Regulation - Regulation, Pharmaceutical

Filter

Current filters:

RegulationPharmaceutical

Popular Filters

1 to 25 of 2139 results

US DEA publishes final rule to reschedule hydrocodone combination products

US DEA publishes final rule to reschedule hydrocodone combination products

22-08-2014

The US Drug Enforcement Administration (DEA) has today published in the Federal Register the Final Rule…

AnalgesiaPharmaceuticalRegulationUS Drug Enforcement AdministrationUSA

FDA expands indication for Eliquis to treatment of DVT and PE

FDA expands indication for Eliquis to treatment of DVT and PE

22-08-2014

US pharma majors Bristol-Myers Squibb and Pfizer late yesterday said that the US Food and Drug Administration…

Boehringer IngelheimCardio-vascularEliquisPfizerPharmaceuticalPulmonary embolismRegulationUSA

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

Public Citizen expert slams aspects of FDA draft drug labeling guidance

Public Citizen expert slams aspects of FDA draft drug labeling guidance

21-08-2014

The US Food and Drug Administration recently issued draft guidance that would let the pharmaceutical…

PharmaceuticalRegulationUSA

US FDA backs approval of GSK’s Arnuity Ellipta for asthma

US FDA backs approval of GSK’s Arnuity Ellipta for asthma

21-08-2014

UK pharma giant GlaxoSmithKline revealed late yesterday that the US Food and Drug Administration has…

Arnuity ElliptaGlaxoSmithKlinePharmaceuticalRegulationRespiratory and PulmonaryUSA

IQWiG finds added benefit for Novartis’ Jakavi in myelofibrosis

IQWiG finds added benefit for Novartis’ Jakavi in myelofibrosis

20-08-2014

In an early benefit assessment under the German Act on the Reform of the Market for Medicinal Products,…

Federal Joint CommitteeGermanyJakaviMyelofibrosisNovartisOncologyPharmaceuticalPricingRare diseasesRegulation

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

Eisai submits marketing authorization to the EU for Fycompa in new seizure indication

Eisai submits marketing authorization to the EU for Fycompa in new seizure indication

20-08-2014

Japanese drug major Eisai has submitted a marketing authorization application to the European Commission…

BrainCNS DiseasesEisaiEpilepsyFycompaJapanPartial-onset seizuresPharmaceuticalPrimary generalized tonic-clonic seizuresRegulationSeizure types

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

Pfizer files palbociclib NDA with FDA for breast cancer

Pfizer files palbociclib NDA with FDA for breast cancer

19-08-2014

US pharma giant Pfizer says it has completed the submission of a New Drug Application to the US Food…

OncologypalbociclibPfizerPharmaceuticalRegulationUSA

Globavir to seek approval and launch of novel Ebola treatment by year-end

Globavir to seek approval and launch of novel Ebola treatment by year-end

19-08-2014

Privately-held US biotech firm Globavir Biosciences said yesterday that it intends to develop its lead…

Antibiotics and Infectious diseasesGBV006Globavir BiosciencesMarkets & MarketingPharmaceuticalRegulationRest of the WorldTropical diseasesUSA

Proposal to expand the quality control of medicines sold in Brazil

Proposal to expand the quality control of medicines sold in Brazil

18-08-2014

Brazilian House Bill 6763/13 introduced by Gorete Pereira (PR-EC) sets the standards to ensure the quality…

BrazilPharmaceuticalProductionRegulation

Eisai files for US and EU approval of lenvatinib for hard to treat thyroid cancer

Eisai files for US and EU approval of lenvatinib for hard to treat thyroid cancer

18-08-2014

Japanese pharma major Eisai has filed applications with the US Food and Drug Administration and the European…

DonepezilEisaiEuropelenvatinibOncologyPharmaceuticalRegulationUSA

IQWiG again turns down Eisai’s epilepsy drug Fycompa

IQWiG again turns down Eisai’s epilepsy drug Fycompa

17-08-2014

The German Institute for Quality and Efficiency in Healthcare (IQWiG) has said that epilepsy drug Fycompa…

EisaiEpilepsyFycompaGermanyNeurologicalPharmaceuticalPricingRegulation

Brazil plans to update the regulatory framework, expand production of medical products

Brazil plans to update the regulatory framework, expand production of medical products

15-08-2014

The Brazilian Ministry of Health has opened a public consultation to establish the criteria for product…

BrazilFederal governmentPharmaceuticalProductionRegulation

FDA FOCUS: FDA Regulations and Drug Shortages in America

FDA FOCUS: FDA Regulations and Drug Shortages in America

15-08-2014

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

FDAFood and Drug AdministrationPharmaceuticalPharmaceutical sciencesRegulationUSA

Pfizer’s meningococcal B vaccine BLA accepted; gains priority review

Pfizer’s meningococcal B vaccine BLA accepted; gains priority review

15-08-2014

The US Food and Drug Administration has accepted for review the Biologics License Application for bivalent…

Invasive meningococcal diseaseLP2086PfizerPharmaceuticalRegulationrLP2086USAVaccines

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

FDA panel recommends Boehringer drug for the maintenance treatment of COPD

FDA panel recommends Boehringer drug for the maintenance treatment of COPD

15-08-2014

There was good news late yesterday for German family-owned pharma major Boehringer Ingelheim, when an…

Boehringer IngelheimPharmaceuticalRegulationRespiratory and PulmonarySpirivatiotropiumUS Food and Drug AdministrationUSA

NICE says benefit of prostate cancer drug Zytiga does not justify price

NICE says benefit of prostate cancer drug Zytiga does not justify price

15-08-2014

The UK’s National Institute for Health and Care Excellence (NICE) has not recommended Zytiga (abiraterone)…

AbirateroneAndrew DillonJanssenOncologyPharmaceuticalRegulationUKZytiga

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

1 to 25 of 2139 results

Back to top