Regulatory Recon: GSK Employees Indicted for Stealing Trade Secrets, Storm Pushes FDA to Postpone Sarepta DMD Panel (21 January 2016)

Posted 21 January 2016 | By Michael Mezher 

Regulatory Recon: GSK Employees Indicted for Stealing Trade Secrets, Storm Pushes FDA to Postpone Sarepta DMD Panel (21 January 2016)

Welcome to Regulatory Reconnaissance, your daily 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

In Focus: International

  • Five Charged With Conspiring to Steal Trade Secrets From GlaxoSmithKline (WSJ-$) (NYTimes)
  • To Fight 'Superbugs,' Drug Makers Call for Incentives to Develop Antibiotics (NYTimes) (Reuters) (EFPIA)
  • Biocad announces the trastuzumab biosimilar approval in Russia (Biosimilar News)
  • Sierra Leone confirms new Ebola case, second in less than a week (Reuters)
  • Australia's TGA Becomes Newest ICH Observer (SCRIP-$)
  • The Medicines Patent Pool Signs First Sub-licences for Hepatitis C Medicine Daclatasvir (PharmaAfrica)

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US: Pharmaceuticals and Biotechnology

  • Muscular Dystrophy Drugs Face New FDA Questions (WSJ)
  • FDA Renews  Pharmaceutical Science and Clinical Pharmacology Advisory Committee  (FDA)
  • Podcast: What's Coming Down The QA/RA Pike In 2016? 5 Issues Firms Should Keep An Eye On (Gray Sheet-$)
  • Medical journal editors call for greater data sharing on clinical trials (STAT)
  • Janssen Voluntarily Suspends FAAH Inhibitor Phase 2 Trials In Wake Of Bial Tragedy (Forbes) (BioCentury)
  • Four big problems with the FDA's analysis of Sarepta's Duchenne drug data (Boston Business Journal)
  • 10 Potential Drug Approvals To Look Out For In 2016 (SCRIP-$)
  • High Hopes For Merck/AiCuris Late-Stage CMV Candidate Despite Chimerix Failure (SCRIP-$)

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

  • AmpliPhi Biosciences Announces Dosing of First Patient in Phase 1 Clinical Trial of Bacteriophage AB-SA01 (Press)
  • Lilly and Incyte Announce Submission of New Drug Application to FDA for Oral Once-Daily Baricitinib for Treatment of Moderate-to-Severe Rheumatoid Arthritis (Press)
  • Janssen Research & Development, LLC Voluntarily Suspends Dosing in Phase 2 Clinical Trials of Experimental Treatment for Mood Disorders (Press)
  • Profectus Viosciences initiates Ebola vaccine Phase 1 clinical trial (MNT)
  • FDA approves Arzerra (ofatumumab) as extended treatment for recurrent or progressive chronic lymphocytic leukemia (MNT)
  • Galapagos moves AbbVie-partnered drug into PhI as multipronged attack on CF takes shape (FierceBiotech)
  • Cytori Partner Kerastem Expands US Phase II Trial for Early Stage Hair Loss (Press)
  • vTv Therapeutics Initiates Phase 2 Trial Evaluating TTP273 for the Treatment of Type 2 Diabetes (Press)
  • University of Maryland School of Medicine Research Leads to FDA Approval of Crucial Drug for Radiation Sickness (Press)
  • Alkermes Announces Topline Results of FORWARD-3 and FORWARD-4, Two Phase 3 Studies of ALKS 5461 in Major Depressive Disorder (Press)
  • Agenus Announces Clearance of Investigational New Drug Applications by the FDA for anti-CTLA-4 and anti-GITR Antibodies (Press)

US: Medical Devices

  • Facilities Sterilizing Devices via 'Novel' Methods Will See New FDA Inspections (Focus) (FDA)
  • Selling a New Device? Do This One Thing First (MDDI)
  • Patient Power Drives FDA—But Where? (MDDI)
  • Delcath launches Phase III trial for ocular melanoma treatment (MassDevice I,II)
  • Implanted Blood Access Devices for Hemodialysis (FDA)
  • Trade group's dispute with FDA highlights need to watch for report revisions (AHCJ)
  • Advances in continuous glucose monitoring technology will pave the way to an artificial pancreas (MNT)
  • SciBase's PMA application Advances to Evaluation Phase at FDA (Press)
  • Advanced Cooling Therapy's Esophageal Cooling Device FDA Cleared (medGadget)
  • Responding To Cybersecurity Threats: FDA Addresses Postmarket Questions In Draft Guidance (Gray Sheet-$)
  • Under The Weather? A Drop Of Blood Can Tell If Antibiotics Are Needed (Forbes)
  • Courtagen Life Sciences Receives New York State Clinical Laboratory Approval (Press)
  • Pelvalon Receives FDA Clearance of Second-Generation Non-Surgical Therapy for Women Suffering from Loss of Bowel Control (Press)
  • Allergan Announces FDA Approval of Updated Label for New Dosing Regimen for DALVANCE (Press)

US: Assorted and Government

  • Summary of Senate Health Committee Staff Draft: Bipartisan Legislation to Improve Health Information Technology for Patients and Families (Senate HELP)
  • Appeals Court Supports Patent Board Flexibility In Ethicon Case (Gray Sheet-$)
  • Precision medicine not a key goal for hospitals, health systems (FierceHealthIT)
  • US NIAID awards $5m to researchers developing non-traditional therapeutics for bacterial infections (In-PharmaTechnologist)
  • Senate Skips Critical Measures In Step-By-Step 'Cures' (SCRIP-$)
  • Pharma's Tone-Deaf Message On Pricing Needs To Change (Pink Sheet-$)
  • Federal Research Opportunities: DOE, DOD, and HHS Need Better Guidance for Participant Activities (GAO)
  • Four Key Issues In Health Law That Are As Relevant As Ever In 2016 (Harvard Bill of Health)
  • Washington, D.C. Changes Pharmaceutical Detailer License Requirements (Policy and Medicine)
  • Fed. Circ. Affirms PTAB Ruling Axing Glucose-Testing Patent (Law360-$)

Upcoming Meetings and Events              


  • More on Patent Settlements Including Litigation at the European Courts (FDA Life)
  • Cancer patients join genome sequencing project (MHRA)
  • European Collaboration Building Novel Biopsy Robot (medGadget)
  • UK Pfizer boss criticised for NHS conflict of interest (Pharmafile)
  • The Commission needs to tackle non-communicable diseases (EurActiv)
  • Too Much Too Soon? Eurasian Medtech Reg Framework Speeds ahead But Russian Concerns Persist (Clinica-$)
  • Cleveland Biolabs Attains Orphan Drug Status From The Ema For Entolimod As A Radiation Countermeasure (Press)
  • Baxalta gets EU marketing authorization for its Oncaspar to treat rare blood cancer (PharmaLetter-$)
  • UCB's new epilepsy drug BRIVIACT receives EU approval (MNT)
  • European Professional Card now available, making it easier for pharmacists to work across EU states (Pharmaceutical Journal-$)


  • Roche Cooperates with India Probes Into Off-Label Avastin Use (FDANews-$)
  • Health Ministry seeks pharma companies' views on ease of doing business (Economic Times)
  • India rejects licence plea for AstraZeneca's anti-diabetic (Economic Times)
  • Mankind Pharma to open manufacturing plant in US, invest Rs 300 crore (Economic Times)
  • New diabetes drug cuts cost by 80% (Economic Times)
  • Glenmark Pharma gets USFDA nod for two generic drugs (Economic Times)
  • Natco Pharma signs agreement for manufacturing, sale of hepatitis C drug (Economic Times)


  • China FDA plowed through trial and new drug applications in 2015, commissioner says (FiercePharmaAsia)
  • CFDA announces implementation scheme to improve drug approval system (Ropes & Gray)
  • NeuroMetrix Reports Regulatory Approval for DPNCheck in China (Press)


  • Japan's Daiichi Sankyo, Coherus become players in Enbrel biosimilar race (FiercePharmaAsia)
  • "Huge Seller" Re-Pricing to Hit Sovaldi, Harvoni, Avastin, Plavix (Pharma Japan Web)


  • Consultation: Proposed amendments to the Poisons Standard - ACMS and ACCS meeting, March 2016 (TGA)
  • Cannabis re-scheduling proposal - questions and answers (TGA)

Other International

  • Pharmacopeial Discussion Group Meeting Highlights Nov 2015 (PMDA)
  • Korean biosimilars making a splash on world stage (FiercePharmaAsia)
  • H1N1 swine flu kills 18 in Armenia, three in Georgia: officials (Reuters)
  • Birth defects linked to Zika virus still rising in Brazil (Reuters)
  • Zika virus may infect up to 700,000 people in Colombia: government (Reuters)
  • Fear, doubts obstruct efforts to contain Ebola in Sierra Leone (Reuters)
  • Venezuela needs urgent foreign medical aid, pharma group says (Reuters)

General Health and Other Interesting Articles

  • After mastectomy, women may lack facts on breast reconstruction (Reuters)
  • Skin cancer more deadly when caught during pregnancy (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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