The Compounding Quality Act, part of the Drug Quality and Security Act, signed into law last month, creates a volunteer registration of “outsourcing facilities” that will be subject to scrutiny by the FDA, including routine inspections.
Forest Laboratories Inc. joined the litany of big pharma companies announcing restructuring programs last week. But the major restructuring, dubbed Project Rejuvenate, appears to be more about streamlining operations than downsizing.
The FDA approved 35 new molecular/biological entities (NMEs/NBEs) on average in 2011-2012, substantially higher than the 20-year average of 28 approvals.
Adeno-associated virus (AAV)-based systems are ideally suited for delivering gene therapy. After the viral vector infects the cell, the DNA doesn’t integrate into the host genome, instead existing primarily in an episomal form, which allows for long-term expression in nonreplicating cells without DNA damage to the host cells and the risk of inducing malignancy.
While some genes have been linked to autism spectrum disorder, the exact cause of the disease isn’t known. With a dearth of knowledge about the disease, there haven’t been any drugs specifically developed to treat autism, although Risperdal (risperidone, Johnson & Johnson) and Abilify (aripiprazole, Bristol-Myers Squibb Co. and Otsuka Pharmaceutical Co. Ltd) are approved to treat irritability associated with autism.
Companies need to start planning for reimbursement from Medicare and private insurances well ahead of FDA approval according to a new guide to reimbursement put out by the Alliance for Regenerative Medicine.
Last week Pfizer Inc. told Pain Therapeutics Inc. that it plans to continue development of the abuse-resistant pain medication Remoxy (oxycodone) extended-release capsules CII.
After an insane second quarter, funding of U.S. biotechs by venture capital cooled off a bit as the weather warmed up. (See BioWorld Today, July 2, 2013.)
