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US pharma giant Merck & Co and Endocyte have withdrawn their conditional marketing authorization applications…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

EFPIA calls for collaboration in the implementation of Clinical Trials Regulation

03-04-2014

The global market for clinical trials is becoming increasingly competitive and Europe runs the risk of…

EuropePharmaceuticalRegulationResearch

MEPs vote for more transparent and simpler European clinical trial rules

03-04-2014

Pharmaceutical companies and academic researchers will have to post the results of all their European…

EuropePharmaceuticalRegulationResearch

US FDA eases clinical hold on Geron’s imetelstat

US FDA eases clinical hold on Geron’s imetelstat

21-03-2014

There was a touch of good news yesterday for Geron Corp, after the US Food and Drug Administrated partially…

BiotechnologyGeron CorpimetelstatNorth AmericaOncologyRegulationResearchUSA

Brazil Senate discusses pathways for advancement of clinical research

Brazil Senate discusses pathways for advancement of clinical research

20-03-2014

The Brazilian Senate's Social Affairs Committee (CAS) held a hearing on March 18 to debate the progress…

BrazilPharmaceuticalRegulationResearch

Geron nosedives on FDA clinical hold for blood disorders drug imetelstat

Geron nosedives on FDA clinical hold for blood disorders drug imetelstat

12-03-2014

USA-based Geron Corp saw its shares plunge 59% to $1.79 when the company revealed that it had received…

BiotechnologyGeron CorpimetelstatNorth AmericaOncologyRegulationResearchUSA

FDA probing Regeneron and Sanofi’s investigational drug alirocumab

FDA probing Regeneron and Sanofi’s investigational drug alirocumab

10-03-2014

French drug major Sanofi has revealed in a regulatory filing that the US Food and Drug Administration…

alirocumabCardio-vascularNorth AmericaPharmaceuticalRegeneronRegulationResearchSanofiUSA

Takeda files for diabetes drug trelagliptin succinate approval in Japan

Takeda files for diabetes drug trelagliptin succinate approval in Japan

09-03-2014

Takeda Pharmaceutical, Japan’s largest drugmaker, has submitted a New Drug Application to the Japanese…

Asia-PacificBlopressCardio-vascularDiabetesJapanPharmaceuticalRegulationResearchTakeda Pharmaceuticalstrelagliptin

Ph III study for Jakavi meets endpoint in patients with polycythemia vera

Ph III study for Jakavi meets endpoint in patients with polycythemia vera

07-03-2014

Swiss pharma major Novartis today announced positive results from a pivotal Phase III trial of Jakavi…

IncyteJakaviNovartisOncologyPharmaceuticalRare diseasesRegulationResearch

Boehringer Ingelheim presents new data for HCV/HIV candidate faldaprevir

Boehringer Ingelheim presents new data for HCV/HIV candidate faldaprevir

06-03-2014

German family-owned pharma major Boehringer Ingelheim announced positive results from STARTVerso 4 in…

Anti-viralsBoehringer IngelheimfaldaprevirPharmaceuticalRegulationResearch

Titan Pharma in general agreement with FDA on pathway for Probuphine

Titan Pharma in general agreement with FDA on pathway for Probuphine

04-03-2014

California, USA-based Titan Pharma and its partner, Braeburn Pharmaceuticals, have agreed in principle…

Braeburn PharmaceuticalsNeurologicalNorth AmericaPharmaceuticalProbuphineRegulationResearchTitan PharmaceuticalsUSA

“Overwhelming approval” in store for Heplisav if Dynavax delivers sufficient safety data, says analyst

“Overwhelming approval” in store for Heplisav if Dynavax delivers sufficient safety data, says analyst

27-02-2014

Despite citing the need for further safety studies, both US and EU regulators have lauded the immunogenicity…

Anti-viralsBiotechnologyDynavax TechnologiesHeplisavRegulationResearchVaccines

FDA to review heart failure risk with AstraZeneca diabetes drug

FDA to review heart failure risk with AstraZeneca diabetes drug

12-02-2014

The US Food and Drug Administration has requested clinical trial data from Anglo-Swedish drug major AstraZeneca,…

AstraZenecaDiabetesKombiglyzeNorth AmericaOnglyzaPharmaceuticalRegulationResearchUSA

2014 to be transition year for Japan pharma

2014 to be transition year for Japan pharma

11-02-2014

2014 will be marked as a transition year for the Japanese Pharma industry – but the year is bound to…

Asia-PacificPharmaceuticalPricingRegulationResearch

Regulatory update on Indian clinical research approval timelines

04-02-2014

The Drug Controller General of India (DCGI) has provided written confirmation to the pharmaceutical industry…

Asia-PacificIndiaPharmaceuticalRegulationResearch

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