Strategies & Technologies Driving Drug Discovery to Market
Impure Drugs Cost Ranbaxy $500M
May 13, 2013 2:28 pm | by Eric Tucker | News | CommentsA subsidiary of India's largest pharmaceutical company has agreed to pay $500 million in fines and civil penalties for selling adulterated drugs and lying about tests of the medications to federal regulators. Prosecutors said the guilty plea by Ranbaxy USA Inc. represents the largest financial penalty by a generic drug company for violations of the Federal Food, Drug and Cosmetic Act, which prohibits the sale of impure drugs.
Lyme Disease Vaccine Shows Promise in Trial
May 13, 2013 1:59 pm | News | CommentsThe results of a phase 1/2 clinical trial in Europe of an investigational Lyme disease vaccine co-developed by researchers at Stony Brook University, Brookhaven National Laboratory and at Baxter International Inc., a U.S. based healthcare company, revealed it to be promising and well tolerated, according to a research paper published online in The Lancet Infectious Diseases.
Alzheimer's Predicted Before Symptoms Develop
May 12, 2013 8:00 pm | News | CommentsScientists have helped identify many of the biomarkers for Alzheimer’s disease that could potentially predict which patients will develop the disorder later in life. Now, studying spinal fluid samples and health data from 201 research participants, researchers have shown the markers are accurate predictors of Alzheimer’s years before symptoms develop.
FDA Denies Endo's Opana Request
May 10, 2013 5:53 pm | by The Associated Press | News | CommentsIn a surprise move Friday, federal health regulators denied a request by Endo Health Solutions to block generic versions of its painkiller Opana ER, which the company argued are more easily abused than its branded product. Endo's Opana ER is a long-acting narcotic drug used to treat moderate and and severe pain. Such medications are frequently crushed and then injected or snorted by drug abusers to achieve a euphoric effect.
Actavis, Warner Chilcott Talk Combination
May 10, 2013 3:38 pm | by MARLEY SEAMAN - AP Business Writer - Associated Press | News | CommentsThe drugmakers Actavis Inc. and Warner Chilcott PLC say they are holding early discussions about a possible combination of the two companies. The companies say there is no guarantee that Actavis will make an offer for Warner Chilcott, however. Actavis expects to generate more than $8.1 billion in revenue this year while Warner Chilcott expects raise about $2.3 billion to $2.4 billion.
Lilly Ends Enzastaurin Development
May 10, 2013 2:50 pm | News | CommentsEli Lilly and Co. said it will stop development of an experimental cancer drug after it failed in a late-stage clinical trial.The company was studying enzastaurin as a treatment for diffuse large B-cell lymphoma, a cancer that affects a type of white blood cell.
Pfizer Having Second Thoughts on Remoxy
May 10, 2013 11:35 am | by The Associated Press | News | CommentsPfizer Inc. may not pursue further development of Remoxy, an experimental pain drug that has been plagued with delays in regulatory approval. Durect Corp. developed Remoxy and licensed it to Pain Therapeutics Inc. who in turn sublicensed the drug to Pfizer.
ASMS Conference on Mass Spectrometry and Allied Topics
May 10, 2013 10:52 am | EventsThe 61st ASMS Conference on Mass Spectrometry and Allied Topics begins on Sunday, June 9 with tutorial lectures at 5:00 pm and the opening session and plenary lecture at 6:45 pm. A welcome reception in the poster/exhibit hall will follow.
Muscular Dystrophy Trial Starting
May 9, 2013 6:15 pm | News | CommentsThe National Center for Neurology and Psychiatry and drugmaker Nippon Shinyaku Co. will start a clinical trial of a drug to treat Duchenne muscular dystrophy, a genetic disease that affects around one in 3,500 boys, aiming to release it for sale in five years.
State Pharmacists Back FDA Oversight
May 9, 2013 2:47 pm | by Matthew Perrone | News | CommentsThe National Association of Boards of Pharmacy has thrown its support behind a proposal giving the Food and Drug Administration authority over large compounding pharmacies, in an effort to head off more outbreaks tied to contaminated medications.
Competition Hammers Provenge Sales
May 9, 2013 1:54 pm | News | CommentsDendreon Corp. said that sales of its prostate cancer therapy Provenge fell in the first quarter because of increased competition from two newer drugs. Regulators approved Medication's Xtandi in August, and Johnson & Johnson has received approval to market Zytiga for use against prostate cancer.
Lawsuit Alleges Merck Gender Discrimination
May 9, 2013 11:48 am | News | CommentsA Merck & Co. sales representative is suing the drugmaker for at least $100 million, saying Merck doesn't give women equal opportunities for advancement and that women are told they have to choose between having children and taking bigger roles at the company.
A Target Rich Environment
May 9, 2013 11:45 am | by Cynthia Fox, Science Editor | Articles | CommentsRecent meetings have provided a showcase for many potential druggable tumor targets. The range of potential new drug targets has been expansive, especially if one counts the whole-exome sequencing work being performed for the Cancer Genome Atlas project.
Almac Out-Licenses ALM201
May 9, 2013 10:45 am | News | CommentsAlmac Discovery announced the licensing of its novel anti-angiogenic peptide ALM201 to Shin Poong Pharmaceutical Company Ltd. for clinical development and marketing in South Korea. Shin Poong will make an undisclosed upfront payment and pay milestones and royalties as part of the deal.
Vaccine Program Aimed at Vulnerable Girls
May 9, 2013 7:34 am | by Linda A. Johnson | News | CommentsTwo multinational drugmakers are teaming up with top global health groups to protect millions of girls in the world's poorest countries from deadly cervical cancer. The ambitious project ultimately is intended to inoculate more than 30 million girls in more than 40 countries by 2020.
