Regulatory Focus™ > News Articles > Regulatory Recon: FDA, Eli Lilly and a Peculiar Regulatory Mystery (13 January 2015)

Regulatory Recon: FDA, Eli Lilly and a Peculiar Regulatory Mystery (13 January 2015)

Posted 13 January 2015 | By Alexander Gaffney, RAC 

Regulatory Recon: FDA, Eli Lilly and a Peculiar Regulatory Mystery (13 January 2015)

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

In Focus: US

  • FDA: Tainted Cialis came from Lilly Australia plant. Lilly: No, it Didn't. (IBJ) (In-Pharma) (Fierce) (Bloomberg)
  • Extended-Release Drugs Get Extra Scrutiny in U.S. Quality Focus (Bloomberg)
  • Ferring’s Nocdurna Nixed By FDA Panel, But Gets Multiple Paths Forward (Pink Sheet-$) (Tarius)
  • Show Me The Money: FDA Recruitment Efforts Challenged By Government Salaries (RPM Report-$)
  • Hospira seeks FDA nod for Epogen/Procrit biosimilar (SCRIP-$) (Pink Sheet-$) (Law 360-$)
  • 23andme Aims to End FDA Standoff This Year After Public Shaming (Bloomberg)
  • US FDA Approves New Larger-Capacity Insulin Pump, t:flex (Medscape) (Mass Device)

In Focus: International

  • Britain's health service to halt access to some costly cancer drugs (Reuters) (Pharma Times)
  • EMA Adopts ICH guideline E2B (R3) - questions and answers (EMA)
  • EMA Adopts ICH guideline Q3D on elemental impurities (EMA)
  • EMA Adopts ICH guideline M2 on eCTD - file format criteria (EMA)
  • France's ANSM Says it Wants to Study Use of Medical Devices (ANSM-French)
  • India court bars Cipla from selling copy of Novartis respiratory drug (Reuters)

US: Pharmaceuticals and Biotechnology

  • FDA: Tainted Cialis came from Lilly Australia plant. Lilly: No, it Didn't. (IBJ) (In-Pharma) (Fierce) (Bloomberg)
  • Extended-Release Drugs Get Extra Scrutiny in U.S. Quality Focus (Bloomberg)
  • Ferring’s Nocdurna Nixed By FDA Panel, But Gets Multiple Paths Forward (Pink Sheet-$) (Tarius)
  • Public Citizen to FDA: Reject Nocdurna (Press)
  • Show Me The Money: FDA Recruitment Efforts Challenged By Government Salaries (RPM Report-$)
  • Why FDA proposals for antibiotic pathways don't go far enough for bad bugs (BioCentury-$)
  • FDA Complete Response Letters: the design v. reality of FDA’s responses to drug applications (Lexology)
  • New FDA Biotech Inspection Program Will Mine Ten Years of Industry Data to Enhance Targeting and Execution; Field Refining Risk Ranking Process Across Pharma Spectrum (IPQ-$)
  • District Court Sides with FDA, 505(b)(2) Applicant in Challenge to Colchicine Capsules Approval (FDA Law Blog)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations

  • Hospira seeks FDA nod for Epogen/Procrit biosimilar (SCRIP-$) (Pink Sheet-$) (Law 360-$)
  • FDA seeks more safety data on Antares testosterone drug (Reuters) (Press)
  • Merck Accelerates Drug-Submission Plans (WSJ-$)
  • Sparsentan Gains Orphan Drug Designation for Rare Nephropathy (MPR)

US: Pharmaceuticals and Biotechnology: General

  • Hepatitis Drug Prices Fall So Low, No Exclusives Needed (Bloomberg)

US: Medical Devices

  • 23andme Aims to End FDA Standoff This Year After Public Shaming (Bloomberg)
  • US FDA Approves New Larger-Capacity Insulin Pump, t:flex (Medscape) (Mass Device)
  • FDA Clears Hepatiq Software for Quantifying Liver Disease (Medscape)

US: Dietary Supplements

  • Company agrees to FTC demand to stop making claims on supplements aimed at kids with speech disorders (NI-USA)

US: Assorted And Government

  • Obama waves veto pen at GOP regulations bill (The Hill)

Upcoming Meetings

Europe

  • Britain's health service to halt access to some costly cancer drugs (Reuters) (Pharma Times)
  • EMA Adopts ICH guideline E2B (R3) - questions and answers (EMA)
  • EMA Adopts ICH guideline Q3D on elemental impurities (EMA)
  • EMA Adopts ICH guideline M2 on eCTD - file format criteria (EMA)
  • France's ANSM Says it Wants to Study Use of Medical Devices (ANSM-French)
  • Pharma calls for NICE overhaul as special cancer drugs fund nixes meds (Fierce)
  • BMS Opdivo PIM designation a boost for UK early access scheme (SCRIP-$)
  • Another NICE no for Dendreon cancer drug Provenge (Pharmafile) (Pharma Times)
  • Lung Therapeutics, Inc. Granted Orphan Drug Designation in the European Union for LTI-01 (Press)
  • European Medicines Agency Grants Positive Opinion for Orphan Drug Status for Ovarian Cancer Oncolytic Vaccine (Press)
  • Scotland first in the UK to recommend the use of Xolair (omalizumab) to treat chronic spontaneous urticarial (MNT)
  • SMC recommends Erbitux for use in the first line treatment of metastatic bowel cancer patients in Scotland (MNT)

India

  • India court bars Cipla from selling copy of Novartis respiratory drug (Reuters)
  • Health ministry extends deadline to Jan 15 for suggestions on draft Drugs & Cosmetics (Amendment) Bill, 2015 (PharmaBiz)
  • Use of Proper Informed Consent Questioned in Trials of Merck's Gardasil (Daily Mail)
  • Indian manufacturer meeting: Regulator sets tough tone, declines 'friend' request (SCRIP-$)
  • Five more drugs, including Sovaldi, get local clinical trial waiver for importing, marketing in India (PharmaBiz)
  • India’s Draft National Intellectual Property Policy (Two-Four Insight)

Australia

  • eCTD workshops: Question and answer sessions (TGA)
  • Australia needs targeted reform to reflect global regulatory environment: Medicines Australia chief (PharmaLetter-$)

General Regulatory And Interesting Articles

  • BPA alternative disrupts normal brain-cell growth, is tied to hyperactivity, study says (Washington Post) (Reuters)

Regulatory Reconnaissance #470 – 13 January 2015

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.

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

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


Categories: Recon, Regulatory News

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