Regulatory Recon: EMA, TGA Focus on Regulatory Transparency Biotech Execs Reap Profits From Legal Insider Trades (8 August 2016)

Posted 08 August 2016 | By Michael Mezher 

Regulatory Recon: EMA, TGA Focus on Regulatory Transparency Biotech Execs Reap Profits From Legal Insider Trades (8 August 2016)

Welcome to Regulatory Reconnaissance, your adaily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

In Focus: US

  • GM mosquito trial will not significantly impact environment: FDA (Reuters) (NPR) (CNN)
  • FDA Issues Draft Guidance on 510(k) Device Modifications (Focus) (FDA)
  • Biotech Insiders: Run Your Companies And Leave Hedge Fund Management To Us (Forbes)
  • FDA Guidance Could Improve Cybersecurity (Politico)
  • Insanitary Conditions 101: FDA Issues Draft Guidance for Compounding Facilities Based on Prior FDA Inspections: Comments due October 3, 2016 (FDA Law Blog) (Focus)
  • How biotech executives profit from legal insider trades (STAT)
  • Clinical Trialists Dig In And Vote For Status Quo (CardioBrief)
  • NIH Closes In-House Pharmacy Faulted for Sterility Processes (WJS-$)
  • Biosimilar Labeling: Should FDA Just Throw Up Its Hands And Finalize Guidance? (Pink Sheet-$)
  • AbbVie Files Patent Suit Over Amgen's Copy of Humira (WSJ-$) (BioCentury) (Pink Sheet-$)
  • Ethically Speaking: Patients deserve a stronger voice in clinical trial design (BioWorld)
  • Real World Evidence: The Times They Are a- (Slowly) Changin' (Morning Consult)
  • MSD files Lantus biosimilar with FDA (Pharmafile) (Press)
  • Bristol-Myers' High-Risk Opdivo Lung Cancer Study Shows Challenges Of Clinical Trials (Forbes 1, 2, 3) (EP Vantage) (SCRIP-$)
  • Devices May Be Over-the-Hill, but Regulatory Developments and Challenges Show No Signs of Slowing Down (HPM)
  • You know, On Second Thought… (Turnover in the Biopharma Industry) (In The Pipeline)

In Focus: International

  • EMA, TGA Release Paper on Transparency in Drug Regulation (TGA) (EMA) (Paper)
  • Lapses push Pfizer to shut Chennai unit temporarily (Economic Times 1, 2)
  • Novartis' fevipiprant hailed a "game-changer" in asthma treatment (PharmaTimes)
  • ICH M4(R4) Guideline reaches Step 4 of the ICH Process (ICH)
  • NZ's PHARMAC to list Praxbind and achieves price cut on Pradaxa (PharmaLetter-$)
  • Russia may introduce criminal responsibility for 'unfounded drug price' increases (PharmaLetter-$)
  • India Draft Clinical Trial Guidelines Stress Consent, Privacy (Bloomberg) (Pink Sheet-$)
  • Hepatitis C And PrEP Bring More Funding Headaches For NHS England (Pink Sheet-$)
  • China proposes revised Drug Registration Rules (BioCentury)
  • ANVISA Officially Extends Deadline for IVD and Cadastro Technical Dossier Requirement (Emergo)

US: Pharmaceuticals & Biotechnology

  • Doctors should offer women birth control right after babies arrive (Reuters)
  • 2016 Meeting Materials of the Clinical Chemistry and Clinical Toxicology Devices Panel (FDA)
  • Will Prodigy change everything? (Stem Cell Assays)
  • US FDA orders Adaptimmune to halt fat cancer cell therapy trial (BioPharmaReporter)
  • Over-the-Counter Monograph User Fees: Reopening of Comment Period; Stakeholder Meeting (FDA)
  • AbbVie Hit With Hedge Fund's Suit Over Failed Shire Deal (Law360-$)
  • Measuring a serial entrepreneur's success (C&EN)
  • Hospitals Reaping Benefits From SP Market Growth (Specialty Pharmacy)
  • ​Duchenne advocates' wait for an FDA decision nears the six-month mark (Boston Biz Journal)
  • Quiet revolution gets under way in stem cell transplantation (EP Vantage)
  • Hospira Issues a Voluntary Nationwide Recall For One Lot Of 0.25% Bupivacaine Hydrochloride Injection, USP Due to The Presence Of Particulate Matter Within a Single Vial (FDA)
  • Celgene Passes on Acetylon as Another Option-to-Buy Deal Flames Out (Xconomy)
  • WuXi AppTec's STA Subsidiary Opens Operations in San Diego (Press)
  • National Cancer Institute Awards Cellectar $2M For Clinical Study (Xconomy)
  • Sharp Packaging Services Selects TraceLink to Achieve DSCSA Compliance for 100+ Pharmaceutical Manufacturers (Press)
  • Off-Label Marketing – Industry Groups Step into the Breach (Drug and Device Law)

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

  • Pfizer Announces Publication of New Analysis Showing Long-Term Therapy with VYNDAQEL (tafamidis) Slowed Progression of Rare Neurodegenerative Disease (Press)
  • FDA Approves Merck's KEYTRUDA (pembrolizumab) for Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma with Disease Progression on or After Platinum-Containing Chemotherapy (Press)
  • Alkermes Submits Supplemental New Drug Application to FDA for Two-Month Dosing Option of ARISTADA® for Treatment of Schizophrenia (Press)
  • Alnylam Completes Enrollment in ENDEAVOUR Phase 3 Study with Revusiran, an Investigational RNAi Therapeutic for Patients with Hereditary ATTR Amyloidosis with Cardiomyopathy (hATTR-CM) (Press)
  • Antibe Therapeutics Announces Successful Phase 2 Trial of ATB-346 in Osteoarthritis (Press)

US: Medical Devices

  • FDA PMA Approvals: July 2016 (FDA)
  • Smith & Nephew closes $350m Truclear sale to Medtronic, launches $300m buyback (MassDevice)
  • Endologix releases Q2, updates on Nellix discussions with FDA (MassDevice)
  • Johnson & Johnson wins 5-year, $60m supply DoD contract (MassDevice)
  • Check-Cap partners with GE to dev indigestible X-ray screening capsule (MassDevice)
  • Luminex Corporation Receives FDA Emergency Use Authorization for Zika Virus Molecular Detection Assay (Press)

US: Assorted & Governmentw

  • FTC Sends Warning Letters to Online Sellers Making Zika Virus-Protection Claims (FTC)

Upcoming Meetings & Events


  • Allergan and Richter push ahead despite PhIII fail for depression drug (Fierce)
  • Here's Why Allergan's Earnings Report Could Be Lackluster (The Street)
  • New Head of Communication and media spokesperson at Swissmedic (Swissmedic)
  • Medicines: forms to make a variation to a Blood establishment Authorisation (MHRA)


  • This Cancer Genetics Startup Hopes To Boost Medical Tourism In HK (Forbes)
  • Beximco Pharma starts exports of generics to the US (Manufacturing Chemist)
  • Taiwan to beef up medical cooperation with the ASEAN (BioSpectrum)
  • Kyowa Hakko Kirin completes $70m mAb manufacturing plant in Japan (BioPharmaReporter)
  • Viveve lands S. Korea regulatory clearance for Viveve System (MassDevice)


  • CDSCO to Host Demonstration of SUGAM Online Application Portal on 10 August 2016
  • Drug firms worried over govt plan to add MRP to bar codes (Business Standard)
  • Opdivo and Keytruda set for India launches by end of year (Pharmafile)
  • Glenmark receives ANDA approval for Nystatin, Triamcinolone Acetonide ointment BioSpectrum)
  • GAVIS Pharma LLC looking to exit Bengaluru-based Wintac Ltd (Economic Times)


  • Valeant Pharmaceuticals Announces Changes To Executive Management Team (Press)


  • Rubio: No abortions for Zika-infected women (Politico)
  • Florida governor criticizes Washington for lagging in Zika fight (Reuters)

Other International

  • ​​Gains in fight to control yellow fever outbreak: but response must continue (WHO)

General Health & Other Interesting Articles

  • Patients on social media cause ethics headache for doctors (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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