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.
The 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.
Plaintiffs 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.
Difficult-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.
While 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 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.