Regulatory Focus™ > News Articles > 7 > Recon: AbbVie Reverses $140M AndroGel Verdict, Biogen-Eisai Alzheimer’s Drug Makes a Comeback

Recon: AbbVie Reverses $140M AndroGel Verdict, Biogen-Eisai Alzheimer’s Drug Makes a Comeback

Posted 06 July 2018 | By Ana Mulero 

Recon: AbbVie Reverses $140M AndroGel Verdict, Biogen-Eisai Alzheimer’s Drug Makes a Comeback

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

In Focus: US In Focus: International Pharmaceuticals & Biotechnology
  • Hitting cancer early: AstraZeneca's bid to outmaneuver rivals (Reuters)
  • Drug Development For Neglected Diseases Has Stagnated (Forbes)
  • Amazon undercuts drugstores on prices for most over-the-counter drugs (CNBC)
  • Baxter, Hospira Freed From Saline Price-Fixing Case For Now (Law360-$)
  • In shadow of Shire sale, Takeda's TiGenix takeover nears completion (The Pharma Letter-$)
  • After breathing new life into old mice, senescence startup Cleara bags cash to move toward the clinic (Fierce) (Press)
  • Bill signed allows women year supply of birth control pills (AP News)
  • Opioid stigma is keeping many cancer patients from getting the pain control they need (STAT)
  • In the age of mail-order DNA, a firm seeks to increase safety without slowing progress (STAT-$)
  • Cash-rich Cambridge startup Rubius to build $155M cell therapy manufacturing site in Rhode Island (Endpoints)
  • Is Gilead Poised for a Comeback? (BioSpace)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • Siga Technologies touts pivotal data for oral smallpox therapy (DDBN)
  • One step closer to personalized treatments for bladder cancer (Fierce)
  • Arming antibiotics with a vaccination-like immune response (Fierce)
  • A case study in the fast-rising threat of antibiotic resistance (STAT-$)
Medical Devices
  • Putting AI and cloud computing to work automating hardware maintenance (Healthcare IT News)
  • FDA green-lights 14 digital health products, continues to evolve regulations (MobiHealthNews)
  • VA facilities across Ohio lost $1 million worth of medical equipment (10TV)
  • Fireworks among the small and mid-cap device makers (EP Vantage)
  • Drug-coated balloon developer Urotronic raises $6m (DDBN)
  • StratoScientific raises $12m for smartphone stethoscope (MassDevice)
  • Intuitive Surgical wins FDA nod for 60mm stapler (MassDevice)
  • Association of the US Department of Justice Investigation of Implantable Cardioverter-Defibrillators and Devices Not Meeting the Medicare National Coverage Determination, 2007-2015 (JAMA)
  • FDA Clears The Way: Lipogems' Receives FDA Clearance For Microfragmented Adipose Tissue System Utilizing Body's Own Fat To Support Tissue Repair In Orthopaedic And Arthroscopic Surgeries (Press)
US: Assorted & Government
  • FDA announces revised guidance on the testing of donated blood and blood components for Zika virus (FDA)
  • Supporting the Next Generation of Biomedical Researchers (JAMA)
  • Big Data and Predictive Analytics: Recalibrating Expectations (JAMA)
  • To Bring Health Information Privacy Into The 21st Century, Look Beyond HIPAA (Health Affairs)
  • U.S. pushes back on global declaration for TB drugs, a move advocacy groups say will restrict access (STAT-$)
  • California to Pharmacies: Start Balancing your Opioid Checkbook (FDA Law Blog)
  • Troublesome News: Numbers Of Uninsured On The Rise (Forbes)
Upcoming Meetings & Events Europe
  • Brexit uncertainty leacescompanies ‘having to prepare for every scenario’, says BIA (BioPharma-Reporter)
  • EHR Vendor Mistake Impacts 150,000 U.K. Patients (GovInfoSecurity)
  • Orion takes repurposed heart failure drug into phase 3 for ALS (Fierce)
  • PathoFinder Granted CE Mark For Combined Trichomonas Vaginalis, Mycoplasma Genitalium, Azithromycin-Resistance PCR Test (GenomeWeb)
Asia India
  • NPPA has fixed/revised ceiling prices/retail prices of 58 formulations under Drugs (Prices Control) Order, 2013 in related Notification /order dated 04.07.2018. (NPPA)
  • Bihar drug makers heave sigh of relief as HC quashes ban on levofloxacin, ofloxacin formulations for paediatric use (Pharmabiz)
  • Tamil Nadu to come up with new pharma policy; industry welcomes move (Business Standard)
  • A shot of confidence for Indian pharma, its regulator (Hindu Business Line)
  • India may formulate standards for pharma industry’s antibiotic residue (Hindustan Times)
Australia
  • Profits before Patients – Insurer’s claims hide a deeper agenda (MTAA)
  • Submissions received: Options for the implementation of a claimer for efficacy assessed non-prescription medicines (TGA)
  • TGA presentation: National Medicines Symposium, 30 May 2018 (TGA)
Canada
  • Notice: Prescription Drug List: Multiple additions (Health Canada)
General Health & Other Interesting Articles
  • Air pollution may account for 1 in 7 new diabetes cases (Reuters)
  • The Health 202: 'Gag clauses' mean you might be paying more for prescription drugs than you need to (The Washington Post)
  • Listen to ‘The Daily’: How the Opioid Crisis Started (NYT)
  • New approach to breast cancer screening — tailoring guidelines for each patient — may save lives and money, study says (STAT)
  • He Went In for a Heart Transplant. He Suffered Severe Brain Damage. Now His Family Is Suing St. Luke’s. (ProPublica)
  • How Holograms Are Helping Medical Training (WSJ)
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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