Regulatory Recon: FDA Mulling Ways to Break Silos GSK's Witty: Drug Prices to Drop Regardless of US Vote (8 November 2016)

Posted 08 November 2016 | By Michael Mezher 

Regulatory Recon: FDA Mulling Ways to Break Silos GSK's Witty: Drug Prices to Drop Regardless of US Vote (8 November 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Missed yesterday's Recon? Read it here.

In Focus: US

  • CardioBrief: Cardiac Devices Could Become a Big Problem for FDA (Medpage)
  • Promotion of Drugs for Off-label Uses: The US Food and Drug Administration at a Crossroads (JAMA)
  • California's Drug Price Initiative: Will Voters 'Send a Signal to Washington'? (KHN)
  • When can Non-Inferiority Trials Establish Efficacy? FDA Explains With Guidance (Focus)
  • Drug Marketing on Twitter: FDA to Study Space-Limited Communications (Focus)
  • Device Reporting Requirements for Manufacturers: FDA Finalizes Guidance (Focus)
  • Knowing When and How to Use Medical Products: A Shared Responsibility for the FDA and CMS (JAMA)
  • Oral arguments set to begin next month in major CRISPR patent case (STAT) (Oral Argument Order)
  • Supreme Court lets pay-to-delay ruling against pharma stand (STAT) (Law360-$)
  • FDA Mulling Ways to Break Silos, Review Products by Clinical Areas (Bloomberg)
  • Election Uncertainty Hasn't Slowed Cancer 'Moonshot' Momentum (Bloomberg)
  • Novel system to get dying patients an experimental cancer drug raises hopes — and thorny questions (STAT)
  • Companies Bet on Designer Bacteria as New Way to Treat Disease (MIT Technology Review)
  • Drug Prices to Drop Regardless of U.S. Vote Outcome, Witty Says (Bloomberg)
  • The Promise of a Strong U.S.-Cuba Health Partnership (HHS)
  • Medtronic agrees to share data in patient-safety effort (Star Tribune)
  • Biopharma deal-making holds up during investor exodus, price disputes (BioWorld)
  • CMS official says drug costs are 'unsustainable' and there are 'too many' bad actors (STAT)
  • FDA's Pazdur To Retain Drug Approval Duties In Oncology Center Of Excellence (Pink Sheet-$)
  • Zika Is On The Ballot In Florida -- And Science-Based Decision-Making (Forbes)
  • E&C Lawmakers Probe FDA On Device Cybersecurity, Eye Hearing (IHP) (Letter)
  • Senators demand Mylan repay $50 million to the Pentagon for EpiPen (STAT) (Reuters)
  • US Senate panel urges FTC to launch antitrust probe of Mylan (Reuters)

In Focus: International

  • Abbott wins Japanese approval for Absorb (MassDevice)
  • Vive la biotech (BioCentury)
  • Solving The Trial Safety Information Puzzle: Regulators And Industry Pitch In (Pink Sheet-$)
  • Monthly cost of providing key drugs could be $1-2 per person: experts (Reuters) (STAT)
  • China's low level of reimbursement drives biopharma markets west (BioWorld)
  • Vertex to file for EU approval of cystic fibrosis drug (PharmaLetter-$)
  • Valeant shares fall after sales and earnings targets cut (Financial Times)
  • Roche pushes Tecentriq combos into PhIII melanoma trials (PharmaTimes)
  • Biocad to continue sales of anti-cancer drugs in Sri Lanka despite Roche protests (PharmaLetter-$)
  • SMC endorses use of five meds on NHS Scotland (PharmaTimes) (PMLive)
  • Eisai kicks off mid-stage study of sleep drug (PharmaTimes)

US: Pharmaceuticals & Biotechnology

  • FDA Issues 483 to New Jersey Sterile Drug Producer (Focus)
  • Marken to be acquired by UPS (Outsourcing Pharma)
  • Mylan and Biocon Announce U.S. FDA Submission for Proposed Biosimilar Trastuzumab (Press)
  • Calculating A Few Too Many New Compounds (In The Pipeline)
  • Stanford uses CRISPR to correct sickle cell, human trials planned (Reuters) (Fierce)
  • Coherus says U.S. Patent Office denies Humira patent review (Reuters) (BioCentury)
  • US probe against generic drugs overblown: Experts (Economic Times)
  • Biogen and Ionis near approval for spinal muscular atrophy drug (MedCityNews) (EPVantage)
  • BioInvent hit with clinical hold on midstage myeloma test (Fierce) (Press) (Endpoints)
  • The Medicines Company drops MDCO-216 as med comes up short (Fierce) (Press)
  • A cure that's not affordable is like the proverbial falling tree (BioWorld)
  • The Race to bring Penicillin to the Troops in WWII (FDAVoice)
  • Impax is Slowly Stealing Market Share from Mylan, but Manufacturing Could Get in the Way (The Street)
  • Nearly half of all clinical trials not published (PMLive)
  • FDA 483 Issued to Guardian Pharmacy Services Texas Facility (FDA)
  • Versant's global biotech team is reloading with $350M-plus fund (Endpoints)
  • Likelihood Of Approval Matters When Evaluating A Drug Development Partner (SCRIP-$)
  • FDA's Workforce: A Critical Infrastructure that Needs Strengthening (FasterCures)
  • Endo finds buyer for Charlotte manufacturing plant (InPharmaTechnologist)
  • U.S. Enforcing Insurance Law to Help Fight Opioid Abuse (NYTimes)
  • Nestlé Health Science invests $145m in food allergy biotech (PMLive)
  • Teva gets FDA OK for Tribenzor generic, launches generic Azor (DSN)

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

  • Orphan status for AbbVie's PARP inhibitor (PharmaTimes)
  • Bayer files Stivarga sNDA for advanced liver cancer (PharmaLetter-$) (PharmaTimes)
  • Surface Oncology Announces First Fully Human CD47 Antibody Entering Clinical Development in 2017 (Press)
  • FDA grants priority review for Novartis' first-line treatment of HR+/HER2- advanced breast cancer (EPR)
  • Case report on long-term survival of kidney cancer patients treated with AGS-003 individualized immunotherapy published (MNT)
  • Eloxx Pharmaceuticals Announces Orphan-Drug-Status for ELX-02 in Mucopolysaccharidose Type 1 (MPS 1) in the USA and Europe (Press – German)
  • Mucosis Starts Phase I Trial of Needle-Free Nasal-Spray RSV Vaccine (BioPharm)
  • Seattle Genetics and Takeda Complete Enrollment of Phase 3 ECHELON-2 Clinical Trial Evaluating ADCETRIS® (Brentuximab Vedotin) in Frontline Mature T-cell Lymphoma (Press)
  • Sirnaomics Received Green Light from US FDA for a Clinical Phase IIa Study of Its Leading siRNA Therapeutic Candidate, STP705, for Treatment of Hypertrophic Scar (Press)
  • DBV Technologies Completes Enrollment of Phase II Study of Viaskin Milk for the Treatment of Milk Allergic Patients (Press)
  • Cerenis Therapeutics Announces Last Patient Dosed in CARAT Phase II Study with CER-001 in Post-Acute Coronary Syndrome Patients (Press)
  • Bellion Spirits Provides Additional Clinical Trial Evidence Proving Liver Protective Effects of NTX Technology (Press)

US: Medical Devices

  • Vanishing stent vs durable stent wars continue (MedCityNews)
  • FDA Must Regulate the Servicing of Medical Imaging Devices to Ensure Patient Safety (MDDI)
  • Meeting Clinical Needs in Human Factors Engineering (MDDI)
  • Abbott tries to escape Alere's grasp (EPVantage)
  • Siemens picks up point-of-care interface dev Conworx Tech (MassDevice)
  • EOS imaging Receives FDA 510(k) Clearance for kneeEOS 3D Surgical Planning Software for Total Knee Arthroplasty (Press)
  • Mallinckrodt Announces U.S. FDA Approval of OFIRMEV® IV Bag Presentation (Press)
  • KATOR Receives FDA Clearance for Knotless Suture Anchor System (Press)

US: Assorted & Government

  • How Could A New Administration Tackle Affordable Care Act Challenges? Look To Medicare (Health Affairs Blog)
  • Valeant To Pop Out Paragon To Quell FTC Antitrust Concerns (Law360-$) (FTC)
  • No Matter What, Congress Will Act On Health Care Next Year (Health Affairs Blog)
  • The 2016 Election Reveals The Differences On Health Care Are Deeper Than Ever (Health Affairs Blog)
  • BTG unit pleads guilty in U.S. to misbranding, to pay $36 million (Reuters) (DoJ)
  • What $100 million bought pharma in California (Politico)
  • Grassley, Warren Introduce Bill To Loosen FDA Oversight Of Hearing Aids (IHP)
  • Medicare Monday: How existing CMMI models affect Medicare Part B (PhRMA)
  • GOP may try to hobble CMS Innovation Center (Modern Healthcare)
  • Behind Diplomat Pharmacy's Plunge: A Primer on DIR Fees in Medicare Part D (DrugChannels)
  • Clinton Foundation emails link BD with Russian program (MassDevice)
  • Justices' Guidance Still Needed On Pay-For-Delay Accords (Law360-$)
  • A Fraudulent Concealment Win Coupled with a Unfavorable Learned Intermediary Ruling (Drug and Device Law)

Upcoming Meetings & Events


  • St. Jude wins CE Mark for MRI safe labeling for Quadra CRT-P (MassDevice)
  • The EDQM "Electronic submissions for CEP applications Roadmap 2016-2020" has been revised. (EDQM)
  • Almirall on the rise as 2016 growth continues (PharmaLetter-$)
  • Targovax announce the appointment of CEO (Pharmafile)
  • Audio conference of the HSC (EC)


  • Takeda announces digital health collaborations to power clinical trials (MobiHealthNews)
  • Draft Guidelines on Pneumonia Treatment Set Guides for Selecting Antibacterial Agents: Respiratory Society(Nov.7.2016) (PharmaJapan)


  • Sun Pharma's Mohali manufacturing site being inspected by US FDA: Sources (Economic Times)



  • Testing of investigational inactivated Zika vaccine in humans begins (NIH) (NPR)

Other International

  • 'Lazy mosquitoes' mean more women than men get chikungunya: scientists (Reuters)

General Health & Other Interesting Articles

  • 'Non-lump' symptoms in 17 percent of breast cancers (PharmaTimes)
  • Pregnant women must be able to access the right care at the right time (WHO)
  • Anesthesia before age 4 may have small effect on academics later (Reuters)

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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