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New legislation for regenerative medicine in Japan

New legislation for regenerative medicine in Japan

22-11-2013

The Japanese legislature (Diet) has approved new legislation targeted at regenerative medicine therapies.…

Asia-PacificBiotechnologyCytori TherapeuticsLegalRegulationResearch

Australia’s TGA streamlines adverse event reporting

21-11-2013

Australia’s medicines regulator the Therapeutic Goods Administration (TGA) has introduced a streamlined…

Asia-PacificPharmaceuticalRegulationResearch

Following talks with FDA, Sanofi drops fedratinib development

Following talks with FDA, Sanofi drops fedratinib development

18-11-2013

French drug major Sanofi this morning revealed its decision to halt all clinical trials and cancel plans…

fedratinibOncologyPharmaceuticalRegulationResearchSanofi

UK expert group calls for earlier patient access to medicines

17-11-2013

In a report published Friday (November 15) by the UK’s Medicines and Healthcare Products Regulatory…

EuropePharmaceuticalRegulationResearch

EMA staffers see excessive risk aversion in medicines regulation as a problem

EMA staffers see excessive risk aversion in medicines regulation as a problem

15-11-2013

Excessive risk aversion in regulatory decision-making on medicines is not in the best interest of patients…

EuropePharmaceuticalRegulationResearch

Sarepta plunges as FDA questions eteplirsen trial results

Sarepta plunges as FDA questions eteplirsen trial results

12-11-2013

Shares of US RNA-based drug developer Sarepta Therapeutics plummeted in pre-market trading on November…

BiotechnologydrisaperseneteplirsenGlaxoSmithKlineNorth AmericaRare diseasesRegulationResearchSarepta Therapeutics

UK study shows increasing levels of disclosure for industry-sponsored clinical trials

UK study shows increasing levels of disclosure for industry-sponsored clinical trials

12-11-2013

The publication this week of a study assessing clinical trial transparency is a baseline on the current…

EuropePharmaceuticalRegulationResearch

Curis plunges on negative CUCD-427 news; 3rd-qtr loss down

07-11-2013

Oncology focussed US biotech firm Curis saw its shares sink 21% to $3.08, after it revealed receipt of…

BiotechnologyCUCD-427CurisFinancialNorth AmericaOncologyRegulationResearch

US orphan status for Pharmalink’s Busulipo

US orphan status for Pharmalink’s Busulipo

29-10-2013

Swedish specialty pharma group Pharmalink says its product Busulipo, (busulfan), a best-in-class conditioning…

BusulipoNefeconNephrology and HepatologyNorth AmericaOncologyPharmaceuticalPharmaLinkRegulationResearch

Rigel sees clear forward path for fostamatinib but will drop R333

25-10-2013

Clinical-stage US drug developer Rigel Pharmaceuticals has announced mixed updates on two of its pipeline…

BiotechnologyDermatologicalsfostamatinibImmunologicalsR333RegulationResearchRigel Pharmaceuticals

Merck & Co expects to file BLA for HPV vaccine candidate V503 this year

Merck & Co expects to file BLA for HPV vaccine candidate V503 this year

25-10-2013

Merck & Co yesterday provided an overview of the clinical trial program for V503, the company’s investigational…

Merck & CoNorth AmericaPharmaceuticalRegulationResearchV503Vaccines

Ariad stops Ph III Iclusing trial on blood clot woes

18-10-2013

US biotech firm Ariad Pharmaceuticals’took another tumble, falling 35% to $2.91, as the company said…

Ariad PharmaceuticalsBiotechnologyIclusigNorth AmericaOncologyRegulationResearch

Oxford BioMedica gets US and French go-ahead to resume recruitment into ocular clinical trials

17-10-2013

Oxford BioMedica has received agreement from the US Food and Drug Administration and the French regulatory…

BiotechnologyEuropeOphthalmicsOxford BioMedicaRegulationResearch

Reliable assessment of drugs is only possible on the basis of clinical study reports, says IQWiG

Reliable assessment of drugs is only possible on the basis of clinical study reports, says IQWiG

11-10-2013

In 2012, researchers from the German Institute for Quality and Efficiency in Health Care (IQWiG) presented…

EuropePharmaceuticalRegulationResearch

Bioniche’s Canadian filing for Urocidin delayed

10-10-2013

Canadian biopharma firm Bioniche Life Sciences has provided an update on its plans for a New Drug Submission…

Bioniche Life SciencesLicensingPharmaceuticalRegulationResearchUrocidin

FDA clinical hold on Iclusig sees Ariad stock go into free-fall

FDA clinical hold on Iclusig sees Ariad stock go into free-fall

10-10-2013

US drugmaker Ariad Pharmaceuticals saw its shares plunge 59% to $6.99 yesterday, wiping $2 billion off…

Ariad PharmaceuticalsBiotechnologyIclusigNorth AmericaOncologyRegulationResearch

PhRMA calls for regulatory environment to support rare disease research

PhRMA calls for regulatory environment to support rare disease research

08-10-2013

US biopharmaceutical research companies are developing 452 new medicines for rare diseases, according…

North AmericaPharmaceuticalRare diseasesRegulationResearch

New data support GSK plan to file for approval of malaria vaccine in 2014

New data support GSK plan to file for approval of malaria vaccine in 2014

08-10-2013

Results from a large-scale Phase III trial, presented today at the Multilateral Initiative on Malaria…

GlaxoSmithKlinePharmaceuticalRegulationResearchRTS,STropical diseasesVaccines

Japanese lawmakers are stepping in to Diovan investigation

07-10-2013

Members of Japan’s Diet (Congressmen) have formed a bipartisan study group to examine Swiss drug major…

Asia-PacificCardio-vascularDiovanNovartisPharmaceuticalPoliticsRegulationResearch

Europe’s biopharma SMEs endorse further clinical data sharing but with reservations

04-10-2013

European Biopharmaceutical Enterprises, a specialized group of the EFPIA, says it recognizes the potential…

EuropePharmaceuticalRegulationResearch

EFPIA expresses serious concerns on EMA draft policy for clinical trials data

08-09-2013

Representing the research-based pharma industry in Europe, the European Federation of Pharmaceutical…

EuropePharmaceuticalRegulationResearch

Phase III data support biosimilarity of BOW-015 to Remicade

29-08-2013

Privately-held US biotech firm EPIRUS Biopharmaceuticals, which is focused on the development and production…

Anti-Arthritics/RheumaticsBiotechnologyEPIRUS BiopharmaceuticalsGenericsinfliximabRegulationRemicadeResearch

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