Strategies & Technologies Driving Drug Discovery to Market
Leukemia Pathway Discovery May Yield New Treatments
June 7, 2013 12:32 pm | News | CommentsThrough genetic engineering of laboratory models, researchers have uncovered a vulnerability in the way cancer cells diverge from normal regenerating cells that may help treat children with leukemia. The researchers are trying to understand the key pathways that distinguish how a normal blood cell grows and divides compared to the altered growth that occurs in leukemia.
Eylea Meets New Study Goal
June 7, 2013 12:14 pm | News | CommentsRegeneron Pharmaceuticals Inc. and Bayer HealthCare said that their eye drug Eylea met its main goal in a new late-stage clinical trial. The companies said Eylea was more effective than a sham injection in treating a condition called myopic choroidal neovascularization, a retina disease that affects people who are severely myopic.
Belviq Gets US Launch Date
June 7, 2013 12:03 pm | by Matthew Perrone | News | CommentsArena Pharmaceuticals says its weight loss drug Belviq will be available to U.S. patients beginning next week, nearly a year after the drug was officially approved by federal regulators. The Food and Drug Administration approved Belviq last June for adults who are obese or who are overweight and have at least one serious medical condition, such as diabetes or high cholesterol.
Panel Favors Avandia Changes
June 6, 2013 5:44 pm | by Matthew Perrone | News | CommentsFederal health experts are recommending changes to safety restrictions on former blockbuster diabetes pill Avandia, in light of a new analysis suggesting that the drug may not increase the risk of heart attack as previously believed. A majority of Food and Drug Administration advisers voted to modify or remove measures that currently limit patient access to GlaxoSmithKline's Avandia.
Automating Lead Optimization
June 6, 2013 5:00 pm | by Bobby Chavli, Associate Director, Marketing, BD, and Customer Service; Hamilton Robotics, Reno, Nev.; Mary Napier, Consultant; GeneCom Group, San Francisco, Calif. | Articles | CommentsThe drug discovery business is changing rapidly. More pharmaceutical companies are working with smaller biotech firms to create early-stage compounds, and thus need quicker and standardized solutions to early-stage development problems.
Following Up on Genotoxicity
June 6, 2013 4:49 pm | by Scott Hickman, Marketing Manager, Toxicology; BioReliance Corp., Rockville, Md. | Articles | CommentsA positive genotoxicity result can throw the fate of a promising drug candidate—in which a firm has invested significant time and money—into doubt. The statistical improbability and challenges of bringing a drug to market become paramount.
Momenta Rises After UBS Upgrade
June 6, 2013 4:43 pm | News | CommentsShares of Momenta Pharmaceuticals Inc. jumped after a UBS analyst upgraded the shares, saying she thinks it's more likely the company will be able to start selling a generic version of the multiple sclerosis drug Copaxone in the next few years. Analyst Ami Fadia raised her rating on the shares to "Buy" from "Neutral" and increased her price target to $17 per share from $13.
Targeting Pol I to Selectively Activate p53 and Kill Cancer Cells
June 6, 2013 4:39 pm | by Sean E. O’Brien, Vice President Research; Denis Drygin, Vice President Biology; Cylene Pharmaceuticals, San Diego, Calif. | Articles | CommentsCancer is a disease of dysregulated cellular growth and signaling characterized by the loss or gain of function—through mutation or epigenetic change—of important regulatory proteins and cellular processes. Foremost among these is the tumor suppressor protein known as p53.
Blocking Biosimilars
June 6, 2013 4:29 pm | by Ted Agres, Contributing Editor | Articles | CommentsAs the U.S. Food and Drug Administration finalizes regulations to establish a pathway for approving biopharmaceutical or biosimilar drugs, branded drug manufacturers are looking ahead and lobbying state legislatures to enact laws that would limit the substitution of biogenerics for brand-name drugs.
Digitizing Pathology
June 6, 2013 4:21 pm | by Mike May, Contributing Editor | Articles | CommentsMoving from manual to automated histology expands the data available in drug research. Traditional pharmaceutical industry methods for bringing a drug to market require extensive studies with tissues or tissue microarrays, often manually read.
Adapting to the Times
June 6, 2013 4:12 pm | by Peter Bennett, Editor | Articles | CommentsThe industry has changed a great deal over the last decade and will continue to evolve in the coming years. In order to survive the multitude of technological, political, and regulatory changes that will no doubt arise, the biopharmaceutical industry must prove its adaptability.
Patients Seek to Reopen Lilly, BMS Cases
June 6, 2013 11:59 am | News | CommentsPlaintiffs who sued two pharmaceutical companies soon after the 2001 arrest of a Kansas City pharmacist who diluted patients' drugs to enrich himself received much larger settlement payouts than those who waited, a new court filing shows.
Neurons Reprogrammed from Skin Cells
June 6, 2013 11:50 am | News | CommentsDifficult-to-study ailments such as Alzheimer's disease, schizophrenia, and autism now can be probed more safely and effectively thanks to an innovative new method for obtaining mature brain cells called neurons from reprogrammed skin cells.
Amyloid Beta: Friend or Foe?
June 6, 2013 11:30 am | by Cynthia Fox, Science Editor | Articles | CommentsWhile some researchers cling to the anti-amyloid hypothesis—despite the failure of seven large clinical trials of drugs targeting the misfolded protein—others are taking a new approach and attempting to see whether amyloid beta might be a misunderstood Good Samaritan.
Endo Shrinking Its Business
June 5, 2013 6:39 pm | News | CommentsEndo partially reversed course on several years of expansion, saying it will explore strategic options for its HealthTronics urology business and for its branded drug development platform and eliminate almost 700 jobs. The company said it will reduce annual spending by about $325 million.
