Regulatory Recon: Amicus Abandons Wound Treatment After Phase III Miss; Mylan Says Allergan Misusing Tribal Sovereignty (13 September 2017)

Posted 13 September 2017 By Michael Mezher

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

In Focus: US

  • How 3-D Printing Is Changing Health Care (WSJ)
  • Additive manufacturing: A long-term game changer for manufacturers (McKinsey)
  • Drug Companies Tie Costs to Outcomes (WSJ)
  • Drug Plans Are Fighting States to Keep Prices in the Dark (Bloomberg)
  • Streamlined FDA reviews fail to catch dangerous glitches in health software, study finds (STAT)
  • FDA to Close Loophole Allowing Companies to Skirt Pediatric Study Requirements (Focus)
  • Amicus scraps a top rare disease drug after it flunks a pivotal test — and shares spike (Endpoints) (Reuters)
  • Mylan attacks Allergan over its Mohawk-allied patent strategy — but the CEO is sticking to his guns (Endpoints) (Reuters)
  • Sanofi indicates dupilumab could be used to treat nasal polyps (Reuters)
  • After conjunctivitis flop, Aldeyra plays on positives for dry eye disease (Fierce)
  • Does Sage Therapeutics' Failure Predict Its Future Results? (Forbes) (Endpoints) (Reuters)
  • A Billion Here, A Billion There: Selectively Disclosing Actual Generic Drug Prices Would Save Real Money (Health Affairs Blog)
  • PhRMA, BIO Dispute Cancer Drug R&D Cost Study (PhRMA) (BIO) (JAMA)
  • CDRH Finalizes Guidance on Reporting Age, Race and Ethnicity Data in Studies (Focus)
  • Nonclinical Recommendations for Radiopharmaceuticals: FDA Drafts Guidance (Focus) (FDA)
  • FDA says Tecentriq won't lose its bladder cancer nod despite phase 3 failure, Roche reports (Fierce)
  • Prevnar 13 among blockbusters industry watchers peg as tribal licensing candidates (Fierce)

In Focus: International

  • Former CDC chief launches $225 million global health initiative (Washington Post) (NPR) (NYTimes) (Reuters)
  • Progress on global poverty and disease at risk, Gates says (Reuters)
  • MSD launches blockbuster cancer drug Keytruda in India (Economic Times)
  • Clinigen boost unlicensed drugs business with Quantum takeover (Reuters)
  • Raising awareness of the perils of antimicrobial resistance (EMA)
  • No fraud, no conspiracy, no error: France and Merck say reformulated Euthyrox is safe (InPharmaTechnologist)
  • Asia Regulatory Roundup: TGA Takes Tougher Line on Incomplete GMP Clearance Applications (Focus)
  • Novartis' Cosentyx proves long-term efficacy in psoriasis skin clearance (Pharmafile) (Endpoints)
  • UK collaboration presents promising data in the fight against antibiotic resistance (Pharmafile)
  • Indian Generics Firms Must Shift Gears For Third Wave, Says Lupin MD (SCRIP-$)
  • Finalized ICH Guide Supports Global Approach To Collecting Genomic Samples, Data During Trials (Pink Sheet-$)
  • Hepatic Safety Of Biogen Idec's Zinbryta Under Close Scrutiny In EU (Pink Sheet-$)
  • New Treatments For Psoriasis, Ovarian Cancer And MS Seeking CHMP Thumbs Up This Week (Pink Sheet-$)

Pharmaceuticals & Biotechnology

  • Otonomy brings out the ax after a catastrophic PhIII failure (Endpoints)
  • Generic Chemo Is Too Expensive To Help Curb Cancer Spending, Study Says (Forbes)
  • Cardiovascular Drug Approval Rate in the U.S. Fell as Development Time Rose (Tufts)
  • Accelerating Accelerated Approval & Other Drug Development Signals from FDA's Approval of 1st  Therapy for Chagas (FDA Law Blog)
  • Erytech mulls first-line use for pivotal pancreatic cancer trial (Fierce)
  • ProQR spins out a new RNA biotech focused on CNS diseases (Endpoints) (Fierce)
  • Searching for a few great drugs, BridgeBio bags $135M to back a fresh slate of R&D bets (Endpoints)
  • The art of clinical trial design: Generating real world evidence that satisfies regulators and payers (MedCityNews)
  • NIPTE is Awarded up to $35M "Manufacturing Sector Research Initiative" FDA Grant (Press)
  • Gene therapy startup Rocket Pharma reverse merges with troubled Inotek after $25M raise (Endpoints)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • FDA grants fast-track designation for Shire's lung drug (PharmaTimes)
  • Results of a six-month study combining Roche's Esbriet with nintedanib in patients with IPF presented at ERS (Press)
  • Bristol-Myers advances new LAG-3 drug relatlimab to fight PD-1 resistance (Fierce)
  • bluebird bio Announces First Patient Treated in Expansion Cohort of CRB-401, Phase 1 Study of Anti-BCMA CAR T Therapy bb2121 (Press)
  • Clovis Oncology's Rucaparib ARIEL3 Study Data Published in The Lancet (Press)
  • U.S. FDA Accepts for Review Astellas' Supplemental New Drug Application for mirabegron for Use in Combination with solifenacin succinate 5 mg for the Treatment of Overactive Bladder (Press)
  • Daily Blood Glucose Measures In Phase 3 Clinical Trials Demonstrated Better Stability With Sanofi's Toujeo® Vs. Insulin Glargine 100 Units/ml (Press)

Medical Devices

  • Old legacy devices pose greatest security risk, experts say (MobiHealthNews)
  • Philips' IntelliView MX40 Patient Worn Monitor (WLAN) Vulnerabilities (DHS)
  • Edap submits new FDA 510(k) for Focal One HIFU (MassDevice)
  • Abbott to Stop Selling Absorb (MDDI)
  • Aethlon Medical wins FDA EAP designation for Hemopurifier (MassDevice)
  • Did Congress just kill medical device innovation? (Medical Design & Outsourcing)
  • Douglas Medical Products Inc. Receives FDA 510(k) Clearance for the TUBETECH® IV Administration Set (Press)
  • Blood test could mean earlier diagnosis, better treatment for macular degeneration (Fierce)
  • Medtronic IN.PACT Admiral DCB Global Two Year Data and IN.PACT SFA Four Year Data Presented in VIVA Late Breaking Clinical Trials (Press)

US: Assorted & Government

  • Key U.S. senators reach deal on funding children's health program (Reuters)
  • Bernie Sanders Unveils Single-Payer Health Legislation (WSJ)
  • The Third Circuit Fosamax Preemption Error Has Got to Go (Drug & Device Law)
  • Tech entity has tribal patent deal similar to Allergan's (Reuters)

Upcoming Meetings & Events

Europe

  • Santhera Hopeful On EU DMD Indication Extension (Pink Sheet-$)
  • IQWiG finds added benefit for nivolumab in specific patients (PharmaLetter-$)
  • IVDR, IVDs and mass extinction (MedicalDevicesLegal)
  • Sixty-Seventh Session of the WHO Regional Committee for Europe (WHO)
  • EUnetHTA Magazine - Fall 2017 now available (EUnetHTA)
  • Science focus to First Minister's Plans (ABPI)
  • Senseonics wins CE Mark for Eversense XL glucose monitor (MassDevice)
  • Abbott nabs U.K. reimbursement win for FreeStyle Libre CGM (MassDevice) (PharmaTimes)

India

Australia

  • Codeine stock management for wholesalers, sponsors and retail pharmacies (TGA)

General Health & Other Interesting Articles

  • Menopause hormone therapy not linked to premature death (Reuters)
  • Middle-age women can choose Pap smear or HPV test for cancer screening (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 news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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