Regulatory Focus™ > News Articles > Regulatory Reconnaissance (24 July 2013)

Regulatory Reconnaissance (24 July 2013)

Posted 24 July 2013 | By Alexander Gaffney, RAC 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

  • FDA advisory panel votes against new use of AbbVie's Humira (Reuters) (Pink Sheet) (Pharma Times) (SCRIP) (BioCentury)
  • FDA panel narrowly backs new use of UCB's arthritis drug certolizumab (Reuters)
  • Medical Device Hackers Find Government Ally to Pressure Industry (Bloomberg) (Fierce)
  • FTC: Recent Supreme Court Decision Puts Agency in Stronger Position to Protect Consumers From Anticompetitive Pay-for-Delay Drug Settlements (FTC) (Reuters) (US PIRG) (Pink Sheet) (Pharma Letter) (Law 360)
  • Encore? FDA Could Come Close To Record 2012 NME Count This Year (PAM)
  • Companies mixed on whether FDA's GAIN guidance will spur new antibiotics (BioCentury)
  • Ibrutinib, Obinutuzumab Are Early Tests Of How Fast Breakthrough Reviews Will Be (PAM)
  • Verastem Receives Orphan Drug Designation from the U.S. FDA for Defactinib in Mesothelioma (Verastem)
  • Merck Announces FDA Acceptance of New Drug Application for Vorapaxar, Investigational Anti-Thrombotic Medicine (Merck)
  • After FDA meeting, Sarepta plans fast filing for DMD drug eteplirsen (Fierce) (Forbes) (Reuters) (The Street)
  • Government Seizes Dietary Supplements Containing DMAA in Three States (DOJ)

In Focus: International

  • EMA hatches compromise to release clinical trial data with minimal restrictions (BioCentury)
  • NICE gives final backing to drugs from Bayer, GSK and Otsuka (Pharma Times) (PMLive) (SCRIP)
  • UK rejects meningitis B vaccine (BBC) (UK)
  • Loophole free: EU's highest court backs health claim regulation in disease ruling (Nutra Ingredients)
  • Indian govt to revoke suspension of Pioglitazone (BioSpectrum)
  • Pakistan Vows Major Improvements To National Drug Authority (PharmAsia)
  • Years Of Natco Battles For Biotech Cancer Drug Copy Bears No Fruit (PharmAsia)
  • Brazil's Hot New Drug Market Offers Challenges To Would-Be Entrants (PharmAsia)
  • Two more AstraZeneca employees questioned in China (Reuters) (BioSpectrum)

Comments? Suggestions? Email me at news@raps.org.

US

Pharmaceuticals/Biotechnology
  • FDA advisory panel votes against new use of AbbVie's Humira (Reuters) (Pink Sheet) (Pharma Times) (SCRIP) (BioCentury)
  • FDA panel narrowly backs new use of UCB's arthritis drug certolizumab (Reuters)
  • FTC: Recent Supreme Court Decision Puts Agency in Stronger Position to Protect Consumers From Anticompetitive Pay-for-Delay Drug Settlements (FTC) (Reuters) (US PIRG) (Pink Sheet) (Pharma Letter) (Law 360)
  • Encore? FDA Could Come Close To Record 2012 NME Count This Year (PAM)
  • Companies mixed on whether FDA's GAIN guidance will spur new antibiotics (BioCentury)
  • Ibrutinib, Obinutuzumab Are Early Tests Of How Fast Breakthrough Reviews Will Be (PAM)
  • Verastem Receives Orphan Drug Designation from the U.S. FDA for Defactinib in Mesothelioma (Verastem)
  • Merck Announces FDA Acceptance of New Drug Application for Vorapaxar, Investigational Anti-Thrombotic Medicine (Merck)
  • After FDA meeting, Sarepta plans fast filing for DMD drug eteplirsen (Fierce) (Forbes) (Reuters) (The Street)
  • FDA Wants Preemptive Lupus Treatment Suit Nixed (Law 360)
  • Nuvo's partner Mallinckrodt to resubmit osteoarthritis treatment to US FDA (Pharma Letter)
  • Cytokinetics expands ALS drug study after computer error (SCRIP)
  • Schrodinger's Candidate? Achillion's Sovaprevir On Clinical Hold, But Phase II Combo Trial Continues (PAM)
  • Breo Asthma NDA Remains Up In The Air (PAM)
  • Breo Inverts Traditional Path To COPD Indication For LABA Combinations (PAM)
  • An Extensive Menu Of Novel Agents With Upcoming User Fee Goals (PAM)
  • FDA alerts companies to stop illegal sale of treatments for diabetes (FDA) (FDA) (Reuters) (ABC)
  • Tetracycline Shortage To Go On as US FDA Cannot Find New Source (In-Pharma Technologist)
  • Actavis, Cephalon pay-for-delays remain in FTC's bull's-eye (SCRIP)
  • Warning Letter to Kresenius Kabi (FDA)
  • Burlington Re-inspection Earns AMRI New US FDA Form 483 (Outsourcing Pharma)
  • Cytokinetics patches up ALS drug trial after costly study snafu (Fierce)
  • Esbelin Silouttte Te and Esbelin Siloutte Vitamin Supplement: Recall - Undeclared Drug Ingredients (FDA)
  • FDA reminds consumers spray-on sunscreens can catch fire (CBS)
  • New Animal Drugs; Change of Sponsor; Fentanyl; Iron Injection (FDA)
  • Novartis' Serelaxin Poised For Standard FDA Review (PAM)
  • Oritavancin Phase III Results Support FDA's New Endpoint, Sponsor Says (PAM)
  • Roche's breakthrough leukaemia drug hits PhIII targets, Superior to Rituxan (Pharma Times) (Genentech) (Reuters) (PMLive) (Pharmafile) (Fierce)
  • InSite Phase 3 Clinical Study for AzaSite and DexaSite Fail to Meet Intended Endpoints (InSite) (BioCentury)
  • Hatch-Waxman Watch: Safe Harbor Edition (Patent Docs)
  • Generics Cos. Haven't Shaken Label Claims Post-Mensing (Law 360)
  • Medicis Conspired To Block Generic Solodyn, Suit Says (Law 360)
  • FDA Presentations Posted from Small Business Conference (FDA)
Citizen Petitions
  • Hyman, Phelps & Mc.Namara, P.C - Citizen Petition: Determine Ampicillin for Injection 1g and 2g in ADD-Vantage Vial to be a RLD (FDA)
  • Hyman, Phelps & McNamara, P.C. - Citizen Petition: Designate Oxacillin for Injection 1g and 2g in ADD-Vantage Vial as RLD (FDA)
  • Bayer HealthCare Pharmaceuticals Inc. (Ropes & Gray LLP) - Citizen Petition: Grant Five Years Market Exclusivity to Natazia (FDA) (FDA)
  • Spec Pharma, LLC (Fish & Richardson P.C.) - Citizen Petition: BetaVet NADA Contains Data Improperly Used by Generic Applicant (FDA)
  • K&L Gates, L.L.P. - Citizen Petition: Grant Approval for Generic Kuvan (FDA)
  • Lachman Consultant Services, Inc. - Citizen Petition: Declare Hydrocodone Bitartrate and Acetaminophen Tablets Suitable for ANDA Submission (FDA) (FDA) (FDA)
Pharmaceuticals: General
  • HRSA Releases Proposed Rule Making Changes to the National Vaccine Injury Compensation Program (HRSA)
  • There are drugs to help fight painkiller addiction, but access is an issue with insurer restrictions (MedCity News)
  • Harvard Pilgrim sued over coverage for compounded drugs (Boston Herald)
  • Plan B pill on shelves, but strife continues (Boston Herald)
  • Top 20 orphan drugs by 2018 (Fierce)
  • Millions of Opioid Prescriptions Go to 'Doctor Shoppers' (MedScape)
Medical Devices
  • Medical Device Hackers Find Government Ally to Pressure Industry (Bloomberg) (Fierce)
  • FDA warns Prodigy Diabetes Care over glucose testing systems (Fierce)
  • uChek aims to follow Scanadu's pre-FDA crowdfunding strategy (MobiHealth News)
  • Intuitive Surgical reveals details of FDA warning letter, follow-up visit (Mass Device)
  • FDA Approves Aptima HPV Assay For Use On Hologic's Panther System (Aptima)
  • Gold Standard Diagnostics' and DIAsource ImmunoAssays' 25-OH Vitamin D, Total Assay Receives 510k FDA Clearance (GSD)
  • Investment, reimbursement and the FDA | 5 Questions with Icykar Therapeutix CEO Amar Sawhney (Mass Device)
  • MedStream Programmable Infusion Pump: Class 1 Recall - Malfunction In The Fill Level Sensor (FDA)
Assorted And Government
  • FDA Announces Major Conference Including Involvement of Shuren, Throckmorton and Taylor (FDA)
  • Government Seizes Dietary Supplements Containing DMAA in Three States (DOJ)
  • FDA's GMP expert Brad Williams joins NSF staff (Nutra Ingredients USA)
  • Report finds sequester barely affecting regulators (The Hill)
  • Ten Principles for Better Regulations (FDA)
  • Cost Estimate: H.R. 698, HIV Organ Policy Equity Act (CBO)
  • Cost Estimate: H.R. 2094, School Access to Emergency Epinephrine Act (CBO)
Upcoming Meetings And Events
  • 22-23 July 2013: Arthritis Advisory Committee Meeting (FDA)
  • 23 July 2013: Meeting: Current Cardiac Risk Paradigm: Arrhythmia Risk Assessment During Drug Development without the Thorough QT Study (FDA)
  • 23 July 2013: Hearing: "Pay-for-Delay Deals: Limiting Competition and Costing Consumers" (Senate Judiciary Cmmte)
  • 23 July 2013: Brookings Webinar: Active Medical Product Surveillance Roundtable (FDA)
  • 24 July 2013: Answering a Compelling Need: Expediting Life-Saving Treatments to Patients (FOCR)
  • 24 July 2013: House Hearing on US-EU Free Trade Agreements and Regulatory Barriers (House)
  • 25 July 2013: CBER Webinar on its Direct Recall Classification Program (FDA)
  • 25 July 2013: Webinar on FDA's Draft GFI on Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment (FDA)
  • 25 July 2013: Webinar on FDA's Draft GFI On Rheumatoid Arthritis - Developing Drug Products For Treatment (FDA)
  • 25-26 July 2013: Meeting on Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (FDA)
  • 31 July 2013: Nonprescription Drugs Advisory Committee Meeting  (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • EMA hatches compromise to release clinical trial data with minimal restrictions (BioCentury)
  • NICE gives final backing to drugs from Bayer, GSK and Otsuka (Pharma Times) (PMLive) (SCRIP)
  • British watchdog NICE rejects GSK's lupus drug again (Reuters) (SCRIP)
  • GSK's Revolade recommended by UK's NICE for low blood platelet counts (Pharma Letter)
  • UK's NICE approves NHS funding for Novartis' Xolair for all eligible patients (Pharma Letter)
  • MSD cleared by PMCPA (Pharmafile)
  • UK rejects meningitis B vaccine (BBC) (UK)
  • Loophole free: EU's highest court backs health claim regulation in disease ruling (Nutra Ingredients)
  • EU investigates German drug companies over possible state aid (Reuters)

Asia

  • Indian govt to revoke suspension of Pioglitazone (BioSpectrum)
  • Pakistan Vows Major Improvements To National Drug Authority (PharmAsia)
  • Lilly And Boehringer Ingelheim File Biosimilar Lantus In Europe, Japan Application Planned (PharmAsia)
  • Indian Medical Journal Seeks Ban on Pentavalent Vaccine (PharmaBiz)
  • As New Drug Pricing Law Comes into Effect in India, Shortages Expected (PharmaBiz)
  • Years Of Natco Battles For Biotech Cancer Drug Copy Bears No Fruit (PharmAsia)

China Scandal

  • Two more AstraZeneca employees questioned in China (Reuters) (BioSpectrum)
  • GSK Claims R&D Misconduct In China Has Been Eliminated (Law 360)
  • Bribery serves as life-support for Chinese hospitals (Reuters)
  • GlaxoSmithKline sees hit from China corruption scandal (Reuters)
  • GSK's China crisis: chief executive Andrew Witty speaks (The Guardian)
  • GSK's China crisis: questions that need answers (The Guardian)
  • ASIA BEAT: GSK, bribery and the China conundrum (SCRIP)

Other International

  • Cipla Recalls Febridol in Australia After Tablet Mix-up (TGA)
  • Brazil's Hot New Drug Market Offers Challenges To Would-Be Entrants (PharmAsia)
  • Stryker pulls spinal devices off the shelves in Australia following failure reports (Mass Device)

General Regulatory And Interesting Articles

  • Researchers: Pre-clinical animal research must improve (EurekAlert) (PLoS) (MNT)
  • Mount Sinai researchers identify vulnerabilities of the deadly Ebola virus (EurkeAlert)
  • Unusual Tick-Borne Virus Lurks In Missouri's Woods (NPR)

Regulatory Reconnaissance #115  - 24 July 2013

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 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.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at news@raps.org.


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