FDA Panel Ayes Eyelash-Boosting Drug

FDA Advisory Committee Recommends Approval of First Prescription Eyelash Enhancer Latisse
By Miranda Hitti
WebMD Health News
Reviewed by Louise Chang, MD

Dec. 5, 2008 -- An FDA advisory panel today recommended approving Latisse, a drug to promote longer, thicker, darker eyelashes.

Latisee is a spin-off of the glaucoma drug Lumigan. The FDA approved Lumigan in 2001 as an eyedrop. Eyelash growth is a known side effect of the drug.

Allergan Inc., the drug company that makes Lumigan, studied the drug to see how well it promoted eyelash growth, thickness, and darkness when dabbed like an eyeliner at the roots of the eyelashes on the upper eyelid.

In that study, 137 people used Latisse and 141 people used a placebo solution for 16 weeks. The result: Thicker, longer, darker eyelashes were more common by the end of the study in the Latisse group. And people in the Latisse group reported more satisfaction with their lashes than people who used the placebo.

Side effects, which were generally temporary and mild, included eye redness, which stopped when the use of the drug was discontinued, according to Allergan documents submitted to the FDA.

Lumigan's prescribing information notes that the drug may darken eyelid skin and gradually increase pigmentation of the iris, making eyes browner. Those iris color changes, which may not be noticeable for several months to years, may be permanent but don't progress after stopping Lumigan.

The Latisse study, however, doesn't report any cases of iris color changes. Unlike Lumigan, Latisse isn't meant to go directly on the eyes, and each Latisse dose uses only 5% of a Lumigan drop.

The FDA panel also recommended further studies to assess Latisse's use in certain groups of patients, such as young patients and people who lost their eyelashes because of chemotherapy, according to an Allergan news release.

Latisse isn't headed to the market just yet. The FDA considers, but doesn't always follow, the recommendations of its advisory panels. And if the FDA approves Latisse, it will be a prescription drug, not an over-the-counter cosmetic.

Allergan anticipates launching Latisse in 2009, according to a company news release.

Bioinformatics Sites

* EMBnet node in Oslo .
* RNA World
* EBI , the EMBL Outstation Hinxton.
* EMBL , Heidelberg.
* EMBnet , the European network for molecular biology.
* BIOSCI , Bionet electronic newsgroups.
* CBS , Center for Biological Sequence Analysis, Technical University of Denmark.
* Expasy , Geneve.
* BIBISERV , Bielefeld University Bioinforrmatics Server.
* Nee-How , The Bioresource Finder
* BSM , Biomolecular Structure and Modelling at UCL.
* Human Genome Project Information
* Sanger centre , Hinxton, England.
* SEQNET , Daresbury, England.
* The Johns Hopkins University BioInformatics Web Server.
* W. M. Keck Center for advanced training in computational biology.
* B3E , Bioinformatics in France.
* UK MRC HGMPRC UK Human Genome Mapping Project Resource Centre.
* NCBI National Center for Biotechnology Information (USA).
* NLM National Library of Medicine (USA).
* CGATBSS , Canadian Genome Analysis & Technology (CGAT) Bioinformatics Support Services.
* DDBJ DNA data bank, Japan.
* GDB Genome Data Base.
* ANGIS Australian National Genomic Information Service.
* ANU Bioinformatics Hypermedia Service .
* HUM-MOLGEN Human Molecular Genetics.
* BioMOO The Virtual Meeting Place for Biologists
* BioBox , Finland.
* Information theory and molecular biology , Tom Schneider's group.
* ISREC (Swiss Institute for Experimental Cancer Research), Bioinformatics Group.
* DoubleTwist
* WWW in Biology , bionet.software.www.
* UCSC Computational Biology .
* Bioinformatics and Computational Biology at George Mason University .
* Computational Biology USC , University of Southern California.
* HUJI , Hebrew University of Jerusalem Hadassah Medical School: The Genomic and BioInformatics Server.
* Centre of Bioinformatics , Peking.
* Bioexchange.com

Bioanalytical Chemists

Seeking individual with 5-10 years experience in the pharmaceutical or related industry conducting bioanalytical assays utilizing HPLC, LC/MS/MS state of the art instrumentation, in compliance with GLPs. Hands on knowledge is required. Qualified individual with have a Ph.D. in analytical chemistry, strong knowledge of assay implementation and validations. Expertise in various biological matrices required. Strong communication skills and experience with regulatory/agency interactions (FDA and other) desired.

To apply:
http://www.toxikon.com

Vitamin C, E Pills Fail to Prevent Cancer
Study Shows No Sign of Lower Cancer Risk in People Taking Vitamin E and Vitamin C Supplements

Taking vitamin E and vitamin C supplements may not make cancer less likely, a new study shows.

Taking vitamin E and vitamin C supplements may not make cancer less likely, a new study shows.

That finding comes from the Physicians' Health Study II, which recently showed that taking vitamin C and vitamin E supplements may not lower the risk of heart attack or stroke.

Researchers have now analyzed study data on cancer risk and found no sign of lower cancer risk in people taking vitamin E and vitamin C supplements daily during the study.

Here's a look at the study, which was presented yesterday in Washington, D.C., at an international meeting on cancer prevention research hosted by the American Association for Cancer Research (AACR).
Supplement Study

The study included some 14,600 male doctors aged 50 and older in the U.S.

Some of the doctors were assigned to take 400 international units (IU) of vitamin E every other day. Others were assigned to take 500 milligrams of vitamin C every day during the study. For comparison, a third group of doctors got placebo pills.

Among all the doctors, there were 1,929 cases of cancer, including 1,013 cases of prostate cancer, during the study. Cancer rates were similar among the doctors taking vitamin E or vitamin C supplements and those taking the placebo.

"After nearly 10 years of supplementation with either vitamin E or vitamin C, we found no evidence supporting the use of either supplement in the prevention of cancer," Howard Sesso, ScD, MPH, says in an AACR news release.

Sesso, who is an assistant professor of medicine at Brigham and Women's Hospital in Boston, adds that there was also no sign that either supplement was harmful.

The findings are only about vitamin E and vitamin C from supplements, not foods.

"Individual vitamin supplements such as vitamin E and C do not appear to provide the same potential advantages as vitamins included as part of a healthy, balanced diet," J. Michael Gaziano, MD, MPH, says in the AACR news release. Gaziano, an associate professor of medicine at Brigham and Women's Hospital, worked with Sesso on the study.
Supplements Industry Responds

The study was "well done" but has some limits, notes Andrew Shao, PhD, vice president for scientific and regulatory affairs at the Council for Responsible Nutrition, a trade group for the supplements industry.

Shao points out that the doctors were "probably very healthy" to begin with, and that the study started when they were already "well along, in terms of age."

The study doesn't settle questions about whether different doses might be more effective, or if starting supplementation earlier in life might make a difference, Shao says.

Beyond that, Shao says lifestyle -- including diet, exercise, and other habits -- seems to matter more than one or two nutrients.

"It really comes down to what is the total package," Shao says. "We can't necessarily expect a couple of nutrients to have a magic bullet effect," especially in a healthy group of people.

List of Grad Schools - Bioinformatics

Arizona State University Tempe, Arizona
•MS in Computational Biosciences

Boston University Boston, Massachusetts
•Bioinformatics Graduate Program; MS, PhD

Brandeis University's Rabb School of Summer and Continuing Studies Waltham, Massachusetts
•MS in Bioinformatics
•Graduate Certificate in Bioinformatics

Carnegie Mellon University Pittsburgh, Pennsylvania
•Merck Computational Biology and Chemistry Program; BS, MS, PhD tracks

Columbia University New York, New York
•Medical Informatics; MS, PhD

Duke University Durham, North Carolina
•Center for Bioinformatics and Computational Biology; Postdoctoral, Certificate, PhD

Florida State University Tallahassee, FL
•Biomedical Mathematics; MS, PhD

George Mason University Fairfax, Virginia
•PhD in Computational Sciences and Informatics
•PhD in Bioinformatics
•MS in Bioinformatics
•MNPS in Bioinformatics, Biotechnology, and Forensic Biosciences

Georgetown University Washington, D.C.
•Biotechnology and Bioinformatics; MS track

Georgia Institute of Technology Atlanta, Georgia
•Bioinformatics; BS, MS, PhD tracks
•MS in Bioinformatics
•PhD in Bioinformatics

Harvard-MIT Division of Health Sciences and Technology Cambridge, Massachusetts
•Bioinformatics and Integrative Genomics; PhD track

Indiana University School of Informatics Bloomington, Indiana
•BS in Informatics
•MS in Bioinformatics
•MS in Chemical Informatics

International Bioinformatics and Computational Biology Programs From the Web site of the International Society for Computational Biology, a listing of universities worldwide that offer degrees in bioinformatics and computational biology.

Iowa State University Ames, Iowa
•Interdisciplinary PhD Program in Bioinformatics and Computational Biology; MS, PhD

Johns Hopkins University Baltimore, Maryland
•Program in Computational Biology; PhD track

Keck Graduate School Claremont, Southern California
•MS in Bioscience

Marquette University Milwaukee, Wisconsin
•Special Interdisciplinary Major/Minor (Dept. of Mathematics, Statistics, and Computer Science); BS
•Bioinformatics Graduate Program (with the Medical College of Wisconsin and UW Parkside); MS

McGill University Montreal, Canada
•Centre for Bioinformatics; BS minor; proposed MS and PhD

Medical College of Wisconsin Milwaukee, Wisconsin
•Bioinformatics Graduate Program; MS

Montana State University Bozeman, Montana
•Center for Computational Biology; MS, PhD track

New Jersey Institute of Technology Newark, New Jersey
•MS in Computational Biology
•PhD in Computational Biology

North Carolina State University Raleigh, North Carolina
•Statistical Genetics and Bioinformatics
•PhD in Bioinformatics
•Master of Bioinformatics
•Program in Statistical Genetics

Northeastern University Boston, Massachusetts
•Bioinformatics Essentials Graduate Certificate
•Graduate Certificate in Pharmacogenetics

Northern Illinois University DeKalb, Illinois
•Bioinformatics Specialization and Certificate; MS, Certificate

Oregon Health & Science University Portland, Oregon
•Medical Informatics; MS

Rensselaer Polytechnic Institute Troy, New York
•Interdisciplinary Program in Bioinformatics and Molecular Biology; BS, MS, PhD

Rice University�fs Keck Center for Computational Biology Houston, Texas
•An Integrated Training Program: Bioinformatics and Computational Biology Training Program, and Computational Biology Research Training Program; PhD track

Rochester Institute of Technology Rochester, New York
•Bioinformatics and Biotechnology Programs; BS, MS

Rutgers University Camden, New Jersey
•Graduate Studies in Computational Molecular Biology; PhD

Stanford University Stanford, California
•Biomedical Informatics; MS, PhD
•Bioinformatics Certificate

University of California, Davis Davis, California
•Graduate Program in Medical Informatics; MS
•Designated Emphasis in Biotechnology; PhD
•Summer Short Courses in Bioinformatics and Proteomics

University of California, Irvine Irvine, California
•Informatics in Biology and Medicine; MS and PhD track

University of California, San Diego San Diego, California
•Interdisciplinary Bioinformatics Program; PhD
•Certificate in Bioinformatics

University of California, San Francisco San Franciso, California
•Graduate Program in Biological and Medical Informatics; MS, PhD

University of California, Santa Cruz Santa Cruz, California
•Program in Bioinformatics; BS; Proposed MS and PhD

University of Colorado at Denver Denver, Colorado
•Center for Computational Biology; Certificate, MS, PhD

University of Illinois, Chicago Chicago, Illinois
•Bioinformatics; BS, MS, PhD

University of Massachusetts, Lowell Lowell, Massachusetts
•Bioinformatics; BS, MS, PhD

University of Medicine and Dentistry of New Jersey Newark, New Jersey
• Graduate Programs in Biomedical Informatics; PhD, MS, MSN, certificate

University of Memphis Memphis, Tennessee
•Masters Degree Concentration in Bioinformatics

University of Michigan Ann Arbor, Michigan
•Bioinformatics; MS, PhD

University of Minnesota Twin Cities, Minnesota
•Graduate Program in Bioinformatics; MS and PhD minor

University of Nebraska, Omaha Omaha, Nebraska
•Bioinformatics; MS and PhD track

University of New South Wales Sydney, Australia
•BS in Engineering (Bioinformatics)

University of Pennsylvania Philadelphia, Pennsylvania
•Computational Biology; BS, MS, PhD track

University of Southern California Los Angeles, California
•MS in Computational Molecular Biology
•Computational Biology and Bioinformatics; PhD track

University of Texas, Austin Austin, Texas
•Graduate Program in Cell & Molecular Biology, with specialized track in Bioinformatics; PhD track

University of Texas, El Paso El Paso, Texas
•Bioinformatics; MS

University of the Sciences in Philadelphia Philadelphia, Pennsylvania
•Bioinformatics; BS, MS

University of Washington Seattle, Washington
•Biomedical and Health Informatics; MS; PhD and certificates proposed
•Computational Molecular Biology; PhD track

University of Waterloo Ontario, Canada
•Bioinformatics; BS, MS, PhD

University of Wisconsin Madison, Wisconsin
•Biostatistics and Medical Informatics; MS, PhD
•Graduate Certificate/Capstone Certificate in Bioinformatics; Certificate programs for graduate and post-doctoral students

Vanderbilt University Nashville, Tennessee
•Graduate Program in Biomedical Informatics; MS, PhD

Virginia Polytechnic Institute and State University Blacksburg, Virginia
•Graduate Options in Bioinformatics; MS and PhD track

Washington University in Saint Louis
Saint Louis, Missouri
•Computational Biology; PhD

BIOINFORMATICS/Java Programmer @ NYU--New York, NY (US)

RESPONSIBILITIES:
Candidate will be responsible for developing and designing a web-interface for a Functional Genomics facility at the NYU School of Medicine; monitoring project status, identifying and resolving problems which may impact the project results; maintaining software and hardware; working with departmental leadership on developing and implementing policies; consulting with departmental leadership regarding application alternatives, security, software usage, capacity planning, training, recovery and backup procedures. Individual should be able to seamlessly interface biology with computational skills, plus all related duties.

REQUIREMENTS:
Individual should possess BS/MS in computer science, computational biology, or bioinformatics, and at least 2 years professional programming experience. Experience with multiple programming languages, mainly Java and Perl and knowledge of SQL and Oracle database is required. Must have experience with Unix, web development including CSS and HTML.

NYU Medical Center

Career path in Bioinformatics

When people refer to the field of bioinformatics, they’re usually referring to two overlapping areas. The first is what you would call “bioinformatics”, which is more technical, and examples are creating tools to analyse data for biologists, or specific databases to store and retrieve information. For example if you created a new tool that could analyse microarray data in a way that hasn’t been done previously, then this is bioinformatics. Many journals such as Nature and Bioinformatics, have sections purely for articles about new methods and tools.

The second path is what you might call “computational biology”, which is all about doing biological research, using a computer instead of a pipette. A strong understanding of biology is important, as well as the ability to phrase, then answer a research question. For example, if you believed that duplicate genes were less well conserved compared with non duplicates, and you tested this hypothesis across a set of genomes, then this would be computational biology.

These two fields are not distinct, and overlap a fair amount. Some universities have bioinformatics departments in both the computer science and life science faculties, indicating the type of research carried out in each.

Psoriasis Drug Raptiva Gets FDA Warning

he psoriasis drug Raptiva is getting a "black box" warning, the FDA's sternest warning, about the risk of life-threatening infections including a rare brain infection and meningitis.

The FDA announced that news today. Raptiva's warning will highlight the risk of opportunistic infections including:

* Bacterial sepsis: a blood infection that can affect organs throughout the body
* Viral meningitis: a brain infection
* Invasive fungal disease: fungal infection that can spread throughout the body
* Progressive multifocal leukoencephalopathy (PML): a rare brain infection

Raptiva is given by injection once a week to treat moderate to severe plaque psoriasis in adults who are candidates for systemic (whole body) therapy or phototherapy (light therapy) to control their psoriasis. Raptiva works by suppressing the immune system to reduce psoriasis flare-ups, but suppressing the immune system can raise the risk of serious infections and malignancies.

Raptiva's label will also be updated to include data from studies done on young mice that show a potential risk for permanent suppression of the immune system when given repeatedly in this age group, which the FDA says is equivalent to children up to 14 years old. Raptiva isn't approved for use in children younger than 18.

The FDA ordered Raptiva's "black box" warning and other label changes after receiving reports of serious infections in some patients taking Raptiva, notes Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, in a news release.

But the FDA acknowledges that those reports, which include one case of PML, don't prove that Raptiva caused any illnesses.
FDA's Advice to Patients

The FDA isn't telling patients to stop taking Raptiva.

"Doctors and other prescribers should carefully evaluate and weigh the risk/benefit profile of Raptiva for patients who would be more susceptible to the risks," Woodcock says.

The FDA also urges patients to get up to date on their vaccinations before starting Raptiva, and not to get vaccinations while taking Raptiva, because they may not develop immunity to the vaccination virus.

Patients taking Raptiva should also watch for signs and symptoms of infection, as well as these problems:

* Confusion, dizziness or loss of balance, difficulty talking or walking, and vision problems (possible symptoms of PML)
* Dizziness upon standing, weakness, or jaundice (possible symptoms of anemia)
* Bruising, bleeding gums, pinpoint-sized red or purple dots under the skin (possible symptoms of thrombocytopenia, or low platelet count)
* Worsening of psoriasis or arthritis
* Sudden onset of numbness, tingling, or weakness in the arms, legs, or face (possible signs of a nervous system disorder).

The FDA recommends that patients taking Raptiva seek immediate medical attention for those problems.

Genentech, the drug company that makes Raptiva, says it will issue a letter to doctors and other health care providers detailing the label changes. "We feel it's important that patients and doctors are educated about the signs and symptoms of infections and the other information included in the boxed warning," Genentech spokeswoman Krysta Pellegrino tells WebMD.

Senior Scientist -Pharmaceutical Chemistry


Job Description:

The scientist plans and executes research activities and applies basic understanding of scientific data/literature to support physicochemical characterization of new chemical entity; preformulation to support evaluation of appropriate dosage forms for animal study or exploratory clinical trials. The scientist will acquire knowledge that is critical for formulation-process development. He/she is expected to present ideas to continuously improve existing process/procedure and have familiarity with GLP/cGMP guidelines.



Responsibilities:
Characterize/assess physicochemical properties of assigned molecules for developing pre-formulation of any new chemical entity and new active ingredients of feasibility program. Contribute to the study of chemical reactivity/degradation pathways between APIs and excipients to support oral/injectable/inhalation formulation development. Apply basic scientific principles and techniques to develop strategies for formulation stabilization or solubility enhancement; Develop/modify initial test methods for new drug substances and drug products; Write technical reports to support regulatory submission; Participate in Project Teams.



Minimum Education & Experience Requirements :

Ph.D. in Organic/Physical/Analytical chemistry or any pharmaceutical relevant science; 3-5 years of industrial experiences. Candidates with direct experiences in pre-formulation and solution kinetics are desired. Hand-on experiences in LC-MS is a plus.



Knowledge/Skills Needed:

The candidate should have a strong background in chemical research, with a proven experience in the area of Pharmaceutical R&D.

http://www.alkermes.com

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Myriad Genetics, Inc. (MYGN) Acquires Novel Therapeutic Drug Management Technology From Saladax Biomedical Inc. (SBI)

India's Malladi Drugs & Pharmaceuti al Ltd. to Invest US$300 Million in Malaysia, Global "One-Stop Shop"