Recon: Sales of Essure birth control implant halted by Bayer


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Posted 20 July 2018 | By Ana Mulero 

Recon: Sales of Essure birth control implant halted by Bayer

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

In Focus: US

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In Focus: International

  • Swiss, German drugmakers join U.S. price freeze (Reuters) (Endpoints)
  • Fearing ‘No Deal’ Brexit, E.U. Shifts Into High Gear to Keep Goods Flowing (NYT) (Reuters)
  • India launches probe as Chinese company recalls BP drug (Economic Times)
  • AZ suffers setback as NICE slaps restrictions on Fasenra (pharmaphorum) (Fierce)
  • Australia-led global push to tackle PCOS — the principal cause of infertility in women (Science Daily) (ABC News)

Pharmaceuticals & Biotechnology

  • Roche Hiked Cancer-Drug Prices Before Pledge to Keep Them Flat (Bloomberg)
  • Drug Firms Blame Opioid Crisis on Illicit Websites, Dealers (Bloomberg)
  • Trump meets with drug giant’s CEO as part of price squeeze (Politico)
  • Proposed US Patient Advocacy Bill Will Toughen Financial Reporting Obligations For Pharma (Forbes)
  • Spooked AbbVie investors are selling off shares—but do they need to be? (Fierce)
  • Doctors could prescribe drugs more accurately — if they could get the data (STAT)
  • On Jadedness (Science Translational Medicine)
  •  CBO’s Estimates of the Effects of Changes in the Manufacturers’ Discount in the Part D Coverage Gap (CBO)
  • BIO Applauds Advancement of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 (Press)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • Agios scores its second new drug approval, ivosidenib heads to the AML market (Endpoints)
  • Scientists explore a new kind of immunotherapy to treat autoimmune diseases (STAT-$)
  • Dr. Reddy’s Announces the Launch of Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg in the U.S. Market (Press)
  • FDA Grants Approval of TIBSOVO, the First Oral, Targeted Therapy for Adult Patients with Relapsed/Refractory Acute Myeloid Leukemia and an IDH1 Mutation (Press)
  • FDA Approves New Indications for ZOMACTON (somatropin) as Ferring Plans Launch of Needle-Free Delivery System (Press)
  • Genentech to Present New Data Demonstrating the Breadth and Depth of Its Alzheimer’s Program at the Upcoming Alzheimer’s Association International Conference (AAIC) (Press)

Medical Devices

  • Intuitive Surgical Beats Expectations, Driven By da Vinci System (Forbes)
  • Liquid Biopsy Controversy Rages On (Forbes)
  • Medical device company settles US case over false claims (San Francisco Chronicle)
  • Tendyne investors sue Abbott over $50m milestone (MassDevice)
  • Medtronic agrees to $43m deal to settle shareholder Infuse lawsuit (MassDevice)
  • Memory Foam for Vascular Treatment Receives FDA Clearance (NIH)
  • FDA grants Breakthrough Device Designation for Roche’s Elecsys cerebrospinal fluid (CSF) assays to support the improved diagnosis of Alzheimer’s disease (Press)
  • AVITA Medical Announces Expansion of Management Team to Support Planned U.S. Launch of RECELL Device (Press)

US: Assorted & Government

  • Rite Aid-Albertsons Comeback Hinges On Narrow Pharmacy Networks (Forbes)
  • We need to improve Medicare’s annual wellness visit to better detect early dementia (STAT)
  • Warren Questions Trump Administration on Ongoing Failures to Address Opioid Crisis (Sen. Elizabeth Warren)

Upcoming Meetings & Events

Europe

  • UK industry highlights code violations (The Pharma Letter)
  • Sobi signs $450M deal for rare disease drug emapalumab, boosting its inflammation, I/O pipeline (Endpoints)
  • UK drug advisors recommend rescheduling of medical cannabis (PharmaTimes)
  • NICE backs radionuclide therapy for some neuroendocrine tumours (PharmaTimes)
  • Companion Medical Announces CE Mark of InPen System (Press)
  • Updated: Conferences and events (MHRA)
  • Guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg) (EMA)
  • Annex to Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues (EMA)

Asia

India

  • Revisiting the ceiling price of Primary Knee implants and Revision Knee implants: Request for price data (NPPA)
  • Amazon Hurricane Heading Towards Indian Pharma? (Scrip-$)
  • E-commerce players brace for big battle over online pharma (Economic Times)

Australia

  • The last chance drug that gave Max a fresh shot at life (The Sydney Morning Herald)
  • Share your thoughts with us in the 2018 TGA surveys (TGA)
  • Australian Public Assessment Reports for prescription medicines (AusPARs) (TGA)

Canada

  • Register of Innovative Drugs (Health Canada)
  • Thornhill Medical Completes ‘Series A’ Financing Round Led by Shanghai Based Yonghua Investment Management Co., Ltd. (Press)

General Health & Other Interesting Articles

  • When medication is essential to mental health (The Outline)
  • A Health Insurer Tells Patients It Won’t Pay Their E.R. Bills, but Then Pays Them Anyway (NYT)
  • State Prisons and the Delivery of Hospital Care: How states set up and finance off-site care for incarcerated individuals (Pew)
  • ‘Diseases Of Despair’ Contribute To Declining U.S. Life Expectancy (Forbes)
  • The opportunity ‘is huge’: Why tech developers are trying to tackle mental health (STAT)

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? Email us at news@raps.org.

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

 


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