Pharma Strategy Blog

A class of drugs already approved as cancer treatments might also help to beat alcohol addiction. That's the conclusion of a discovery in flies of a gene, dubbed 'happyhour', that has an important and previously unknown role in controlling the insects' response to alcohol. Animals with a mutant version of the gene grow increasingly resistant to alcohol's sedative effects, the research shows. The researchers report further evidence that the gene normally does its work by blocking the so-called Epidermal Growth Factor (EGF) pathway. That EGF pathway is best known for its role in cancer, and drugs designed to inhibit the EGF receptor, including erlotinib (trade name Tarceva) and gefitinib (trade name Iressa), are FDA-approved for the treatment of non-small cell lung cancer.

AP Pharma has submitted a New Drug Application (NDA) for its APF530 product to the US Food and Drug Administration (FDA). The NDA has been submitted under the section 505(b)(2) of the Federal Food, Drug and Cosmetic Act, meaning AP Pharma can rely on the FDA's safety and efficacy findings for APF530's active ingredient granisetron. APF530 is being created for preventing chemotherapy-induced nausea and vomiting. Essentially, AP Pharma is tagging it's Biochronomer drug delivery technology to a generic to try and improve efficacy. ETA: 60-90 days.

Results of a phase I clinical trial of a novel herb-based therapeutic called Zyflamend have demonstrated that the therapy is associated with minimal toxicity and no serious adverse events in men at high-risk for developing prostate cancer. Findings published in the current issue of the Journal of the Society for Integrative Oncology. In the study, 23 men ages 40-75 years-old who were diagnosed with high-grade prostatic intraepithelial neoplasia (HGPIN) at biopsy, lesions that indicate an increased risk of developing prostate cancer, were admitted into this prospective clinical trial, in order to determine the safety and tolerability of Zyflamend when administered orally for 18-months, either alone or along with various dietary supplements.

I'll never forget a tweet from Sen John McCain moaning about how/why certain species of fish research ended up in the stimulus bill for science. The simple answer is that scientists can use fish as models for disease in humans. Zebrafish are being used to gain insight into the influence of known cancer genes on the development and progression of melanoma, an aggressive form of human skin cancer with limited treatment options.

Johnson & Johnson and Cougar Biotechnology, a development stage biopharmaceutical company with a specific focus on oncology, announced a definitive agreement (May 22, 2009) whereby Cougar Biotechnology will be acquired for approximately $1.0 billion in a cash tender offer. Cougar Biotech has compounds in development for the treatment of prostate cancer (abiraterone), as well as breast cancer and multiple myeloma and will work with Ortho Biotech Oncology Research & Development, a Johnson & Johnson company.