Regulatory Focus™ > News Articles > Regulatory Reconnaissance (5 March 2013)

Regulatory Reconnaissance (5 March 2013)

Posted 05 March 2013 | By Alexander Gaffney, RAC 

Good morning and welcome to another edition of Regulatory Reconnaissance. One biologics group is worried the sequester could slow down the development of a biosimilars pathway. Are their concerns warranted?

In the US, CDER is undergoing a big organizational shakeup, a generic liability case will soon go before the Supreme Court, J&J's Xarelto gets shot down by FDA, Hospira and Impax both get hit with manufacturing problems, Woodcock thinks e-health could help regulatory, robosurgery is under fire, FDA is hitting decorative contact lens manufacturers with warnings, a biohazard preparedness bill awaits Obama's signature, and spending on prescription medicines fell last year thanks to generics.

Abroad, a British firm is being slammed in the media for supplying poor-quality drugs to Kyrgyzstan (but MHRA can do little), Canada's out with new guidance on the classification of drug-device products, India has once again struck down Bayer's patent for Nexavar, AstraZeneca loses its Crestor patent case in Australia, and Roche gets EU approval for its breast cancer treatment Perjeta.

Five in Focus:

  1. CDER's OTS to house new Office of Computational Science (BioCentury) (FDA News) ($)
  2. FDA denies approval to expanded use of J&J/Bayer's Xarelto (Reuters) (Forbes)
  3. Depomed slams brakes on hot-flash drug after FDA advisers vote to reject (Fierce Biotech) (Med Page Today) (Reuters)
  4. House passes biohazard preparation bill, sends to Obama (The Hill) (Regulatory Focus) (E&C)
  5. British firm accused of supplying poor-quality drugs to Kyrgyzstan (The Guardian)

US

Sequester & Budget

  • Alliance for Safe Biologic Medicines Concerned Sequestration Cuts Could Delay Biosimilars Pathway (ASBM)
  • AdvaMed Going to Bat for FDA User Fees (Fierce Medical Devices)
  • Budget deadlock spells trouble for med-tech firms (Star Tribune)
  • Deal to avert government shutdown likely, officials say (Washington Post)
  • Obama, Congress Must Reach Deal On Budget By March 1, And Then April 1, And Then April 20, And Then April 28, And Then May 1 (The Onion) (SATIRE)
  • Cancer patients denounce sequester research cuts (The Hill)

Pharmaceuticals/Biotechnology

  • CDER's OTS to house new Office of Computational Science (BioCentury) (FDA News) ($)
  • Justices to Take Up Case on Generic Drug Makers' Liability (NYTimes)
  • FDA denies approval to expanded use of J&J/Bayer's Xarelto (Reuters) (Forbes)
  • Impax shares drop as FDA flags new concerns on manufacturing plant (Reuters)
  • Hospira woes continue as GSK sues for $25M over quality failures (Pharmafile)
  • E-Health Records Could Help CER Data Meet Regulatory Standards - FDA's Woodcock (The Pink Sheet) (Woodcock Editorial)
  • Study Raises Significant Doubts About Practical use of Gilead's Truvada  (NIH) (Reuters) (Bloomberg)
  • Comments Pour In Regarding FDA's Strategic Plan to Address Drug Shortages (FDA Docket) (Amgen) (AstraZeneca)
  • Pfizer settles 2,000-plus Chantix suits, takes $273M charge (Fierce Pharma)
  • Depomed slams brakes on hot-flash drug after FDA advisers vote to reject (Fierce Biotech) (Med Page Today) (Reuters)
  • Zometa Generic Exclusivity Suit By Sun Flames Out Against FDA (The Pink Sheet Daily) ($)
  • US Spending on Basic Prescriptions Decreases (WSJ) (Reuters) (Bloomberg)
  • What is a Breakthrough Product Designation? (FDA)
  • Blumenthal: FDA Inspections of Compounders 'Evidence of a Wider Systemic Problem' (Blumenthal)
  • Sharp Increase in FDA Drug Approvals a Major Factor in Biotech Industry's Success in 2012 (Marketwire)
  • Much "Ado" About Biosimilars (RPM Report)
  • J&J, Gilead combo quells hep C in 100% of PhII cohort (Fierce Biotech)
  • Boehringer Ingelheim announces interim results from a Phase III trial in HIV patients co-infected with chronic hepatitis C (Boehringer Ingelheim)
  • Celgene provides more apremilast psoriasis data (BioCentury)
  • AcelRx pain treatment meets late-stage study goal (Reuters)
  • New Legislation Would Upgrade California to CURES Rx Monitoring System (California Healthline)
  • Meeting: Advisory Commission on Childhood Vaccines (HRSA)

Medical Devices

  • Robosurgery Suits Detail Injuries as Death Reports Rise (Bloomberg)
  • Meeting Materials of the Circulatory System Devices Panel - 20 March 2013 (FDA)
  • Philips to Market Navigator for Structural Heart Disease Repairs (Bloomberg)
  • FDA Clears First Blood Glucose Monitoring System To Automatically Send Results Wirelessly Via Bluetooth® Technology to iOS Devices (PR Newswire)
  • Email to On-line Distributors About Unlawful Marketing of Decorative Contact Lenses (FDA)
  • Bogus Electrodermal Testing Devices and the Failure of Regulators to Act (Science-Based Medicine) (Wiley)

Assorted

  • Should US-Supported Standards be Available for Free to the Public? (Sunlight Foundation)
  • House passes biohazard preparation bill, sends to Obama (The Hill) (Regulatory Focus) (E&C)
  • PhRMA Urges Trans-Pacific Partnership Negotiators to Adopt a Strong Intellectual Property Framework (PhRMA)
  • FDA's Looking for a Company to Help it Manage its Social Media Efforts (FedBizOpps)
  • 491 days, 490, 489 . . . . The Social Media Guidance Countdown Is Still Going (Drug and Device Law)
  • Physician Payment Sunshine Act: Sunshine Alerts and Analysis (Policy and Medicine)
  • Bioethics Commission kicks off webinar series on "Privacy and Progress" hosted by Genetic Alliance (Pres. Commission for the Study of Bioethical Issues)
  • Biogen Idec, Forest and Bayer Among Top Sponsors Rated by Investigative Sites in New CenterWatch Survey (Center Watch)
  • Health IT Firms Join Forces To Create National System For Sharing Medical Records (Forbes) (Bloomberg)
  • FDA revisits rule on cow intestines in food, cosmetics (The Hill) (FDA)
  • Monster Beverage Strikes Back Against Lawsuit Claiming Energy Drink Killed 14-Year-Old (AP)
  • Woodcock Receives Arthritis Foundation Award (PR Newswire)
  • It's Past Time to Appoint an OIRA Administrator (CPR Blog)
  • House members look to stop feds from ducking regulatory transparency rules (The Hill)
  • Conductors to be tested for OTC drugs after rail accidents (The Hill)

International

  • British firm accused of supplying poor-quality drugs to Kyrgyzstan (The Guardian)
  • Canadian government to tighten counterfeit law (Outsourcing Pharma)
  • Canada: Guidance Document: Factors Influencing the Classification of Products at the Device-Drug Interface (Health Canada) (More)
  • India sinks Bayer's hopes on Nexavar patent (Fierce Pharma) (Pharmalot)
  • Novo's Lantus rival Tresiba hits European markets (PM Live)
  • Roche gets EU approval for breast cancer drug Perjeta (Reuters) (Roche)
  • Inspections Can't Solve Import-Related API Shortage Concerns says MHRA (In-Pharma Technologist)
  • Australia Federal Court holds CRESTOR patents invalid (AstraZeneca) (PM Live)
  • IQWiG rejects Cell Therapeutics' Pixuvri (PM Live)

Interesting

  • Study Raises Significant Doubts About Practical use of Gilead's Truvada  (NIH) (Reuters) (Bloomberg)
  • A Reality Checkpoint for Mobile Health: Three Challenges to Overcome (PLoS)

Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.

Did we miss a story? Send us a tweet at @RAPSorg or @AlecGaffney and we'll check it out for inclusion in our next edition of Regulatory Reconnaissance. Want this in your inbox each morning? Sign up for RF Today, our morning intelligence newsletter here.


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