Regulatory Recon: CVS Makes $66B Bid for Aetna Endo Sues FDA Over Compounding Rules (27 October 2017)

Posted 27 October 2017 | By Michael Mezher 

Regulatory Recon: CVS Makes $66B Bid for Aetna Endo Sues FDA Over Compounding Rules (27 October 2017)

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

In Focus: US

  • FDA hires top Mylan executive: report (The Hill)
  • CVS makes more than $66 billion bid for Aetna: sources (Reuters) (WSJ) (Financial Times)
  • Endo International units sue FDA over drug compounding policy (Reuters)
  • Trump declares opioids a US public health emergency (Reuters) (NPR) (FDA)
  • Words, Not Action, From Mr. Trump on Opioids (NYTimes)
  • What Trump's opioid announcement means -- and doesn't mean (CNN) (STAT) (AP)
  • Billionaire Insys founder charged in US opioid bribe case (Reuters) (DOJ)
  • Amazon Said to Have Obtained Wholesale Pharmacy Licenses In at Least 12 States (The Street) (Reuters) (Financial Times)
  • In a switch, Merck CEO signals he's in a deal-making frame of mind (Endpoints)
  • AbbVie says Humira sales will balloon to $21 billion in 2020, shares rise (Reuters) (Endpoints) (Financial Times)
  • Shire earnings beat estimates with 20% profit climb (Financial Times)
  • Seattle Genetics Reports Third Quarter 2017 Financial Results (Press)
  • Gilead 3rd-quarter profit falls, but beats Wall Street estimates (Reuters) (Endpoints) (STAT) (Fierce) (Press)
  • When Silver Costs More Than Gold: How Trump's Actions Have Scrambled Insurance Prices (NYTimes)

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In Focus: International

  • China announces plans to fast-track drug approval (Nature)
  • How Europe Plans to Address Orphaned Medical Device Manufactures and NB De-notification (Emergo)
  • UK: North Korea was behind the WannaCry cyber-attack that crippled health service (CNBC) (Pharmafile)
  • Global measles deaths fall, but elimination goals far off (Reuters)
  • PRAC recommends further restrictions for multiple sclerosis medicine Zinbryta due to risk of serious liver damage (EMA)
  • Review of flupirtine-containing medicines started (EMA)
  • EMA starts new review of hydroxyethyl-starch containing medicines (EMA)
  • Meeting highlights from the Pharmacovigilance Risk Assessment Committee (EMA)
  • China Resources Planning China Pharma Fund (BioCentury)
  • Lloyds Pharmacy closes 190 stores, blaming government cuts (The Guardian)
  • Companies Should Market All Centrally Approved Medicines In All EU Markets, Says The Netherlands (Pink Sheet-$)

Pharmaceuticals & Biotechnology

  • The fantastic voyage of a bag of cells shipped west to be trained in the art of cancer killing (STAT)
  • Narcan available at more than 8,000 Walgreens locations nationwide (CBS)
  • CAR-T Indication-Based Pricing May Be Evaluated In Medicare Demo (Pink Sheet-$)
  • Gilead Says 16 Cancer Centers Getting Ready To Administer Yescarta (SCRIP-$)
  • Biotech Peer Review: Magenta onboards five new VPs; BioInvent is hunting for a new CEO (Endpoints)
  • Drug discovery effectiveness from the standpoint of therapeutic mechanisms and indications (Nature)
  • Trends in GPCR drug discovery: new agents, targets and indications (Nature)
  • Tocagen's new gene therapy offers a flicker of hope for aggressive brain cancer (STAT) (Fierce)
  • NIH study identifies new targets for anti-malaria drugs (NIH)
  • Scientists find a role for Parkinson's gene in the brain (NIH)
  • New analysis backs benefit-risk profile of Merck's Mavenclad (PharmaTImes)
  • Shire's HAE drug Firazyr cleared for children (PharmaTimes)
  • PDL goes public with hostile bid to buy Neos (Fierce)
  • Integrating disposable tech? Size matters, says BMS (BioPharmaReporter)
  • Lonza maintains 2017 target and says US plant and Capsugel integration on track (InPharmaTechnologist)
  • New NARMS Report Shows Mixed Results on Antibiotic Resistance (National Law Review) (FDA)
  • Determination That CARDENE SR (Nicardipine HCl) Extended-Release Capsules, 30 Milligrams, 45 Milligrams, and 60 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness (FDA)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • With 'breakthrough' status and a handy nickname, BioMarin plots speedy PhIII for gene therapy (Endpoints)
  • New OCREVUS (ocrelizumab) data at ECTRIMS advance clinical understanding of underlying progression in multiple sclerosis (Press)
  • Kyowa Hakko Kirin Announces Marketing Authorisation Application for Mogamulizumab Validated by European Medicines Agency (Press)
  • Lin BioScience Receives US FDA Orphan Drug Status for LBS-008 for the Treatment of Stargardt Disease (Press)
  • CureVac Initiates Phase I Clinical Trial of RNAdjuvant® Candidate as Intratumoral Therapy for Solid Tumors (Press)
  • Efficacy and Safety Results from First Phase III Trial of Oral Ozanimod (SUNBEAM™) Versus an Active Comparator in Relapsing Multiple Sclerosis Presented at MSParis2017 – 7th Joint ECTRIMS – ACTRIMS Meeting (Press)
  • Otsuka to Host Web Briefing on Tolvaptan Phase 3 Trial Results in Polycystic Kidney Disease (Press)

Medical Devices

US: Assorted & Government

  • A Talcum Powder Tort Blowout (WSJ)
  • DC District Court Says FDA's Rescission of a Mistaken ANDA Approval (and Placement Back Into the Review Queue) is Not Final Agency Action (FDA Law Blog)
  • Three Strikes And . . . You Get Another Chance? (Drug & Device Law)
  • Even with Obamacare, childhood cancer survivors may face high costs (Reuters)
  • Parent Company Escapes Suboxone Product-Hop Suit (Law360-$)
  • Fed. Circ. Affirms Obviousness Of Merck Antibiotic Patent (Law360-$)

Upcoming Meetings & Events


  • Record low for sales of antibiotics for use in animals (GOV.UK)
  • Medinol wins CE Mark for EluNir drug-eluting coronary stent system (MassDevice)


  • FiercePharmaAsia—Dr. Reddy's drug recall, China's Ebola vaccine, Bharat Biotech's typhoid vaccine (Fierce)


  • Cipla gets USFDA nod for generic version of Renvela tablets (Economic Times)
  • United States Food and Drug Administration (USFDA) - BioResearch Monitoring Program (BIMO) Conducted 2 Inspections at Veeda CR – Ahmedabad (Press)


  • TGA presentations: Devices Sponsor Information Day, 11 October 2017 (TGA)

General Health & Other Interesting Articles

  • Some GI disorders get disproportionate share of US research funding (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

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

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