This drug-device combination product
utilizes the Antares Pharma QuickShot device which was specifically developed to deliver a rapid injection of highly viscous drug products such as progesterone in oil, through a fine gauge nonvisible needle.
The need for early collaboration is especially important when a combination product
is to be marketed in multiple countries.
Successful combination product
launches for newer, cutting-edge medicines require four critical process scale-up considerations by the delivery platform manufacturer to ensure it is safe and produced to meet demand.
While the annuity combination product
market is currently underserved, many industry observers expect to see new market entrants as interest rates rise.
Under a license agreement, Valeant has received an exclusive, worldwide commercial and manufacturing rights to EyeGate's EyeGate II Delivery System and EGP-437 combination product
(the product) in the field of uveitis, as well as a right of last negotiation to license the product for other indications.
While the development of a combination product
comes with significant patient benefits through technology and molecule innovation, reward can be offset by the range of regulatory complexity and uncertainty encountered with bringing a product to market, in addition to any post-marketing activities.
Food and Drug Administration (FDA) defines a combination product
as: A product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product.
LIMRA reported that all life combination product
lines grew in 2011, with universal life (UL) combination products
becoming the dominant product (increasing 67 percent in premium compared to 2010).
PCI Biotech said it will continue to focus on clinical studies for the combination product
PC-A11, which contains the patented lead candidate Amphinex, and the development of new combination products
with Amphinex for localised cancer treatment.
At a meeting last month, the FDB)s Endocrinologic and Metabolic Drugs Advisory Committee reviewed data from two clinical trials of the combination product
that contains an immediate-release formulation of phentermine, which is a sympathomimetic amine approved as an obesity treatment, and a controlled-release formulation of topiramate, an antiepileptic drug approved for treating seizures and migraines.
A lot of those people are taking old life insurance policies and converting them to a combination product
, and in essence, what they're doing is getting a single premium life insurance policy with LTCI without additional premium payments," he said.
Premiums--Some policies are available only with a single premium, but according to Freidrich, there's a move among insurers to offer more flexible-premium products as well, recognizing that not all people who would consider purchasing a combination product
have the liquidity to make a lump sum payment of $50,000 or more.