Strategies & Technologies Driving Drug Discovery to Market
BMS Exec Admits Insider Trading
June 10, 2013 4:43 pm | News | CommentsFederal prosecutors in New Jersey say a former executive for Bristol-Myers Squibb has admitted using his high-level position and access to nonpublic information to make about $310,000 from insider trades. Robert Ramnarine has pleaded guilty to securities fraud.
Vitaros Approved in 10 Countries
June 10, 2013 12:45 pm | News | CommentsApricus Biosciences Inc. said that its impotence drug Vitaros has been approved in 10 European countries. The company said Vitaros is now approved in the Netherlands, Germany, France, Italy, and the U.K., among other countries, for the treatment of erectile dysfunction.
Elan Rejects New Royalty Bid
June 10, 2013 11:12 am | News | CommentsThe board of directors of the Irish drugmaker Elan Corp. PLC on Monday rejected an increased offer from Royalty Pharma and says it has received unsolicited interest from other parties it didn't name. Royalty's latest offer last week was for $13 per share plus up to $2.50 per share in payments based on performance milestones.
FDA Finds More Tainted Steroids
June 10, 2013 11:08 am | News | CommentsFederal health officials say they have found bacteria and fungus in drug vials from a Tennessee specialty pharmacy that recalled all of its injectable medicines last month. The Food and Drug Administration said in an online posting that it identified the growths in two unopened vials of a steroid injection distributed by the Main Street Family Pharmacy, a compounding pharmacy in Newbern, Tenn.
AstraZeneca in $560M Deal for Pearl
June 10, 2013 7:48 am | News | CommentsBritish drugmaker AstraZeneca PLC says it is to acquire Pearl Therapeutics Inc., a Redwood-City, California-based company involved in therapies for asthma and chronic obstructive pulmonary disease for at least $560 million. The deal could involve further payments of up to $590 million if if sales and drug development targets are met.
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.
