Regulatory Recon: Catch Up on All the News You Missed Over the Holidays (3 January 2017)

Posted 03 January 2017 By Michael Mezher


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

In Focus: US

  • Prioritization of Generic Drug Review (JAMA)
  • The FDA's Rigged Drug Committees (WSJ 1, 2)
  • New drug approvals fall to six-year low in 2016 (Reuters) (FDA) (Pink Sheet-$) (PharmaLetter-$)
  • Drop In FDA Approvals (And New Administration) Rekindles Fears For The Future Of Pharma (Forbes)
  • IND Submissions, Postmarket Safety Reporting on FDA Rulemaking Agenda for 2017 (FDANews-$)
  • House Republicans Fret About Winning Their Health Care Suit (NYTimes)
  • Paul: Repeal, replace ObamaCare simultaneously (The Hill)
  • Job No. 1 for a New Congress? Undoing Obama's Health Law (NYTimes)
  • After Obama, Some Health Reforms May Prove Lasting (NYTimes)
  • Donald Trump Could Lower The Bar For FDA Drug Approvals, But Payers Will Limit Access (Forbes)
  • Germany's Model For Drug Price Regulation Could Work In The US (Health Affairs)
  • FDA says food livestock can no longer be fed medically important antibiotics (STAT)
  • The head of the FDA defends the importance of drug effectiveness (Washington Post)
  • Patient Pushback On FDA Reform: Efficacy Matters (Pink Sheet-$)
  • Life-extending capacity of new cancer drugs varies widely (Reuters) (JAMA)
  • Biosimilar Trends: What 2017 May Have In Store (SCRIP-$)
  • What Does 2017 Hold For Pharma? (SCRIP-$)
  • Costly Drug for Fatal Muscular Disease Wins FDA Approval (NYTimes) (Pharmafile) (Endpoints) (FDA)
  • The FDA's Christmas Breakthrough (Forbes)
  • Inotek's Glaucoma Drug Flunks in First Phase 3 Test, Shares Crumble (Xconomy) (The Street) (Reuters)
  • Seattle Genetics stock tumbles after 4 deaths force the FDA to slap a clinical hold on AML drug (Endpoints) (Xconomy) (Pharmafile)

In Focus: International

  • Philippine FDA orders Sanofi to take down dengue vaccine ads (AP)
  • London-based regulator for EU drugs fears staff exodus (FinancialTimes)
  • E.U. Agency in Limbo as Hidden Costs of 'Brexit' Continue to Mount (NYTimes)
  • December CHMP decisions bring year's total approvals to 81 (PharmaTimes)
  • ASEAN Regulators To Pilot Joint Assessment Of Drug Applications In 2017 (Pink Sheet-$)
  • China's $9 billion effort to beat the U.S. in genetic testing (Washington Post)
  • NICE backs Roche's Perjeta, but bars Kadcyla (PharmaTimes)
  • Colombia's Glivec Pricing Means "Worst Of Scenarios" For Pharma Industry (Pink Sheet-$)
  • Sanofi and Boehringer confirm successful exchange of businesses (Pharmafile)
  • Sanofi, MSD successfully terminate vaccines JV (PharmaTimes)
  • Jounce rings out the old year with a $75M IPO bid for the New Year (Endpoints)
  • Sanofi files lawsuit against Novo Nordisk over 'false allegations' (Pharmafile)
  • Russian pharma firms to be allowed to produce one drug under different brand names (PharmaLetter-$)
  • EMA Guidance On Investigational ATMPs To Focus On Exploratory And Pivotal Trials (Pink Sheet-$)

US: Pharmaceuticals & Biotechnology

  • National Biotechnology Panel Faces New Conflict of Interest Questions (NYTimes)
  • Everything You Need to Know About Gene Therapy's Most Promising Year (MIT Technology Review)
  • Massachusetts Delays Opening of Marijuana Shops (NYTimes)
  • Pfizer and Opko end 2016 downbeat as hGH-CTP fails phase 3 trial (Fierce) (Endpoints)
  • Cell Therapy 2016 – Year in Review (part 1) (Cell Trials)
  • 17 Thoughts on Biotech Stocks to Kick Off 2017 (The Street)
  • FDA Proposes Consolidating Manufacturing Information In Applications (Pink Sheet-$)
  • Watching for NIH Innovation in 2017—and Drug Pricing, Trade Deals (Xconomy)
  • Drug patents expiring in 2017? It's all smoke and mirrors (MedCityNews)
  • 21st century FDA ad-promo compliance (PhillyCooke Consulting)
  • Fake Medical Journals Are Spreading, And They Are Filled With Bad Science (Forbes)
  • Mylan ends 2016 with spate of generics (Pharmafile)
  • FDA 483 Finds Deficiencies at Baxter Healthcare Facility in Puerto Rico (FDANews-$)
  • Pharma business development news over Christmas (EP Vantage)
  • US FDA rejects Xaracoll NDA (PharmaLetter-$)
  • FDA Rejects Cempra Antibiotic, Asks for Another Clinical Trial (Xconomy) (Fierce) (Endpoints)
  • Medical marijuana for kids: Often, no clear path, legally and practically (Washington Post)
  • 2017 predictions for biomedicine (MassDevice)
  • A powerful new form of medical marijuana, without the high (Washington Post)
  • Draft Guidance: Labeling of Red Blood Cell Units With Historical Antigen Typing Results; Draft Guidance for Industry; Availability (FDA )
  • Guidance: Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability (FDA)
  • Draft Guidance: Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities (FDA)
  • Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act  (FDA)
  • Draft Guidance: Compounding and Repackaging of Radiopharmaceuticals By Outsourcing Facilities (FDA)
  • Guidance: Botanical Drug Development (FDA)

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

  • Glenmark pharmaceuticals receives FDA clearance of Ind for GBR 1302-beat phase I trial (Reuters) (Press)
  • Eagle Pharmaceuticals' Pemetrexed NDA Submitted for Review (Press)
  • Kite Pharma Submits Investigational New Drug (IND) Application for KITE-718, an Investigational Next Generation T-Cell Receptor (TCR) Therapy Targeting Cancer Antigens MAGE A3 and MAGE A6 (Press)
  • Teligent, Inc. Announces FDA Approval For Three Abbreviated New Drug Applications (Press)
  • Tracon Pharmaceuticals receives special protocol assessment agreement from FDA (Reuters)
  • Axsome therapeutics receives FDA clearance of IND for Phase 2/3 trial of AXS-05 (Reuters)
  • Akari Therapeutics reports FDA allowance of IND for clinical development of coversin in pnh (Reuters)
  • Ensysce Biosciences to present initial Phase 1 data on abuse deterrent opioid, PF614, at Biotech Showcase™ 2017. (Press)
  • Marinus Pharmaceuticals receives FDA orphan drug designation for Ganaxolone to treat Fragile X Syndrome (Reuters)
  • Humacyte Commences U.S. Phase II Arterial Bypass Clinical Trial (Press)
  • ImmunoGen Announces Mirvetuximab Soravtansine Phase 1 Expansion Cohort Results in Platinum-Resistant Ovarian Cancer Published in the Journal of Clinical Oncology (Press)

US: Medical Devices

  • CDRH Finalizes Benefit-Risk Factors in Making Compliance and Enforcement Decisions Guidance (FDA Law Blog)
  • What the FDA did in digital health in 2016 (MobiHealthNews)
  • FDA Grants PMA Approval for Hologic's Aptima® HIV-1 Quant Assay (Press)
  • Allergan Announces FDA Approval of NATRELLE INSPIRA® SoftTouch Breast Implants (Press)
  • Abbott's St. Jude Deal Aligns With Shift To Value-Based Care (Forbes) (StarTribune)
  • Final Guidance: Medical Device Accessories – Describing Accessories and Classification Pathway for New Accessory Types (FDA)
  • Draft Guidance: Premarket Notification (510(k)) Submissions for Bone Anchors (FDA)

US: Assorted & Government

  • Life Sciences Legislation And Regulation To Watch In 2017 (Law360-$)
  • Life Sciences Cases To Watch In 2017 (Law360-$)
  • Decision Limiting Duties regarding Automated External Defibrillators Does Not Shock The Conscience (Drug & Device Law)
  • 21st Century Cures Act Clarifies (And Somewhat Reduces) Regulation of Stand Alone Software Products Used In Healthcare (FDA Law Blog)

Upcoming Meetings & Events


  • Stakeholder focus group meeting on availability of lumpy skin disease (LSD) vaccines authorised to EU standards (EMA)


  • China conditionally approves Abbott Laboratories' acquisition of St Jude (Reuters)
  • China confirms another human bird flu case (Reuters)
  • Ascletis' regulatory filing for HCV Treatment danoprevir accepted by CFDA (PharmaLetter-$)


  • Sun Pharma to buy rights to cancer drug Odomzo (PharmaLetter-$)
  • Pharma & healthcare sectors see R&D, manufacture & predictive analytics as growth drivers in 2017 (Pharmabiz)
  • Lupin gets USFDA nod for cevimeline hydrochloride capsules (Economic Times)
  • DoP rejects Sun Pharma's review petition against fixation of ceiling price on ondansetron tablet (Pharmabiz)
  • Gujarat tops list of CLAA approved medical devices units with 150 out of total 284 (Pharmabiz)
  • Natco Pharma Launches First Generic Hep C Med in India (Pharmaceutical Manufacturing)


  • Notice - The Regulatory Enrolment Process (REP) Functional Pilot (Health Canada)


  • ACSMD meeting statement, Meeting 13, 4 March 2016 (TGA)

General Health & Other Interesting Articles

  • Parental obesity linked to delays in child development, NIH study suggests (NIH)
  • Are scientific advances getting harder to achieve? If so, what do we do? (The Incidental Economist)

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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