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Bristol-Myers to file Opdivo BLA earlier than expected

Bristol-Myers to file Opdivo BLA earlier than expected

10-07-2014

Following discussions with the US Food and Drug Administration, Bristol-Myers Squibb is planning a third…

Bristol-Myers SquibbnivolumabOncologyOpdivoPharmaceuticalRegulationUSA

Orphan drug approvals rise, but high costs pose challenges for patients

Orphan drug approvals rise, but high costs pose challenges for patients

10-07-2014

Although the pace of approvals for new orphan drugs - medicines that treat relatively rare conditions…

EuropePharmaceuticalPricingRare diseasesRegulationUSA

EU orphan designations for OPKO's clotting Factor VIIa-CTP

EU orphan designations for OPKO's clotting Factor VIIa-CTP

10-07-2014

The European Committee for Orphan Medicinal Products (COMP) gave a positive opinion recommending the…

EuropeFactor VIIa-CTPHematologyOPKO HealthPharmaceuticalRare diseasesRegulation

Research shows FDA approval process for ADHD drugs does not study long-term safety or efficacy

Research shows FDA approval process for ADHD drugs does not study long-term safety or efficacy

10-07-2014

Researchers have highlighted a flaw in the US Food and Drug Administration’s approval process for attention…

Kenneth MandlNeurologicalPharmaceuticalPharmacologyPharmacovigilanceRegulationRitalinUSA

Proveca reaches agreement with EMA over heart failure drug for children

Proveca reaches agreement with EMA over heart failure drug for children

10-07-2014

UK pharmaceutical company Proveca has reached its fourth key agreement with the European Medicines Agency…

CaptoprilCardio-vascularPharmaceuticalRegulationUK

UK’s NICE backs Lundbeck drug for alcohol dependence

UK’s NICE backs Lundbeck drug for alcohol dependence

10-07-2014

In new draft guidance, the UK drug watchdog the National Institute for Health and Care Excellence (NICE)…

LundbeckNeurologicalPharmaceuticalPricingRegulationSelincroUK

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

France adopts draft law on off-label use of drugs

France adopts draft law on off-label use of drugs

09-07-2014

The French National Assembly yesterday voted on the draft law proposal, which would potentially allow…

AvastinDraft law proposalEuropeFranceLegalOphthalmicsPharmaceuticalRegulationRoche

Novo Nordisk gains FDA backing for new NovoSeven RT indication

Novo Nordisk gains FDA backing for new NovoSeven RT indication

09-07-2014

Danish diabetes care giant Novo Nordisk’s hemophilia treatment NovoSeven RT (coagulation factor VIIa…

HematologyNovo NordiskNovoSevenNovoSeven RTPharmaceuticalRare diseasesRegulationUSA

New Zealand proposes contestable fund for medicines for rare disorders

New Zealand proposes contestable fund for medicines for rare disorders

09-07-2014

New Zealand’s Pharmaceutical Management Agency PHARMAC will be running a commercial process to fund…

FinancialNew ZealandPharmaceuticalRare diseasesRegulation

Swissmedic approves Amitiza for opioid-induced constipation

Swissmedic approves Amitiza for opioid-induced constipation

08-07-2014

US biopharma firm Sucampo Pharmaceuticals has received approval from Swissmedic, Switzerland’s Agency…

AmitizaEuropeGastro-intestinalsPharmaceuticalRegulationSucampo

Novartis receives fifth Breakthrough Therapy designation with CTL019 for leukemia

Novartis receives fifth Breakthrough Therapy designation with CTL019 for leukemia

08-07-2014

Swiss drug major Novartis has been granted Breakthrough Therapy designation for its leukemia treatment…

CancerCTL019LeukemiaNovartisOncologyPharmaceuticalRefractory acute lymphoblastic leukemiaRegulationUSA

Sanofi's NDA for basal insulin Toujeo accepted by FDA

Sanofi's NDA for basal insulin Toujeo accepted by FDA

08-07-2014

The US Food and Drug Administration has accepted for review French pharma major Sanofi’s New Drug Application…

DiabetesPharmaceuticalRegulationSanofiToujeoUSA

Bristol-Myers hepatitis C treatment Daklinza+Sunvepra OKed in Japan

Bristol-Myers hepatitis C treatment Daklinza+Sunvepra OKed in Japan

07-07-2014

The Japanese Ministry of Health, Labor and Welfare has approved Daklinza (daclatasvir), a potent, pan-genotypic…

Anti-viralsBristol-Myers SquibbDaklinzaDaklinza+SunvepraJapanPharmaceuticalRegulationSunvepra

CASI granted Orphan Drug designation in treatment of hepatocellular carcinoma

CASI granted Orphan Drug designation in treatment of hepatocellular carcinoma

07-07-2014

US-based pharmaceutical company CASI, which develops therapeutics for the treatment of cancer and other…

CASIENMD-2076Hepatocellular carcinomaOncologyPharmaceuticalRegulationUSA

AcelRx and Grunenthal file for EU approval of Zalviso

AcelRx and Grunenthal file for EU approval of Zalviso

07-07-2014

USA-based AcelRx Pharmaceuticals revealed this morning that its partner, family-owned German drugmaker…

AcelRxEuropeGrunenthalNeurologicalPharmaceuticalRegulationZalviso

Positive WHO assessment of China’s vaccines regulatory authority

Positive WHO assessment of China’s vaccines regulatory authority

06-07-2014

China's national vaccine supervision system has met or passed all the standard requirements of the World…

ChinaPharmaceuticalRegulationVaccines

GSK receives EU approval for Mekinist for melanoma

GSK receives EU approval for Mekinist for melanoma

04-07-2014

The European Commission has granted marketing authorization for UK pharma giant GlaxoSmithKline’s Mekinist…

EuropeGlaxoSmithKlineMekinistOncologyPharmaceuticalRegulation

Japan marketing approval for Canaglu; vaccine license for Daiichi Sankyo

Japan marketing approval for Canaglu; vaccine license for Daiichi Sankyo

04-07-2014

Japanese drug major Mitsubishi Tanabe Pharma has received approval to manufacture and market the SGLT2…

canagliflozinCanagluDaiichi SankyoDiabetesJapanMitsubishi TanabePharmaceuticalRegulationSanofi PasteurVaccines

Japan first to approve Roche’s lung cancer drug alectinib

Japan first to approve Roche’s lung cancer drug alectinib

04-07-2014

The Japanese Ministry of Health, Labor and Welfare has approved Swiss pharma major Roche’s alectinib…

alectinibJapanOncologyPharmaceuticalRegulationRoche

FTC puts conditions on Valeant’s acquisition of Precision Dermatology

FTC puts conditions on Valeant’s acquisition of Precision Dermatology

04-07-2014

Canada’s Valeant Pharmaceuticals International and its takeover target Precision Dermatology have agreed…

ActavisDermatologicalsMatawan PharmaceuticalsMergers & AcquisitionsPharmaceuticalPreCision DermatologyRegulationValeant Pharmaceuticals International

Brazil’s ANVISA opens public consultation on bioavailability/bioequivalence of medicines

Brazil’s ANVISA opens public consultation on bioavailability/bioequivalence of medicines

04-07-2014

The Brazilian National Health Surveillance Agency, ANVISA, has initiated a public consultation to review…

BrazilPharmaceuticalRegulation

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