Regulatory Recon: Former Congressman Waxman Says Drugmakers are Taking Advantage of Orphan Incentives ANVISA Approves GW's Cannabis-Based Sativex (17 January 2017)

Posted 17 January 2017 | By Michael Mezher 

Regulatory Recon: Former Congressman Waxman Says Drugmakers are Taking Advantage of Orphan Incentives ANVISA Approves GW's Cannabis-Based Sativex (17 January 2017)

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

In Focus: US

  • Where the US Actually Gets Its Drug Supply: QuickTake Q&A (Bloomberg)
  • The US Government Should Buy Gilead For $156 Billion To Save Money On Hepatitis C (Forbes)
  • Former US Rep. Henry Waxman Shares Deep Concerns About Orphan Drugs (KHN)
  • Drugmakers Manipulate Orphan Drug Rules To Create Prized Monopolies (KHN) (NPR)
  • Timeline: The Orphan Drug Act (KHN)
  • What Is The Trump Pharmaceutical Policy? (National Law Review)
  • Donald Trump and Peter Thiel vs. the FDA: Be afraid. Be very afraid. (Science-Based Medicine)
  • The Stem-Cell Revolution Is Coming — Slowly (NYTimes)
  • Shionogi Eyes '17 US Cefiderocol Filing After New Results (SCRIP-$)
  • Drug Compounding With Bulk Substances: FDA Offers Interim Policies (Focus)
  • AZ to rework ongoing immuno-oncology trials to "enhance options" (Pharmafile)
  • Allergan, Gedeon Richter Plan 2017 FDA Filing for Uterine Fibroids Drug Ulipristal (GEN) (PharmaLetter-$)
  • Biogen to pay $1.25 billion in license fees to protect MS drug (Reuters)
  • Trump's Cabinet pick invested in company, then introduced a bill to help it (CNN)
  • Trump Health Secretary Pick's Longtime Foes: Big Government and Insurance Companies (NYTimes)
  • Draining The Swamp? Not With Tom Price As Head Of Health (Forbes)
  • Top Price Contributor Allegedly Leaned On Employees To Support PAC (KHN)
  • The Unhealthy Return to Individual Responsibility in Health Policy (Harvard Bill of Health)
  • Meet Forward, An Ex-Googler's Plan To Reinvent Healthcare With A Dose Of Apple, Netflix And AI (Forbes)
  • 'Repeal and Replace': Words Still Hanging Over G.O.P.'s Health Care Strategy (NYTimes)
  • Fear Spurs Support for Health Law as Republicans Work to Repeal It (NYTimes)
  • Outgoing CDC chief talks about agency's successes — and his greatest fear (Washington Post)
  • Ophthotech cuts to hit around 80% of staffers after phase 3 failures (Fierce)

In Focus: International

  • NICE Halts Plans to Charge for Appraisals (Focus)
  • How the Response to Zika Failed Millions (NYTimes)
  • New NICE ultra-rare disease proposals "not fit for purpose", says BIA (Pharmafile)
  • Brazil issues first license for sale of a cannabis-based drug (Reuters)
  • OECD report warns of rising drug prices, urges new approach (PharmaLetter-$)
  • EFPIA and ABPI urge UK to keep drug regs consistent with EU post Brexit (InPharmaTechnologist)
  • EMA And National Agency Heads Join Forces On Medicines Availability and Big Data (Pink Sheet-$)
  • EMA Reveals List of Eligible Industry Stakeholder Organizations (Focus)
  • AstraZeneca sees opportunity in China, boosts clinical trial program (PharmaLetter-$)
  • Counterfeit hep C drug Harvoni found in Japan (Securing Industry)
  • Alcobra to stop testing sole drug for ADHD after study fails (Reuters) (PharmaLetter-$)
  • SMC rejects Janssen's multiple myeloma treatment Darzalex (Pharmafile)
  • Two Important Decisions Addressing ANVISA's Prior Approval of Pharmaceutical Patents in Brazil (National Law Review)
  • Sourcing Medical Devices in China: Phase 2 – Contract Negotiation (Pacific Bridge Medical)

US: Pharmaceuticals & Biotechnology

  • 2017 pharma trends: Bon chance! (PMLive)
  • 'Cures' Challenges and Communication Changes Ahead (PharmExec)
  • BioMarin Set Sights On Pivotal Gene Therapy Hemophilia Study (SCRIP-$)
  • MannKind 'aggressively' moving forward with inhalable epinephrine (InPharmaTechnologist)
  • Poor provider engagement drives low patient recruitment, says Tufts (OutsourcingPharma)
  • FDA Finalizes Repackaging Guidance, Revises Draft on Biologics Mixing, Diluting and Repackaging (Focus)
  • Beyond the margins: real-time detection of cancer using targeted fluorophores (Nature)
  • Stimulant boosts function in patients recovering from depression (Reuters)
  • The Weirdness of Ebselen (In the Pipeline)
  • GEA and Siemens team on continuous processing tech (InPharmaTechnologist)
  • InDevR Licenses FDA Influenza Antibodies for VaxArray™ (Press)
  • Biological Product Suffix Submissions Limited To 10 Candidates By US FDA (Pink Sheet-$)

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

  • Remedy Pharmaceuticals' CIRARA Granted Orphan Drug Designation For Treatment of Severe Cerebral Edema Caused By Acute Ischemic Stroke (Press)
  • BioLineRx Announces Initiation of Immuno-Oncology Phase 2 Study to Investigate Combination of BL-8040 and KEYTRUDA® for Pancreatic Cancer (Press)
  • Psyadon Announces Positive Results from Phase 2b Clinical Study of Ecopipam for the Treatment of Tourette's Syndrome in Children (Press)
  • Brief-Pulmatrix Drug Candidate Receives QIPD Designation From FDA (Reuters)

US: Medical Devices

  • FDA Final Guidance Issued on Key Factors for IDE Benefits, Risks (Emergo) (Focus)
  • SpineGuard® Receives FDA Clearance to Market Its DSG™ Integration Module for Making Pedicle Screws "Smart" (Press)

US: Assorted & Government

  • First Circuit Rejects Fraud-on-FDA Allegations Under False Claims Act (FDA Law Blog)
  • Lengthy Decision, Simple Conclusion – Preemption Win Across the Board (Drug & Device Law)
  • Zydus settles with Kowa and Nissan over Livalo dispute (PharmaLetter-$)
  • Ex parte Itagaki and Nishihara (Patent Docs)

Upcoming Meetings & Events


  • High investment in pharmaceutical R&D underpins increased investment in collaborative working (ABPI)
  • Parliament's presidential election: Tajani, Pittella and Stevens lead after second ballot (European Parliament)
  • Stroke risk for Alzheimer's patients using certain tranquilizers, says Finnish study (PharmaLetter-$)


  • Daiichi Sankyo moves HC to block Singh brother's bid to sell stake in Fortis (Economic Times)
  • Amid growing concern about quality of products, CDSCO begins inspections at manufacturing sites in Bihar (Pharmabiz)
  • Pharmacist associations urge health ministry not to allow non pharmacist drug wholesalers in trade (Pharmabiz)
  • India clamps down on OTC antibiotic sales to stem spread of superbugs (InPharmaTechnologist)
  • India must protect innovators' work product, says BIO chief (PharmaLetter-$)
  • Indian Teen's Fight For Lifesaving TB Drug Highlights Access Issues (Pink Sheet-$)
  • Profit on stents ranges from 270% to 1,000% (Economic Times)
  • NPPA issues final warning to 694 companies to register themselves on IPDMS by Jan 21, 2017 (Pharmabiz)


  • Australian Public Assessment Reports for prescription medicines (AusPARs) (TGA)


  • Medical marijuana recall expanded after banned pesticide found (Globe and Mail)

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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