Regulatory Focus™ > News Articles > Regulatory Recon: Califf Wants to Stay at FDA Under Next President; Polls Narrow for California Drug

Regulatory Recon: Califf Wants to Stay at FDA Under Next President Polls Narrow for California Drug Pricing Measure (7 November 2016)

Posted 07 November 2016 | By Michael Mezher 

Regulatory Recon: Califf Wants to Stay at FDA Under Next President Polls Narrow for California Drug Pricing Measure (7 November 2016)

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

In Focus: US

  • After Controversial Drug Decision, FDA Tries Transparency (Roll Call)
  • Califf Maintains Desire To Stay At FDA, But Would Either Presidential Candidate Keep Him? (Pink Sheet-$)
  • FDA's Jenkins on Decline in New Drug Approvals in 2016: Not due to Standards Shift (Focus)
  • FDA Finalizes Guidance on Neurological Device Trials (Focus)
  • FDA's OPDP Issues 5th Warning of 2016, Calls out Video's Misleading (Focus)
  • Roche says flexible pricing ready for cancer, not MS drugs (Reuters)
  • FDA panel narrowly backs Cempra's antibiotic solithromycin (Reuters) (PharmaTimes)
  • Editorial: Drug marketing veers off-label (Modern Healthcare)
  • Biogen and Ionis' spinal muscular atrophy drug meets primary endpoint (Pharmafile) (Endpoints) (Press)
  • Celyad posts Phase I data on NKG2D CAR-T cells (Fierce) (Press)
  • Competition Would Be the Best Solution to Rising Drug Prices (NYTimes)
  • Strengthening the FDA is critical to the fight against cancer (Washington Post)
  • GSK launches patent infringement action against Pfizer (Pharmafile)
  • Medical device tax emerges as issue in congressional races (MedCityNews)
  • FDA approves first therapy for paediatric psoriasis treatment (Pharmafile) (Press)
  • Sex and drugs: Something doesn't 'Addyi' up (Bioworld)
  • Sick Dogs Could Be Key to Unlocking Mysteries of Immunotherapy (MIT Technology Review)
  • Tumour-associated mesenchymal stem/stromal cells: emerging therapeutic targets (Nature)
  • How FDA Announces Drug Approval Decisions: A Broken FDA "System" That Must Be Fixed (FDA Law Blog)
  • Is California Proposition 61 Really The Right Treatment For Rising Drug Prices? (Forbes)
  • Poll shows tight contest for California drug price initiative (Reuters)
  • Regulatory, Legal Uncertainties Are Barriers To Value-Based Agreements For Drugs (Health Affairs Blog)
  • Pharma under fire, but firms serious about research will pay off, expert says (CNBC)
  • Regeneron's 3rd-qtr sales miss but EPS beats analysts' expectations (PharmaLetter-$)
  • Cures Roundtable Participant: "Patients need to be Congress' top priority as they finish their work in 2016." (E&C)

In Focus: International                                           

  • Health Canada Issues New Medical Device Recall Guide (Focus)
  • Bayer applies for Regorafenib authorization in US, Japan & EU to treat liver cancer (Reuters) (Press)
  • Buyers clubs for cheaper drugs help fight hepatitis and HIV (Reuters)
  • Merck opens pharma plant and plans to build life science services centre in China (Manufacturing Chemist Pharma)
  • Civil Society representatives: Call for expressions of interest for the EMA CAT Committee (EC)
  • Small-cap focus: biotech (Financial Times)
  • Update on Brazil's New Ownership Transfer Rules for Medical Device Registrants (Emergo)
  • U.K. investors team up to create $1.2B cancer-skewed fund (Fierce) (PharmaTimes) (Press)
  • Workshop: working towards new therapies for spinal muscular atrophy – 11 November 2016 (EMA)

US: Pharmaceuticals & Biotechnology

  • FDA to Review Study Data Standardization Plan (SDSP) Template (Federal Register)
  • In October TV pharma ad spending, AbbVie's Humira and Pfizer's Lyrica continue to dominate (Fierce)
  • Two Wrong Genes Can Make a Right, but When? Rules Emerge (GEN)
  • Hard work, little reward: Nature readers reveal working hours and research challenges (Nature)
  • Califf: Work needed to define patient-FDA boundaries (BioCentury)
  • FDA emails show how upset some officials were over the Sarepta approval (STAT)
  • Twitter Rx Drug Promos: FDA Studies Best Way To Convey Risk Info (Pink Sheet-$) (FDA News-$)
  • Califf gives rationale for deferring Sarepta decision (BioCentury)
  • CMS's Slavitt: Drug prices must be tamed (BioCentury)
  • NYSBA's REMS and Other Drug Distribution Restrictions Program Provided an Excellent and Informative Discussion (FDALife)
  • Financial Justification in Pharma (Pharmaceutical Manufacturing)

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

  • Positive Phase 3 Study of ORKAMBI® in Children With Cystic Fibrosis Ages 6-11 Who Have Two Copies of the F508del Mutation Supports a Submission to the European Medicines Agency in the First Half of 2017 (Press)
  • Roche advances skin cancer trials as part of combination therapy strategy (Reuters)
  • Kedrion Biopharma and Kamada Announce FDA Acceptance of BLA Submission for Human Rabies Immunoglobulin as a Post-Exposure Treatment (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)
  • Eloxx Pharmaceuticals Announces Orphan Drug Designation in the U.S. and Europe for ELX-02 in Mucopolysacchardisis Type 1 (MPS 1) (Press)
  • SanBio touts 1-year data on stem cell transplant for stroke (Drug Delivery)
  • Publication of positive Phase 1 study results for EB-101 gene therapy clinical trial for epidermolysis bullosa (MNT)
  • New KEYTRUDA® (pembrolizumab) Data Accepted for Presentation at SITC 2016 Annual Meeting (Press)
  • Pfizer to Present Additional Research For XELJANZ® (Tofacitinib Citrate) In Rheumatologic Diseases, Including Rheumatoid Arthritis and Psoriatic Arthritis (Press)

US: Medical Devices

  • Reshaped Philips targets higher sales and improved margins (MassDevice)
  • Why We Chose Edwards Lifesciences as the 2016 Medtech Company of the Year (MDDI)
  • Medicare revokes Alere's Arriva division enrollment (MassDevice)
  • FDA clears Propeller Health sensor for GSK Ellipta inhaler (MedCityNews)

US: Assorted & Government

  • Another Modest Proposal (This Time, About Discovery) (Drug and Device Law)
  • USPTO to Hold Roundtables on Subject Matter Eligibility (PatentDocs)
  • Worst-Performing Stocks of 2016: Health Care (WSJ)
  • Interoperable EHRs: If Not Now, When? (Medpage)
  • Two Pakistani Nationals Sentenced for Conspiring to Illegally Ship Pharmaceuticals into the United States (DoJ)
  • Oklahoma Becomes the Latest State To Apply Learned Intermediary Principles To Pharmacies (Drug and Device Law)

Upcoming Meetings & Events


  • Committee for medicinal products for human use (CHMP) - Draft agenda for the meeting on 07-10 November 2016 (EMA)
  • St. Jude Medical Gains CE Mark Approval for MRI Labeling of its Quadra Allure MP Cardiac Resynchronization Therapy Pacemaker (Press)
  • Business Planet: The vital role of SMEs in medical research (EC)
  • Report suspected side effects to help make medicines safer: MHRA launches social media campaign (MHRA)
  • Export medical devices: special rules (MHRA)
  • HPRA Hiring a GCP/Pharmacovigilance Inspection Manager (HPRA)


  • South Korea's workforce expands 27% in last four years (Pharmafile)
  • Japan's Fujifilm Holdings to acquire Takeda's arm? (BioSpectrum)
  • Biocon Malaysia insulin plant set to supply Lantus biosimilar under EU review (BioPharmaReporter)


  • Lupin Receives EIR From US FDA for Goa, March 2016 Inspection (Press)
  • As Delhi pollution increases, so do medicine sales (Economic Times)
  • Grandmothers to defend scions of Ranbaxy's Singh brothers in court (Economic Times)


  • Submissions received: Draft clinical evidence guidelines - Medical devices (TGA)
  • GSK to shut down its Sydney plant by 2020 (BioSpectrum)
  • Medtronic model 37751 recharger - used with neurostimulators (TGA)
  • Australian Public Assessment Reports for prescription medicines (AusPARs) (TGA)


  • Notice: Release of Draft (Step 2) International Council for Harmonisation (ICH) Guidance: E11(R1): Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population (Health Canada)
  • Summary Basis of Decision (SBD) Cinqair (Health Canada)
  • Regulatory decision summary for IZBA (Health Canada)
  • Regulatory decision summary for DESCOVY (Health Canada)
  • Regulatory decision summary for HEMANGIOL  (Health Canada)
  • Regulatory decision summary for HOLKIRA PAK  (Health Canada)

Other International

  • Antibacterial coated suture wins WHO recommendation (Drug Delivery)

General Health & Other Interesting Articles

  • First cases of Candida auris reported in United States (CDC)
  • Proposal to Allow First-Year Resident Physicians to Work 28 Hours in a Row Puts Residents, Patients, Public at Risk of Serious Injury, Death (Public Citizen)
  • Early diagnosis of ectopic pregnancy is essential to reduce deaths, says guideline (TheBMJ)
  • Patients with multimorbidity need longer GP consultations, says RCGP (TheBMJ)

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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