FDA approval

FDA holds back approval for J&J schizophrenia med

John Carroll — Wed, 27 Aug 2008 10:11:34 -0400

The FDA has put up at least a temporary roadblock to J&J's schizophrenia drug paliperidone palmitate. A once-monthly injectable with the same active ingredient as Invega, a newly approved antipsychotic, the agency says it will need more information on the therapy before they can give it the stamp of approval. But it might not present a lengthy delay. J&J noted that the FDA is not asking for a new trial and says it will work with the FDA in answering all of its questions. The therapy uses technology from Elan, which stands to gain from an approval.

- check out the Johnson & Johnson release
- read the report from the Wall Street Journal

FDA approval drought despite surge in apps

John Carroll — Tue, 26 Aug 2008 11:09:11 -0400

The long drought of FDA approvals for new molecular entities is occurring despite some big efforts by drug developers to push through new drugs. In a new study examining NME approvals for 2007, Parexel noted that approvals scraped the bottom of the record books at 16. But applications jumped 33 percent last year. Approvals of therapies with a new active substance (an NAS), declined 19 percent last year, while applications jumped from 21 to 28.

"NME and NAS approvals are key measures of new drug productivity in the biopharmaceutical industry, and these measures tend to improve based on the volume of new drug submissions," said Mark Mathieu, Parexel's director of publications and editor of The US Drug Approval Trends and Yearbook 2008/2009. "The recent increase in the number of NME submissions is an encouraging sign. NMEs are a closely watched category because they are medicines that have never before been approved for any use."

- here's Paraxel's release
- check out the report from the Boston Globe

FDA approves Amgen's Nplate

Maureen Martino — Mon, 25 Aug 2008 09:38:13 -0400

Amgen has received FDA approval for Nplate for the treatment of immune thrombocytopenic purpura (ITP). ITP is a bleeding condition--which affects about 60,000 people in the U.S.-- that causes the body to attack its own blood clotting cells. The injectable drug stimulates the body's bone marrow, which raises platelet count.

Back in March an expert panel unanimously recommended the drug and Amgen as been waiting for an approval since July. Analysts say the drug could earn between $66 million and $117 million in 2009.

- see Amgen's release
- here's the WSJ report

FDA wants more information on Doribax

John Carroll — Thu, 21 Aug 2008 11:01:00 -0400

Johnson & Johnson is having a hard time making its case to the FDA for using Doribax as a therapy for hospital-acquired pneumonia. The agency says it wants to see more information on the drug before giving the drug its stamp of approval for that indication. Johnson & Johnson filed for the approval more than a year ago.

An expert committee had voted to endorse the drug, but differed on whether the goal set in the clinical trial was justified. The company declined to detail exactly what the FDA is looking for, but says it will work with regulators to gain the approval.

--read the AP report

FDA OK's first drug for Huntington's disease

John Carroll — Mon, 18 Aug 2008 12:12:07 -0400

The FDA has OK'd Prestwick Pharmaceuticals' Xenazine, a new drug that can be used to moderate the symptoms of Huntington's disease. This is the first drug to be approved for Huntington's, which can afflict people for 10 to 20 years before killing them as the victim's brain cells waste away. And throughout that time the involuntary movements associated with Huntington's prevents them from leading normal lives.

The FDA notes that the data indicates a short-term improvement in symptoms but has also been linked to depression and cognition issues that will make it inappropriate for some patients.

"Chorea is not just a mere inconvenience; it can prevent Huntington's disease patients from walking, talking, working, watching television and almost every aspect of one's life. We are ecstatic that, through the approval of Xenazine, patients and families will have the option to take the only drug developed specifically for treating the movements of Huntington's disease," said Nancy Wexler, Ph.D., Higgins Professor of Neuropsychology in the departments of neurology and psychiatry at Columbia University and president of the Hereditary Disease Foundation.

- check out the Prestwick Pharmaceuticals release
- read what the Huntington's Disease Society of America (HDSA) has to say
- read the story from the Calgary Herald

Drought of approvals gets worse for developers

John Carroll — Thu, 31 Jul 2008 12:12:44 -0400

The long dry spell for new drug approvals has actually worsened a bit. In Vivo notes that the FDA approved six new molecular entities in the first half of the year, down one from the dreadful pace set in 2007. Last year only 16 NMEs made it through, the worst record in a generation at a time that pharma companies have been desperate to add new products to their lineup.

But don't panic yet. In Vivo also notes that there are at east 30 NMEs up for approval at the FDA with a PDUFA date falling prior to New Year's Day. And even though the FDA is increasingly likely to blow off its deadlines, there's still a good chance that 2008 will turn out better than 2007. Let the office pools begin.

- check out the report from In Vivo

Pharma finds promise, peril in biotech revolution

John Carroll — Wed, 02 Jul 2008 09:44:37 -0400

The problem with the European pharmaceuticals industry--at least in part--is biotechnology. Or that's what the European Federation of Pharmaceutical Industries and Associations believes. The big trade association says that the slowdown in new drug approvals seen around the world can be directly linked to the biotech revolution, which has revealed a host of new drug targets while making the drug discovery process more complex and costly.

"The increasing information on the genetic basis of disease and the inherent diversity of human biology means that we are discovering new disease targets which push the boundaries of our knowledge and make the development of drugs difficult and costly," EFPIA added in a document quoted by BioWorld. The EFPIA prepared its arguments in response to critics who attribute the slowdown in drug discovery to antitrust activities.

"The biotechnology revolution has been just that, a revolution," said the EFPIA. "It has presented pharmaceutical companies with so many promising targets and opportunities for innovation that identifying the best candidates is costly and results in many blind alleys. Translating new discoveries into marketable products has taken the industry longer than expected."

- read the article from BioWorld

Biopharma sees tougher FDA approval process

John Carroll — Mon, 30 Jun 2008 09:55:31 -0400

The Wall Street Journal offers more bleak assessments from the pharma industry on their ability to win an FDA approval for a new therapy. Schering-Plough has already shuttered two programs it once held high hopes for and it may soon axe a third. Delays on prasugrel and Cordaptive are adding to the uncertainty and tomorrow an FDA panel will ponder tougher approval standards for diabetes drugs.

"What will it take to get new drugs approved?" Schering-Plough CEO Fred Hassan asks. "The point is, we don't know."

The WSJ notes that it's getting tougher to win an FDA approval even as the number of NDAs is already scraping a 24-year low.

- read the report from the Wall Street Journal

ALSO: Developers say FDA may force higher costs, more time for diabetes programs. Article

BioSante Pharma exploring its strategic alternatives

John Carroll — Tue, 10 Jun 2008 11:54:01 -0400

BioSante Pharmaceuticals has brought in Deutsche Bank to advise the company on its "strategic alternatives." The developer has advanced LibiGel, a topical therapy for female sexual dysfunction, into a late stage trial. BioSante has told investors that it hopes to gain an FDA approval on the treatment by 2010.

News of the Deutsche Bank move helped buoy shares of BioSante. The company announced in March that it had begun a Phase III trial on LibiGel.

- read the AP report

ALSO NOTED: ASCO already churning out news; Lilly, FDA ironing out Zyprexa shot problems; and much more...

Fri, 30 May 2008 06:59:50 -0400

> Today marks the start of the annual ASCO. Here's a round-up of some of the news coming out of the conference. ASCO report

> More from the Web-marketing frontier, where portals and blogs are passé: An Arizona entrepreneur is working up a site where cancer doctors and drugmakers can mix and mingle. Report

> Pharmacy records could soon become an open book in California. Yesterday, the state Senate passed a bill allowing pharmacies to sell patient info to third-party firms working for drugmakers. Report

> Eli Lilly says it's making progress with the FDA on approval of its long-acting, injectable form of Zyprexa. FDA report

And Finally... Solving the mystery of why type 1 diabetes is so prevalent in Finland could be the key to teasing out the causes of the disease. Report