Federal 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.
Apricus 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.
The 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.
Federal 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.
British 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.
Through 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.
Regeneron 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.
Arena 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.
Federal 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.
The 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.
A 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.
Shares 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.
Cancer 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.
As 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.
Moving 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.