The U.S. Food and Drug Administration has granted approval for an Abbreviated New Drug Application for Akorn-Strides‘ Pamidronate Disodium Injection, 3 mg/mL and 9 mg/mL in 10 mL vials. The joint venture between Akorn and Strides was formed to develop liquid, dry powder and lyophilized formulations of generic injectable pharmaceuticals for a wide market with focus on painkillers, anti-infectives and CNS medications. Pamidronate Disodium Injection has received the indication for use in the treatment of hypercalcemia related to tumors and Paget’s disease.

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.

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 US Food and Drug Administration (FDA) has granted priority review to Novartis’ RAD001 (everolimus) on the basis of the drug’s potential to benefit patients suffering from advanced kidney cancer who showed no improvement after the standard treatment. The data collected from a trial shows that RAD001 curbs tumor growth, reducing the risk of disease progression by 70%.Novartis has already applied for marketing authorization for RAD001 with the European Medicines Agency (EMEA) and the Swiss Agency for Therapeutic Products (Swissmedic). EMEA has even accepted the proposed brand name for RAD001, Afinitor®.

The FDA has decided to postpone the approval for Genesense (oblimersen sodium) due to the lack of adequate data available for the drug. The drug is used in relapsed or refractory chronic lymphocytic leukemia. The Center for Drug Evaluation and Research (CDER) and the FDA agreed that the drug achieved the primary endpoint in the pivotal trial, drug maker Genta said. CDER has asked the company to come up with confirmatory evidence for the drug.

Oncothyreon has filed an INDA with the FDA for PX-866, a small molecule phosphatidylinositol-3-kinase (PI-3-kinase) inhibitor for the treatment of advanced cancers. The compound has been shown to have good single agent in vivo antitumor activity and works well in combination with other agents in a number of human tumor models, the company said. Following FDA review, the company plans to initiate a Phase I clinical trial.

Xoft Inc. has received clearance from the FDA for applicators to be used with the Axxent electronic brachytherapy system for the treatment of endometrial cancer. Previously cleared for accelerated treatment of early stage breast cancer, the system also recently received expanded approval for use in the treatment of other cancers or conditions where radiation therapy is indicated. The system that delivers electronic, X-ray-based radiation treatment may reduce external radiation therapy from seven weeks to five days.