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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

FDA FOCUS: The need for open clinical trial data for FDA approval

FDA FOCUS: The need for open clinical trial data for FDA approval

15-09-2014

In the second of a monthly FDA-focused blog published exclusively by The Pharma Letter, Dr Nicola Davies…

PharmaceuticalPharmacologyRegulationResearchUSA

HAI takes issue with move of pharma policy to DG Enterprise and Industry

HAI takes issue with move of pharma policy to DG Enterprise and Industry

12-09-2014

Consumer advocacy group Health Action International says it is “appalled” by the European Commission’s…

EuropePharmaceuticalPoliticsRegulationResearch

Indian clinical trial rules counter-productive, says ASSOCHAM

Indian clinical trial rules counter-productive, says ASSOCHAM

10-09-2014

The Associated Chambers of Commerce and Industry of India (ASSOCHAM ) has expressed concern at the setback…

IndiaPharmaceuticalPoliticsRegulationResearch

New report debunks some common perceptions of R&D productivity

New report debunks some common perceptions of R&D productivity

08-09-2014

The 2014 edition of the Thomson Reuters CMR Pharmaceutical R&D Factbook, published today, contains some…

GlobalMarkets & MarketingPharmaceuticalRegulationResearch

FDA accepts Actavis’ NDA for ceftazidime-avibactam

FDA accepts Actavis’ NDA for ceftazidime-avibactam

05-09-2014

Ireland-headquartered generic drugs major Actavis today confirmed that the US Food and Drug Administration…

ActavisAntibiotics and Infectious diseasesceftazidime-avibactamPharmaceuticalRegulationResearchUSA

FDA lifts partial clinical hold on OncoMed's ipafricept

05-09-2014

Shares of US biotech companies OncoMed Pharmaceuticals rose 5.6% to $17.68 on news that the US Food and…

BayerBiotechnologyipafriceptOncologyOncoMed PharmaceuticalsRegulationResearchUSA

Novartis' investigational heart failure drug LCZ696 shows striking efficacy

Novartis' investigational heart failure drug LCZ696 shows striking efficacy

31-08-2014

Swiss drug major Novartis on Saturday presented striking new data for its LZC696 heart drug at the European…

Cardio-vascularLCZ696NovartisPharmaceuticalRegulationResearch

Lilly’s ixekizumab shows superiority over etanercept and placebo in Ph III

Lilly’s ixekizumab shows superiority over etanercept and placebo in Ph III

21-08-2014

US pharma major Eli Lilly’s investigational medicine ixekizumab was superior to etanercept and placebo…

Eli LillyInflammatory diseasesixekizumabPharmaceuticalRegulationResearch

Positive top-line Ph III results for Baxter’s BAX 855 in hemophilia A

Positive top-line Ph III results for Baxter’s BAX 855 in hemophilia A

21-08-2014

US drugmaker Baxter International has announced positive results from its Phase III pivotal clinical…

AdvateBAX 855Baxter InternationalHematologyPharmaceuticalRegulationResearch

Positive Ph III data for Amicus’ migalastat as Fabry monotherapy

Positive Ph III data for Amicus’ migalastat as Fabry monotherapy

21-08-2014

US biopharma company Amicus Therapeutics has revealed positive 18-month data from its second Phase III…

Amicus TherapeuticsBiotechnologymigalastatRare diseasesRegulationResearch

Australia’s NHMRC reports on progress to improve clinical trials

Australia’s NHMRC reports on progress to improve clinical trials

20-08-2014

The National Health and Medical Research Council (NHMRC), tasked with implementing a range of initiatives…

AustraliaClinical researchNational Health and Medical Research CouncilPharmaceuticalRegulationResearchTrials portal

Alexza updates on the five post-EMA approval studies for Adasuve

Alexza updates on the five post-EMA approval studies for Adasuve

14-08-2014

US drugmaker Alexza Pharmaceuticals has provided an update on its European Medicines Agency post-approval…

AdasuveAlexza PharmaceuticalEuropeNeurologicalPharmaceuticalPiperazinesPsychiatryRegulationResearch

FDA modifies Tekmira's TKM-Ebola clinical hold to partial hold

FDA modifies Tekmira's TKM-Ebola clinical hold to partial hold

08-08-2014

Canadian RNA interference (RNAi) therapeutics developer Tekmira Pharmaceuticals revealed yesterday that…

Anti-viralsEbolaMicrobiologyPharmaceuticalRegulationResearchTekmira PharmaceuticalsTKM-EbolaUS Food and Drug AdministrationUSA

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

Harlan aims to provide expertise for biologics and biosimilars

31-07-2014

Switzerland-based Harlan Laboratories, a privately held provider of general and specialty toxicology…

BiosimilarsBiotechnologyContract research servicesHarlanRegulationResearchSwitzerlandToxicology services

Is Europe putting cancer research at risk?

25-07-2014

The European Society for Medical Oncology (ESMO) has expressed concern that the proposed European Union…

EuropeOncologyPharmaceuticalRegulationResearch

Sarepta tanks despite positive data on eteplirsen in Duchenne MD

Sarepta tanks despite positive data on eteplirsen in Duchenne MD

11-07-2014

US RNA-based drug developer Sarepta Therapeutics saw its shares plunge, despite the company releasing…

BiotechnologyeteplirsenRare diseasesRegulationResearchSarepta TherapeuticsUSA

EMA delays formal adoption of publication of clinical trial data policy

EMA delays formal adoption of publication of clinical trial data policy

10-07-2014

The European Medicines Agency management board has postponed formal adoption of the policy on publication…

EuropeEuropean Medicines AgencyEuropean UnionPharmaceuticalRegulationResearch

US FDA delays Allergan’s Semprana decision, approves Ozurdex

US FDA delays Allergan’s Semprana decision, approves Ozurdex

01-07-2014

US drugmaker Allergan, the subject of a hostile $53 billion takeover pursuit by Canada’s Valeant Pharmaceuticals…

AllerganBimatoprost Ophthalmic Solution 0.03% for GlaLevadexNeurologicalOphthalmicsOzurdexPharmaceuticalRegulationResearchSempranaUSA

Positive data on Merck & Co’s nausea drug Emend Ph III trial in children

Positive data on Merck & Co’s nausea drug Emend Ph III trial in children

30-06-2014

Positive results have been announced by US pharma giant Merck & Co from a global, investigational Phase…

EmendMerck & CoOncologyPharmaceuticalRegulationResearch

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