ImClone Systems Inc. has launched its ERBITUX® (cetuximab) in Canadian market in collaboration with Bristol-Myers Squibb Canada. The product will be commercially available for use in the treatment of metastatic colorectal cancer. It has Health Canada’s approval for use in conjunction with irinotecan in the treatment of cancer patients who are intolerant to irinotecan-based chemotherapy alone. The trial supporting this approval was conducted by Merck, Germany, ImClone’s partner for ERBITUX outside North America.

The U.S. Food and Drug Administration has given clearance to Ikonisys’ oncoFISH HER2 test, a fully computerized microscopy application to determine HER2 status in human specimens of breast cancer developed with Abbott’s PathVysion® HER2 DNA Probe Kit. The company’s proprietary CellOptics® platform which features the Ikoniscope® drives the test by providing an earlier and precise indication for amplification of gene. This diagnosis reveals whether a patient is a candidate for Herceptin (trastuzumab) treatment. Higher quantity of HER2 protein can lead to rapid growth of tumor, resistance to some types of treatment, prolonged illness and reduced survival period.

The U.S. Food and Drug Administration approved PharmaMar’s proposal for the process of production of Aplidin®. A novel anti-tumor agent derived from the sea, Aplidin® (Plitidepsin) is in its clinical stage of development and will be used for the treatment of hematological tumors. The starting materials needed to initiate the production process have also got the approval. FDA requires the companies producing drugs to submit all the paperwork regarding the method of production of their products.

A novel drug delivery system has been developed by scientists from the USA, Canada and France which can cross the blood-brain barrier to reach the cancer cells in the brain and kill them. Currently, the technology is in Phase I of its clinical trial. At present, not even 5 % of drugs can cross this barrier. The non-invasive tool is being developed by Angiochem Inc.

The U.S. Food and Drug Administration has granted the Orphan Drug Designation to a unique drug for children suffering from Ewing’s Sarcoma cancer developed by the Cure Our Children Foundation. The non profit and charitable organization was successful in development of this drug because of the generous volunteers, doctors in industry and researchers at two universities. The approval facilitates the development of the drug by providing fee waivers, FDA’s assistance for review and other benefits. The new drug is a combination of biotechnology and nanotechnology. Cell matter is modified to have the genetic code of tumor cells. When the cancer cells uptake this matter, they stop reproducing and die.

The U.S. Food and Drug Administration has granted orphan drug designation to Reata Pharmaceuticals, Inc.’s RTA 402 for treating patients suffering from pancreatic cancer. Currently in Phase 1/2 of its trial, RTA 402 receives economic incentive for further development in the form of reduction/exemption in regulatory fees, seven years of exclusivity in market and other support from FDA for R&D initiatives.

Safety labeling revision for GlaxoSmithKline’s Tykerb (lapatinib tablets) that includes a boxed warning about the risk of hepatotoxicity has been approved by the U.S. Food and Drug Administration. Hepatotoxicity cases have been reported during clinical trials, some of them being severe. The FDA has noted that the onset of the disease has taken place within a few months from initiation of the therapy. Tests for liver functioning should be taken before starting and during lapatinib treatment, every month. Lapatinib is a kinase inhibitor to be used along with capecitabine in the treatment of advanced breast cancer in patients who did not benefit from a therapy earlier.

The joint venture of Biocon in Abu Dhabi, NeoBiocon has launched Abraxane, the drug for breast cancer, based on nanotechnology, in the UAE. Developed by Abraxis BioScience, Inc., Abraxane will be marketed in South Asia and West Asia by Biocon,  as per the agreement they signed in 2007. The drug will be effective for patients who did not benefit from combination therapy. A chemotherapy agent, the drug combines paclitaxel with a naturally occurring human protein, albumin. The drug can be delivered without the use of solvents, allowing for a higher dosage. Also, the time to administer is 6 times lesser.

Revlimid (lenalidomide), a new medication that has the potential (in combination with dexamethasone) to extend longevity and slowing down the progression of multiple myeloma, has been approved by Health Canada for patients who have undergone at least one treatment.. This makes the drug one of the few once-daily oral therapies that are available for treating this form of blood cancer effectively. The approval was given on the basis of the results of clinical trials that were published in the New England Journal of Medicine. Revlimid is available in capsules of 15 mg and 25 mg.

To relieve the patients who have undergone prostate cancer surgery from the pain of recovery, doctors at Weill Cornell Medical College have developed an approach which is patient-friendly in the sense that it eliminates the use of a penile urinary catheter. The novel technique which is used along with robotic prostatectomy (the surgical removal of the prostate) does away with the discomfort that is associated with the standard catheter. In this approach, urine is redirected from the bladder through a narrow tube that goes out through a small needle puncture below the gut.