New Jersey capsule technology specialist Capsugel has picked up a drug delivery platform developed at Australia's Monash University that makes use of lipidlike counter-ion salts to improve the bioavailability of certain drugs.
"Modified release is a high-risk area, so we're going to put a lot of emphasis on it," said the deputy director of the FDA's new Office of Pharmaceutical Quality, Lawrence Yu, during a press conference describing the new division.
Alnylam and Isis Pharmaceuticals announced an intellectual property cross-licensing agreement that they hope will leave them both better equipped to deal with the challenges of developing the first commercial RNAi therapy, including utilization of the promising but still-unproven RNA interference drug delivery pathway, and sometimes jittery investors.
The FDA just approved AbbVie's novel formulation of the standard Parkinson's drugs carbidopa and levodopa, Duopa, which is delivered straight into the patient's small intestine over 16 consecutive hours using an infusion pump and procedurally placed tube.
Biotech startup Carbylan Therapeutics is looking to raise $86 million in an IPO to support its injectable osteoarthritis pain treatment, which is currently in Phase III with another late-stage trial on the way in mid-2015.
Blend Therapeutics announced that it has received $21 million in new financing via a Series B venture round, as well as debt financing from an institutional investment firm to advance its Pentarin biologic drug conjugates.
Australia's EnGeneIC announced the completion of a $10 million Series B round for its antibody-targeted EDV nanocell technology platform for cancer drug delivery, led by Boston's GRT Capital Partners.
Researchers have developed graphene strips that have demonstrated the ability to carry two different cancer drugs and target each to the part of the cell where it will be most effective. The surface area of a flat strip in particular suits these particles to the delivery of the cancer drugs TRAIL and doxorubicin.
NeuroDerm's subcutaneously delivered alternative to oral levodopa shows promise in Parkinson's trial
Investors were thrilled by the Phase IIa clinical trial results of Neuroderm's continuously delivered Parkinson's candidates that are administered via a belt or patch pump, offering patients an alternative to traditional orally delivered levodopa, which is notorious for its fluctuating concentrations in the blood.
With FDA approval now in hand, Dyloject, an injectable nonsteroidal anti-inflammatory drug, could fill the void left by the expiration of most of the patents protecting Hospira's sedative, Precedex, which accounted for around 11% of the company's annual sales of $4 billion in mid-2014.
Starting today, CytoSorbents, maker of the CytoSorb extracorporeal cytokine adsorber to reduce inflammation in critically ill and cardiac surgery patients, will begin trading on the Nasdaq Capital Market instead of the over-the-counter market.
South Korean researchers at the University of Illinois Urbana-Champaign have developed a delivery technique that uses bits of gelatin to encapsulate drugs and carry them to the brain without surgery. The method shows promise for stroke patients, extending the window during which treatment can be effective.
Squeezing it in at the end of the year, Endo Pharmaceuticals and BioDelivery Sciences filed an NDA with the FDA for the companies' buccal Buprenorphine painkiller.
Two recent surveys covered by FierceDrugDelivery have shown that the vast majority of patients don't use their drug delivery devices properly. Device training specialist Noble says improved patient education is the key.
Cerulean Pharma announced last week that the first patient has received its Phase I/IIa cancer candidate, CRLX301, delivered using its RNA-based Dynamic Tumor Targeting Platform.
Arrowhead Research Corporation is looking to add another entrant into the clinical trial-based race to commercialize the first RNAi-based compound, a market category that could become a new class of drugs akin to monoclonal antibodies and produce revenues exceeding $1 billion by 2020 according to one projection. The company recently announced that it has submitted its Investigational New Drug application for its RNAi candidate, ARC-520, for the treatment of the chronic hepatitis B virus.
The evidence is clear: Patients don't properly use drug delivery devices like inhalers or epinephrine autoinjectors--such as Mylan's EpiPen.
Researchers have found a way to sneak peptides past the immune system by fitting them with cages that cover binding sites on the proteins like a hat. These prevent the binding sites from revealing the peptides' true nature as something from the outside.
The FDA approved Sanofi's Fluzone Intradermal Quadrivalent in adults age 18 through 64.
Researchers at the University of Maryland and Bethesda, MD-based Weinberg Medical Physics have created a startup called Iron Focus Medical that attempts to build on their prior research to commercialize a novel drug delivery system.