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FDA News Flash                                                                January 16, 2012

FDA REGULATORY AND COMPLIANCE NEWS

• On Friday, FDA Commissioner Margaret Hamburg, MD, announced that the agency has completed their recommendations for three user fee programs, including the new Generic Drug User Fee and the Biosimilar and Interchangeable Products User Fee programs, as well as the fifth authorization of the Prescription Drug User Fee Act (PDUFA).  Dr. Hamburg stated that user fees were critical to ensuring that FDA has the necessary resources to conduct timely reviews, especially when facing greater budgetary constraint.  [FDA Press Release] (FDA.gov)
• FDA has expanded the approved use for WL Gore’s endovascular graft, the Gore TAG Thoracic Endoprosthesis, to include treatment of life-threatening tears or ruptures of the aorta (thoracic aortic transection).  This expanded use will provide surgeons with a minimally invasive alternative to open chest surgery to treat thoracic aortic transection and other endovascular lesions.  [FDA Press Release] (FDA.gov)
• FDA’s Gastroenterology and Urology Devices Panel unanimously voted that the clinical benefits of Torax Medical Inc.’s LINX gastroesophageal reflux management system outweigh the risks for treatment of gastroesophageal reflux disease (GERD).  The panel also supported Torax’s proposal for two postmarket studies, one to extend their PMA pivotal study, and the other to test a new patient cohort.  (The Gray Sheet)
• In response to a White House initiative, FDA has developed standards for scientific integrity to be issued in a new FDA Staff Manual.  Dr. Jesse Goodman, FDA’s Chief Scientist and Deputy Commissioner for Science and Public Health, recently reported on the status of this new staff manual, which he said would provide an overview of FDA principles, policies, and practices which would preserve and promote scientific integrity within the agency, both in decision making processes and other FDA activities.  (The Gray Sheet)            

CLIENT NEWS

• AstraZeneca establishes new Science and Technology Integration Office (The Telegraph)
• Roche, Ind-Swift Ltd. enter agreement to sell Roche Diagnostics’ heart attack detection kits (Reuters)
• Ventana, Syndax Pharmaceuticals enter agreement to develop companion diagnostic test for non-small cell lung cancer treatment (PRNewswire)

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MEETINGS

This week

• Tobacco Products Scientific Advisory Committee Meeting.  January 18-19, 2012.  Discuss issues related to the nature and impact of the use of dissolvable tobacco products on the public health, including such use among children, and discuss topics such as the composition and characteristics of dissolvable tobacco products, product use, potential health effects, and marketing.  [FR Notice]
• Advisory Committee for Reproductive Health Drugs.  January 20, 2012.  Discuss the benefits and risks of new drug application 22-139 progesterone gel 8%, Columbia Laboratories, Inc., for the proposed indication of “reduction of risk of preterm birth in women with short uterine cervical length regardless of other risk factors in the mid-trimester of pregnancy.”  Columbia Laboratories, Inc., (NASDAQ:CBRX).  [FR Notice]

Next 30 days

• Pediatric Advisory Committee.  January 30, 2011.  Discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act for Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein), Cervarix (Human Papillomavirus Bivalent (Types 16 and 18) vaccine, recombinant, Focalin XR (dexmethylphenidate), Daytrana (methylphenidate), Seroquel (quetiapine), Pancreaze (pancrelipase), Zenpep (pancrelipase), Creon (pancrelipase), Xerese cream 5%/1% (acyclovir and hydrocortisone), Xolair (omalizumab), Benicar (olmesartan medoxomil), Atacand (candesartan cilexetil), Mirena (levonorgestrel— releasing intrauterine system), Plan B One Step (levonorgestrel), and Flomax (tamsulosin).  [FR Notice]
• Oncologic Drugs Advisory Committee.  February 8, 2012.  Discuss supplemental biologics license application 125320/28 for XGEVA (denosumab) injection, application submitted by Amgen, Inc.  The proposed indication for this product is for the treatment of men with castrate-resistant prostate cancer at high risk of developing bone metastases, or spread of cancer to the bones.  Amgen, Inc., (NASDAQ:AMGN).  [FR Notice]
• Oncologic Drugs Advisory Committee.  February 9, 2012.  Discuss supplemental new drug application (NDA) 21790/010 for DACOGEN (decitabine) for injection, application submitted by Eisai, Inc.  The proposed indication for this product is for the treatment of acute myelogenous leukemia (AML) in adults 65 years of age or older who are not considered candidates for induction chemotherapy.  Discuss NDA 022481, with the proposed trade name PIXUVRI (pixantrone dimaleate) injection, application submitted by Cell Therapeutics, Inc.  The proposed indication for this product is as a single agent treatment for patients with relapsed or refractory, aggressive Non-Hodgkin’s Lymphoma who received two or more prior lines of therapy.  Cell Therapeutics, Inc., (NASDAQ:CTIC).  [FR Notice]
• Anesthetic and Analgesic Drug Products Advisory Committee.  February 9, 2012.  Discuss the available efficacy and safety data for supplemental new drug application (sNDA) 22395/S–013, QUTENZA (capsaicin 8%) Patch, by NeurogesX, Inc., for the proposed indication of management of neuropathic pain (nerve pain) related to HIV-associated peripheral neuropathy.  NeurogesX, Inc., (NASDAQ:NGSX).  [FR Notice]
• Neurological Devices Panel of the Medical Devices Advisory Committee.  February 10, 2012.  Discuss and make recommendations regarding the possible reclassification of cranial electrotherapy stimulator (CES) devices.  [FR Notice]
• Cellular, Tissue, and Gene Therapies Advisory Committee.  February 10, 2012.  Hear updates of the research programs in the Cellular and Tissue Branch, Office of Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation and Research, FDA.  [FR Notice]

Next 90 days

• Endocrinologic and Metabolic Drugs Advisory Committee.  February 22, 2012.  Discuss the safety and efficacy of new drug application (NDA) 22-580, proposed trade name QNEXA (phentermine/topiramate) Controlled-Release Capsules, manufactured by VIVUS, Inc., as an adjunct to diet and exercise for weight management in patients with a body mass index (BMI) equal to or greater than 30 kilograms (kg) per square meter or a BMI equal to or greater than 27 kg per square meter if accompanied by weight-related comorbidities.  VIVUS, Inc., (NASDAQ:VVUS).  [FR Notice]
• Cardiovascular and Renal Drugs Advisory Committee.  February 23, 2012.  Discuss the new drug application (NDA) 203202, proposed trade name NORTHERA (droxidopa capsules), submitted by Chelsea Therapeutics, Inc., for the treatment of symptomatic neurogenic orthostatic hypotension in patients with primary autonomic failure (Parkinson’s Disease, Multiple System Atrophy, and Pure Autonomic Failure), Dopamine Beta-Hydroxylase Deficiency, and Non-Diabetic Autonomic Neuropathy.  Chelsea Therapeutics, Inc., (NASDAQ:CHTP).  [FR Notice]
• Dermatologic and Ophthalmic Drugs Advisory Committee.  February 27, 2012.  Comment on the following topics related to the use of ophthalmic drug products:  Appropriate types of clinical evidence for developing anti-inflammatory drugs for the treatment of postoperative drugs and reduction of ocular pain in patients who have undergone ocular surgery; and the appropriateness of marketing a single bottle of ophthalmic product for use in both eyes for postsurgical indications as it relates to the potential risk for infection.  [FR Notice]
• FDA Rare Disease Patient Advocacy Day.  March 1, 2012.  Meeting to enhance the awareness of the rare disease community as to FDA’s roles and responsibilities in the development of products (drugs, biological products, and devices) intended for the diagnosis, prevention, and/or treatment of rare diseases or conditions.  [FR Notice] 
• Public Workshop.  March 7-8, 2012.  FDA Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice.  Co-sponsored by the FDA Los Angeles District Office and the Society of Clinical Research Associates (SoCRA).  Aid the clinical research professional’s understanding of the mission, responsibilities, and authority of the FDA and to facilitate interaction with FDA representatives; focus on the relationships among FDA and clinical trial staff, investigators, and institutional review boards (IRB).  [FR Notice]
• Arthritis Advisory Committee Meeting.  March 12, 2012.  Discuss the anti-nerve growth factor (Anti-NGF) drug class that is currently under development and the safety issues possibly related to these drugs.  [FR Notice]
• Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting.  March 14, 2012.  Discuss the clinical pharmacology aspects of  pediatric clinical trial design and dosing to optimize pediatric drug development.  [FR Notice]
• Public Workshop.  May 3, 2012.  Clinical Development Programs for Sedation Products.  Solicit information on a variety of issues related to the clinical development and use of sedation products in adult and pediatric age groups as FDA develops guidance on clinical development programs for sedation products.  [FR Notice] 
• Public Workshop.  April 12, 2012.  Role of Naloxone in Opioid Overdose Fatality Prevention.  [FR Notice]
• POSTPONED:  Immunology Devices Panel.  TBD.  Discuss, make recommendations, and vote on a premarket approval application for the Progensa PCA3 assay, which is indicated to aid in the decision for repeat biopsy in men 50 years of age or older who have had one or more previous negative prostate biopsies and for whom a repeat biopsy would be recommended based on current standard of care, before consideration of PCA3 assay results.  Gen-Probe, Inc., (NASDAQ:GPRO).  [FR Notice]

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