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Regenerative Medicine Expert Group publishes report with action plan for UK implementation

Regenerative Medicine Expert Group publishes report with action plan for UK implementation

24-03-2015

The Regenerative Medicine Expert Group has published its report ‘Building on our own potential: a UK…

BiotechnologyPricingRegulationResearchUK

Dilaforette's sevuparin granted orphan drug designation by FDA in sickle-cell disease

Dilaforette's sevuparin granted orphan drug designation by FDA in sickle-cell disease

20-03-2015

Dilaforette, a portfolio company of Karolinska Development, a Nordic investor in life sciences, has been…

DilaforetteHematologyPharmaceuticalRegulationResearchSevuparinSwedenUSA

Regulatory and HTA scientific advice activities are crucial to SME drug development success

18-03-2015

EuropaBio, the European Association for Bioindustries, and the Deerfield Institute have partnered to…

BiotechnologyEuropeRegulationResearch

ACADIA tanks as it delays Nuplazid filing; CEO retires unexpectedly

ACADIA tanks as it delays Nuplazid filing; CEO retires unexpectedly

12-03-2015

Shares of US biotech firm ACADIA Pharmaceuticals plunged 22% to 34.70 in after-hours trading, after it…

ACADIA PharmaceuticalsBiotechnologyBoardroomNeurologicalNuplazidRegulationResearchUSA

Egalet to file NDA for abuse-deterrent morphine in 4th-qtr

Egalet to file NDA for abuse-deterrent morphine in 4th-qtr

11-03-2015

Shares of US biotech firm Egalet Corp rose 3.65% to $14.48 after it said it plans to file a New Drug…

BiotechnologyEgalet CorpEgalet-001NeurologicalRegulationResearchUSA

Positive Ph III results for Portola’s Xarelto antidote andexanet alfa

02-03-2015

USA-based Portola Pharmaceuticals saw its shares jump 7.2% to $40.83 after it announced positive results…

andexanet alfaBayerBiotechnologyCardio-vascularPortola PharmaceuticalsRegulationResearchUSA

Positive Ph III results from Biogen Idec and SOBI’s Alprolix in pediatric study

Positive Ph III results from Biogen Idec and SOBI’s Alprolix in pediatric study

28-02-2015

US biotech major Biogen Idec and Nordic drugmaker Swedish Orphan Biovitrum have announced positive top-line…

AlprolixBiogen IdecBiotechnologyEuropeHematologyRegulationResearchSobiSwedish Orphan Biovitrum

Federal Trade Commission puts conditions on Novartis acquisition of GSK oncology portfolio

Federal Trade Commission puts conditions on Novartis acquisition of GSK oncology portfolio

24-02-2015

The US Federal Trade Commission has put conditions on the proposed acquisition by Novartis of GlaxoSmithKline’s…

Array BioPharmaGSKLegalMergers & AcquisitionsNovartisOncologyPharmaceuticalRegulationResearchUSA

Health care is up for a revolution with the rise of personal genomic tests; report

24-02-2015

As the era of personalized medicine dawns on health care, the need to understand an individual’s genetic…

BiotechnologyGlobalRegulationResearch

EMA recommends suspending medicines over flawed studies at GVK Biosciences

EMA recommends suspending medicines over flawed studies at GVK Biosciences

23-01-2015

A number of medicines for which authorization in the European Union was primarily based on clinical studies…

EuropeGVK BiosciencesIndiaPharmaceuticalRegulationResearch

FDA removes hold on CytRx's aldoxorubicin Phase III trials

FDA removes hold on CytRx's aldoxorubicin Phase III trials

20-01-2015

The US Food and Drug Administration has removed the partial clinical hold on biopharma oncology company…

aldoxorubicinBiotechnologyCytRxOncologyRegulationResearchUSA

Merck & Co updates on plans to accelerate new drug submissions and future growth

Merck & Co updates on plans to accelerate new drug submissions and future growth

13-01-2015

US pharma giant Merck & Co has reported on the ongoing execution of its multi-year, strategic initiative…

Anti-viralsgrazoprevir/elbasvirKeytrudaMerck & CoOncologyPharmaceuticalRegulationResearchUSA

“Achievements and goals are endless in health care,” says head of Turkey’s AİFD

05-01-2015

Secretary general and chief operating officer of Turkey’s Association of Research-Based Pharmaceutical…

BiosimilarsHealthcarePharmaceuticalRegulationResearchTurkey

Sumitomo Dainippon’s lurasidone meets primary endpoint in Ph III study

30-12-2014

Japanese drug major Sumitomo Dainippon Pharma has released positive preliminary findings from a Phase…

Dainippon Sumitomo PharmaJapanLatudalurasidoneNeurologicalPharmaceuticalRegulationResearch

EMA update on review of studies performed at GVK Biosciences site in Hyderabad, India

06-12-2014

Some European Union member states have decided to suspend the marketing authorizations of medicines that…

EuropeGVK BiosciencesIndiaPharmaceuticalRegulationResearch

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

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