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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

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

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 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

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

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

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

FDA accepts Actavis’ NDA for ceftazidime-avibactam

FDA accepts Actavis’ NDA for ceftazidime-avibactam

05-09-2014

Ireland-headquartered generic drugs major Actavis today confirmed that the US Food and Drug Administration…

ActavisAntibiotics and Infectious diseasesceftazidime-avibactamPharmaceuticalRegulationResearchUSA

FDA lifts partial clinical hold on OncoMed's ipafricept

05-09-2014

Shares of US biotech companies OncoMed Pharmaceuticals rose 5.6% to $17.68 on news that the US Food and…

BayerBiotechnologyipafriceptOncologyOncoMed PharmaceuticalsRegulationResearchUSA

FDA modifies Tekmira's TKM-Ebola clinical hold to partial hold

FDA modifies Tekmira's TKM-Ebola clinical hold to partial hold

08-08-2014

Canadian RNA interference (RNAi) therapeutics developer Tekmira Pharmaceuticals revealed yesterday that…

Anti-viralsEbolaMicrobiologyPharmaceuticalRegulationResearchTekmira PharmaceuticalsTKM-EbolaUS Food and Drug AdministrationUSA

Sarepta tanks despite positive data on eteplirsen in Duchenne MD

Sarepta tanks despite positive data on eteplirsen in Duchenne MD

11-07-2014

US RNA-based drug developer Sarepta Therapeutics saw its shares plunge, despite the company releasing…

BiotechnologyeteplirsenRare diseasesRegulationResearchSarepta TherapeuticsUSA

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

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

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

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

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

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

1 to 25 of 36 results

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