Regulatory Recon: Abbott, AbbVie Announce Billion Dollar Acquisitions New Bill Would Overhaul Opioid Approval Process (27 April 2016)

Posted 28 April 2016 | By Michael Mezher 

Regulatory Recon: Abbott, AbbVie Announce Billion Dollar Acquisitions New Bill Would Overhaul Opioid Approval Process (27 April 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

In Focus: US

  • Abbott to spend $19.3B to buy St. Jude Medical (Star Tribune) (MassDevice) (Press)
  • AbbVie to Buy Cancer Drugmaker Stemcentrx for $5.8 Billion (Bloomberg)
  • Pfizer to pay $784.6 million to resolve Wyeth false claims lawsuit (Reuters) (DoJ)
  • Rep. Maloney Introduces Bill to Revamp Opioid Approval Process at FDA (Congress)
  • GSK chief says pressure on US drug prices to rise (Financial Times-$)
  • GDUFA Reauthorization: GPhA and Catalent Make Specific Requests (Focus)
  • Sarepta Can Win Speedy FDA Drug Approval (The Street)
  • Opioid REMS: FDA Sees No Clear Verdict On Risk Management Program's Impact (Pink Sheet-$)
  • UBS Wealth Clients Invest $471 Million for Cancer-Drug Fund (Bloomberg) (Reuters)
  • Sanofi launches $9.3 billion fight for U.S. cancer firm Medivation (Reuters)
  • The quiet revolutionary: How the co-discovery of CRISPR explosively changed Emmanuelle Charpentier's life (Nature)
  • Arbitrary Pharmaceutical Price Gouging: Valeant Defends its Business Model (Focus) (WSJ-$) (Forbes)

In Focus: International                                                                                            

  • Ironwood's bargain might be a poisoned chalice (EP Vantage)
  • Is Allergan On The Prowl For New Deals? (Forbes)
  • Samsung BioLogics looking to tap IPO for as much as $2.6B this year (Fierce)
  • With more cash, we can eliminate malaria within our lifetime: ex-WHO official (Reuters)
  • Medical Device Regulations: Dark Clouds over Europe? (Emergo)
  • Involving general practitioners in regulatory decisions on medicines (EMA)
  • Shareholders urged to push for cheaper pneumonia drugs (The Guardian)
  • Sir Andrew Witty fuels GSK turnround hopes with results boost (Financial Times-$) (Pink Sheet-$)
  • Indian Government Appoints Panel To Restrict Import Of Refurbished Radiology Devices (SCRIP-$)
  • When Will Medtech Actually Have To Comply With New EU Regs? This May Surprise You (Clinica-$)

US: Pharmaceuticals & Biotechnology

  • What's The Big Deal About US Biosimilar Approval? (Law360-$)
  • Taking the Uncertainty out of Drug Development: Statistical Bootstrapping Method Using a Bias-Corrected Acceleration Approach for Highly Variable Dissolution Data (The 505(b)(2) Blog)
  • New Bill Would Establish Prize for Alzheimers Treatments (Congress)
  • Valeant's New CEO Joe Papa Will Make Over $500 Million If Stock Rockets To $270 By 2020 (Forbes)
  • The Patient Experience Will Define Clinical Trial Evolution (Geeks Talk Clinical)
  • Interview – Boehringer's new look aims to boost innovation (EP Vantage)
  • VP Biden Outlines Plans for 'Moonshot' at AACR (Medpage)
  • 'Moonshot' for Cancer: A Good Metaphor? (Medpage)
  • Well-managed warfarin still useful for stroke prevention (Pharmaceutical Journal-$)
  • McKinsey & Google: Pharma needs to seize social media opportunity (MedCityNews)
  • Partnerships leading the way for Biopharma's immuno-oncology pipeline (BioPharma-Reporter)
  • Why Big Pharma and small biotech need each other now (MedCityNews-$)
  • Pall: Bioprocessing's future is made of virtual reality (BioPharma-Reporter)
  • Dynavax slides after FDA extends review of Heplisav-B (BioCentury)
  • Oral Ixazomib, Lenalidomide, and Dexamethasone for Multiple Myeloma (NEJM)
  • Scientists teaching machines to make clinical trials more successful (MNT)
  • Nivolumab should be standard for head and neck cancer (Pharmaceutical Journal-$)
  • Mass. life science firms get $20M to create 1,300 jobs this year (Boston Business Journal)
  • Oncology PROs: Limited Use Due To Small Trials, Fast Drug Development (RPM Report-$)
  • How much does the chicken pox vaccine cost? Depends on where you live. (Vox)
  • Big Data Tamps Down HIV Outbreaks (IEEE Spectrum)
  • GSK VP: From HIV to oncology: widening access through flexible IP (EPR)
  • PTC Therapeutics appoints Tuyen Ong as chief medical officer (Pharmafile)
  • Acid-Reducing Drug Prescribing Still Common for Infants Despite Warnings (MPR)
  • MicroRNA Pathway Could Lead to New Avenues for Leukemia Treatment (DD&D)
  • Nanoparticles Hold Promise as Double-Edged Sword Against Genital Herpes (ICT)
  • Parasitic worms may hold key to cutting spread of HIV: researchers (Reuters)
  • UF researchers find ADHD drug does not heighten suicide risk despite FDA warning (MNT)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations

  • FDA accepts Opko's resubmitted Rayaldee NDA (BioCentury) (Press)
  • Celgene misses target despite Revlimid surge (PharmaPhorum)
  • Phase 3 Trial Results for First Oral Proteasome Inhibitor NINLARO (ixazomib) Published in The New England Journal of Medicine (Press)
  • Alkermes Announces Plan to Initiate Second Clinical Trial of ALKS 7119 Based on Preliminary Phase 1 Results (Press)
  • Arrowhead Pharmaceuticals Files for Regulatory Clearance to Begin Phase 1/2 Study of ARC-521 (Press)
  • Ocular TherapeutixTM Completes End-of-Phase 2 Review with FDA for OTX-TP (Sustained Release Travoprost) for Glaucoma and Ocular Hypertension (Press)
  • Semaglutide reduces the risk of major adverse cardiovascular events in trial (EPR)
  • Positive topline results from a Phase Ib study of BioChaperone Lispro (EPR)

US: Medical Devices

  • Vantage Point – Will medtech venture capital return to early-stage investments? (EP Vantage)
  • FDA Fails to Cite Its Own Human Factors Guidance (MDDI)
  • Edwards CEO: TAVR is a $5 Billion-Plus Opportunity (MDDI)
  • Dana Farber, Fitbit to study the impact of weight loss on breast cancer recurrence (mobihealthnews)
  • MillaporeSigma: increasing ease of use for single-use tech (BioPharma-Reporter)
  • FDA Biocompatibility Tips: Multiple Absorbability, Allergenicity Testing Methods To Choose From (Gray Sheet-$)
  • FDA Investigators Tell What They Look For When Inspecting Facilities – But Device Firms Won't Choke If They Adequately Prepare (Gray Sheet-$)
  • Medtronic Demonstrates Commitment to EVAR in Comparison Study of ENGAGE Global Registry and Landmark EVAR 1 Trial (Press)
  • Synergy, Watchman help Boston Scientific swing to Q1 black (MassDevice)

US: Assorted & Government

  • State Drug Price Cap Laws: How Do They Work? (Harvard Bill of Health)
  • Senate Bill Would Prevent Catastrophic Out of Pocket Spending for Seniors and People with Disabilities (Congress)
  • Tested Mettle: Vifor Fresenius Petitions FDA to Make a Decision on NCE Exclusivity for Iron-based Phosphate Binder VELPHORO (FDA Law Blog)
  • C.D. Cal. Dismisses Infusion Pump Complaint (Drug and Device Law)
  • Medtech Patent Position Might Be Shakier As Supreme Court Seems To Favor IPR Standard (Gray Sheet-$)
  • Democrats Increasingly Want Expansion Of Health Law, Poll Finds (KHN)
  • Ryan wants to end Obamacare cost protections for sick consumers (Reuters)

Upcoming Meetings & Events


  • Cash-Strapped MHRA Looks to Stay Flexible (Focus)
  • Servier's Lonsurf approved in Europe for colorectal cancer (PharmaTimes)
  • 10 Years of Biosimilar Medicines in Europe: Transforming Healthcare (Biosimilar News)
  • Lynparzatm (olaparib) now available to NHS patients in England and Wales with BRCA-mutated ovarian cancer (MNT)
  • Lonza to invest in existing mammalian cell culture facilities after strong Q1 (Outsourcing-Pharma)
  • Diabetes drug test results boost Novo Nordisk (Reuters)
  • UK doctors urge wide promotion of e-cigs to help smokers quit (Reuters)


  • Korean President rolls out plans to beef up biotech sector (BioSpectrum)
  • Announcement: Date of the 21th AHWP Annual Meeting & Capacity Traning in Philippines (AHWP)
  • China Fast-Tracks Multiple HCV Drugs With Access In Mind (PharmasiaNews-$)
  • Japan Policy Threats Worry Lilly (PharmasiaNews-$)
  • Bespoke catering offers a shot in the arm for Indonesian diabetics (Reuters)
  • Wuxi sets up drug supplier network to ease pharma sourcing (Outsourcing-Pharma)
  • Newborn disease outbreaks push South Korea to stiffen care center oversight (Reuters)


  • Strides Shasun to Acquire Controlling Stake in Universal Corporation, Kenya (24 Insight)
  • India on USTR's Priority Watch List for the 21st Straight Year (24 Insight)
  • Biocon, Mylan likely to appeal Delhi HC ruling on Roche's cancer drug trastuzumab (Economic Times)


  • Reasons for scheduling delegate's final decisions - NCEs (Medicines) - April 2016 (TGA)



  • Democrats Renew Call for $1.9 Billion to Fight Zika (Focus)
  • House Speaker Ryan: All options open on Zika funding (Reuters)

General Health & Other Interesting Articles

  • Everyday stressors tied to sperm damage (Reuters)
  • Women less likely than men to get cardiac rehab (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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