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BMJ alleges Boehringer Ingelheim withheld Pradaxa dosing information from regulators

BMJ alleges Boehringer Ingelheim withheld Pradaxa dosing information from regulators

24-07-2014

German family-owned drug major Boehringer Ingelheim has been accused of withholding ‘important analyses’…

Boehringer IngelheimDabigatranGermanyHematologyPharmaceuticalPradaxaPyridinesRegulationUKUniversity of California

UK's NICE changes guidance to recommend Eli Lilly’s Efient for blood clots

UK's NICE changes guidance to recommend Eli Lilly’s Efient for blood clots

23-07-2014

The National Institute for Health and Care Excellence (NICE), the UK’s health care guidance body, has…

Acute coronary syndromesCardio-vascularEfientEli LillyPharmaceuticalprasugrelRegulationUK

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

Halozyme resumes enrolment and dosing of patients under revised protocol with US FDA

Halozyme resumes enrolment and dosing of patients under revised protocol with US FDA

22-07-2014

US-based pharmaceutical company Halozyme Therapeutics has said it is once again enrolling and dosing…

Halozyme TherapeuticsHyaluronidaseOncologyPancreatic cancerPEGylationPharmaceuticalRegulationUSA

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

Valeant takes Allergan's 'false and misleading statements' to Quebec and US financial regulators

Valeant takes Allergan's 'false and misleading statements' to Quebec and US financial regulators

22-07-2014

In the latest in an ongoing takeover attempt of Allergan by Valeant, Valeant has contacted financial…

AllerganBausch & LombCanadaFinancialPharmaceuticalRegulationUSAValeant Pharmaceuticals

Arena Pharma in deal with Teva unit for marketing Belviq in Israel

Arena Pharma in deal with Teva unit for marketing Belviq in Israel

21-07-2014

USA-based Arena Pharmaceuticals has entered into an exclusive marketing and supply agreement for its…

AbicArena PharmaceuticalsBelviqLicensingMetabolicsObesityPharmaceuticalRegulationRest of the WorldTeva Pharmaceutical Industries

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

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

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

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

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

The EMA’s scientific advice to pharma companies is a conflict of interest, says industry coalition

The EMA’s scientific advice to pharma companies is a conflict of interest, says industry coalition

15-07-2014

A coalition of major European medicines advocates has criticized the European Medicines Agency for providing…

EuropeEuropean Medicines AgencyHealth technology assessment bodiesPharmaceuticalPricingRegulation

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

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

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