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


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


Phase III data support biosimilarity of BOW-015 to Remicade


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

Anti-Arthritics/RheumaticsBiotechnologyEPIRUS BiopharmaceuticalsGenericsinfliximabRegulationRemicadeResearch

Positive results with MannKind's type 1 diabetes drug please investors


There was good news for loss-making US drugmaker MannKind (Nasdaq: MNKD), when the company announced…

AfrezzaDiabetesMannKindNorth AmericaPharmaceuticalRegulationResearch

HAI Europe questions pharma commitment to clinical trial data transparency, claiming leaked documents suggest otherwise


Consumer advocacy Health Action International (HAI) Europe says it welcomes any initiative that grants…

BiotechnologyEuropeNorth AmericaPharmaceuticalPoliticsRegulationResearch

Vertex slumps as FDA delays hepatitis C trial


US drug maker Vertex Pharmaceuticals (Nasdaq: VRTX) saw its shares drop 11% to $78 a share, in after-hours…

Anti-viralsBiotechnologyNorth AmericaPharmaceuticalRegulationResearchVertexVX-135

US orphan designation for defactinib in mesothelioma


US cancer drug developer Verastem (Nasdaq: VSTM) says that its lead cancer stem cell inhibitor, VS-6063…


European and US drugmakers commit to responsible clinical data sharing


In a joint statement issued this morning (July 24), the European Federation of Pharmaceutical Industries…

BiotechnologyEuropeNorth AmericaPharmaceuticalRegulationResearch

FDA grants orphan designation for Armagen's lead product


California, USA-based Armagen says that the US Food and Drug Administration has granted orphan drug designation…

AGT-182ArmagenPharmaceuticalRare diseasesRegulationResearch

Annual approvals of new drugs for neglected diseases nearly doubled since early 2000s and 2009-12; Tufts


The annual number of new drug approvals worldwide to treat neglected diseases has nearly doubled in recent…

Anti-viralsPharmaceuticalRegulationResearchTropical diseases

Celgene gets negative NICE view on Revlimid in rare blood cancer; presents new data in newly-diagnosed MM


US biotech firm Celgene (Nasdaq: CELG) today (July 11) expressed disappointment at the preliminary decision…

BiotechnologyCelgeneEuropeOncologyPricingRare diseasesRegulationResearchRevlimid

The case for Insmed's CF drug candidate Arikace; analysts' views


The 16% decline in US biotech firm Insmed's (Nasdaq CM: INSM) stock is an overreaction to results from…

ArikaceBiotechnologyFinancialInsmedRare diseasesRegulationResearchRespiratory and Pulmonary

Indian pharma threatened by trend of shifting R&D operations overseas: survey


Red tape is putting India's multi-billion dollar worth pharmaceutical industry at risk, with most of…

Asia-PacificGenericsMarkets & MarketingPharmaceuticalRegulationResearch

US FDA puts partial clinical hold on Cell Thera's blood cancer drug tosedostat trial


US biotech firm Cell Therapeutics (Nasdaq: CTIC) revealed this week in a filing with the Securities Exchange…

BiotechnologyCell TherapeuticsNorth AmericaOncologyRegulationResearchtosedostat

EMA consults on policy for the publication and access to clinical-trial data; slammed by industry


The European Medicines Agency has released a draft policy on the publication and access to clinical-trial…


European Commission updates on Pediatric Regulation


The European Commission has published a progress report on medicines for children covering the five years…


Positive Ph III findings on ALK's new house dust mite allergy immunotherapy; EU filing expected in 2014


Denmark-based allergy specialist ALK Abello (ALKB: DC) has announced positive outcome of the first of…

ALK AbelloImmunologicalsPharmaceuticalRegulationResearchRespiratory and Pulmonary

American Diabetes Association calls for independent review of incretin-based therapy


The American Diabetes Association is asking all pharmaceutical companies involved in the development…

DiabetesJanuviaMerck & CoPharmaceuticalRegulationResearch

US FDA considering making "masked" trial data available to outside experts


According to a Federal Register posting, the US Food and Drug Administration is seeking public comments…

BiotechnologyNorth AmericaPharmaceuticalRegulationResearch

European Medicines Agency and EUnetHTA review progress of their cooperation


The European Medicines Agency and EUnetHTA, the European network for Health Technology Assessment (HTA),…


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