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Medac’s Rasuvo approved for RA while Antares’ injunction is denied

Medac’s Rasuvo approved for RA while Antares’ injunction is denied

14-07-2014

USA-based Medac Pharma, a wholly-owned subsidiary of privately-held German firm medac GmbH, says that…

Antares PharmaAnti-Arthritics/RheumaticsLegalMedac PharmaPharmaceuticalRasuvoRegulationUSA

Updated legislation may boost phytotherapic drug production in Brazil

Updated legislation may boost phytotherapic drug production in Brazil

14-07-2014

Pharma companies are unsure of the extent of the commercialization of phytotherapic drugs in Brazil,…

BrazilPharmaceuticalRegulation

Canadian approval for Sunovion’s Aptiom

Canadian approval for Sunovion’s Aptiom

14-07-2014

USA-based drugmaker Sunovion Pharmaceuticals, a subsidiary of Japan’s Dainippon Sumitomo, has received…

AptiomBIA-2093-301CanadaDainippon Sumitomo PharmaEpilepsyNeurologicalPharmaceuticalRegulationSunovion Pharmaceuticals

Astellas submits sNDA for Irribow/Irribow OD in Japan

Astellas submits sNDA for Irribow/Irribow OD in Japan

14-07-2014

Japanese drug major Astellas Pharma has submitted a supplemental New Drug Application for the indication…

Astellas PharmaGastro-intestinalsIrribowJapanPharmaceuticalRegulation

Lundbeck and Otsuka file for US approval of brexpiprazole

Lundbeck and Otsuka file for US approval of brexpiprazole

14-07-2014

Danish CNS drug specialist Lundbeck and Japanese drugmaker Otsuka have submitted a New Drug Application…

brexpiprazoleLundbeckMarkets & MarketingNeurologicalOtsukaPharmaceuticalPiperidinesRegulationUSA

US regulatory warnings on drug producers extend well beyond India

US regulatory warnings on drug producers extend well beyond India

14-07-2014

Hauled up by the US Food and Drug Administration for product recalls and quality issues, Indian pharmaceutical…

CiplaDr Reddy's LaboratoriesGenericsIndiaLupinProductionRanbaxy LaboratoriesRegulationSun PharmaceuticalUSA

EUCOPE slams French plans to cut spending through off-label drugs

EUCOPE slams French plans to cut spending through off-label drugs

12-07-2014

The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) says it is very concerned about legislative…

AvastinEuropeFranceLegalOphthalmicsPharmaceuticalRegulationRoche

Actavis confirms patent challenge to Duchesnay’s Diclegis

Actavis confirms patent challenge to Duchesnay’s Diclegis

12-07-2014

Ireland-based generics major Actavis on Friday confirmed that it has filed an Abbreviated New Drug Application…

ActavisDiclegisDuchesnayGenericsPatentsRegulationUSAWomen's Health

NICE issues positive draft FAD guidance on Tecfidera

NICE issues positive draft FAD guidance on Tecfidera

11-07-2014

UK health care cost watchdog the National Institute for Health and Care Excellence (NICE) has issued…

Biogen IdecBiotechnologyMultiple sclerosisNeurologicalPricingRegulationTecfideraUK

UK cancer patients face increasing coverage restriction, US report shows

UK cancer patients face increasing coverage restriction, US report shows

11-07-2014

New US research released yesterday quantifies the extent to which centralized value assessments by the…

OncologyPharmaceuticalPricingRegulationUK

Sarepta tanks despite positive data on eteplirsen in Duchenne MD

Sarepta tanks despite positive data on eteplirsen in Duchenne MD

11-07-2014

US RNA-based drug developer Sarepta Therapeutics saw its shares plunge, despite the company releasing…

BiotechnologyeteplirsenRare diseasesRegulationResearchSarepta TherapeuticsUSA

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

Regado Biosciences announces FDA’s clinical hold of Ph III trial

Regado Biosciences announces FDA’s clinical hold of Ph III trial

10-07-2014

The US Food and Drug Administration (FDA) has informed US-based cardiovascular specialist Regado Biosciences…

Acute coronary syndromeBiotechnologybivalirudinCardio-vascularMedicineRegadoRegulationUSA

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

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