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NICE recommends Amitiza to treat long-term, painful constipation

NICE recommends Amitiza to treat long-term, painful constipation

23-07-2014

The UK’s National Institute for Health and Care Excellence (NICE) has recommended Amitiza (lubiprostone)…

AmitizaGastro-intestinalsGastroenterologyPharmaceuticalRegulationSucampoUK

UK’s NICE recommends Xtandi and Yervoy under patient access schemes

UK’s NICE recommends Xtandi and Yervoy under patient access schemes

23-07-2014

The UK’s National Institute for Health and Care Excellence (NICE) has issued guidance recommending…

Astellas PharmaBristol-Myers SquibbOncologyPharmaceuticalRegulationUKXtandiYervoy

Novasep sites approved by US FDA

Novasep sites approved by US FDA

22-07-2014

French active ngredients company Novasep has successfully completed US Food and Drug Administration pre-approval…

Active pharmaceutical ingredientFranceNovasepPharmaceuticalRegulationUSA

New cancer drugs approvals in Canada delayed due to extra layer of bureaucratic review

New cancer drugs approvals in Canada delayed due to extra layer of bureaucratic review

21-07-2014

The organization that reviews oncology medicines in Canada may unnecessarily delay approvals while cancer…

BevacizumabCanadaFraser InstituteOncologyPharmaceuticalRegulation

ABPI and Bioindustry Association team up to improve biosimilar understanding

ABPI and Bioindustry Association team up to improve biosimilar understanding

21-07-2014

The Association of the British Pharmaceutical Industry (ABPI) and the Bioindustry Association (BIA) have…

Association of the British Pharmaceutical IndustryBiosimilarsRegulationUK

Australian Health Ministers sign on to end HIV transmissions by 2020

Australian Health Ministers sign on to end HIV transmissions by 2020

21-07-2014

All Australian Health Ministers have committed to working towards the virtual elimination of new Australian…

AIDSAnti-viralsAustraliaHealthcareHIV/AIDSPharmaceuticalPoliticsRegulation

US breakthrough status for InterMune’s pirfenidone

US breakthrough status for InterMune’s pirfenidone

21-07-2014

US biotech firm InterMune’s Esbriet (pirfenidone) has been granted Breakthrough Therapy designation…

BiotechnologyEsbrietFood and Drug AdministrationInterMunepirfenidoneRare diseasesRegulationRespiratory and PulmonaryUSA

Ireland to make more drugs available over the counter

Ireland to make more drugs available over the counter

20-07-2014

Last week, Ireland’s Health Products Regulatory Authority (HPRA) published a list of 12 active substances…

Health Products Regulatory AuthorityIrelandPharmaceuticalRegulation

Harmonizing drugs standards in West Africa

Harmonizing drugs standards in West Africa

18-07-2014

The recent decision by the heads of National Medicine Regulatory Authorities (NMRA) and West African…

AfricaPharmaceuticalRegulationRest of the World

Pharming and Salix gain US approval for Ruconest

Pharming and Salix gain US approval for Ruconest

17-07-2014

Netherlands-based Pharming Group and Salix Pharmaceuticals have received approval from the US Food and…

BiotechnologyPharmingRare diseasesRegulationRuconestSalix PharmaceuticalsUSA

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

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