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US breakthrough designation in IPF for Boehringer’s nintedanib

US breakthrough designation in IPF for Boehringer’s nintedanib

17-07-2014

The US Food and Drug Administration has granted Breakthrough Therapy designation for German family-owned…

Boehringer IngelheimnintedanibPharmaceuticalRegulationRespiratory and PulmonaryUSA

Canada approves Pendopharm’s all-oral ribavirin treatment Ibavyr for hepatitis C

Canada approves Pendopharm’s all-oral ribavirin treatment Ibavyr for hepatitis C

16-07-2014

Quebec-based Pendopharm, a division of privately-held Canadian drugmaker Pharmascience, says the regulator…

Anti-viralsBiotechnologyCanadaIbavyrPendopharmPharmascienceRegulation

Breast cancer: DMP is largely consistent with guidelines, says IQWiG

Breast cancer: DMP is largely consistent with guidelines, says IQWiG

16-07-2014

The German Institute for Quality and Efficiency in Health Care (IQWiG) has today published the results…

Breast cancerGermanyInstitute for Quality and Efficiency in Health CareOncologyPharmaceuticalRegulation

CellAct Pharma receives orphan drug designation in EU for cancer drug

CellAct Pharma receives orphan drug designation in EU for cancer drug

16-07-2014

The European Medicines Agency’s Committee for Orphan Medicinal Products has granted German cancer specialists…

CAP7.1CellAct PharmaEuropeGermanyHepatologyOncologyPharmaceuticalRegulationTreatment of biliary tract cancers

Breakthrough therapy designation likely to positively influence oncologists

Breakthrough therapy designation likely to positively influence oncologists

15-07-2014

Breakthrough therapy designation is likely to positively influence perceptions of the drug for both oncologists…

Decision Resources GroupOncologyPharmaceuticalRegulationUSA

Ariad says PRAC requires additional data on Iclusig

Ariad says PRAC requires additional data on Iclusig

15-07-2014

US specialty pharma firm Ariad Pharmaceuticals says that the Pharmacovigilance Risk Assessment Committee…

Ariad PharmaceuticalsEuropeIclusigOncologyPharmaceuticalPharmacovigilance Risk Assessment CommitteeRegulation

Boehringer Ingelheim’s Pradaxa available in UK for DVT

Boehringer Ingelheim’s Pradaxa available in UK for DVT

15-07-2014

German family-owned drug major Boehringer Ingelheim says that Pradaxa (dabigatran etexilate) will be…

Boehringer IngelheimDeep vein thrombosisHematologyPharmaceuticalPradaxaRegulationUK

FDA accepts Teva’s NDA for albuterol MDPI

FDA accepts Teva’s NDA for albuterol MDPI

15-07-2014

Israel-based generic giant Teva Pharmaceuticals Industries says that the US Food and Drug Administration…

albuterolExercise-induced bronchospasmGenericsPulmonologyRegulationRespiratory and PulmonaryTeva Pharmaceutical IndustriesUSA

US Pharma and BIO appeal Alameda Ordinance on drug disposal

US Pharma and BIO appeal Alameda Ordinance on drug disposal

15-07-2014

The counsel for the Pharmaceutical Research and Manufacturers of America (PhRMA), joined by the Biotechnology…

LegalPharmaceuticalRegulationUSA

Janssen files to expand label for Invega Sustenna to show delayed time to relapse in schizophrenia

Janssen files to expand label for Invega Sustenna to show delayed time to relapse in schizophrenia

15-07-2014

US health care giant Johnson & Johnson’s Europe-based subsidiary Janssen has submitted a supplemental…

Invega SustennaJanssenNeurologicalPharmaceuticalRegulationSchizophreniaUSA

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

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