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Regulatory Recon: FDA Panel Votes No on Bayer's Inhaled Cipro Takeda CEO Eyes Deals Outside Japan (17 November 2017)

Posted 17 November 2017 | By Michael Mezher 

Regulatory Recon: FDA Panel Votes No on Bayer's Inhaled Cipro Takeda CEO Eyes Deals Outside Japan (17 November 2017)

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

In Focus: US

  • FDA Committee Votes No On Bayer's Inhaled Cipro (BioCentury) (Medpage) (Pink Sheet-$)
  • Painful Truth: Successful Failure Of A Biotech Startup (LifeSciVC)
  • FDA backs Roche's Gazyva in first-line follicular lymphoma (Reuters) (Press)
  • Roche to buy US-based Viewics amid diagnostic data push (Reuters) (Press)
  • Booming Regeneron gets the green light for a major expansion (Endpoints)
  • FDA expands approval for Pfizer cancer drug Sutent (Reuters) (Press) (FDA)
  • Is the FDA approving drugs faster than ever? No, as the data show (STAT)
  • FDA Unveils New Regenerative Medicine Framework (Focus) (NYTimes)
  • $1 million price tag in spotlight as gene therapy becomes reality (Reuters)
  • A New Gene-Editing Therapy Would Benefit Kids Most—Here's Why They Won't Get It Yet (MIT Technology Review)
  • Johnson & Johnson hit with $247 million verdict in hip implant trial (Reuters) (Law360-$)
  • Johnson & Johnson wins California lawsuit claiming asbestos in talc caused cancer (Reuters) (Fierce)
  • House Passes GOP Tax Overhaul With Orphan Drug Tax Credit Repeal Included (Focus)
  • Devices Referencing Drugs: Questions Raised Over Potential Regulatory Pathways (Focus)
  • FDA Finalizes 2015 Draft Guidance on UDI Marking Requirements (Focus)
  • Gottlieb Statement on IV Fluid Shortages (FDA)
  • Endo unit cleared of liability in first testosterone replacement trial (Reuters)
  • Cue Biopharma in $374M-plus Merck immunotherapy pact (Fierce)
  • Pentagon will not decide on battlefield drug/device approvals (Fierce)

In Focus: International

  • Struggling Oncolytics Biotech signs $86.6M Asia deal with China's Adlai Nortye (Endpoints)
  • Takeda CEO Seeks Deals to Form Identity Beyond Japan Drug Market (Bloomberg)
  • Interview: Building Merck KGaA's Specialty Business In EMEA (SCRIP-$)
  • Political Bargaining Intensifies Before Vote On EMA's New Home(SCRIP-$)
  • Could Milan be the new home for the EMA? (EPR)
  • Improved diagnostics fail to halt the rise of tuberculosis (Nature)
  • Singapore's pharmaceutical market value to reach $1.15 billion by 2021 (PharmaLetter-$)
  • Canada acts as 2017 opioid deaths surpass 3,000 (PharmaLetter-$)
  • Holes In Road To Unified Patent Court Could Derail The Project – And Hit Plans For EU SPC (Pink Sheet-$)
  • Germany Life Sciences Report 2017-2018 (HealthCapital)

Pharmaceuticals & Biotechnology

  • What's a successful failure? Atlas' Booth sounds taps for Merck-backed Quartet Medicine (Endpoints)
  • Pfizer to Hire 400 at API site (Pharmaceutical Manufacturing)
  • Receipt of Notice That a Patent Infringement Complaint Was Filed Against a Biosimilar (FDA)
  • Public Complete Response Letters? Don't Hold Your Breath (Pink Sheet-$)
  • At Seattle Children's, Another Piece of Ambitious CAR-T Plan in Place (Xconomy)
  • Negligible Benefit Of Nerlynx, A Breast Cancer Drug, Highlights Need For Caution In Prescribing Treatment (Forbes)
  • Signs of progress, challenges in fighting Alzheimer's (The Hill)
  • Biotech Institute's Growing Patent Portfolio -- U.S. Patent No. 9,095,554 and the Path Forward (Patent Docs)
  • AstraZeneca On Bridging The Gap Between Accelerated Approval And HTA Requirements (Pink Sheet-$)
  • Upcoming events – US approvals due for Glaxo and Novo Nordisk (EP Vantage)
  • Mitsubishi Tanabe Pharma America Announces 1,000 People with ALS Have Received FDA-Approved Treatment Option in First Three Months Available (Press)
  • While The Money Flows, So Will Biopharma IPOs (SCRIP-$)
  • SMEs 'carry the hope' in AMR fight, says research network (PharmaLetter-$)
  • Capricor's DMD Cell Therapy Has HOPE, But Market Is Unsure (SCRIP-$)
  • CRISPR Patents Must Be 'Reined In,' Experts Say (GenomeWeb)
  • GlaxoSmithKline reports 13.3 percent stake in Spero Therapeutics (Reuters)
  • Separating side effects could hold key for safer opioids (NIH)
  • In conversation with: Alice Zhang, CEO of Verge Genomics (Fierce)
  • Evelo taps Mayo Clinic expertise for therapeutic bacteria programs (Fierce)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • Loss of efficacy after switching to biosimilar infliximab in Behcet's patients (GaBI)
  • Aerie Pharmaceuticals Initiates Netarsudil Ophthalmic Solution Phase 2 Clinical Trial Designed to Meet Requirements of Regulatory Filing in Japan (Press)
  • Announcing FDA Approval for the New HiFocus™ SlimJ Electrode (Press)

Medical Devices

  • Letter to HHS Requesting Development of Software Bill of Materials for Health Care Technologies (E&C)
  • Medical Devices; Exemption From Premarket Notification: Over-The-Counter Denture Repair Kits (FDA)
  • Dexcom CEO: We don't think patients will drop our feature-filled glucose monitors for Abbott's (CNBC)
  • Design History File vs. 510(k) vs. Technical File: What Do Medical Device Developers Need to Know? (MDDI)
  • FDA Turns to Emerging Tech for Opioid Crisis (MDDI)
  • Alcyone Lifesciences wins FDA nod for Alivio hydrocephalus shunt flusher (MassDevice)
  • Insulia wins FDA nod, CE Mark clearance to titrate Tresiba, Basaglar insulin (Drug Delivery)
  • GE, Golden Meditech ink cord blood storage deal (MassDevice)
  • Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection of Zika Virus (FDA)
  • Interpace Diagnostics Wins NY State Approval for Thyroid Cancer Testing Service (GenomeWeb)

US: Assorted & Government

  • Lilly used nursing services as kickbacks to boost insulin prescriptions, lawsuit claims (Fierce)
  • Calif.'s New Focus On Drug Pricing Transparency (Law360-$)
  • CMS is looking for ideas on reducing drug prices for Medicare Part D (MedCityNews)
  • Economic burden of opioid epidemic hit $95 billion in 2016 (Modern Healthcare)
  • Opioid limits proposed for Minnesota prescribers to fight painkiller abuse (Star Tribune)
  • Chandler, Gilbert police begin carrying opioid overdose drug and putting it to use (AZ Central)
  • Hammond sues drug companies, distributors for 'responsibility' in opioid crisis (Chicago Tribune)
  • The Breakthrough: Used as 'Guinea Pigs' by the U.S. Military, Then Discarded (ProPublica)
  • Items of Interest on the Federal Civil Rules Committee Agenda (Drug & Device Law)

Upcoming Meetings & Events


  • Annalisa Jenkins' next career chapter takes her back to Europe (Endpoints)
  • Accelerating advanced therapies with patient-focused science and partnerships (ABPI)


  • Varian Medical wins Japanese nod for Halcyon oncology radiotherapy system (MassDevice)
  • The 22nd AHWP Annual Meeting would be held on 4 - 8 Dec 2017. Please find attached the tentative program for the Meeting. (AHWP)


  • Daiichi gave Delhi High Court wrong information: Singh brothers (Economic Times)
  • Lenders of Orchid Pharma appoint Sripatham Ramkumar as resolution professional (Economic Times)
  • USFDA gives final approval to Cipla's anti-asthma product (Economic 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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