Regulatory Recon: FDA Rejects Drug Over Manufacturing Issues; Advisory Panel Backs Pfizer’s Mylotarg (12 July 2017)

Posted 12 July 2017 By Zachary Brennan

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

In Focus: US

  • FDA again rejects Ocular drug over manufacturing failings (Stat) (Fierce)
  • Years after accelerated approval debacle, FDA panel backs Pfizer's Mylotarg (Fierce) (Pharmaphorum) (Press)
  • One FDA About Face Doesn’t Mean an Orphan-Drug Bonanza (Bloomberg)
  • FDA Deal Would Relax Rules on Reporting Medical Device Problems (NY Times-$) (E&C)
  • FDA Struggles with Sizing Up Abuse-Deterrent Opioids (MedPage Today)
  • The price dilemma over a $16,000 drug (Wall Street Journal-$)
  • A prescription for cancer diagnostics (Nature Medicine)
  • Mallinckrodt Agrees to Pay Record $35 Million Settlement for Failure to Report Suspicious Orders of Pharmaceutical Drugs and for Recordkeeping Violations (Department of Justice)
  • Is The 510(k) Process As Worthless As The Federal Courts Seem to Believe? (FDA Law Blog)
  • Examining HRSA’s Oversight of the 340B Drug Pricing Program (Energy and Commerce)
  • Paying Professors: Inside Google’s Academic Influence Campaign (WSJ-$)
  • UL 2900 Cybersecurity Standards Set for FDA Adoption (Emergo)
  • FDA Eases Notice Requirement on More Than 1,000 Medical Devices (BNA) (Focus)
  • FDA, PDUFA, And Patient Engagement — What Pharma Companies Need To Know (And Do) (Pharmaceutical Online)
  • The Effects of the Actavis Decision on Reverse Payment Settlement Agreements in ANDA cases -- Four Years After (Patent Docs)

In Focus: International

  • Dutch offer €250mn office for EU medicines agency (EU Observer)
  • Korea Oks first cell gene therapy Invossa (Korea Herald)
  • MHLW to Announce Data Required for Conditional Early Approval (Pharma Japan-$)
  • Stada takeover back in motion after revised bid (Pharmafile)
  • Medicure Buys US-Indian API Firm (InPharma-Tech)
  • Daiichi Sankyo halts Coherus development in Japan (BioPharma-Reporter)
  • India to set up joint pharma venture in Russia, Pharmexcil seeks suggestions from industry (PharmaBiz)
  • China program to vaccinate poultry against bird flu will be nationwide (Reuters)
  • 2.1 billion people lack safe drinking water at home, more than twice as many lack safe sanitation (WHO)

Pharmaceuticals & Biotechnology

  • Gilead HIV drug API sourcing suit reopened (InPharma-Tech)
  • The top 15 highest-paid biopharma executives (Fierce)
  • Erytech pens academic pact to advance rare disease drug (Fierce)
  • Bristol-Myers Squibb adds new fundraising options, celeb partners to 'Ready. Raise. Rise.' I-O push (Fierce)
  • One Man's Plan to Make Sure Gene Editing Doesn't Go Haywire (Atlantic)
  • FDA will review bid to extend label for Sprycel in chronic myeloid leukemia (PharmaLetter-$)
  • The Booming 340B Contract Pharmacy Profits of Walgreens, CVS, Rite Aid, and Walmart (Drug Channels)
  • Forget the science. These investors think they can pick biotech winners by algorithm (Stat)
  • Working through mounting issues, Galena cuts staff, seeks ‘alternatives’ (Fierce)
  • Ex-Insys Sales Reps Plead Guilty In Opioid Kickback Scheme (Law360-$)
  • In wake of Opana ER's demise, FDA plans to intensify pharma's opioid-education job (Fierce)
  • Erytech, Queen's Partner to Develop Red Blood Cell-Encapsulated Enzyme Therapy (GEN)

Pharmaceuticals and Biotechnology: Clinical Study Results, Filings & Designations

  • Multidisciplinary approach to AMR research invaluable in developing genome database (MRC UK)
  • Big Pharma-backed E-Scape Bio hits $63M in extended series A (Fierce)
  • Final Phase III study results reinforce safety and efficacy of Praxbind (PharmaLetter-$)

Medical Devices

  • Demands for Simpler, More Streamlined Mass Spec Provide Opening for Miniaturized Devices (GenomeWeb-$)
  • Z-Medica wins FDA de novo nod for QuickClot Control+ (Mass Device)

US: Assorted & Government

  • Sessions to Unveil Health-Care Fraud Crackdown This Week, Sources Say (Bloomberg)
  • Senate Republicans push forward with repeal effort (Politico)
  • FDA Form 483 for Zhejiang Bangli Medical Products Co. (FDA)
  • Withdrawal of Approval of a New Animal Drug Application (FDA)

Upcoming Meetings & Events

Europe

  • GLP Principles in relation to ATMPs (EMA)
  • Ustekinumab for moderately to severely active Crohn’s disease after previous treatment (NICE)

General Health & Other Interesting Articles

  • Iranian Researcher Set To Work At Boston Children's Hospital Is Sent Back To His Country (WBUR)
  • On malaria, rhetoric must meet reality (The Hindu)

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.

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