Regulatory Recon: FDA Approves Teva's Huntington's Drug Austedo; Califf Speaks Out Against Trump Budget Proposal (4 April 2017)

Posted 04 April 2017 By Michael Mezher

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

In Focus: US

  • Teva wins FDA approval for Huntington's drug (Reuters) (Endpoints) (Pharmafile) (In the Pipeline) (Press)
  • Robert Califf: Scientific community must speak out against 'ridiculous' budget proposal (STAT)
  • Drug spun off by AstraZeneca shows promise in hot flashes (Reuters) (Press)
  • A.I. VERSUS M.D. What happens when diagnosis is automated? (The New Yorker)
  • FDA nominee goes before Senate Committee (Politico) (Pink Sheet-$)
  • FDA Grants Third Extension of UDI Compliance Date to Soft Contact Lens Labelers (Focus)
  • Strategies To Address The Challenges Of Outcomes-Based Pricing Agreements For Pharmaceuticals (Health Affairs Blog)
  • Overcoming Challenges Of Outcomes-Based Contracting For Pharmaceuticals: Early Lessons From The Genentech–Priority Health Pilot (Health Affairs Blog)
  • Paratek's antibiotic succeeds in second late-stage study (Reuters) (Endpoints)
  • Mylan hit with new class action lawsuit over EpiPen pricing (Reuters) (WSJ)
  • Arizona Law Puts Pressure on FDA to Change Off-Label Policies (Bloomberg)
  • Researchers worry immunotherapy may hasten growth of tumors in some patients (STAT)
  • United Therapeutics shares fall after regulatory delays push back product launch (CNBC) (Drug Delivery)
  • CDC Study Finds Flu Vaccine Saves Children's Lives (CDC)
  • Study: 20% of patients with serious conditions are first misdiagnosed (Washington Post)
  • Trump says repeal isn't dead (Politico) (Reuters)
  • Trump's Effort To Lure Consumers To Exchanges Could Bring Skimpier Plans (KHN) (NYTimes)
  • Biden attacks Trump's proposed cuts to medical research (Washington Post)
  • Obama vs. Trump: Early report card on how health and science are changing (STAT)
  • Iowa's Largest Insurer Says It Will Withdraw From Obamacare Exchanges (NYTimes)

In Focus: International

  • Bayer's Adaptive Pathways Experience: 'Disappointing', But Valuable Lessons Learned (Pink Sheet-$)
  • The Scientists Trying to Keep Zika Out of Your Placenta (Wired)
  • The Campaign to Lead the World Health Organization (NYTimes)
  • 'Critical' Issues Need Resolution Before ICH Q12 Proceeds To Next Step (Pink Sheet-$)
  • EMA Adopts Updated Guideline on Fixed Dose Combination Drugs (Focus)
  • EMA Crafts New Framework to Better Collaborate With Academia (Focus)
  • Progress uneven as global child death rates fall (Reuters) (NPR)
  • UK launch for Nordic's novel methotrexate pen (PharmaTimes)
  • Novartis combo expands into lung cancer with EU approval (Pharmafile)
  • Medical Device Marketing Authorization (MDMA) Application Changes Planned in Saudi Arabia (Emergo)
  • Roche could face competition for Tamiflu in Russia (PharmaLetter-$)
  • Russian tax service to tighten control of foreign pharma firms on domestic market (PharmaLetter-$)
  • Indian Firms' US Revenues Slow Sharply But Balance Sheets Still Solid (SCRIP-$)
  • 4th Invitation to manufacturers and suppliers of medicinal products for treatment of hepatitis B and C to submit an expression of interest for product evaluation (EOI) (WHO)

US: Pharmaceuticals & Biotechnology

  • Future of Drug Development (FDA - Slides)
  • Ten Drugs Make New FDA Watch List (MedScape)
  • Behind Rare Disease Day 2017 (Pharmafile)
  • FDA Panel To Discuss Dynavax's Heplisav-B (BioCentury)
  • Amgen's Money Back Guarantee For Its Cholesterol Drug, Repatha (Forbes)
  • A Look At Payers' Early Game Plans For Driving Biosimilar Use (Pink Sheet-$)
  • Let's Go for a Win on Opioids (NYTimes)
  • Opioid Abuse-Deterrence: Immediate Release Formulation Is Chance For US FDA To Reassess Goal Posts (Pink Sheet-$)
  • Running The Drug Catalyst Gauntlet: What To Look For In Q2 2017 (SCRIP-$)
  • Allergan exec Sanjiv Patel becomes new CEO at upstart Relay (Fierce)
  • Viracta nabs $18.4M, Soon-Shiong as vice chair in Series B (Fierce)
  • Celgene Notified of ANDA Filing for Pomalyst (Press)
  • Vaccinating pregnant moms protects newborns from whooping cough (Reuters)
  • Chemists Shed Some Light On Sunscreen Ingredients (Forbes)
  • Determination That CEDAX (Ceftibuten Dihydrate) For Oral Suspension, 90 Milligrams/5 Milliliters and 180 Milligrams/5 Milliliters, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness (FDA)

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

  • Bristol-Myers' checkpoint star Opdivo fails a PhIII study for glioblastoma (Endpoints) (Press)
  • Wockhardt gets USFDA nod for abridged clinical trial for new antibiotic drug (Live Mint) (Press)
  • Angionetics Nears Key Gene Therapy Trial for Coronary Heart Disease (Xconomy)
  • Sanofi boasts observational hypoglycemia rates for Toujeo insulin injection (Drug Delivery)
  • Roche's Tecentriq Shows Survival In Triple-Negative Breast Cancer, For Some (SCRIP-$)
  • TherapeuticsMD Presents Positive Phase 3 Data in Two Presentations for TX-001HR at ENDO 2017 (Press)
  • Kadmon Submits Second Abbreviated New Drug Application Filing for Trientine Hydrochloride to FDA (Press)
  • Verona Pharma doses first patient in cystic fibrosis trial (PharmaTimes)
  • Prothena pushes Roche-partnered Parkinson's drug into phase 2 after initial trial success (Fierce)

US: Medical Devices

  • A Familiar Technology with a Futuristic Spin (MDDI)
  • Medtech Startup Showdown 2017: Round 3 (MDDI)
  • BD launches surgical infection control and prevention program (MassDevice)
  • Computerized phone therapy might help curb back pain (Reuters)
  • New York State Licenses PreventionGenetics (GenomeWeb)
  • ETS Wound Care Gains FDA Clearance for MIRRAGEN Advanced Wound Matrix (Press)

US: Assorted & Government

  • Ampyra, Patents, And The Perils Of Letting PTAB Get Your Hopes Up (Pink Sheet-$)
  • ACRO Strongly Endorses Domestic Research Enhancement Act Of 2017 (ACRO)
  • Nevada lawmakers seek business data on costly prescriptions (KTNV)
  • Is it Scheduling or Rescheduling? DEA Issues Interim Rule on Oral Solutions of Dronabinol (FDA Law Blog)
  • Philadelphia Court Tosses Off-Label Promotion Claims (Drug & Device Law)
  • Lilly, Pfizer, et al. back Sanofi and Regeneron in PCSK9 patent appeal. AbbVie doesn't (Fierce)
  • PTAB Life Sciences Report -- Part II (Patent Docs)
  • Another Step Toward Reasonable Preemption Case Law (Law360-$)
  • Kimberly-Clark Gowns Should Have Been Recalled, Jury Told (Law360-$)
  • Novartis' Hep C Patents Invalid Under Alice, AbbVie Says (Law360-$)
  • Tom Price's $150,000-Plus Stock Windfall (ProPublica)
  • Missouri Rejects Federal Money In Order To Set Up Its Own Abortion Restrictions (KHN)
  • US raises Medicare payments to insurers by 0.45 percent in 2018 (Reuters)
  • Kansas House Narrowly Upholds Governor's Veto of Medicaid Expansion (NYTimes)

Upcoming Meetings & Events

  • FDA Advisory Committee Calendar
  • Food and Drug Administration/Xavier University Medical Device Conference (MedCon) – 3-5 May 2017
  • Antibody Mediated Rejection in Kidney Transplantation; Public Workshop – 12 April 2017
  • FDA/C-Path PRO Consortium: Second Annual Workshop on Clinical Outcome Assessments (COAs) in Cancer Clinical Trials – 25 April 2017

Europe

  • Draft guideline on multiplicity issues in clinical trials (EMA)
  • Concept paper on the need to revise appendix 4 (on condition-specific guidance) to the guideline on the evaluation of anticancer medicinal products in man (EMA)
  • Final figures for 2016 confirm good year-end results, says Stada Arz (PharmaLetter-$)
  • Open Letter: Biopharma Leaders Call For Diversity Drive (SCRIP-$)
  • Scientists find common antibiotic could prevent or treat PTSD (Reuters)
  • Commission publishes guides on patient blood management (EC)
  • Sartorius buys its PAT and QbD software partner for $72.5m (BioPharmaReporter)
  • IBM invests to accelerate innovation, collaboration and fast-track healthcare solutions in Finland (IBM)
  • Nico wins CE Mark for BrainPath (MassDevice) (Press)

Asia

India

  • IPA punches holes into drug pricing policy implementation (Economic Times)
  • Sun Builds On Psoriasis Data But Can It Hold In Crowded Space? (SCRIP-$)
  • NPPA revises ceiling prices of 728 scheduled formulations of Schedule-I under DPCO Amendment Order, 2016 (PharmaBiz)

Australia

  • Permissible Ingredients Determination: Forecast of updates (TGA)

Other International

  • MERS causes new Saudi hospital outbreak: WHO (Reuters)
  • WHO calls for increased support for health aid in Syria and refugee-hosting neighbouring countries (WHO)

General Health & Other Interesting Articles

  • Should You Have a Scan for Skin Cancer? (WSJ)
  • Experts urge huge expansion of online therapy for mental illness (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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