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WHO's calls for more thorough clinical trial result disclosure welcomed by Germany's IQWiG

WHO's calls for more thorough clinical trial result disclosure welcomed by Germany's IQWiG

27-11-2014

The World Health Organization (WHO) has made an official statement on the disclosure of clinical trial…

GlobalHealthPharmaceuticalRegulationResearchWorld Health Organization

Strengthen IP to reposition Australia as a global leader, says Medicines Australia chief to government

Strengthen IP to reposition Australia as a global leader, says Medicines Australia chief to government

26-11-2014

The chief executive of Medicines Australia has called for a strengthening of Australia’s intellectual…

AustraliaBiotechnologyLegalMedicines AustraliaRegulationResearch

HHS and NIH take steps to enhance clinical trial results transparency

20-11-2014

The US Department of Health and Human Services today issued a Notice of Proposed Rulemaking (NPRM), which…

PharmaceuticalRegulationResearchUSA

EMA responds to Ombudsman questioning of AbbVie trial redactions

13-11-2014

The European Medicines Agency says it has taken note of the European Ombudsman’s recent remarks on…

AbbVieAnti-Arthritics/RheumaticsEuropeHumiraPharmaceuticalRegulationResearch

CNS drugs development takes longer than other drugs, says Tufts CSDD

05-11-2014

Drugs that treat central nervous system (CNS) diseases take more than a year longer to develop and are…

NeurologicalPharmaceuticalRegulationResearchUSA

FDA study shows Pradaxa reduces stroke risk but raises chances of GI bleeding

FDA study shows Pradaxa reduces stroke risk but raises chances of GI bleeding

03-11-2014

A study carried out by the US Food and Drug Administration on Pradaxa (dabigatran etexilate mesylate)…

Boehringer IngelheimHematologyPharmaceuticalPradaxaRegulationResearchUSAWarfarin Sodium

US FDA reveals discussions with Sarepta over eteplirsen

US FDA reveals discussions with Sarepta over eteplirsen

31-10-2014

In what is viewed as an unusual step, the US Food and Drug Administration made a website posting of its…

eteplirsenNeurologicalPharmaceuticalRare diseasesRegulationResearchSarepta TherapeuticsUSA

EMA advises GlaxoSmithKline on Ebola vaccine development

29-10-2014

The European Medicines Agency has given scientific advice to UK pharma major GlaxoSmithKline on its development…

Anti-viralsGlaxoSmithKlinePharmaceuticalRegulationResearchVaccines

EuropaBio’s new White Paper 'Realising the Potential of Personalized Medicine in Europe'

27-10-2014

Biotechnology trade group EuropaBio has issued a new White Paper, aiming to identify the required adaptations…

BiotechnologyEuropeRegulationResearch

EMA moves further to push Ebola treatments development

EMA moves further to push Ebola treatments development

23-10-2014

During the past months, the European Medicines Agency has put in place a system to give the best possible…

Anti-viralsEuropePharmaceuticalRegulationResearchVaccines

EMA urging firms with Ebola candidates to seek orphan status

21-10-2014

The European Medicines Agency is aiming to encourage developers of treatments or vaccines against Ebola…

Anti-viralsEuropePharmaceuticalRare diseasesRegulationResearchUSA

Northwest Bio says DCVax-L hospital exemption program under way in Germany

Northwest Bio says DCVax-L hospital exemption program under way in Germany

15-10-2014

US biotech firm Northwest Biotherapeutics, which is developing DCVax personalized immune therapies for…

BiotechnologyDCVax-LGermanyNorthwest BiotherapeuticsOncologyRegulationResearch

UK Bioscience Forum: Incentivize investors to hold their investment for more than 10 years

UK Bioscience Forum: Incentivize investors to hold their investment for more than 10 years

08-10-2014

One of the main messages from the keynote speech at the UK Bioscience Forum by Paul Drayson, chief executive…

BiotechnologyLegalLicensingPatents & Trade marksProductionRegulationResearchSocial IssuesUK

FDA Breakthrough designation for Ariad’s AP26113

FDA Breakthrough designation for Ariad’s AP26113

03-10-2014

US specialty pharma firm Ariad Pharmaceuticals says that its investigational cancer drug AP26113 has…

AP26113Ariad PharmaceuticalsOncologyPharmaceuticalRegulationResearchUSA

EMA adopts landmark policy to take effect January 2015

EMA adopts landmark policy to take effect January 2015

03-10-2014

In a bid toward greater transparency, the European Medicines Agency has decided to publish the clinical…

EMAEuropePharmaceuticalRegulationResearch

Innovative and orphan drugs to become more accessible in Russia

Innovative and orphan drugs to become more accessible in Russia

30-09-2014

The Russian Parliament (State Duma) plans to ease access to innovative and orphan drugs to the Russian…

PharmaceuticalPharmacologyRegulationResearchRussia

IMS Health identifies 10 events that may transform the delivery of health care

IMS Health identifies 10 events that may transform the delivery of health care

23-09-2014

As the global market for drugs surpasses $1 trillion this year, growing payer scrutiny of value for money…

Anti-viralsFinancialGlobalHealthcarePharmaceuticalRegulationResearchVaccines

FDA lifts clinical hold on Halozyme's PEGPH20 pancreatic cancer trial

FDA lifts clinical hold on Halozyme's PEGPH20 pancreatic cancer trial

22-09-2014

US biotech firm Halozyme Therapeutics says the US Food and Drug Administration has removed the clinical…

BiotechnologyHalozyme TherapeuticsOncologyPEGH20RegulationResearchUSA

First Ph III data in Japanese patients for Merck’s omarigliptin for type 2 diabetes

18-09-2014

US pharma giant Merck & Co has announced the presentation of the first data from the Phase III clinical…

DiabetesJapanMerck & CoomarigliptinPharmaceuticalRegulationResearch

FDA FOCUS: The need for open clinical trial data for FDA approval

FDA FOCUS: The need for open clinical trial data for FDA approval

15-09-2014

In the second of a monthly FDA-focused blog published exclusively by The Pharma Letter, Dr Nicola Davies…

PharmaceuticalPharmacologyRegulationResearchUSA

HAI takes issue with move of pharma policy to DG Enterprise and Industry

HAI takes issue with move of pharma policy to DG Enterprise and Industry

12-09-2014

Consumer advocacy group Health Action International says it is “appalled” by the European Commission’s…

EuropePharmaceuticalPoliticsRegulationResearch

Indian clinical trial rules counter-productive, says ASSOCHAM

Indian clinical trial rules counter-productive, says ASSOCHAM

10-09-2014

The Associated Chambers of Commerce and Industry of India (ASSOCHAM ) has expressed concern at the setback…

IndiaPharmaceuticalPoliticsRegulationResearch

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