Regulation - Research

Filter

Current filters:

Research

Popular Filters

1 to 25 of 319 results

US FDA delays Allergan’s Semprana decision, approves Ozurdex

US FDA delays Allergan’s Semprana decision, approves Ozurdex

01-07-2014

US drugmaker Allergan, the subject of a hostile $53 billion takeover pursuit by Canada’s Valeant Pharmaceuticals…

AllerganBimatoprost Ophthalmic Solution 0.03% for GlaLevadexNeurologicalOphthalmicsOzurdexPharmaceuticalRegulationResearchSempranaUSA

Positive data on Merck & Co’s nausea drug Emend Ph III trial in children

Positive data on Merck & Co’s nausea drug Emend Ph III trial in children

30-06-2014

Positive results have been announced by US pharma giant Merck & Co from a global, investigational Phase…

EmendMerck & CoOncologyPharmaceuticalRegulationResearch

FDA Breakthrough status for Boehringer’s investigational Pradaxa antidote

FDA Breakthrough status for Boehringer’s investigational Pradaxa antidote

26-06-2014

The US Food and Drug Administration has granted Breakthrough Therapy designation to idarucizumab, an…

Boehringer IngelheimCardio-vascularidarucizumabPharmaceuticalPradaxaRegulationResearchUSA

Boehringer Ingelheim pulls out of hepatitis C drug development

Boehringer Ingelheim pulls out of hepatitis C drug development

23-06-2014

German family-owned pharma major Boehringer Ingelheim revealed that, following a re-evaluation of its…

Anti-viralsBoehringer IngelheimfaldaprevirPharmaceuticalRegulationResearch

Alnylam and TAP collaborate on ALN-AAT, for AAT deficiency-associated liver disease

Alnylam and TAP collaborate on ALN-AAT, for AAT deficiency-associated liver disease

19-06-2014

RNAi therapeutics company Alnylam Pharmaceuticals and The Alpha-1 Project (TAP), the venture philanthropy…

ALN-AATAlnylam PharmaceuticalsBiotechnologyNephrology and HepatologyRegulationResearchThe Alpha-1 ProjectUSA

Celgene exercises option for Agios Pharma’s AG-221

Celgene exercises option for Agios Pharma’s AG-221

17-06-2014

Metabolism specialist Agios Pharmaceuticals says that its partner, biotech major Celgene Corp, has exercised…

AG-221Agios PharmaceuticalsBiotechnologyCelgeneLicensingOncologyRegulationResearchUSA

Gilead’s ledipasvir/sofosbuvir achieved 100% SVR12 among chronic hepatitis C patients in Japan

Gilead’s ledipasvir/sofosbuvir achieved 100% SVR12 among chronic hepatitis C patients in Japan

16-06-2014

US anti-virals major Gilead Sciences has released strong top-line results from a Phase III clinical trial…

Anti-viralsBiotechnologyGilead SciencesJapanledipasvirRegulationResearchsofosbuvirSovaldi

ALK’s Japanese partner posts mixed results for house dust mite SLIT-tablet

ALK’s Japanese partner posts mixed results for house dust mite SLIT-tablet

16-06-2014

Denmark-based allergy specialist ALK Abello partner for Japan, Torii Pharmaceutical, has completed its…

ALK AbelloJapanPharmaceuticalRegulationResearchRespiratory and PulmonarySLIT-tabletTorii Pharma

EMA agrees policy on publication of clinical trial data with more user-friendly amendments

EMA agrees policy on publication of clinical trial data with more user-friendly amendments

13-06-2014

The European Medicines Agency management board agreed the policy on publication of clinical trial data,…

EuropePharmaceuticalRegulationResearch

Shire agrees to FDA call for pediatric trials of Vyvanse for ADHD

Shire agrees to FDA call for pediatric trials of Vyvanse for ADHD

12-06-2014

Ireland-headquartered drugmaker Shire says it has agreed to a written request by the US Food and Drug…

NeurologicalPharmaceuticalRegulationResearchShireUSAVyvanse

Achillion HCV program back on track, as FDA lifts sovaprevir study hold; initiates ACH-3422 dosing

Achillion HCV program back on track, as FDA lifts sovaprevir study hold; initiates ACH-3422 dosing

10-06-2014

US drugmaker Achillion has begun dosing ACH-3422, a uridine-analog nucleotide polymerase inhibitor, for…

ACH-3422AchillionAnti-viralsBiotechnologyRegulationResearchsovaprevir

Immunomedics gets orphan drug status for IMMU-132 in pancreatic cancer

Immunomedics gets orphan drug status for IMMU-132 in pancreatic cancer

10-06-2014

US biotech firm Immunomedics says that IMMU-132, its antibody-drug conjugate (ADC) for solid cancer therapy,…

BiotechnologyIMMU-132ImmunomedicsOncologyRegulationResearchUSA

Halozyme can resume PEGPH20 clinical program in pancreatic cancer

Halozyme can resume PEGPH20 clinical program in pancreatic cancer

05-06-2014

US biotech firm Halozyme Therapeutics saw its shares rise after revealing that the US Food and Drug Administration…

BiotechnologyHalozyme TherapeuticsOncologyPEGH20RegulationResearchUSA

EMA “look, but don’t touch” terms of use for clinical study data are impracticable, says IQWiG

EMA “look, but don’t touch” terms of use for clinical study data are impracticable, says IQWiG

28-05-2014

The German Institute for Quality and Efficiency in Health Care (IQWiG) has taken issue with plans announced…

EuropeGermanyPharmaceuticalRegulationResearch

Merck and Endocyte pull CMA for vintafolide and companion imaging component in EU

20-05-2014

US pharma giant Merck & Co and Endocyte have withdrawn their conditional marketing authorization applications…

EndocyteEuropeMerck & CoOncologyPharmaceuticalRegulationResearchvintafolide

EU Ombudsman concerned about change of policy at EMA on clinical trial data transparency

16-05-2014

In a letter to the European Medicines Agency, the European Ombudsman, Emily O'Reilly, has expressed concern…

EuropePharmaceuticalRegulationResearch

Significant decline in 1st-qtr US FDA drug approvals

Significant decline in 1st-qtr US FDA drug approvals

14-05-2014

Warning signs of a decline in pharma R&D activity and successes has come in the form of a new analysis…

PharmaceuticalRegulationResearchUSA

Merck & Co updates on near-term opportunities and strategy

Merck & Co updates on near-term opportunities and strategy

07-05-2014

US pharma giant Merck & Co, which has just sold its consumer health care business to Bayer for $14.2…

Merck & CoPharmaceuticalRegulationResearch

Once-monthly Invega Sustenna reduces risk of relapse in schizoaffetive disorder

Once-monthly Invega Sustenna reduces risk of relapse in schizoaffetive disorder

07-05-2014

US health care giant Johnson & Johnson subsidiary Janssen Pharmaceuticals has released positive results…

Invega SustennaJanssenJohnson & JohnsonNeurologicalPharmaceuticalRegulationResearch

FDA clinical hold on Halozyme’s PEGPH20 pancreatic cancer trial

FDA clinical hold on Halozyme’s PEGPH20 pancreatic cancer trial

09-04-2014

US biopharma firm Halozyme Therapeutics says that the US Food and Drug Administration informed the company…

Halozyme TherapeuticsNorth AmericaOncologyPharmaceuticalRegulationResearchUSA

Alkermes leaps on positive Ph III results for aripiprazole lauroxil for schizophrenia

Alkermes leaps on positive Ph III results for aripiprazole lauroxil for schizophrenia

09-04-2014

US biotech firm Alkermes saw its shares spike on Tuesday, after it announced positive top-line results…

AbilifyAlkermesaripiprazole lauroxilBiotechnologyLundbeckNeurologicalOtsukaRegulationResearch

EMA plans targeted discussions on clinical trial data policy

EMA plans targeted discussions on clinical trial data policy

09-04-2014

The European Medicines Agency will launch a final round of targeted consultations with key stakeholders…

EuropePharmaceuticalRegulationResearch

1 to 25 of 319 results

Back to top