Regulatory Focus™ > News Articles > Regulatory Reconnaissance (2 April 2013)

Regulatory Reconnaissance (2 April 2013)

Posted 02 April 2013 | By Alexander Gaffney, RAC

Good morning and welcome to another edition of Regulatory Reconnaissance. Fallout from the Indian Supreme Court's Novartis patent ruling continues today, with many in industry wondering what the decision means for the future of intellectual property in the country.

In the US, Hospira issues a recall of sodium chloride, AstraZeneca gets a fresh patent setback, FDA's strategic plan to end drug shortages gets lots of feedback, J&J's alleged to have known about problems long before recall, BioCryst rises from the grave on hopes of FDA accepting a submission, pSivida resubmits Iluvien to FDA, Actavis seeks approval for new testosterone strengths, PhRMA pans the Indian Supreme Court case, a new IOM workshop talks about sharing clinical research data, FDA's construction of its White Oak campus continues, and one publication thinks 'pay-for-delay' agreements could ultimately be settled by Congress (not the courts).

Abroad, continued fallout over the Novartis case, Pfizer's Bosulif gets conditional approval in the EU, Takeda's new vaccines could reach millions if approved, Phillipines' FDA blasts DTC TV ads for animal medicines, India's regulation of blood transfusions on hold, and a new UK patent tax break stands to help the life sciences industry.

Plus: Viagra turns 15 tomorrow and President Obama prepares to unveil a massive brain mapping project.

Five in Focus

  1. Hospira recalls sodium chloride after copper particles found (Fierce Pharma Manufacturing) (Outsourcing Pharma) (FDA)
  2. Comments Pour in to Federal Docket on FDA's Strategic Plan to End Drug Shortages (FDA)
  3. Despite sequester, FDA's White Oak construction continues (Gazette)
  4. More claims that J&J knew of hip implant troubles long before issuing a recall (Mass Device)
  5. Court could punt "Pay for Delay" back to Congress (MM&M)


  • Hospira recalls sodium chloride after copper particles found (Fierce Pharma Manufacturing) (Outsourcing Pharma) (FDA)
  • AstraZeneca suffers fresh drug patent setback in US (Reuters) (AstraZeneca)
  • The pill that brought the bounce back in men: Viagra turns 15 on Wednesday (DNA India)
  • Comments Pour in to Federal Docket on FDA's Strategic Plan to End Drug Shortages (FDA)
  • Biologics License Applications: Technical Amendment; Change of Address (FDA)
  • BioCryst's shares spike on hope that flu drug can rise from the grave (Fierce Biotech)
  • Clavis explores its options after second decisive PhIII cancer drug failure (Fierce Biotech) (Bloomberg)
  • Daiichi Sankyo ditches cancer drug program from ArQule (Fierce Biotech)
  • Industry Cool to FDA Quality 'Metrics' Call; Says cGMP is Key to Ending Shortages (FDA News) ($)
  • BioMarin Submits Vimizim BLA (Drug Discovery and Development) (BioCentury)
  • BioCryst's peramivir may get new life, despite 'stop-work' order (Scrip Intelligence) ($)
  • Ribavirin Sponsors Fend Off FDAAA Safety Labeling Changes, For Now (The Pink Sheet) ($)
  • Analyst: Higher Rate Of Genital Fungal Infections Could Curb Sales Of New J&J Drug (Forbes)
  • Medivation and Astellas Provide Update on PREVAIL -Companies Announce Phase 3 PREVAIL Interim Analysis Expected to Occur in 2013 (Astellas)
  • 47 Tylenol Liver Injury Cases Centralized In Philadelphia Federal Court (Lexis Nexis)
  • Advance Pharmaceutical Gets 483 for Quality System Lapses (FDA News) ($)
  • PhRMA Responds to Novartis Patent Case (PhRMA)
  • Actavis seeks approval for additional strength of generic testosterone gel (Drug Store News)
  • GSK Consumer Healthcare commends FDA nicotine replacement therapy proposals (Drug Store News)
  • Rockwell Medical Submits Data To FDA For Approval To Manufacture Calcitriol (RTT News)
  • Biocryst Pharmaceuticals Receives Preliminary Comment Letter From FDA on Peramivir (BioSpace)
  • Multidistrict Litigation Formed For Lawsuits Alleging Injury, Death From Fresenius Dialysis Concentrate (Lexis Nexis)
  • FDA warns about over-the-counter allergy medications for kids (ABC)
  • pSivida announces resubmission of ILUVIEN NDA to FDA for chronic diabetic macular edema (pSivida)
Medical Devices
  • More claims that J&J knew of hip implant troubles long before issuing a recall (Mass Device)
  • Edwards Lifesciences Uses a Hazard List to Get FDA Auditors to Listen (MDDI)
  • LabCorp signs development deal with Bristol-Myers to Provide More Diagnostics for Clinical Trials (Fierce Medical Devices) (Outsourcing Pharma)
  • Allied applies for heart patch approval in US (BioSpectrum)
  • Futura Finds a Partner to Develop Its Gel-Filled Condom (Bloomberg)
  • Draft Guidance for Industry on Scale-Up and Post-Approval Changes: Manufacturing Equipment Addendum; Availability (FDA)
  • IOM: Sharing Clinical Research Data - Workshop Summary (IOM)
  • 2013 Report on Technical Barriers to Trade (USTR)
  • Patient-Centered Outcomes Research Institute Finalizes Multi-Stakeholder Advisory Panels (PCORI)
  • FDA's Indifferent Attitude Towards the First Amendment (FDA Matters)
  • cGMP Compliance: Why It's Essential for Contract Manufacturers of Supplements (Natural Products Insider)
  • AHPA Requires Caffeine Labeling (Natural Products Insider)
  • More Food Litigation and, Yet Again, More Pom Wonderful (Drug and Device Law)
  • FSMA Preventive Controls and OMB: No Cloak or Dagger (FDA Law Blog)
Government and Budget
  • Despite sequester, FDA's White Oak construction continues (Gazette)
  • Obama unveils White House brain-mapping project (NYTimes) (NBC)
  • Court could punt "Pay for Delay" back to Congress (MM&M)
  • ONC seeks input on updating strategic plan (Modern Healthcare)
  • President Obama To Nominate Brian Deese to Deputy Director of the Office of Management and Budget (White House)
  • New York Times Blasts Medical Device Sector for Trying to Repeal Device Tax (NYTimes)
  • Reminder: President's FY2014 Budget Due out Around 8-10 April 2013
Meetings and Events This Week
  • 4 April 2013: Hamburg to Deliver Keynote to 2013 National Rx Drug Abuse Summit (NRxDA Summit)
  • 4 April 2013: NIH's Francis Collins to Appear on Stephen Colbert's 'The Colbert Report' (Colbert Nation)
  • 5 April 2013: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (FDA)
  • 8 April 2013: Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (FDA)
  • 25 April 2013: Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Shortened to a Single Day (FDA)
  • Other Upcoming FDA Advisory Committee Meetings and Topics (Eye on FDA)


  • As Novartis loses Glivec bid, India's war on pharma patents threatens to spread (Fierce Pharma)
  • Novartis sees India Glivec ruling indicative of IP 'de-recognition' (Scrip Intelligence) ($)
  • How two SC judges recused themselves from the case (Economic Times)
  • New UK tax breaks benefit life sciences groups from this week (Pharma Times) (BioCentury)
  • Ex-J&J India head led fight against patent (Economic Times)
  • Pfizer's Bosulif gets conditional green light for CML in Europe (PM Live)
  • Takeda Could Provide Vaccines To 25 Million Japanese In 6 Months If New Vaccine Is Approved (PharmAsia News) ($)
  • Philippines FDA blasts TV ads on animal medicines (ABS-CBN)
  • No move yet to revive Indian National Blood Transfusion Authority proposal (PharmaBiz)
  • China's State-Owned Sinopharm, Private China NT Form JV For Vaccines (PharmAsia News) ($)
  • Agenix seeks China SFDA nod for hepatitis candidate (BioSpectrum)

General Regulatory and Interesting Articles

  • Statin side effects can often be overcome: study (Reuters) (USA Today)
  • For Becton Dickinson, Medication Errors are a Business Opportunity (PharmExec)
  • Computer simulated skin to be used in allergy testing (BioSpectrum)

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.

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