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FDA advisory panel backing for Merck/ALK ragweed allergy immunotherapy Ragwitek

FDA advisory panel backing for Merck/ALK ragweed allergy immunotherapy Ragwitek

28-01-2014

The US Food and Drug Administration’s Allergenic Products Advisory Committee has voted that the available…

Alk-AbelloImmunologicalsMerck & CoNorth AmericaPharmaceuticalRagwitekRegulationUSA

Heron Therapeutics says timeline for Sustol resubmission delayed

28-01-2014

US specialty pharma group Heron Therapeutics saw its shares plunge after the company revealed an around…

Heron TherapeuticsNorth AmericaOncologyPharmaceuticalRegulationSustolUSA

Latest guidance from UK’s NICE on Xtandi disappoints Astellas

Latest guidance from UK’s NICE on Xtandi disappoints Astellas

28-01-2014

UK drugs watchdog the National Institute of Health and Care Excellence (NICE) has issued new draft guidance…

Astellas PharmaEuropeOncologyPharmaceuticalPricingRegulationUKXtandi

European Commission approves Gedeon Richter’s Esmya type II Variation

European Commission approves Gedeon Richter’s Esmya type II Variation

27-01-2014

The European Commission has granted marketing authorization to extend the use of Esmya (ulipristal acetate)…

EsmyaEuropeGedeon RichterPharmaceuticalRegulationWomen's Health

NW Bio to expand manufacturing of DCVax products

27-01-2014

US biotech firm Northwest Biotherapeutics has entered into a set of agreements for large-scale expansion…

BiotechnologyDCVaxEuropeNorth AmericaNorthwest BiotherapeuticsProductionRegulationUSA

Call for strategic regulatory rethink for EU generic medicines industry

Call for strategic regulatory rethink for EU generic medicines industry

27-01-2014

“It is vital that costs associated with regulatory processes do not become a barrier to developing…

EuropeFinancialGenericsRegulation

India loses its attraction for pharma clinical trials, as domestic regulations tighten

India loses its attraction for pharma clinical trials, as domestic regulations tighten

27-01-2014

Considered a global clinical trial hub three years ago, India has suffered a series of setbacks, with…

Asia-PacificBioconIndiaPharmaceuticalPiramal HealthcareRegulationResearch

Medigene acquires Trianta Immunotherapies

27-01-2014

Germany’s Medigene this morning revealed that it has acquired 100% of the shares of the Munich-based…

MedigeneMergers & AcquisitionsOncologyPharmaceuticalTrianta ImmunotherapiesVaccines

Positive EMA/CHMP opinion for GlaxoSmithKline’s diabetes drug Eperzan

Positive EMA/CHMP opinion for GlaxoSmithKline’s diabetes drug Eperzan

24-01-2014

Among a batch of positive opinions issued today by the European Medicines Agency’ s Committee for Medicinal…

DiabetesEperzanGlaxoSmithKlinePharmaceuticalRegulation

New US Breakthrough Therapy Designation has potential to shorten drug development time considerably

New US Breakthrough Therapy Designation has potential to shorten drug development time considerably

24-01-2014

The recently launched Breakthrough Therapy Designation (BTD) program in the USA, aimed at expediting…

North AmericaPharmaceuticalRegulation

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

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