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FDA News Flash                                                            January 31, 2012

 

FDA REGULATORY AND COMPLIANCE NEWS

• Yesterday, FDA announced approval of Erivedge (vismodegib) to treat adult patients with basal cell carcinoma, the most common type of skin cancer.  The drug, manufactured by Roche’s Genentech, is the first FDA-approved drug for metastatic basal cell carcinoma and was reviewed under the agency’s priority review program.  [Press Release] (FDA.gov)
• Yesterday, several members of FDA’s Pediatric Advisory Committee urged the agency to change the labeling for the attention deficit drug Focalin to include a warning about the potentially increased risk of suicidal thoughts reported to FDA by children and adolescents who were taking the drug.  Dr. Tom Laughren, Director of FDA’s Division of Psychiatry Products, however, expressed confusion over the panel’s focus on suicidal ideation given what he described as a small number of difficult to interpret reports for a widely used drug.  (Reuters)     
• Six former and current employees of FDA’s Center for Devices and Radiological Health (CDRH) have filed a federal suit against the agency alleging that senior managers authorized improper surveillance of their work computer activity, including use of personal email accounts after they had complained to Congress about perceived wrongdoing at CDRH.  The lawsuit seeks the reinstatement of the four plaintiffs who were fired or otherwise dismissed from the agency, other financial relief, and an injunction prohibiting the federal government from targeting whistleblowers with selected surveillance and monitoring.  (The Grey Sheet)
• Dr. Janet Woodcock, Director of FDA’s Center for Drug Evaluation and Research (CDER), announced yesterday that Dr. Ellis Unger will succeed Dr. Robert Temple as Acting Director of the CDER Office of Drug Evaluation I (ODE I).  Dr. Temple, who has long lead ODE I, will focus on his role as Deputy Center Director for Clinical Science, which he has also held since 2009.  (The Pink Sheet Daily)   

 

CLIENT NEWS

• Hospira names Richard Davies as Senior Vice President and Chief Commercial Officer (MarketWatch)
• Smith & Nephew acquires the Aderma range of Dermal Pads from Focus Product Development Ltd. (Smith & Nephew Press Release)
• Shionogi establishes an EU developmental subsidiary in the United Kingdom (Shionogi Press Release)
• KCI announces new management structure, including appointment of Joseph Woody as President and Chief Executive Officer (FierceMedicalDevices)
• Johnson & Johnson names Roberto Marques as head of its McNeil Consumer Healthcare unit (The Wall Street Journal)

 

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MEETINGS

 

• NEW:  Pulmonary-Allergy Drugs Advisory Committee.  February 23, 2012.  Discuss new drug application (NDA) 202450, for aclidinium bromide, sponsored by Forest Laboratories, for the proposed indication of long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.  Forest Laboratories, Inc., (NYSE:FRX) [FR Notice]
• NEW:  Blood Products Advisory Committee.  February 29, 2012.  Discuss the evaluation of possible new plasma products manufactured following storage at room temperature for up to 24 hours, namely, plasma for transfusion prepared from whole blood held at room temperature for up to 24 hours prior to separation and freezing, or from apheresis plasma held at room temperature for up to 24 hours before freezing.  [FR Notice]
• NEW:  Public Conference.  March 19-20, 2012.  The FDA/Pharmaceutical Users Software Exchange (PhUSE) Annual Computational Science Symposium.  Align and share experiences to advance computational science, update participants on current FDA initiatives and address specific challenges in accessing and reviewing data to support product development.  [FR Notice]

 

This week

• Pediatric Advisory Committee.  January 30, 2012.  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]

 

Next week

• 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 30 days

• Public Workshop.  February 15, 2012.  Ethical and Regulatory Challenges in the Development of Pediatric Medical Countermeasures.  Plenaries and breakout sessions on the ethical and regulatory challenges in the development of medical countermeasures for the pediatric population.  [FR Notice]
• 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]
• Vaccines and Related Biological Products Advisory Committee.  February 28-29, 2012.  On February 28, hear an overview of the research program in the Laboratory of Mycobacterial Diseases and Cellular Immunology, Division of Bacterial, Parasitic and Allergenic Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA, and discuss and make recommendations on the selection of strains to be included in the influenza virus vaccine for the 2012 and 2013 influenza season.  On February 29, discuss licensure pathways for pandemic influenza vaccines.  [FR Notice]

 

Next 90 days

• 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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