Regulatory Recon: Bayer Halts Non-US Sales of Essure; FDA Approves GSK's Triple Drug COPD Inhaler (19 September 2017)

Posted 19 September 2017 By Michael Mezher

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

In Focus: US

  • Cancer Group Urges Precision Medicine Standards, FDA Flexibility (Bloomberg)
  • FDA approves GSK's three-in-one drug inhaler for COPD (Reuters 1, 2) (PharmaTimes) (Press)
  • Catalent to Acquire Cook Pharmica for $950M (GEN) (Endpoints)
  • Highlighting a major shift at the FDA, regulators put Amicus' once-spurned drug on fast track (Endpoints)
  • Remicade: A Case Study in How U.S. Pricing and Reimbursement Curb Adoption of Biosimilars (Drug Channels)
  • Drug Industry Denied Fast Relief in Nevada Price Law Challenge (Bloomberg)
  • White House backs pharma partnership after delaying other opioid panel proposals (Politico) (AP)
  • Unbudgeted: How the opioid crisis is blowing a hole in small-town America's finances (Reuters)
  • Glaxo loses bid for a new trial in an unusual Paxil suicide case (STAT)
  • Biosimilar cancer drug threat closing in for Roche (Reuters)
  • AbbVie/Roche's venetoclax hits goals in CLL trial (PharmaTimes) (Press)
  • The last-ditch Obamacare repeal bill is gaining steam (Politico)
  • The Latest Health Care Repeal Plan Would Give States Sweeping Discretion (NYTimes)
  • Obamacare repeal plan won't get full CBO analysis by key deadline (Politico) (The Hill)

Sponsored Content: IVDR/MDR Challenges Top Roadshow Agenda

  • BSI's 6th Annual, full-day medical device Roadshow will guide participants to new EU Medical Device/In-Vitro Device Regulation compliance. The program examines key issues facing Med Dev Manufacturers under the new MDR/IVDR starting with an overview, then analyzing legacy products and transitional provisions. Implementation issues including conformity assessments, essential/clinical requirements, SPR, labeling and QMS impacts of these standards will be detailed.
  • Check here for specific dates, locations and the program agenda.

In Focus: International

  • Bayer halts non-US sales of its contraceptive implant (Reuters)
  • South Korean MFDS Revises Recently Enacted Medical Device Regulations (Emergo)
  • WHO launches new NCDs Progress Monitor (WHO)
  • WHO plans global war on cholera as Yemen caseload nears 700,000 (Reuters)
  • The Problem With Free Menstrual Pads (NPR)
  • US AIDS strategy to focus on 13 countries close to controlling epidemic (Reuters)
  • Bill and Melinda Gates Grade the World's Health (NYTimes)
  • Opioid boom in China as patients lose addiction fears (Financial Times)
  • What's Driving The Uptick In Korea-China Biotech Deals (SCRIP-$)
  • Boehringer Navigates 'Impractical' Nintedanib Surveillance Plan In India (Pink Sheet-$)

Pharmaceuticals & Biotechnology

  • CDER Succession: Woodcock's Responsibilities Mount With No Clear #2 In Sight (Pink Sheet-$)
  • Shame Letters from FDA- Will They Work? (Lachman Consultants)
  • FDA's ANDA Approval Rate Slows as Fiscal Year Nears End (FDA News-$)
  • FDA Extends Comment Period on Hatch-Waxman Meeting (FDA)
  • Characterizing Antibody-Secreting Cells One at a Time (Nature Trade Secrets)
  • Exposure to Direct-to-Consumer Pharmaceutical Advertising and Medication Nonadherence Among Patients With Serious Mental Illness (Psychiatric Service)
  • On CAR-T's Edge, Seattle Researchers Plot to Bypass Novartis Therapy (Xconomy)
  • How Bayer and Ginkgo Teamed Up in a $100M Synthetic Biology Bet (Xconomy)
  • 5 Trends shaping the pharma sales force (BioPharmaDive)
  • Smaller sales forces get the job done in rare disease (BioPharmaDive)
  • Infographic: Pharma sales force by the numbers (BioPharmaDive)
  • Sanofi and Amgen, eyeing boost for PCSK9 use, tout benefits for diabetes patients (Fierce)
  • HHS Says Almost All Drug Wholesalers Meet Supply Chain Product Tracing Rules (FDA News-$)
  • J&J, BARDA join forces to prep for pandemic flu, inking deal for vaccine and drug R&D (Fierce)
  • Let Drugmakers Create Their Own REMS to Foster Generics, Says CVS (FDA News-$)
  • Ex-GSK CEO, R&D chief Andrew Witty and Moncef Slaoui are jumping into the biotech VC game (Endpoints) (Fierce)
  • Aerie raids Alcon again, returning this time with an R&D VP (Fierce) (Press)
  • OncoMed chief Paul Hastings goes on medical leave (Endpoints)
  • No Clear Winner in BMS, Exelixis/Ipsen First-line Renal Cancer Race (SCRIP-$)
  • Atlas ramps up a new biotech player focused on neurology, with a $30M round to fund the work (Endpoints)
  • Acceleron takes back drug rights from Celgene to start pulmonary push (Fierce)
  • Teva and Nuvelution Pharma Partner to Accelerate Development of Austedo (deutetrabenazine) Tablets for Use in Tourette Syndrome in the United States (Press)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • FDA Approves Secnidazole (Solosec) for Bacterial Vaginosis (MedScape) (Medpage)
  • Janssen's guselkumab shows long-term benefit in psoriasis (PharmaTimes)
  • MyoKardia Unveils More Phase 2 Data on Heart Disease Treatment (The Street)
  • Optinose Announces FDA Approval of XHANCE™ (fluticasone propionate) Nasal Spray for the Treatment of Nasal Polyps (Press)
  • Amylyx Pharmaceuticals Receives FDA Orphan Drug Designation for AMX0035 for the Treatment of Amyotrophic Lateral Sclerosis (Press)
  • Cycle Pharmaceuticals Receives FDA Approval and Launches Ketorolac Tromethamine Injection 30mg/mL in the U.S. (Press)

Medical Devices

  • Another extension for Abbott's tender for Alere (MassDevice)
  • Claret Medical touts Sentinel data in TAVR study (MassDevice)
  • Medtronic gets FDA clearance for pain management implant that interfaces with Samsung tablet (MobiHealthNews)
  • Boston Scientific touts 3-year Alair follow-up study results (MassDevice)
  • SurModics wins FDA, CE Mark for low-profile PTA balloon dilation cath (MassDevice)
  • Report: DePuy's Attune knee seeing "unusually high" rate of early failure (MassDevice)
  • Masimo wins FDA nod for Rad-97 pulse oximeter, launches in US (MassDevice)

US: Assorted & Government

  • OIG to take a look at fed's cybersecurity preparedness (Fierce)
  • Attorneys General in 37 States Urge Insurance Industry to Do More to Curb Opioid Epidemic (ProPublica)
  • Court Sides With FTC in Pay-For-Delay Suit, Says AbbVie Patent Suits Were Baseless (FDA News-$)
  • Hospira Tells Jury Biosimilar Was Covered By Safe Harbor (Law360-$)
  • Checking Out the B-Side (Drug & Device Law)

Upcoming Meetings & Events

  • FDA Advisory Committee Calendar
  • EMA: Workshop on the reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development – 3-4 May 2018
  • European Medicines Agency information day on measuring the impact of pharmacovigilance activities – 14 November 2017

Europe

  • Zydus and Pharm Aid Ltd. enter into an exclusive agreement for vaccine technology in Russia (Economic Times)
  • Shuwen Biotech Gets CE-IVD Mark for EGFR Mutation Kit (GenomeWeb)
  • Tetracore Gets CE-IVD Mark for RT-PCR Thermocycler (GenomeWeb)

Asia

India

  • Price caps hurting healthcare industry, says Preetha Reddy (Economic Times)
  • Maha FDA awaits funds to establish NPPA cell to monitor ceiling price violation (PharmaBiz)

Canada

  • Canada has a 'big blind spot' on medical device safety: study (CTV)

Australia

  • Australia Sees Decline In Generic Filings, Rise in Extensions And ADR Reports (Pink Sheet-$)
  • TGA updates GMP Clearance Guidance (TGA)
  • AU eCTD Module 1 and regional information: update to the specification (TGA)
  • TGA presentations: 2017 Pharmaceutical Society of Australia Conference (PSA17), 30 July 2017 (TGA

General Health & Other Interesting Articles

  • Smokers with HIV face higher risk from lung cancer than from AIDS (Reuters)
  • Prospect of Synthetic Embryos Sparks New Bioethics Debate (MIT Technology Review)

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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