added indication from US FDA

25-09-2014

The US Food and Drug Administration has approved US drugmaker AbbVie’s Humira (adalimumab) for reducing…

AbbVieGastro-intestinalsHumiraInflammatory diseasesPharmaceuticalRegulationUSA

FDA warning letters rise 78% over six years with increase expected in 2015

FDA warning letters rise 78% over six years with increase expected in 2015

25-09-2014

The number of warning letters sent by the US Food and Drug Administration increased substantially by…

PharmaceuticalRegulationUSA

NICE opens consultation on three drugs for chronic bowel condition

NICE opens consultation on three drugs for chronic bowel condition

24-09-2014

Three drugs to treat ulcerative colitis, a chronic bowel condition, have not been proven to be more cost…

AbbVieGastro-intestinalsHumiraMerck & CoPharmaceuticalPricingRegulationRemicadeSimponi InjectionUK

FDA accepts NDA filing for Lundbeck and Otsuka's brexpiprazole

FDA accepts NDA filing for Lundbeck and Otsuka's brexpiprazole

24-09-2014

The US Food and Drug Administration has accepted the filing for review of brexiprazole for the treatment…

CNS DiseasesLundbeckOtsukaPharmaceuticalRegulationUSA

Tekmira shares jump as US FDA and Health Canada expand access to Ebola drug

Tekmira shares jump as US FDA and Health Canada expand access to Ebola drug

23-09-2014

Shares of Tekmira Pharmaceuticals have rocketed after the US Food and Drug Administration authorized…

Antibiotics and Infectious diseasesCanadaEbolaFDAHealthPharmaceuticalRegulationTekmira PharmaceuticalsTKM-EbolaUSA

Despite limited size, Chile's pharma market offers growing opportunity

23-09-2014

By the end of 2014, the Chilean pharmaceutical market is expected to be worth $2 billion, increasing…

ChileHealthcareMarkets & MarketingPatentsPharmaceuticalRegulation

OxThera’s Oxabact gains orphan drug designation in EU

OxThera’s Oxabact gains orphan drug designation in EU

23-09-2014

Privately-held Swedish biopharmaceutical company OxThera AB’s product Oxabact (oxalobacter formigenes)…

EUGastro-intestinalsOxabactOxTheraPharmaceuticalRegulationSweden

IMS Health identifies 10 events that may transform the delivery of health care

IMS Health identifies 10 events that may transform the delivery of health care

23-09-2014

As the global market for drugs surpasses $1 trillion this year, growing payer scrutiny of value for money…

Anti-viralsFinancialGlobalHealthcarePharmaceuticalRegulationResearchVaccines

Mitsubishi Tanabe Pharma gains approval for Telavic in genotype 2 HCV

Mitsubishi Tanabe Pharma gains approval for Telavic in genotype 2 HCV

22-09-2014

Japanese pharma company Mitsubishi Tanabe Pharma has received approval for an additional indication of…

Anti-viralsJapanMitsubishi TanabePharmaceuticalRegulationTelavic

Europe’s regulatory system for medicines can be used more effectively

Europe’s regulatory system for medicines can be used more effectively

22-09-2014

A new report from Escher, the independent TI Pharma platform for regulatory innovation, shows that the…

Andre BroekmansEuropePharmaceuticalPharmacologyRegulation

Bayer’s Eylea approved in Japan for myopic CNV

Bayer’s Eylea approved in Japan for myopic CNV

22-09-2014

Bayer Yakuhin, the Japanese health care subsidiary if Germany’s Bayer has received approval from Japan’s…

BayerEyleaJapanOphthalmicsPharmaceuticalRegeneron PharmaceuticalsRegulation

Vivus and Auxilium’s Stendra ED drug approved as “on-demand” treatment in USA

Vivus and Auxilium’s Stendra ED drug approved as “on-demand” treatment in USA

19-09-2014

The US Food and Drug Administration has approved a supplemental New Drug Application for Stendra (avanafil),…

Auxilium PharmaceuticalsMen's HealthPharmaceuticalRegulationStendraUSAVivus

FDA calls for tighter controls over testosterone replacement therapies

FDA calls for tighter controls over testosterone replacement therapies

19-09-2014

An advisory panel of the US Food and Drug Administration has voted to tighten use of testosterone replacement…

AndrogensAndrologyClarus TherapeuticsEndocrine systemMen's HealthPharmaceuticalRegulationRextoroTestosterone replacementUSA

FDA approves Lilly’s Trulicity to treat type 2 diabetes

FDA approves Lilly’s Trulicity to treat type 2 diabetes

19-09-2014

The US Food and Drug Administration yesterday approved pharma major Eli Lilly’s Trulicity (dulaglutide),…

BydureonDiabetesdulaglutideEli LillyPharmaceuticalRegulationTanzeumTrulicityUSAVictoza

First Ph III data in Japanese patients for Merck’s omarigliptin for type 2 diabetes

18-09-2014

US pharma giant Merck & Co has announced the presentation of the first data from the Phase III clinical…

DiabetesJapanMerck & CoomarigliptinPharmaceuticalRegulationResearch

UK NICE consults on draft guidance for hepatitis C drug Olysio

UK NICE consults on draft guidance for hepatitis C drug Olysio

18-09-2014

In draft guidance published today UK drugs watchdog the National Institute for Health and Care Excellence…

Anti-viralsJanssenJohnson & JohnsonOlysioPharmaceuticalPricingRegulationUK

1 to 25 of 2137 results

Back to top