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February 24, 2012
Par completes acquisition of Edict

Generic drug maker Par Pharmaceutical has completed its acquisition of an Indian drug company, Par said.

February 23, 2012
FDA accepts NDA filing for Impax's Parkinson's disease treatment

The Food and Drug Administration has accepted a new drug application for the treatment of idiopathic Parkinson’s disease.

February 23, 2012
FDA approves Korlym for Cushing's syndrome

The Food and Drug Administration has approved a drug for a rare disorder that previously had no approved medical therapies, the agency said.

February 21, 2012
FDA moves to address cancer drug shortages

An executive order from the Obama administration has spurred the Food and Drug Administration to address shortages of two cancer drugs and issue draft guidance for the industry to help prevent future shortages, the agency said Tuesday.

February 21, 2012
Pfizer inks generics deal with Chinese drug maker

Pfizer has signed a deal worth more than $500 million with a Chinese drug maker to make generic drugs for China and other markets, the companies said.

February 13, 2012
Columbia Labs transfers NDA for reproductive drug to Watson

Columbia Labs has transferred a new drug application for a topical drug designed to prevent premature birth in pregnant women to Watson Pharmaceuticals.

February 9, 2012
FDA approves Mylan antimicrobial drug

The Food and Drug Administration has approved an antimicrobial drug made by Mylan, the drug maker said Thursday.

February 9, 2012
FDA releases draft guidance for biosimilars

The Food and Drug Administration reached a major milestone on the path to a regulatory regime for follow-on biologics on Thursday with the release of draft guidance on biosimilar product development.

February 1, 2012
Lipitor foreshadows approaching patent cliff for other leading drugs

For the past several years, drug industry experts have spoken in terms of the “patent cliff,” the period when the patents covering several blockbuster drugs are set to expire, thus leaving their manufacturers with a big, gaping hole in their revenues as those drugs face competition from generics.

January 31, 2012
FDA approves Hi-Tech Pharmacal's anxiety drug

The Food and Drug Administration has approved a generic drug for anxiety made by Hi-Tech Pharmacal, the drug maker said Tuesday.

January 26, 2012
Amgen acquiring Micromet for $1.16 billion

Drug maker Amgen is acquiring a Rockville, Md.-based company developing therapies for cancer, the companies said Thursday.

January 24, 2012
FDA approves new administration method for Takeda cancer drug

The Food and Drug Administration has approved a new means of administering a cancer drug made by Takeda, the drug maker said.

January 23, 2012
FDA panel gives thumbs down to Columbia Labs reproductive drug

A panel of experts at the Food and Drug Administration has declined to recommend approval for a topical drug for preventing premature birth in pregnant women, the drug's manufacturers said.

January 20, 2012
GDUFA reduces wait time for generics

For all the talk about generic drugs and their potential to save piles of money for the country’s healthcare system, it’s going to be a while before many of them actually reach consumers because of the Food and Drug Administration’s huge backlog of generic drug regulatory approval applications.


January 20, 2012
Generics face new and long-standing issues

In the Feb. 7, 2011, issue, Drug Store News named three major issues that would define 2011 for the world of generic drugs. Those issues were drug safety, generic user fees and patent settlements.

January 20, 2012
Lipitor’s patent loss signals future for other top drugs

If the patent cliff were a sports team, Pfizer’s cholesterol-
lowering drug Lipitor (atorvastatin) would be its mascot.

January 18, 2012
Frost & Sullivan forecasts strong growth in generic drug market through 2017

Patent expirations of key blockbuster drugs and efforts by payers to contain costs are likely to bring strong growth to the global generic drug market in the next few years as market-earned revenues grow by more than $100 billion, according to an analysis by research firm Frost & Sullivan.

January 18, 2012
Jazz Pharmaceuticals, Azur Pharma combine

Jazz Pharmaceuticals and Azur Pharma will become one company, the two drug makers said.

January 18, 2012
Provectus receives FDA guidance for late-stage trial of melanoma drug

The Food and Drug Administration has provided guidance to Provectus Pharmaceuticals as the drug maker prepares to apply with the agency for approval to start a late-stage clinical trial of a drug for skin cancer, Provectus said Wednesday.

January 16, 2012
FDA submits recommendations for Generic Drug User Fee Act

The Food and Drug Administration has finished and sent to Congress its recommendations for a proposed Generic Drug User Fee Act, drawing praise from the generic drug industry.

January 3, 2012
FDA accepts application for Gilead HIV drug

The Food and Drug Administration has accepted a regulatory approval application from Gilead Sciences for a drug to treat HIV, the company said.

January 3, 2012
FDA panel to review potential new use for Xgeva

Drug maker Amgen will discuss the supplemental biologics license application of Xgeva before a Food and Drug Administration review panel next month.

January 3, 2012
FDA panel to review resubmitted NDA for pixantrone

The Food and Drug Administration's Oncologic Drugs Advisory Committee will review a resubmitted new drug application for a cancer treatment made by Cell Therapeutics.

December 23, 2011
Baxter, Momenta partner on biosimilar development

Baxter and Momenta have agreed to partner to develop and market biosimilar drugs to treat cancer, autoimmune disorders and other chronic conditions.

December 21, 2011
FDA approves Takeda's Edarbyclor

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

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