There’s Little Incentive To Develop Antibiotics, But Does TB Drug’s Recent Success Story Herald New Model For Future?
In recent decades, pharmaceutical funding has been directed primarily toward drug research and development that will yield higher revenue, such as cancer drugs. But TB Alliance relied on donors from across the world to fund the development of its new tuberculosis antibiotic, and experts wonder if this is a path forward for new drugs. In other pharmaceutical news: the Norvartis data manipulation case continues, the FDA flexes its muscles, and a new treatment might help blood cancer patients.
Nonprofit Drug Maker Produces TB Antibiotic After Private Companies Wouldn’t
The U.S. Food and Drug Administration’s approval of a new tuberculosis antibiotic this month could be a significant win not only for TB patients, but for a burgeoning nonprofit model for developing prescription drugs. Tuberculosis kills about 1.6 million people per year worldwide, and drug-resistant strains of the disease are becoming more common, making it difficult to treat. (Rorhich, 8/22)
The Wall Street Journal:
FDA Focuses On Novartis Delay In Reporting Drug-Test Data Manipulation
Federal regulators examining test data manipulation for a gene-therapy drug made by Novartis AG are zeroing in on the company’s two-month delay in launching a formal inquiry, according to documents and interviews. The drug, Zolgensma, is used to treat a sometimes fatal form of spinal muscular atrophy in children and costs about $2.1 million for a one-time infusion. The Food and Drug Administration said this month that it wasn’t informed about the data manipulation until after it approved use of the drug May 24. (Burton, 8/22)
The FDA Is Flexing Its Muscles
Biotechnology companies often have both devoted fans and detractors. But there's one constituency they'd be wise not to anger: U.S. regulators. In the past few weeks, the Food and Drug Administration has dropped the hammer on pharmaceutical giants and biotech upstarts alike. The agency slammed Novartis for manipulating data and rejected what would've been Sarepta Therapeutics's second drug for a rare form of muscular dystrophy. A company that makes a fish-oil pill caught investors by surprise when it said the agency wanted a closer look at its data. Another had a jet-lag drug rejected after the FDA said its clinical merits weren't clear. (Spalding, 8/22)
GSK Builds Oncology Pipeline As Drug Shown To Help Myeloma Patients
GlaxoSmithKline said its experimental multiple myeloma treatment showed a meaningful response in patients that have run out of three previous treatment options, in a boost for the British drugmaker's cancer drug business. Two doses of belantamab mafodotin helped subdue the disease in adults who had received three prior treatments for multiple myeloma, a cancer of the white blood cells, GSK said on Friday, adding that it intends to seek market approval and submit data from the trial to regulatory bodies this year. (Burger and Aripaka, 8/23)