Regulation - Libra Laboratory

Filter

Current filters:

Libra Laboratory

Popular Filters

201 to 225 of 2452 results

“Breakthrough Therapy” designation for GlaxoSmithKline’s Promacta/Revolade for SAA

“Breakthrough Therapy” designation for GlaxoSmithKline’s Promacta/Revolade for SAA

03-02-2014

The US Food and Drug Administration has granted “Breakthrough Therapy” designation for UK pharma…

GlaxoSmithKlinePharmaceuticalPromactaRare diseasesRegulationRevolade

SMEs, academia significant originators of innovative medicines in the EU

SMEs, academia significant originators of innovative medicines in the EU

03-02-2014

More than 40% of innovative medicines recommended for marketing authorization in the European Union between…

EuropePharmaceuticalRegulationResearch

FDA approves Hetlioz, first treatment for non-24 hour sleep-wake disorder in blind people

FDA approves Hetlioz, first treatment for non-24 hour sleep-wake disorder in blind people

03-02-2014

The US Food and Drug Administration on Friday approved US drugmaker Vanda Pharmaceutical's Hetlioz (tasimelteon),…

HetliozNeurologicalPharmaceuticalRare diseasesRegulationVanda Pharmaceuticals

Avanir Pharma files NDA for migraine drug AVP-825

30-01-2014

US drugmaker Avanir Pharmaceuticals has submitted a New Drug Application to the US Food and Drug Administration…

Avanir PharmaceuticalsAVP-825NeurologicalNorth AmericaPharmaceuticalRegulationUSA

US Congressmen express concerns on FDA’s proposed change to generic drug labeling policy

US Congressmen express concerns on FDA’s proposed change to generic drug labeling policy

30-01-2014

US Senator Lamar Alexander (Republican, Tennessee), the senior Republican on the Senate Health Committee,…

GenericsNorth AmericaPoliticsRegulationUSA

Teva gets FDA approval of three-times-a-week Copaxone

Teva gets FDA approval of three-times-a-week Copaxone

29-01-2014

Israel’s Teva Pharmaceutical Industries says that the US Food and Drug Administration has approved…

CopaxoneNeurologicalNorth AmericaPharmaceuticalRegulationTeva Pharmaceutical IndustriesUSA

Chinese health professionals' conduct to be regulated

29-01-2014

China's National Health and Family Planning Commission this week issued a draft regulation on health…

Asia-PacificChinaPharmaceuticalRegulation

China’s pharma blacklist could be weakened by inconsistent enforcement

China’s pharma blacklist could be weakened by inconsistent enforcement

29-01-2014

Though Chinese regulators are pushing ahead with a blacklisting system to combat bribery in pharmaceutical…

ChinaLegalPharmaceuticalRegulation

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

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

201 to 225 of 2452 results

Back to top