Regulatory Recon: US, UK Launch New Partnership for Antibiotic Development Abbott Wants Out of Alere Deal (29 July 2016)

Posted 29 July 2016 | By Michael Mezher 

Regulatory Recon: US, UK Launch New Partnership for Antibiotic Development Abbott Wants Out of Alere Deal (29 July 2016)

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

  • FDA approvals for the first 6 months of 2016 (Nature)
  • FDA takes steps to protect blood supply in Florida amid Zika probe (Reuters) (FDA)
  • At the DNC, the debate over drug prices gives way to charcuterie and cheese
  • The Unique Voices of Our Patient Representatives (FDA Voice)
  • Embattled Theranos promises first-ever peek at its science — but doubts abound (STAT)
  • Democrats Tell FDA, CMS to Hand Over Theranos Data (Focus)
  • FDA Declares 'General Wellness' Devices Exempt From Regulations (Focus)
  • Abbott wants to exit Alere deal (Crain's)
  • NIH-led researchers develop software that could facilitate drug development (NIH)
  • Medical Device Companies to See Slight Discount in FDA User Fees in 2017 (Focus)
  • Artificial Pancreas Is First To Raise $1 Million Under New Crowdfunding Rules (MIT Technology Review)
  • Why 'Government Patent Use' To Lower Drug Costs Won't Stifle Innovation (Health Affairs Blog)
  • How Focusing On Obscure Diseases Made BioMarin A $15 Billion Company (Forbes)
  • Judge rules against nearly 1,300 lawsuits over Bayer's Mirena IUD (Reuters)
  • FDA Encouraging Stakeholder Feedback on NGS Guidances, Participation to Improve Reliability of Tests (GenomeWeb)
  • AbbVie revenue jumps 17.8 percent on higher demand for drug Humira (CNBC)

In Focus: International

  • US and UK form global partnership to speed new antibiotics (Reuters) (WSJ-$)
  • Make Drugmakers Pay: England's Strategy for Cancer Medicines (Bloomberg)
  • Teva, Mylan eye Pfizer's Brazil venture, sources say (Reuters)
  • Sanofi sales and profit slide on U.S. pricing, Venezuela (Reuters) (Press)
  • Innovations give African leaders hope malaria can be beaten by 2030 (Reuters)
  • Better identification of medicinal products: ISO IDMP Webinar (EMA)
  • Dr Reddy's Q1: warning letter 'significantly impacted our earnings' (InPharmaTechnologist)
  • Sanofi begins dengue immunization program in South Brazil (BioSpectrum)
  • UK MHRA Aims To Address "Fundamental Failures" In Data Integrity (Pink Sheet-$)
  • European Regulatory Roundup: Sandoz, Sanofi and Teva Drugs Face Suspension After EMA Faults Bioequivalence Tests (Focus)
  • WHO's New Hepatitis C Drug Patent Profiles To Boost Access Worldwide (Pink Sheet-$)
  • Swiss Medtech Voices Brexit Business Fears, Prepares For EU Regs (MedtechInsight-$)

US: Pharmaceuticals & Biotechnology

  • Vertex Pharma Loss Narrows as Cystic Fibrosis Drug Sales Grow (WSJ-$) (Fierce)
  • ​Vertex to apply next year for approval of a drug that could replace Orkambi (Boston Biz Journal)
  • Ubl Gets Personal, Lays Out Vision for Future of PhRMA (Policy and Medicine)
  • ICER Eyes QALY Ratios, Budget Impacts In Methods Review (Pink Sheet-$)
  • Merck Announces Second-Quarter 2016 Financial Results (Press)
  • NIH names Dr. Joshua Gordon director of the National Institute of Mental Health (NIH)
  • Strengthening Global Medicines Quality: USP's New Role in Harmonization (USP)
  • The Industry Hopes Congress Approves PDUFA Program in 2016 (PharmTech)
  • What instructions? Majority of Americans misuse prescription drugs (STAT)
  • A Grain Of Salt For Your Nose Antibiotic (Forbes)
  • Regulus hopes for quick turnaround on FDA hold on hep C drug (Fierce)
  • Doc's Dilemma: Lucentis or Avastin? (Medpage)
  • Technology alone may not close disparities in medical research (Reuters )
  • Alexion's Strensiq beats expectations (BioCentury)
  • 87% Of Surveyed Life Science Organizations Report At Least Partially Centralized Drug Safety Structures (Cutting Edge Info)
  • 3 Areas of Focus When Responding to FDA Inspection Findings (GxP Lifeline)
  • The economic impact of biosimilars in the US (GaBI)

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

  • Pfizer Announces Positive Top-Line Results from Pivotal Phase 3 Maintenance Trial of Oral XELJANZ® (Tofacitinib Citrate) in Ulcerative Colitis (Press)
  • Priority Review for BioMarin's Batten therapy (BioCentury)
  • FluGen Starts Clinical Trial for Universal Flu Vaccine (Xconomy)
  • FDA fast tracks Shire's SHP626 nonalcoholic steatohepatitis drug (Pharmafile) (Press)
  • Pfizer and Western Oncolytics Announce Immuno-Oncology Research Collaboration to Investigate Novel Oncolytic Virus Technology (Press)
  • Neon Therapeutics Announces FDA Acceptance of Investigational New Drug Application for Cancer Vaccine NEO-PV-01 (Press)
  • Seres shares crash after microbiome drug flunks PhII (Fierce) (Press)
  • Pfizer Announces Positive Top-Line Results from Pivotal Phase 3 Maintenance Trial of Oral XELJANZ® (Tofacitinib Citrate) in Ulcerative Colitis (Press)
  • Neurovance announces positive centanafadine Phase 2b results for adult ADHD, and plans for Phase 3 trials (MNT)

US: Medical Devices

  • Medical Device Co. To Pay $11.5M Over Alleged Kickbacks (Law360-$)
  • Robotic Surgery for Prostate Cancer May Offer No Benefits Over Regular Surgery (NYTimes)
  • UDI: When the Rule is Not Enough (FDA Law Blog)
  • UDI Guidance: Five Key Steps to FDA Unique Device Identifier Compliance (Emergo)
  • FDA gives nod to first percutaneous peripheral nerve stimulation device (MedCityNews)
  • CareFusion Recalls AVEA Ventilator Due to an Electrical Issue Which May Cause an Unexpected Shutdown (FDA)
  • Heartware Q2 sees losses shrink, beats the street (MassDevice)
  • Penumbra touts stent retriever study data (MassDevice)
  • Zimmer Biomet shares lift after reporting big gains in sales (MassDevice)
  • Smith & Nephew touts 1st-use of Navio robotic-assisted knee system (MassDevice)

US: Assorted & Government

  • Fraud and Other Threats to Medicare (NYTimes)
  • Mylan Gets FTC Approval for Meda Deal (WSJ-$)
  • Par Pharma Sued For Abusing Monopoly Of Vasopressin (Law360-$)
  • The Olympus Settlement – What It Can Tell Us About the Compliance Officer (Policy and Medicine)
  • A Clinton Twist On Price Negotiation: Hillary's Role With PEPFAR (Pink Sheet-$)
  • California Federal Court Dismisses Inferior Complaint (Drug and Device Law)

Upcoming Meetings & Events


  • Roche urges reform of Cancer Drugs Fund as NICE takes control (Pharmafile)
  • ABPI statement on 'go-live' of 2016/17 Cancer Drugs Fund (ABPI)
  • Andrew Evans appointed chief pharmaceutical officer for Wales (Pharmaceutical Journal)


  • Revised China Drug Regulation Sets Back IPR Protection – Experts (Pink Sheet-$)
  • Orthofix wins Japanese regulatory win for Phoenix spinal fixation system (MassDevice)
  • Luoxin picks up NSCLC candidate from Yuhan (BioCentury)


  • Govt mulling making pharma marketing uniform code compulsory (Economic Times)
  • Fixing drug prices helped consumers save Rs 5,000 crore: Government (Economic Times)
  • DRL, Cipla, Aurobindo among others to buy products from Teva (Economic Times)


  • MSD set to take on Pfizer in Oz after Samsung Bioepis' biosimilar Enbrel is approved (BioPharmaReporter)


  • Summary Safety Review - Hydrocodone-containing products - Assessing the Risk of Serious Breathing Problems (respiratory depression) in Children and Adolescents (Health Canada)


  • DNA vaccines against Zika virus speed into clinical trials (Nature)
  • Puerto Rico is being pummeled by Zika, with hundreds of cases of birth defects feared (STAT)

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.

Categories: Recon, Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.


Most Viewed Articles