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Another ban by US FDA on a Ranbaxy production facility

Another ban by US FDA on a Ranbaxy production facility

24-01-2014

As if the Indian drug major has not had enough negative news from the US regulator, the US Food and Drug…

Asia-PacificDaiichi SankyoGenericsIndiaNorth AmericaProductionRanbaxy LaboratoriesRegulationUSA

UK’s NICE gives green light to Roche’s MabThera for GPA and MPA

UK’s NICE gives green light to Roche’s MabThera for GPA and MPA

24-01-2014

UK drugs watchdog the National Institute for Health and Care Excellence (NICE) today approved the use…

EuropeImmunologicalsMabTheraPharmaceuticalPricingRegulationRocheUK

BioLineRx gains orphan status for novel stem cell mobilization treatment

BioLineRx gains orphan status for novel stem cell mobilization treatment

23-01-2014

Israeli drug developer BioLineRx has received notice from the US Food and Drug Administration confirming…

BioLineRxBiotechnologyBL-8040Rare diseasesRegulationResearch

Proposed US legislation on biosimilars welcomed by BIO and WBBA

Proposed US legislation on biosimilars welcomed by BIO and WBBA

23-01-2014

The USA’s Biotechnology Industry Organization (BIO) and the Washington Biotechnology & Biomedical Association…

BiosimilarsGenericsLegalNorth AmericaRegulationUSA

FDA cites insufficient information in response to AMAG’s Feraheme application

FDA cites insufficient information in response to AMAG’s Feraheme application

23-01-2014

US drug company AMAG Pharmaceuticals (Nasdaq: AMAG) has received a complete response letter from the…

AMAG PharmaceuticalsFerahemeHematologyNephrology and HepatologyPharmaceuticalRegulationUSA

Actavis confirms challenge to Allergan’s Restasis

22-01-2014

Generics drug major Actavis has confirmed that its Watson Laboratories unit has submitted an Abbreviated…

ActavisAllerganGenericsNorth AmericaOphthalmicsPatentsRegulationRestasisUSAWatson Pharmaceuticals

Evidence used for FDA decisions “varies widely,” study claims

Evidence used for FDA decisions “varies widely,” study claims

22-01-2014

The quality of clinical trial evidence used by the US Food and Drug Administration as the basis for recent…

PharmaceuticalRegulationUSA

Eisai’s amatuximab gains orphan status in EU for malignant mesothelioma

Eisai’s amatuximab gains orphan status in EU for malignant mesothelioma

22-01-2014

The investigational monoclonal antibody amatuximab (development code: MORAb-009), has today been granted…

amatuximabEisaiEuropePharmaceuticalRare diseasesRegulation

Lundbeck’s Brintellex available in US pharmacies for depression

Lundbeck’s Brintellex available in US pharmacies for depression

22-01-2014

Lundbeck (LUN: CO) and Takeda Pharmaceutical (TYO: 4502) jointly announced today that Brintellix (vortioxetine)…

BrintellixLundbeckMarkets & MarketingNeurologicalPharmaceuticalRegulationTakeda PharmaceuticalsUSA

AstraZeneca’s fixed-dose diabetes drug Xigduo approved in Europe

AstraZeneca’s fixed-dose diabetes drug Xigduo approved in Europe

22-01-2014

The European Commission has approved Anglo-Swedish drug major AstraZeneca and soon to be ex-partner USA-based…

AstraZenecaBristol-Myers SquibbdapagliflozinDiabetesPharmaceuticalRegulationXigduo

NICE recommends Sanofi’s Aubagio as new treatment option for MS

NICE recommends Sanofi’s Aubagio as new treatment option for MS

22-01-2014

In final guidance, UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has…

AubagioBiotechnologyGenzymeNeurologicalNorthern EuropePricingRegulationSanofiUK

Norgine and Kissei’s Savene approved in Japan

21-01-2014

Independent Dutch firm Norgine and its Japanese partner Kissei Pharmaceutical received approval from…

Asia-PacificKissei PharmaceuticalNorgineOncologyPharmaceuticalRegulationSavene

New data reveals substantial variation in patients’ access to medicines across England

New data reveals substantial variation in patients’ access to medicines across England

21-01-2014

Analysis showing the extent to which the UK National Health Service (NHS) is prescribing National Institute…

HealthcarePharmaceuticalRegulationUK

Santhera's Raxone granted temporary use in France

21-01-2014

Switzerland-based Santhera Pharmaceuticals (SIX: SANN) announced today that the French National Agency…

FranceNeurologicalPharmaceuticalRaxoneRegulationSanthera Pharmaceuticals

81 European marketing authorization recommendations in 2013

81 European marketing authorization recommendations in 2013

21-01-2014

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended 81…

EuropePharmaceuticalRegulation

Japanese approval for Bayer’s riociguat for CTEPH

Japanese approval for Bayer’s riociguat for CTEPH

20-01-2014

German pharma major Bayer has received approval from the Ministry of Health, Labor and Welfare for riociguat,…

AdempasAsia-PacificBayerPharmaceuticalRegulationRespiratory and Pulmonaryriociguat

Mexico backs marketing of Aegerion’s Juxtapid for HoFH

Mexico backs marketing of Aegerion’s Juxtapid for HoFH

20-01-2014

US emerging biotech firm Aegerion Pharmaceuticals says that the Mexican Federal Commission for the Protection…

Aegerion PharmaceuticalsJuxtapidMexicoPharmaceuticalRare diseasesRegulationSouth America

Astellas gains Japanese clearance for diabetes drug Suglat

Astellas gains Japanese clearance for diabetes drug Suglat

20-01-2014

Japanese drug major Astellas Pharma has obtained the marketing approval of selective SGLT2 inhibitor…

Asia-PacificAstellas PharmaDiabetesipragliflozinKotobuki PharmaceuticalMerck & CoPharmaceuticalRegulationSuglat

“Differing views” see Zealand and Boehringer change collaboration compound

“Differing views” see Zealand and Boehringer change collaboration compound

20-01-2014

Zealand Pharma and Boehringer Ingelheim will change the development program involving novel glucagon/GLP-1…

Boehringer IngelheimDenmarkDiabetesGermanyPharmaceuticalResearchZealand Pharma

Gilead’s Sovaldi gains EC approval for chronic hepatitis C

Gilead’s Sovaldi gains EC approval for chronic hepatitis C

20-01-2014

US antivirals specialist Gilead Sciences has received marketing authorization from the European Commission…

Anti-viralsBiotechnologyEuropeGilead SciencesPricingRegulationSovaldi

Takeda's lymphoma drug Adcetris approved in Japan

Takeda's lymphoma drug Adcetris approved in Japan

18-01-2014

Japan’s largest drugmaker Takeda Pharmaceutical has received approval from the country’s Ministry…

AdcetrisFinancialOncologyPharmaceuticalRegulationSeattle GeneticsTakeda Pharmaceuticals

Brazil initiates public consultation on interchangeability of biosimilar drugs

Brazil initiates public consultation on interchangeability of biosimilar drugs

17-01-2014

Biosimilar drugs, also known as follow-on biologics, may soon be substituted in place of the reference…

BiosimilarsBrazilPharmaceuticalRegulationSouth America

FDA advisory panel nixes approval of J&J and Bayer’s Xarelto for wider use

FDA advisory panel nixes approval of J&J and Bayer’s Xarelto for wider use

17-01-2014

The US Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee has voted against…

BayerCardio-vascularJanssenJohnson & JohnsonNorth AmericaPharmaceuticalRegulationUSAXarelto

Breakthrough year for unmet diseases, as FDA backs 37 designations in 2013

Breakthrough year for unmet diseases, as FDA backs 37 designations in 2013

17-01-2014

Since the US Food and Drug Administration’s breakthrough therapy designation (BTD) was put into effect…

GazyvaGilead SciencesImbruvicaJohnson & JohnsonPharmaceuticalRegulationRocheSovaldiUSA

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