Drugs & Biologics

• Pfizer gets FDA approval of kidney cancer drug Inlyta
  The FDA approved Pfizer's Inlyta, saying the drug works in patients with metastatic kidney cancer whose initial therapy did not work. Inlyta, or axitinib, delayed tumor progression by two months during a head-to-head trial with Nexavar, a targeted agent by Bayer and Onyx Pharmaceuticals. Reuters (1/27)

• FDA approves weekly diabetes therapy Bydureon
  Amylin Pharmaceuticals and Alkermes' Bydureon, or exenatide, was approved by the FDA as a once-weekly treatment for type 2 diabetes. The glucagonlike peptide-1 receptor agonist costs about $4,200 a year. Amylin is conducting an FDA-requested trial to determine whether Bydureon heightens the risk of heart attacks, thyroid cancer and pancreatitis. The New York Times (tiered subscription model) (1/27)

• Douglas Pharmaceuticals' isotretinoin obtains FDA approval
  The FDA authorized generic acne medicine isotretinoin, produced by Douglas Pharmaceuticals. The company faced regulatory challenges in the past 10 years, including creating a brand name for isotretinoin and proving its bioequivalency to Roche Holding's Accutane, Director Jeff Douglas said. Douglas Pharmaceuticals' product will be marketed as Myorisan by U.S. partner VersaPharm. National Business Review (New Zealand) (1/25), The New Zealand Herald (1/30)

• Cephalon pulls one batch of lymphoma medicine Treanda
  Cephalon withdrew a single lot of injectable blood cancer drug Treanda after discovering particulate contamination in a glass vial of 25 milligrams per 8 milliliters. Treanda is used with chemotherapy in some patients with indolent B-cell non-Hodgkin lymphoma. The drugmaker said it has not received reports of adverse effects. The Philadelphia Inquirer/PhillyPharma blog (1/27)

• FDA agrees to review Pfizer's leukemia drug bosutinib
  Pfizer's bosutinib, an oral drug candidate for chronic myeloid leukemia, was accepted for FDA evaluation. The drug is targeted at adults previously treated with Bristol-Myers Squibb's Sprycel and Novartis' Tasigna. CBS MoneyWatch/The Associated Press (1/27)

• EU drops complaint about Servier's argument in antitrust inquiry
  The European Commission closed a case alleging that Les Laboratoires Servier gave misleading information during an investigation into a practice that delays generic-drug launches. The commission said it will focus on pending antitrust cases against several drugmakers, including Servier. Reuters (1/27), Bloomberg (1/27)

• FTC lawsuit aims to stop Omnicare's takeover of PharMerica
  The Federal Trade Commission filed a lawsuit to block Omnicare's proposed $440.8 million acquisition of PharMerica. A merger of the drug suppliers would "diminish competition and raise health care costs, leaving taxpayers and patients to foot the bill," said Richard Feinstein, head of the FTC's Bureau of Competition. Bloomberg (1/28)

• Rule aims for more transparency in Medicaid drug reimbursement
  The CMS proposed a rule to bolster transparency in Medicaid drug reimbursement and better align medication costs with what pharmacies pay. The move could help federal and state governments save about $17.7 billion over five years. Public input will be accepted until April 2. Modern Healthcare (subscription required) (1/29)

Food & Dietary Supplements

• Proposed FSIS changes have significant advantages, official says
  A proposal by the USDA's Food Safety Inspection Service to shift focus from monitoring quality assurance to evaluating safety procedures in poultry production would have significant benefits, Deputy Administrator Philip Derfler said during an FDLI conference. "We're going to emphasize food safety, totally, as the emphasis for what we're doing ... We really do believe that product is going to be a lot safer as a result," Derfler said. FoodSafetyNews.com (1/30)

• Other News

• Former FDA food-safety director Richard Ronk dies at age 78
  The Washington Post (1/29)

Featured Content

Medical Devices

• 6 sue FDA over monitoring of personal e-mail
  Six doctors and scientists sued the FDA in federal court, saying their personal email accounts were monitored, leading to harassment and dismissal. FDA documents say the six disclosed information about devices under review, but the HHS inspector general said they had the right to share concerns about safety with lawmakers and journalists. The Washington Post (1/29)

• CDRH: Medtech-related public inquiries, issues rose 11% last year
  The ombudsman of the FDA's Center for Devices & Radiological Health reports it had 461 contacts with the public last year, up 11% from the previous year. The ombudsman's office implemented an electronic system to keep track of the contacts last year, which covered inquiries and complaints (44% each), disputes (9%) and other issues. MassDevice.com (Boston) (1/26)

• AMD, glaucoma upgrades to Cirrus software score FDA clearance
  A software upgrade for Carl Zeiss Meditec's Cirrus HD-OCT has received the go-ahead from the FDA. The updated software now includes tools for diagnosing glaucoma and dry age-related macular degeneration. OSN SuperSite (1/26)

• Russian authorities to issue new medtech regulations
  Officials in Russia reportedly are developing medical device rules that could be available in the coming weeks. The regulations are expected to cover vigilance criteria for medical devices, authorized representation, country-of-origin approval, additional certification for measuring devices and a more formal clinical trial system. MassDevice.com (Boston) (1/26)

Hot Topics

Top five news stories selected by FDLI SmartBrief readers in the past week.

• Federal officials seek permanent injunction against Ranbaxy (Google)

• Supreme Court overturns California slaughter law (San Francisco Chronicle)

• FDA addresses use of brand, scientific names in ads (Medical Marketing & Media)

• FDA's medical device arm unveils priority plan for 2012 (MassDevice.com (Boston))

• Novartis unit reaches $99M settlement in overtime-pay lawsuit (Bloomberg Businessweek)

• Results based on number of times each story was clicked by readers.

FDLI Items

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  • Introduction to Medical Device Law and Regulation: How the Government Regulates the Medical Device Industry, March 12-13 in Washington, D.C.
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Position Title Company Name Location Regulatory Counsel Edwards LifeSciences Irvine, CA FDA Associate K&L Gates LLP Washington, DC Senior Officer, Health Impact Project The Pew Charitable Trusts Washington, DC Associate General Counsel, FDA Edge Consulting Boston, MA Regulatory Counsel Food and Drug Administration Silver Spring, MD Senior Corporate Counsel Medivation, Inc. San Francisco, CA Healthcare / Food & Drug Associate Arnall Golden Gregory LLP Washington, DC, DC POL / POC Clinical Trials Specialist (CTS) Sysmex America, Inc. Mundelein, IL Manager, Regulatory Affairs Covidien Plymouth, MN Sr. Director, Regulatory Counsel Incyte Corporation Wilmington, DE Counsel TEVA Pharmaceuticals Frazer, PA

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