Regulatory Recon: Amphastar Hit With CRL for Intranasal Nalaxone NICE Rejects Ipsen's Cabometyx in Draft Guideline (21 February 2017)

Posted 21 February 2017 | By Michael Mezher 

Regulatory Recon: Amphastar Hit With CRL for Intranasal Nalaxone NICE Rejects Ipsen's Cabometyx in Draft Guideline (21 February 2017)

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

In Focus: US

  • Sarepta Sells Priority Review Voucher for $125M to Gilead (Focus) (Endpoints) (Press)
  • An FDA reform agenda: What would Commissioner Scott Gottlieb do in his first six months? (Endpoints)
  • After steering through a controversy over soaring price of naloxone, FDA rejects Amphastar's intranasal version (Endpoints) (Reuters)
  • How Much Is a CRISPR Patent License Worth? (Forbes)
  • 'Right to Try' Laws Don't Help the Dying (Bloomberg)
  • FDA 'Reform' May Harm Patients (Medpage)
  • Biosimilars Council Urges Supreme Court to Reject Additional Six Months Exclusivity for Biologics (Focus)
  • Big pharma bets billions on 'silent' liver disease (Financial Times)
  • HIMSS 2017: FDA debunks 4 medical device cybersecurity myths (Fierce)
  • Judge Gorsuch Could Be Pharma Ally In FDA Disputes (Pink Sheet-$)
  • Alzheimer's: Pharma's Great White Whale Is Still Worth Hunting (WSJ)
  • Trump Backing for Bayer's Monsanto Deal Buoys Investors (WSJ)
  • Company-funded studies of approved drugs may not catch safety issues (Reuters)
  • CardioBrief: After Yet Another Failure, Stem Cell Leaders Double Down (Medpage)
  • Homeopathic remedies harmed hundreds of babies, families say, as FDA investigated for years (STAT)
  • The Emergent Microbiome: A Revolution for the Life Sciences -- Part X, The Big Data Component (Patent Docs)

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In Focus: International

  • Faulty batch of Takeda's paracetamol discovered in Denmark (Pharmafile) (InPharmaTechnologist)
  • EU drugs agency: Don't politicise Brexit relocation, say Athens, Copenhagen (EurActiv)
  • Delay in hiring science advisers intensifies Brexit worries (Nature)
  • EU Court of Justice Clarifies Product Liability for Notified Bodies (Focus)
  • Sun Pharma opens first production unit in Egypt (Economic Times)
  • Strengthening Biotherapeutic Regulation Worldwide Will Remain a High Priority for WHO in 2017 (IPQ)
  • Merck eyes new India bio-production facility (Pharmafile)
  • NICE draft guidelines reject Ipsen's Cabometyx (PharmaTimes) (Pharmafile)
  • EMA: GCP deviations increasing (OutsourcingPharma)
  • Pfizer Gets Pain Indication for Lyrica in Japan (Press)
  • Feel The Quality: Biosimilars Dominate Standards Setting Debate In EU (Pink Sheet-$)
  • Roche's lung cancer drug Alecensa wins EU approval (PMLive) (Press)
  • Surging biotech industry amid strong Sino-Australian trade relations (PharmaLetter-$)
  • How The GDPR Will Impact Life Sciences And Health Care (Law360-$)
  • Mesoblast Eyes Japan Conditional Approval After New RA Cell Therapy Data (SCRIP-$)
    Drive to stimulate Russian pharma industry continues apace (PharmaLetter-$)
  • Belgium To Test Parallel Review Of Clinical Trial Dossiers Ahead Of New Regulation (SCRIP-$)
  • GSK's Vallance On Efficiency In R&D And Entering "The Cure" Era (SCRIP-$)

US: Pharmaceuticals & Biotechnology

  • Triangulene, By Force (In The Pipeline)
  • Do President Trump's Regulatory Freeze-Out and "1-in-2-Out" Orders Affect the Regulation of Compounding? (FDA Law Blog)
  • U.S. Food and Drug Administration looking for new space in Atlanta (Atlanta Business Chronicle)
  • Where are all the new diabetes drugs? (STAT)
  • OPDP Plans Just One Guidance Document for 2017 (Coalition for Healthcare Communication)
  • Travena Makes the Case for Better Post-Surgical Opioid with New Study Data (The Street)
  • Breathing Room For BMS In Renal Cancer As Early Tecentriq Data Mixed (SCRIP-$)
  • Bristol-Myers Squibb Appoints Three New Independent Directors (Press)
  • TiGenix hires Lonza to make cell therapy for Crohn's disease complications (BioPharmaReporter)

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

  • Cell Medica: Lead Cancer Immunotherapy Candidate Receives FDA Fast Track Designation (Press)
  • The Medicines Company Announces FDA Filing Acceptance of New Drug Application for Intravenous Antibiotic Carbavance® (meropenem-vaborbactam) (Press)
  • Pfizer Announces Acceptance of Regulatory Submission for Inotuzumab Ozogamicin by the US Food and Drug Administration (Press)
  • GenSight Biologics Completes Enrollment of REVERSE Phase III Study of GS010 in the treatment of Leber's Hereditary Optic Neuropathy (Press)

US: Medical Devices

  • 2017 Meeting Materials of the Circulatory System Devices Panel (FDA)
  • 2017 Industry Outlook: Medical Device Companies Report Robust 2016 Sales (Emergo)
  • Medtronic's Q3 numbers top estimates (MassDevice) (Press)
  • Philips gets FDA clearance for inpatient continuous monitoring system (MedCityNews)
  • Voxello Receives FDA 510(k) Clearance for the Noddle Speech Generation Device (Press)

US: Assorted & Government

  • Design and Failure to Warn Claims Survive TwIqbal Challenge in Kentucky (Drug & Device Law)
  • Trump energizes the anti-vaccine movement in Texas (Washington Post)
  • Smith & Nephew, Arthrex End Surgical Device Patent Spats (Bloomberg)

Upcoming Meetings & Events


  • NHS books £886m year-to-date deficit (PharmaTimes)
  • Independent review confirms rigour of ABPI exam for UK sales representatives (ABPI)
  • Belgian CRO launches EU joint venture with Chromatography Institute (BioPharmaReporter)
  • Sobi inks new distribution agreement for Ammonul (PharmaLetter-$)
  • BMA report highlights NHS bed crisis (PharmaTimes)


  • Glenmark Pharma's Ankleshwar plant gets 4 FDA observations (CNBC)
  • Cancer drugs at low prices tough to find in open market (PharmaBiz)
  • US Chamber ranks India at bottom in its IP report, Indian Pharmaceutical Alliance terms it flawed assumption (PharmaBiz)
  • Union govt to issue norms to monitor cost of healthcare expenses, begins with watch on stent prices: Minister Ananth Kumar (PharmaBiz)
  • No additional charge on stents as rates include 8% margin: Govt (Economic Times)
  • NPPA slashes margins on stents for hospitals, distributors (Economic Times)
  • Medical tourism will help drive Indian pharma industry to reach $55 billion by 2020 (PharmaLetter-$)



  • TGA presentation: ARCS Seminar, Sydney, 24 January 2017 (TGA)

Other International

  • First Comprehensive Pediatric Hematology-Oncology Initiative Launched in Africa (Press)

General Health & Other Interesting Articles

  • Can Craig Venter Cheat Death? (Forbes)

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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