Regulatory Recon: Califf Nomination Praised as Thoughtful Choice (16 September 2015)

Posted 16 September 2015 | By Zachary Brennan 

Regulatory Recon: Califf Nomination Praised as Thoughtful Choice (16 September 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher , @Zachary Brennan and @RAPSorg on Twitter.

In Focus: US

In Focus: International

  • Consultation on EU GMP Guidelines, revised Annex 17 on the Real Time Release Testing (European Commission)
  • FDA Issues Warning Letter to Indian API Maker (FDANews-$) (Focus)
  • The GVK Case Files: Black And White Or Shades Of Gray? (SCRIP-$)
  • Lessons Learned from FDA Inspections of Foreign API Facilities (PharmaTech)

US: Pharmaceuticals and Biotechnology

  • Adverse Drug Event Reporting in U.S. Beset by Incompleteness and Inaccuracy (Tufts CSDD)
  • Some - Not All - Americans Hate Pharma More Than Ever, Says Gallup Poll (Pharma Marketing Blog)
  • As the World Gets Fatter, This Pharma Giant Gets Richer (Bloomberg)
  • Opinion: Politics, passion and patient power (Manufacturing Chemist)
  • The Big Biosimilars Questions: Will Senate Get Answers? (SCRIP-$)
  • Roche says biotech 'bubble' pushes midsize buys out of reach (Reuters)
  • Pharma Ties to AHA Questioned (PharmExec)
  • Notifications of Suspected Counterfeit Drugs Would Limit Distribution, FDA Says (FDANews-$)
  • Baxalta shifting to biosimilar outsourced model, selling ex-Genmab MN plant (BioPharma-Reporter)
  • The biggest side-effect of making medicine (Pharmafile)
  • 10 game-changing companies that are on track to revolutionize how we treat illness (Business Insider)
  • Provigil Buyers Again Say Class Cert. Order Needs Tweaking (Law360-$)

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

  • Intra-Cellular Surges as Schizophrenia Drug Passes First Key Test (Xconomy) (Press)
  • B-MS’s Opdivo (nivolumab) Receives Breakthrough Therapy Designation from FDA for Advanced Renal Cell Carcinoma (Press)
  • Amgen bets up to $1.7B on Xencor's antibody technology (Press) (FierceBiotech) (First Word Pharma)
  • Novo Nordisk buffs Tresiba's blockbuster rep as Sanofi showdown looms (FierceBiotech) (PMLive)
  • After a $560M Allergan buyout, Naurex vets regroup for CNS R&D (FierceBiotech) (SCRIP-$)
  • Anthera hits another setback as its Japanese partner quits on blisibimod (FierceBiotech)
  • Google, OrbiMed buy into Alector's novel take on Alzheimer's with a $32M round (FierceBiotech)
  • Celgene and Nurix Announce Collaboration Targeting Protein Homeostasis for Next-Generation Therapies in Oncology, Inflammation and Immunology (Press)
  • Lilly Announces Webcast to Discuss EMPA-REG OUTCOME Data (Press)
  • Memorial Sloan Kettering Cancer Center and Illumina Launch Comprehensive Circulating Tumor DNA Program (Press)
  • Compugen Discloses New Results Supporting CGEN-15052 as Novel Immune Checkpoint Target Candidate for Treatment of Cancer (Press)

US: Medical Devices

  • Probe of superbug-tainted medical scopes grows to include cleaning machines (USA Today)
  • Fitbit adds HIPAA compliance to wellness platform (MedCity News)
  • Breathe Technologies touts Medicare reimbursement win (Mass Device)
  • Thoratec Issues Voluntary Device Correction (FDA)
  • Class 2 Device Recall Voyant Open Fusion Device (FDA)

US: Assorted and Government

  • FDA Committee Votes Yes on New Flu Vaccine for Elderly (MPR)
  • Sens. Float 2 Bills To Crack Down On Pay-For-Delay Deals (Law360-$)
  • Medicare Biosimilar Proposal: Senators ‘Conflicted’ By Payer Concerns (Pink Sheet-$)
  • Google Life Sciences Hires The Government's Top Brain Scientist (Forbes) (BioCentury)
  • DARPA Touts Brain Controlled Prosthetic Hand with Natural Sense of Touch (MedGadget)
  • FDA orders Reynolds to stop selling four brands (Reuters)
  • FTC Homeopathic Meeting Features Tort Attorney, Commissioner Critical Of Enforcement (Tan Sheet-$)
  • Dietary Supplements Recalled for Undeclared APIs (Pharmaceutical Manufacturing)
  • BARDA Extends Chimerix Smallpox Contract; Adds $13m (SCRIP-$)
  • Doctors groups file petition to senators to release investigation findings on opioids (Letter)

Upcoming Meetings and Events              


  • Cancer Drugs Fund: Guest comment by Roy Lilley (ABPI)
  • NICE 'no' for Novartis' Farydak a blow for multiple myeloma patients (PharmaTimes)
  • Certifying Excipient cGMPs (PharmaTech)


  • SeleXys TH+ and TPS acetabular shells used in hip replacements (TGA)


  • Biocon launches insulin pen, fully 'made in India' from new device plant (In-PharmaTechnologist)
  • Kerala DC dept issues stop-sale order for statin drug ‘Lodens’ (PharmaBiz)
  • The Organization of Pharmaceutical Producers of India’s HR summit urges change for talent retention (PharmaLetter-$)


  • China R&D innovation, investment catching up to the global markets (BioWorld)

Other International

  • IPEC Federation Publishes Position Paper on Third Party Audit and Certification Programmes (IPEC)
  • Research and Markets: Global Orthopedic Devices Market - Forecast to 2021 (Press)

General Health and Other Interesting Articles

  • False Positives Are Always Waiting (In The Pipeline)
  • Scientists develop egg shell waste processing system to produce pharma ingredients (Manufacturing Chemist)
  • PubChem adds safety summaries (C&EN blog)
  • Chronic Kidney Disease Can Be Dubious Diagnosis (NY Times)
  • Child Safety Measures for Packaging of Laundry Pods Are Approved (NY Times)

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 @Michael_Mezher or send him an email at

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

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