Regulation - South America

Filter

Current filters:

South America

Popular Filters

176 to 200 of 2549 results

European experts criticize the Drugs Act; focus on Bulgarian drug shortages

17-02-2014

European experts have claimed as unlawful the measures introduced by the amendments to the Act for Medicinal…

EuropeMarkets & MarketingPharmaceuticalRegulation

Scancell granted orphan drug designation for melanoma drug

Scancell granted orphan drug designation for melanoma drug

17-02-2014

UK-based immunotherapy company Scancell has been granted orphan drug designation for its SCIB1 ImmunoBody…

ImmunologicalsOncologyPharmaceuticalRegulationScancellSCIB1UKUSA

FDA approves Vimizim to treat rare congenital enzyme disorder

FDA approves Vimizim to treat rare congenital enzyme disorder

17-02-2014

The US Food and Drug Administration on Friday (February 14) approved BioMarin Pharmaceutical’s Vimizim…

BioMarin PharmaceuticalNorth AmericaPharmaceuticalRare diseasesRegulationUSAVimizim

Another FDA delay for Bayer/J&J’s Xarelto in ACS indication

Another FDA delay for Bayer/J&J’s Xarelto in ACS indication

14-02-2014

There was further negative news for Germany’s Bayer and partner US health care giant Johnson & Johnson,…

BayerCardio-vascularJanssenJohnson & JohnsonNorth AmericaPharmaceuticalRegulationUSAXarelto

Bayer gets “green light” for new transparent low dose contraceptive patch in the EU

Bayer gets “green light” for new transparent low dose contraceptive patch in the EU

14-02-2014

Germany’s Bayer says it has successfully concluded the decentralized European registration procedure…

BayerethinylestradiolEuropegestodenePharmaceuticalRegulationReproductive

Actelion’s Opsumit approved by SwissMedic for PAH patients

Actelion’s Opsumit approved by SwissMedic for PAH patients

14-02-2014

Swiss biotech firm Actelion announced today that SwissMedic has approved Opsumit (macitentan) for pulmonary…

ActelionBiotechnologyCardio-vascularNorthern EuropeOpsumitRegulation

Teva gains full FDA approval of CML drug Synribo

Teva gains full FDA approval of CML drug Synribo

14-02-2014

Israel-based Teva Pharmaceutical Industries says the US Food and Drug Administration has granted full…

North AmericaOncologyPharmaceuticalRegulationSynriboTeva Pharmaceutical IndustriesUSA

FDA says Durect’s pain relief drug Posidur needs additional safety studies

FDA says Durect’s pain relief drug Posidur needs additional safety studies

13-02-2014

US drugmaker Durect Corp says that the US Food and Drug Administration has issued a Complete Response…

AnalgesiaDurectPharmaceuticalPosidurRegulationUSA

FDA advisory committee votes against approval of antiplatelet therapy cangrelor

FDA advisory committee votes against approval of antiplatelet therapy cangrelor

13-02-2014

The US Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted yesterday…

cangrelorCardio-vascularPharmaceuticalRegulationThe Medicines CompanyUSA

FDA expands approval of Imbruvica to treat chronic lymphocytic leukemia

FDA expands approval of Imbruvica to treat chronic lymphocytic leukemia

13-02-2014

The US Food and Drug Administration yesterday expanded the approved use of US health care giant Johnson…

ImbruvicaJanssen BiotechJohnson & JohnsonNorth AmericaOncologyPharmaceuticalPharmacyclicsRegulationUSA

Health Canada approves Celgene’s Pomalyst for multiple myeloma

Health Canada approves Celgene’s Pomalyst for multiple myeloma

12-02-2014

Regulatory agency Health Canada has approved US biotech firm Celgene’s drug Pomalyst (pomalidomide…

BiotechnologyCanadaCelgeneNorth AmericaOncologyPomalystRegulation

Sprout Pharmaceuticals to resubmit NDA for flibanserin

Sprout Pharmaceuticals to resubmit NDA for flibanserin

12-02-2014

US privately-held sexual health specialists Sprout Pharmaceuticals has received ‘clear guidance’…

flibanserinPharmaceuticalRegulationSprout PharmaceuticalsUSAWomen's Health

US FDA visit to India results in first Statement of Intent

US FDA visit to India results in first Statement of Intent

12-02-2014

A Statement of Intent has been jointly signed by officials at India’s Ministry of Health and Family…

IndiaPharmaceuticalPoliticsRegulationUSA

UK’s NICE calls for more people at risk of CVD to be prescribed statins

UK’s NICE calls for more people at risk of CVD to be prescribed statins

12-02-2014

The UK’s National Institute for Health and Care Excellence (NICE) is recommending that many more people…

Cardio-vascularHealthcarePharmaceuticalRegulationUK

FDA to review heart failure risk with AstraZeneca diabetes drug

FDA to review heart failure risk with AstraZeneca diabetes drug

12-02-2014

The US Food and Drug Administration has requested clinical trial data from Anglo-Swedish drug major AstraZeneca,…

AstraZenecaDiabetesKombiglyzeNorth AmericaOnglyzaPharmaceuticalRegulationResearchUSA

Increasing investment in Latin American pharma market

Increasing investment in Latin American pharma market

12-02-2014

Around $12.7 billion has been invested in Latin America’s pharmaceutical market through mergers and…

ArgentinaBrazilChileEcuadorFinancialMergers & AcquisitionsPharmaceuticalSouth America

2014 to be transition year for Japan pharma

2014 to be transition year for Japan pharma

11-02-2014

2014 will be marked as a transition year for the Japanese Pharma industry – but the year is bound to…

Asia-PacificPharmaceuticalPricingRegulationResearch

Sorrento acquires further rights to Cynviloq to Include Australia, Canada and Mexico

11-02-2014

US cancer drug developer Sorrento Therapeutics has obtained exclusive rights to Cynviloq (marketed as…

AustraliaCanadaCynviloqMexicoOncologyPharmaceuticalSamyang BiopharmaceuticalsSorrento TherapeuticsSouth America

India raises concerns over FDA action during visit to promote collaboration

India raises concerns over FDA action during visit to promote collaboration

11-02-2014

The US Food and Drug Administration Commissioner Margaret Hamburg has met with India’s Commerce and…

IndiaPharmaceuticalRegulationUSA

Gilead files for US approval of ledipasvir/sofosbuvir combination for hepatitis C

Gilead files for US approval of ledipasvir/sofosbuvir combination for hepatitis C

11-02-2014

US biotech major Gilead Sciences has submitted a New Drug Application (NDA) to the US Food and Drug Administration…

Antibiotics and Infectious diseasesBiotechnologyGilead SciencesledipasvirRegulationsofosbuvirUSA

Actelion gains approval in Australia for Opsumit in PAH

Actelion gains approval in Australia for Opsumit in PAH

07-02-2014

Swiss biotech firm Actelion (SIX: ATLN) has received approval of Opsumit (macitentan) for the treatment…

ActelionAustraliaBiotechnologyCardio-vascularOpsumitRegulation

New data shows FDA’s proposed generic labeling rules would add to health costs

New data shows FDA’s proposed generic labeling rules would add to health costs

06-02-2014

The US Food and Drug Administration’s Proposed Rule on prescription drug labeling would add $4 billion…

FinancialGenericsNorth AmericaRegulationUSA

176 to 200 of 2549 results

Back to top