Pharmaceutical manufacturing: news in brief
from the pharmaceutical manufacturing industry.
The European Medicines Agency (EMEA) has decided the benefits of GlaxoSmithKline's Avandia (rosiglitazone) outweigh the risks in the approved indications for diabetes. The agency likewise concluded Actos (pioglitazone) had a positive benefit-risk balance. The decision followed a Committee for Medicinal Products for Human Use (CHMP) review as part of its continuous monitoring of the safety medicines, because of new information on these medicines' side effects. The agency recommended changing the product information for rosiglitazone and agreed further initiatives to increase scientific knowledge on the safety of medicines. Meanwhile, the EMEA has recommended that the marketing authorisation for all medicines containing clobutinol should be withdrawn throughout the EU following safety concerns. The move follows last month's voluntary recall of clobutinol-containing cough products by Boehringer Ingelheim after studies suggested there was a potential risk of cardiac arrhythmia when taking its drug Silomat. Since Boehringer's recall, the CHMP started to review the safety of the medicines to decide whether regulatory actions needed to be implemented throughout the EU. "Having considered all available evidence, the CHMP concluded that the use of clobutinol is associated with a risk of prolongation of the 'QT interval' . . . In light of these findings, and because clobutinol is used to treat a common complaint for which alternative treatments are available, the CHMP considered that the benefits of these medicines do not outweigh their risks," the committee said in a statement. Northwestern University researchers have shown that nanodiamonds can deliver chemotherapy drugs to cells without the current negative side effects. The team reported that aggregated clusters of nanodiamonds, ranging from 50 to 100 nanometres in diameter, were shown to be ideal for carrying a chemotherapy drug and shielding it from normal cells so as not to kill them, and releasing the drug slowly only after it reached its cellular target. The use of the nanodiamonds also showed they did not cause inflammation once the drug had been released. The drug delivery system works by loading the drug onto the surface of the individual nanodiamonds. In the aggregated state, the drug is inactive and only becomes active when the cluster reaches its target and breaks apart. Because of the large amount of available surface area, the clusters can carry a large amount of the drug - nearly five times the amount carried by conventional materials. The team used the chemotherapy drug doxorubicin hydrochloride. The study, published online by the journal Nano Letters, is the first to demonstrate the use of nanodiamonds, a new class of nanomaterials, in biomedicine. CSL Biotherapies has begun shipping its influenza virus vaccine to the US for the 2007-2008 season, where it will supply two million doses. The shipment follows earlier approval this year of the company's vaccine, which is currently manufactured in Australia. CSL is the newest addition to the influenza vaccine market in the US joining Novartis, MedImmune, GlaxoSmithKline and Sanofi. Orexo is to acquire Biolipox in a move that will create an innovative specialty pharma company with a broad product pipeline and global partnerships. The deal values Biolipox at €93.5m and payment will be made through an issue of a maximum of 8.56 million Orexo shares. The deal, which is conditional on regulatory approvals, will see the new specialty pharmaceutical company focussing on the development and commercialisation of products in the areas of pain management and respiratory diseases. Allergan is another company that has made an acquisition this week. The Californian company announced it had acquired Esprit which would help develop Allergan's core pharmaceutical businesses by creating a dedicated urologics division to serve urologists and their patients. Allergan will take on Sanctura XR (trospium chloride extended release capsules), which Esprit licenses from Indevus Pharmaceuticals, and plans to launch the overactive bladder treatment in the US in the first quarter of next year. Regulatory Affairs Associates, a Michigan company specialising in winning US Food and Drug Administration (FDA) approval for new drugs and medical devices, has been awarded the 2007 Innovation Michigan Award for its development of a fast-track process for the manufacture of drugs used in clinical trials. Called New Drug Xpeditor (NDX), the process uses a micro-plant model to make the process more efficient. "What we have done is turn an arduous serial process into a highly efficient collection of simultaneous, parallel processes," Regulatory Affairs Associates director of manufacturing services Norm Howe said. Polypure has launched its latest monodispersed PEG (polyethylene glycol) derivative - maleimidopropionyl-PEG NHS ester. The heterobifunctional PEG is designed to improve cross-linking between compounds carrying amino groups and thiol functions and would be used to enhance the solubility of poorly soluble drugs.
