We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The Medicines Company expects its Ionsys opioid pain patch to be available in the third quarter of this year, following FDA approval on Thursday. Read More
The Therapeutic Goods Administration is considering raising the maximum limit for classifying rare diseases and specific subsets of patients to broaden the scope of medications that qualify for orphan drug status. Read More
AstraZeneca’s acid-reflux drug Nexium was the highest-costing drug prescribed under Medicare Part D in 2013, totaling $2.5 billion, according to new data released by the Centers for Medicare & Medicaid Services. Read More
A federal judge has ruled that the FDA was right in approving generic versions of Otsuka’s blockbuster antipsychotic Abilify, despite exclusivity remaining on at least one indication, removing any final obstacles to market entry of those drugs. Read More
A slew of observations related to cleanliness and sterility at Patheon Manufacturing Services’ Greenville, N.C., facility have resulted in a Form 483. Read More
The FDA has warned a Kansas compounder for multiple GMP violations, including poor sterile drug manufacturing practices and using ingredients that aren’t FDA-approved. Read More
The agency is concerned that the amount and frequency of doses given to patients were subject to investigator discretion and often inconsistent. Read More
The House Energy and Commerce Committee has released a new draft of its 21st Century Cures Act that would encourage greater use of observational studies, patient registries and real-world therapeutic use to support approvals of new drugs and improve postmarket surveillance. Read More
The U.S. Attorney’s office filed documents Monday challenging Allergan’s efforts to suppress evidence that it submitted false claims related to its blockbuster ophthalmic drug Restasis. Read More
Republicans on the Senate HELP Committee are taking the FDA to task for failing to shore up policies on biosimilar naming and interchangeability before approving the first biosimilar drug nearly two months ago. Read More