Regulatory Recon: FDA Reviewers Find Novo's Semaglutide Effective Ahead of Advisory Committee GSK's Shingles Vaccine Gets First Approval in Canada (16 October 2017)

Posted 16 October 2017 | By Michael Mezher 

Regulatory Recon: FDA Reviewers Find Novo's Semaglutide Effective Ahead of Advisory Committee GSK's Shingles Vaccine Gets First Approval in Canada (16 October 2017)

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

In Focus: US

  • The Drug Industry's Triumph Over The DEA (Washington Post/60 Minutes)
  • DEA responds to explosive "60 Minutes" report about opioid crisis (CBS)
  • Rep. Tom Marino: Drug czar nominee and the opioid industry's advocate in Congress (Washington Post)
  • Novo Nordisk diabetes drug effective, no heart risk -FDA review (Reuters) (Endpoints) (FDA)
  • FDA experts give a thumbs-up to Aerie Pharma's glaucoma drug (Endpoints) (Reuters) (Pink Sheet-$) (Press)
  • Where the FDA Is Going Under Trump (WSJ)
  • Why Gottlieb Should Stay at FDA (BioCentury)
  • What became of biotech's boom beneficiaries? (STAT)
  • Big Tech vs Big Pharma: the battle over US patent protection (Financial Times)
  • Roche ties a $387M knot with Warp Drive Bio in collaboration spotlighting new classes of antibiotics (Endpoints) (Press)
  • That $1.25B Bristol-Myers IDO1 drug? Incyte claims a former staffer stole it (Endpoints) (In The Pipeline)
  • After getting skunked by rivals, Pfizer touts 'breakthrough' cancer drug lorlatinib, heads to the FDA (Endpoints)
  • Cancer drug study data was falsified, says AstraZeneca (The Telegraph)
  • FDA expands Janssen's Stelara to cover adolescent psoriasis patients (Pharmafile) (Press)
  • Senate HELP Committee Hearing on the Cost of Prescription Drugs – 17 October 2017

Preparing for the Spring 2018 RAC Exam?

In Focus: International

  • GSK Shingles Vaccine Shingrix Gets First Okay in Canada (Medscape)
  • WHO says attack on Syria vaccine store leaves children at risk (Reuters) (WHO) (UNICEF)
  • Pharma and medtech industries prepare for hard Brexit (Reuters)
  • Drug Companies Fear Brexit Will Hit Medicine Trade (Bloomberg)
  • European biopharma continues its funding momentum into fourth quarter (BioWorld)
  • CEO of China oncology start-up BeiGene toils to bring drugs to fruition (SCMP)
  • The Indian government is not doing enough to tackle sale of unapproved antibiotics (Quartz)
  • ANVISA Officially Publishes Brazilian GMP Certification Process Changes (Emergo)
  •  Ukranian pharma industry calls for reforms to biosimilars (PharmaLetter-$)
  • European Approval Recommendation Delayed Again For Roche's Ocrevus (SCRIP-$)
  • Canada Prepares To Publish Draft Rules On Release Of Clinical Data (Pink Sheet-$)
  • Pfizer Japan appoints new president (PharmaLetter-$)
  • Sales of antibiotics for animal use decrease by 13% in Europe between 2011 and 2015 (EMA)
  • Two new TB drugs advance to clinic (C&EN)
  • In Early Results, Shorter Treatment for Tuberculosis Proves Effective (NYTimes)
  • Madagascar plague appears to have spread to Seychelles (Reuters)

Pharmaceuticals & Biotechnology

  • Flu experts see potential for a nasty winter season (STAT)
  • Transplant Tailwinds and Momentum (LifeSciVC)
  • People may expect more side effects from pricier drugs (C&EN)
  • FDA Expands Opioid Abuse Research, Outreach (Pink Sheet-$)
  • FDA Hiring Director for OBE Division of Biostatistics (FDA)
  • Racing against Alnylam, Ionis posts positive PhIII ATTR efficacy numbers, but questions linger (Endpoints)
  • Assessing the Economics of Single-Source vs. Multi-Vendon Manufacturing  (Tufts)
  • As Taltz growth stalls, Lilly looks ahead to psoriatic arthritis expansion (Fierce)
  • Seeking Surrogates (BioCentury)
  • Expanding The HAE Tool Kit (BioCentury)
  • Eyeing Complement Data (BioCentury)
  • Request for Nominations for Individuals and Consumer Organizations for Advisory Committees (FDA)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • BrainStorm enrolls first patients in advanced ALS stem cell trial (Reuters)
  • Cognition Therapeutics Receives Fast Track Designation from U.S. FDA for First-in-Class Alzheimer's Candidate, CT1812 (Press)
  • Priority Review For Prometic's Plasminogen Therapy (BioCentury)
  • Roche to present new OCREVUS (ocrelizumab) efficacy and safety data in relapsing and primary progressive forms of multiple sclerosis at ECTRIMS (Press)
  • Chi-Med Reports Preliminary Phase II data on Fruquintinib Combination in First-Line Lung Cancer (Press)
  • Takeda Presents Updated Results from Pivotal Phase 2 ALTA Trial of ALUNBRIGTM (brigatinib) in ALK-Positive Non-Small Cell Lung Cancer (Press)
  • Pfizer Presents Full Results from Phase 2 Study of Next-Generation Investigational ALK-Inhibitor Lorlatinib in ALK-Positive and ROS1-Positive Advanced Non-Small Cell Lung Cancer (Press)
  • Rapidly Progressing Advanced Non-Small Cell Lung Cancer Patients Shown to Benefit in New CYRAMZA® (ramucirumab) Phase 3 Subgroup Analysis (Press)
  • NanOlogy™ Announces First Patient Enrolled in a Phase 2 Clinical Trial of NanoPac® for Treatment of Prostate Cancer (Press)
  • Exelixis liver cancer drug meets late-stage goal, shares jump (Reuters) (Press)
  • Exelixis Announces U.S. FDA Grants Priority Review for CABOMETYX® (Cabozantinib) as a Treatment for Previously Untreated Advanced Renal Cell Carcinoma (Press)
  • Opdivo Alone or Combined with Yervoy Shows Encouraging Response and Survival Rates in Recurrent Small Cell Lung Cancer Patients with High Tumor Mutation Burden, in Exploratory Analysis from Phase 1/2 Study CheckMate -032 (Press)
  • Regeneron-Sanofi food allergy drug succeeds mid-stage study(Reuters) (Press)
  •  New Post-Hoc Analyses Report Early Symptomatic Improvement in Moderately to Severely Active Ulcerative Colitis or Crohn's Disease Patients Taking Entyvio® (vedolizumab), Particularly in Biologic-Naïve Patients (Press)
  • FDA accepts New Drug Application for Methylene Blue MMX™ and sets PDUFA Date for May 21, 2018 (Press)
  • Results from Phase 2 Studies of Oral Ozanimod in Crohn's Disease and Ulcerative Colitis to Be Presented at World Congress of Gastroenterology at ACG2017 (Press)
  • Flex Pharma Initiates CMT Phase 2 Trial with FLX-787 in US (Press)

Medical Devices

  • FDA clears new robotically-assisted surgical device for adult patients (FDA)
  • What's the key to efficient IVD development? (MedCityNews)
  • Instrumentation Laboratory Receives US FDA Clearance For HemosIL® AcuStar HIT-IgG(PF4-H) Assay And Controls (Press)
  • NuVasive Receives Expanded FDA 510(k) Clearance For TLX Interbody System Used In TLIF Procedures (Press)
  • Stryker Receives FDA Clearance for Cementless Mako Total Knee with Triathlon® Tritanium® (Press)

US: Assorted & Government

  • End to Health Care Subsidies Puts Congress in a Tight Spot (NYTImes) (Reuters)
  • Veterans Affairs Head Interviews for Health and Human Services Post (WSJ)
  • Anthem At Odds With Your Decision To Visit The ER, And Refusing To Pay In Certain States (Forbes)
  • Court Ruling Could Shield Drugmakers From Some Rico Suits (BioCentury)
  • MDL Direct Filing & Personal Jurisdiction (Drug & Device Law)
  • Nevro Corp. v. Boston Scientific Corp. (N.D. Cal. 2017) (Patent Docs)
  • Judicial Efficiency: DEA's Expanding Use of Summary Dispositions to Narrow the Opportunity for an Administrative Hearing (FDA Law Blog)
  • California Enacts Bill on Drug Pricing Transparency (Ropes&Gray)

Upcoming Meetings & Events


  • Draft guideline on implementation of risk assessment requirements to control elemental impurities in veterinary medicinal products (EMA)


  • Zydus Cadila gets USFDA nod to market Doxazosin tablets (Economic Times)
  • Indian pharma industry sees need for govt support to propel it up value chain (PharmaBiz)
  • Maha FDA in talks with drug cos to explore investment plans in Nagpur pharma hub (PharmaBiz)

Other International

  • Uruguay to produce medical marijuana for export (Reuters)

General Health & Other Interesting Articles

  • Outcome, a Hot Tech Startup, Misled Advertisers With Manipulated Information, Sources Say (WSJ)

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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