Content about Clinical research

November 16, 2011
FDA approves drug for rare bone marrow disorder

The Food and Drug Administration has approved a new drug for treating a rare bone disease, the agency said Wednesday.

November 10, 2011
AstraZeneca, Targacept: TC-5214 'well-tolerated,' did not meet endpoint in phase-3 trial

AstraZeneca and Targacept released results of the first of four phase-3 clinical trials that investigated the efficacy and tolerability of a drug that could serve as an adjunct therapy to major depressive disorder patients that had an inadequate response to initial antidepressant therapies.

November 10, 2011
Roche seeks FDA approval for vismodegib

The Food and Drug Administration has accepted a new drug application for a skin cancer treatment developed by Roche.

November 3, 2011
FDA report: 35 new drugs approved in past year

The Food and Drug Administration has approved 35 new drugs over the past 12 months, the agency said Thursday.

November 2, 2011
FDA approves update to Takeda cancer drug label

The Food and Drug Administration has approved changes to the labeling of a cancer drug made by Takeda Pharmaceuticals, the drug maker said.

October 28, 2011
FDA approves supplemental new drug application for Abbott's Lupron Depot-PED

The Food and Drug Administration has approved a supplemental new drug application related to a drug made by Abbott, the company said.

October 25, 2011
Lannett gets OK for generic anti-obesity drug

Lannett has received approval from the Food and Drug Administration to market its version of an anti-obesity drug.

October 19, 2011
ParaPRO presents study affirming prescription pediculicide efficacy

ParaPRO on Saturday presented data showing the effectiveness of Natroba (spinosad) topical suspension, 0.9% against head lice and nits following one treatment without nit combing.

October 19, 2011
Takeda launches late-stage trial program for Type 2 diabetes drug

Takeda Pharmaceuticals has started a late-stage clinical trial program for a drug to treat Type 2 diabetes, the drug maker said.

October 11, 2011
ReportersNotebook — Chain Pharmacy, 10/10/11

The Food and Drug Administration has approved Mylan’s promethazine hydrochloride tablets, a generic drug for treating allergies, in the 12.5-mg, 25-mg and 50-mg strengths.

October 6, 2011
Sanofi MS drug shows good results in phase-3 trial

A drug under investigation by Sanofi for multiple sclerosis improved several measures of disease activity in patients, according to results of a late-stage clinical trial.

October 4, 2011
Report: Lupin stands to benefit from drug patent expiries

A wave of patent expirations over the next several years will open up a broad swath of drugs to generic competition, and India's Lupin Pharmaceuticals is looking to benefit, according to published reports.

October 3, 2011
ESI launches suite of services for pharma, biotech companies

Pharmacy benefit manager Express Scripts has launched a suite of services for drug makers through HealthBridge Pharma & Biotech to provide a single-solution approach to patient care.

October 3, 2011
FDA approves Sagent antibiotic

The Food and Drug Administration has approved a generic antibiotic made by Sagent Pharmaceuticals, Sagent said.

September 22, 2011
Orexigen, FDA work out plan for path to approval of obesity drug

Drug maker Orexigen Therapeutics said it had identified a "clear and feasible path" for the approval of its drug for treating obesity by working with the Food and Drug Administration.

September 19, 2011
FDA approves two new indications for Amgen's Prolia

The Food and Drug Administration has approved two new uses for a drug made by Amgen, the drug maker said Monday.

September 15, 2011
GSK, Amicus start phase-3 trial of Fabry disease drug

GlaxoSmithKline and Amicus Therapeutics have started a late-stage clinical trial for a drug to treat a rare genetic disorder, the companies said.

September 12, 2011
FDA reorganizes cancer division

The Food and Drug Administration is reorganizing its division for regulating cancer drugs, the agency said Monday.

September 12, 2011
Pharma faces its own hurricane season

At press time, Hurricane Irene was slowly barreling toward the East Coast and threatening the area with a deluge that prompted cities to shut down and had store shelves wiped clean.


September 7, 2011
FDA accepts new drug application from Vivus

The Food and Drug Administration has accepted a regulatory approval application for a drug made by Vivus for treating erectile dysfunction.

September 1, 2011
FDA approves Sagent drug

The Food and Drug Administration has approved a generic skeletal muscle relaxant made by Sagent Pharmaceuticals, Sagent said.

September 1, 2011
Omnitrope approved for Turner syndrome

The Food and Drug Administration has approved a new use for a follow-on biologic made by Sandoz.

August 30, 2011
FDA accepts application for opioid-induced constipation drug

The Food and Drug Administration has accepted a regulatory approval application from Progenics Pharmaceuticals and Salix Pharmaceuticals seeking an additional approval for a pain drug.

August 26, 2011
FDA approves Shire autoimmune disorder drug

The Food and Drug Administration has approved a drug made by Shire for a rare autoimmune condition, the agency said.

August 24, 2011
M&A: Multitudinous and ample

The final outcome of the battle between Israel’s Teva Pharmaceutical Industries and Canada’s Valeant Pharmaceuticals International to buy Cephalon serves as a good illustration of why it helps to have a plan B.


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