Regulatory Recon: Amgen Fails at Patent Board in Humira Case, NIH Resumes Indian Trials  (19 January 2016)

Posted 19 January 2016 | By Michael Mezher 

Regulatory Recon: Amgen Fails at Patent Board in Humira Case, NIH Resumes Indian Trials  (19 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

  • Even Talking About Reducing Drug Prices Can Reduce Drug Prices ( NYTimes)
  • Johnson & Johnson to cut 3,000 jobs in medical devices division ( Reuters) ( Bloomberg)
  • Love 'Em? Hate 'Em? No Matter. The Drug Industry Gets What It Wants. ( Xconomy)
  • Sarepta Eteplirsen Briefing Document Addendum ( FDA)
  • NIH Resumes Indian Trials But Keen On 'Elaborations' Of Rules ( SCRIP-$)
  • Amgen Fails At US Patent Board In Humira Challenge ( SCRIP-$) ( BioPharma-Reporter)

In Focus: International

  • MSF warns on EU/India trade talks ( PharmaLetter-$)
  • Scientists in the dark after French clinical trial proves fatal ( Nature)
  • To Combat Pandemics, Glaxo Seeks Funding for Infectious Disease Vaccines Proposal ( STAT)
  • Scientists Speculate On What Caused The Bial Drug Testing Tragedy In France ( Forbes)
  • The Changing Regulatory Environment in Latin America – Focus on Good Review Practices ( Thomson Reuters)
  • WHO responded 'too slowly' to Ebola warnings ( OnMedica) ( Report)
  • Brazil to fund development of vaccine for Zika virus ( AP)

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US: Pharmaceuticals and Biotechnology

  • Scientists take steps to make weak TB drugs strong again ( Press)
  • Rx-to-OTC switching: the heart of OTC market, says GBI ( In-PharmaTechnologist)
  • Strong Growth Ahead for Contract Manufacturing ( Pharmaceutical Manufacturing)
  • Florida Pertussis Outbreak Shows Vaccine Works -- But Not Well Enough ( Forbes)
  • Health Policy Brief: Transparency In Clinical Research ( HealthAffairsBlog)
  • FDA Delays Decision On HRTX Drug, Trial Woes Paint EBIO Red, NVLS On Watch ( RTT News)

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

  • FDA Grants Rare Pediatric Disease Designation to MediciNova's MN-166 (ibudilast) for the Treatment of Krabbe Disease ( 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)
  • Enrollment Begun on Phase II Clinical Trial in Crohn's Disease ( Press)
  • Trevena, Inc. Announces Initiation of Oliceridine Phase 3 Clinical Program With Multi-Procedure Safety and Tolerability Study ( Press)

US: Medical Devices

  • Medicines360 and Camargo Pharmaceutical Gain FDA Approval for Intrauterine Contraceptive Device ( Press)
  • HealthMyne Announces FDA Clearance of Imaging Analytics Package ( Press)
  • Unique Biomaterial for Hernia Repair Receives FDA 510K Clearance ( Press)

US: Assorted and Government

  • U.S. deploys newly minted bird flu plan to protect humans, poultry ( Reuters)

Upcoming Meetings and Events              


  • Russia's Biocad shipping high-tech cancer drugs to Vietnam ( PharmaLetter-$)
  • Upcoming EU data protection ruling gives green light for sharing patient data across health and care sector ( MNT)
  • How Effective Is Pharmacovigilance? EMA Committee Intends To Find Out ( SCRIP-$) ( EMA)
  • French Health Minister criticises CRO's slow response to clinical trial accident ( Pharmafile)
  • Reflection paper on the chemical structure and properties criteria to be considered for the evaluation of new active substance (NAS) status of chemical substances ( EMA)
  • Making the case for UK medicines manufacturing ( MHRA)
  • WINDOW INTO HTA: Assessing The Reimbursement Climate For Your Product ( Clinica-$)
  • UK Alzheimer's drugs prescriptions rise six-fold in a decade ( Pharmafile)
  • December 2015: clinics advertising botulinum toxin products ( MHRA)
  • Baxalta Granted EU Marketing Authorization for ONCASPAR (pegaspargase) as a Component of Combination Therapy in Acute Lymphoblastic Leukaemia (ALL) ( Press)
  • Arrowhead's ARC-AAT Granted EMA Orphan Drug Designation ( Press)


  • USFDA observations for Shendra facility not critical: Wockhardt ( Economic Times) ( PharmaLetter-$)
  • A strict FDA, competition may slow pharma growth; export may halve to 8 per cent by 2020: Study ( Economic Times)
  • Government panel wants prices of medical devices like cardiac stents, implants capped ( Economic Times)
  • Inviting Higher Risks By Challenging FDA ( BusinessWorld)
  • Union govt's 'Start-up India' campaign enthuses biotech and pharma sectors ( PharmaBiz)
  • IDMA urges govt not to reduce rate of deduction for expenditure on R&D from 200% to 100% for next 10 years ( PharmaBiz)
  • Maharashtra FDA to start campaign against online sale of 'unhealthy' meds ( Asian Age)



  • Ono Pharma files for approval of etelcalcetide in Japan ( PharmaLetter-$)
  • Telephus secures Japanese Patent for Anti-MRSA Antibodies ( BioSpectrum)


  • Canada Updates Biosimilar Guidance On Reference Drug, Extrapolation, Scientific Advice ( SCRIP-$)
  • Health Canada warning on mycophenolate teratogenicity ( PharmaLetter-$) ( Health Canada)

Other International

  • JPM 2016: Big Pharma Committed To Emerging Markets Despite Volatility ( PharmAsiaNews-$)
  • Fuji Pharma signs license agreement for darbepoetin alfa with CKD of South Korea ( BiosimilarNews)

General Health and Other Interesting Articles

  • The DIY Scientist, the Olympian, and the Mutated Gene ( ProPublica)
  • The Tragic Fate of the People Who Stop Sleeping ( BBC)
  • Ticks carrying Lyme disease in almost half of US counties ( Reuters)
  • Rare case of scurvy seen in infant fed almond milk ( CBS)
  • Treating addicts: The tension between drug treatment and abstinence ( Washington Post)
  • Opioid Overdose statistics ( Washington Post)
  • Is an Annual Physical Necessary? ( 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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