Content about Clinical research

September 4, 2012
FDA approves Wockhardt antidepressant

The Food and Drug Administration has approved a generic antidepressant made by Wockhardt, the Indian drug maker said Tuesday.

August 30, 2012
FDA approves Teva biosimilar

The Food and Drug Administration has approved a biosimilar drug made by Teva Pharmaceutical Industries for a condition that results from certain chemotherapy treatments, the drug maker said Thursday.

August 28, 2012
Sun Pharma's Caraco gets FDA OK to resume operations

The Food and Drug Administration has determined that generic drug maker Caraco is in compliance with relevant paragraphs of the consent decree and may resume operations at its manufacturing facility and packaging sites in Detriot and Wixom, Mich., Caraco's parent company Sun Pharmaceutical Industries said.

August 27, 2012
Genzyme provides update on Lemtrada filing with FDA

Genzyme announced it has received a refuse-to-file letter from the Food and Drug Administration in response to the drug maker's supplemental biologics license application for the approval of Lemtrada (alemtuzumab) as a treatment for relapsing multiple sclerosis.

August 24, 2012
FDA approves Watson pain patch

The Food and Drug Administration has approved a generic medicated patch for treating pain made by Watson Pharmaceuticals, the company said.

August 23, 2012
AcelRx starts third phase-3 trial of drug for post-operative pain

A drug maker that specializes in pain medications started the third late-stage trial of a drug for treating pain in patients who have undergone certain surgeries.

August 23, 2012
FDA approves Wockhardt hypertension drug

The Food and Drug Administration has approved a generic drug for high blood pressure made by Wockhardt, the Indian drug maker said.

August 23, 2012
FDA gives Wockhardt tentative approval for bipolar, schizophrenia drug

Indian drug maker Wockhardt has received tentative approval from the Food and Drug Administration for a generic version of a Pfizer psychiatric drug.

August 9, 2012
Hospira relaunches chemotherapy drug

Hospira has relaunched a generic chemotherapy drug for the U.S. market, the generic drug maker said Thursday.

August 9, 2012
Sagent Pharmaceuticals launches oxaliplatin

Drug maker Sagent Pharmaceuticals has launched a generic chemotherapy drug, the company said Thursday.

August 8, 2012
Teva, Active Biotech plan third MS drug trial

Drug makers Teva Pharmaceutical Industries and Active Biotech will start a third late-stage clinical trial of an experimental drug for treating multiple sclerosis, the companies said Wednesday.

August 6, 2012
Amneal plans $120 million expansion

Generic drug maker Amneal Pharmaceuticals will spend $120 million to expand three of its plants, the company said Monday.

August 2, 2012
Generics saved $1 trillion over last 10 years, study finds

Use of generic drugs has saved consumers and the healthcare system $1 trillion over the past decade, according to a new study released Thursday by a generic drug industry trade organization.

July 31, 2012
AmerisourceBergen books $18 billion-plus in Express Scripts business

AmerisourceBergen on Tuesday announced that it has signed a three-year agreement to supply approximately $18.5 billion in pharmaceuticals to Express Scripts on an annual basis.

July 30, 2012
Takeda resubmits diabetes drug applications

Drug maker Takeda Pharmaceutical has resubmitted regulatory approval applications for two drugs designed to treat diabetes, the company said.

July 18, 2012
FDA approves weight-loss drug

The Food and Drug Administration has approved a new weight-loss drug made by Vivus, the agency said.

July 16, 2012
Par subsidiary gets FDA nod for hypertension drug

A subsidiary of Par Pharmaceutical Cos. acquired earlier this year has received its first Food and Drug Administration approval.

July 13, 2012
FDA appoints new generic drugs office head

The main office of the Food and Drug Administration in charge of regulating generic drugs has appointed a new director, the agency said Friday.

July 13, 2012
PhRMA: More than 100 drugs under development for mental illnesses

Nearly 200 drugs for mental illnesses are under clinical development or under review by the Food and Drug Administration, the largest lobbying group for the drug industry said Thursday.

July 12, 2012
FDA approves Watson arthritis drug

The Food and Drug Administration has approved a generic drug for arthritis made by Watson Pharmaceuticals, the company said.

July 12, 2012
Lilly announces negative results in schizophrenia drug trial

A clinical trial of a drug for schizophrenia did not yield the desired results, the drug's developer said.

July 10, 2012
Obama signs PDUFA reauthorization

President Barack Obama signed into law Monday what some called a "historic" reauthorization of the Prescription Drug User Fee Act.

July 6, 2012
FDA accepts NDA for Agile's contraceptive patch

The Food and Drug Administration has accepted a new drug application for a low-dose, once-weekly contraceptive patch from Agile Therapeutics, the drug maker said.

July 5, 2012
FDA gives tentative approval to generic hypertension drug

Actavis has received a preliminary approval for a generic drug for treating high blood pressure, the drug maker said Thursday.

June 22, 2012
Alexza resubmits Adasuve for regulatory review

A drug maker has resubmitted its new drug application to the Food and Drug Administration for an acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.

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