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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

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

15-08-2013

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

29-07-2013

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

BiotechnologyEuropeNorth AmericaPharmaceuticalPoliticsRegulationResearch

Vertex slumps as FDA delays hepatitis C trial

26-07-2013

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

25-07-2013

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

BiotechnologydefactinibOncologyPharmaceuticalRegulationResearchVerastem

European and US drugmakers commit to responsible clinical data sharing

24-07-2013

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

19-07-2013

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

14-07-2013

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

11-07-2013

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

05-07-2013

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

04-07-2013

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

25-06-2013

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

25-06-2013

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

BiotechnologyEuropePharmaceuticalRegulationResearch

European Commission updates on Pediatric Regulation

24-06-2013

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

EuropePharmaceuticalRegulationResearch

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

20-06-2013

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

12-06-2013

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

12-06-2013

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

07-06-2013

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

BiotechnologyEuropePharmaceuticalRegulationResearch

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