Regulatory Recon: J&J to Acquire Actelion in $30B Deal European Commission Clears Abbott-Alere Merger (26 January 2017)

Posted 26 January 2017 | By Michael Mezher 

Regulatory Recon: J&J to Acquire Actelion in $30B Deal European Commission Clears Abbott-Alere Merger (26 January 2017)

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

In Focus: US

  • Johnson & Johnson Bolsters Drug Roster With $30 Billion Actelion Deal (NYTimes) (Reuters) (WSJ) (The Street)
  • J&J Outlines Pricing Transparency Plan, Will Others Follow? (Pink Sheet-$)
  • Zika Vaccine Makers, 21st Century Cures Task Force Hit By Regulatory Freeze (Pink Sheet-$)
  • Orphan Drug Approvals and Designations Dipped in 2016, But Orphan Drug Designation Requests Skyrocketed (FDA Law Blog)
  • Meet Trump's would-be health czar: A billionaire with a brash vision, a bodyguard — and a divisive record (STAT)
  • Price primed for committee vote (Politico)
  • Doctors Urge Fed. Circ. To Keep Cholesterol Drug On Market (Law360-$)
  • Will Evidence Matter in 2017? (Health Affairs Blog)
  • Eli Lilly Is a Biologics Company (In The Pipeline)
  • Gene-edited cells keep cancer babies well more than one year on (Reuters) (MIT Technology Review)
  • Republican retreat will focus on Obamacare (Politico)
  • Possible liver injury added to label of Biogen MS drug (Reuters)
  • 21st Century Cures: Shifting the Balance of Negotiating Power (Focus)
  • FDA Warns UK Drugmaker for Repeat GMP Violations (Focus)
  • FDA Staff Shortages May Get Worse With Trump's Federal Hiring Freeze (Focus)
  • Why we should listen to Martin Shkreli (STAT)
  • US court issues injunction on assistance for dialysis patients (Reuters) (WSJ)
  • Biosimilar Guidances Could Be Left Out In Cold By White House Regulatory Freeze (Pink Sheet-$)
  • FDA Commissioner Candidate Gulfo Hates Breakthrough, Wants To Reevaluate User Fees (Pink Sheet-$)
  • Celgene scoops up freshman autoimmune startup Delinia in $775M buyout (Endpoints) (GEN) (Fierce) (Forbes) (Press)
  • Device Registry Tool Allows Early Safety Alerting (Medpage) (NEJM, Editorial)
  • McKesson acquiring CoverMyMeds for at least $1.1 billion (MedCityNews) (Reuters) (Press)
  • Drug company to help improve Virginia's prescription drug monitoring system (Washington Post) (Press)
  • FDA Bans Imports of Piston Syringes From Nipro's Thailand Site (Focus)

In Focus: International

  • EU anti-trust regulators OK Abbott-Alere deal (MassDevice) (European Commission)
  • Health Programme - Annual work plan for 2017 (European Commission)
  • WHO seeks new leader to rebuild damaged reputation (Reuters) (The Lancet)
  • WHO Announces Three Nominees for Director General (WHO)
  • W.H.O. Warns of Worrisome Bird Flu in China (NYTimes)
  • Sanctioned UK Trial of Mitochondrial Transfer Nears (JAMA)
  • 'Give Us More On Warning On Publishing Our Clinical Data,' Industry Implores EMA (Pink Sheet-$)          
  • In Pakistan, 'informal' clinical trials raise ethics concerns (BioWorld)
  • Limiting Antibiotics Curbs Deadly Hospital Infections (NYTimes) (The Lancet)
  • Cancer, hepatitis treatments set for boost as China overhauls drugs list (Reuters)
  • US chemical industry body calls for reform of WHO cancer agency (Reuters)
  • Lundbeck bets on shark antibodies for new brain drugs (Reuters) (Financial Times)
  • Report: Siemens to tap banks for Healthineers listing (MassDevice)
  • NHS Cancer Vanguard partners with Amgen, Sandoz (PharmaTimes)
  • NPPA Cuts Prices of Essential Medicines by 30-50% (Economic Times)
  • Final yes from NICE for Gilead's Epclusa (PharmaTimes)
  • Sanofi and Nordic Bioscience deals 'validate' oral delivery tech, Enteris (InPharmaTechnologist)
  • CFDA releases clinical trial guidance (BioCentury)

US: Pharmaceuticals & Biotechnology

  • Regeneron agrees ownership of HQ for $720m after 25 years (Pharmafile)
  • Placebo Beats Supplements for Arthritis Pain (NYTimes)
  • Nearly half of breast cancer patients have severe treatment side effects (Reuters)
  • What Precisely Is Precision Oncology—and Will It Work? (ASCO)
  • Patient requests buoy oral meds from Biogen, Novartis in crowded MS market (Fierce)
  • Biogen Reports 2016 Revenues of $11.4 Billion (Press)
  • Immunomedics Sale Hinges on Proxy Battle Over Fate of Controversial Founder (The Street)
  • Bristol-Myers Squibb Reports Fourth Quarter and Full Year 2016 Financial Results (Press)
  • Celgene Reports Fourth Quarter and Full-Year 2016 Operating and Financial Results (Press)

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

  • Pfizer Announces Positive Top-Line Results from Phase 2 Study of Investigational Clostridium difficile Vaccine for the Prevention of C. difficile Infection (Press)
  • Eisai's Lenvima passes Phase III HCC test (BioCentury) (Press)
  • Vectura wins IND for drug-device combo for pediatric asthma (Drug Delivery)
  • Latest Cellectis UCART19 data show ongoing efficacy (BioCentury) (Fierce) (Science Translational Medicine) (Endpoints)
  • US pediatric exclusivity for Symbicort (PharmaLetter-$)
  • AbbVie Initiates Phase 2 Clinical Trial Programs for ABBV-8E12, an Investigational Anti-Tau Antibody, in Early Alzheimer's Disease and Progressive Supranuclear Palsy (Press) (PMLive)
  • U.S. Food and Drug Administration Approves 72 mcg Dose of LINZESS® (linaclotide) for Adults with Chronic Idiopathic Constipation (Press)
  • X4 Pharmaceuticals Announces Initiation of Clinical Study of X4P-001 in Combination with Opdivo for Patients with Advanced Clear Cell Renal Cell Carcinoma (Press)

US: Medical Devices

  • Gramercy Extremity Orthopedics Receives FDA 510(k) Clearance for GEO™ Bone Screw System (Press)
  • Medtronic Receives IDE Approval to Initiate Study of IN.PACT® Admiral® Drug-Coated Balloon for a New Indication in Patients with End-Stage Renal Disease (Press)
  • PQ Bypass study meets safety, efficacy endpoints (MassDevice)
  • Abbott releases swath of BurstDR neuromod study data (MassDevice)

US: Assorted & Government

  • Scientists March On Washington Being Planned (Forbes)
  • Massachusetts Governor Pitches Health-Insurance Penalty for Employers (WSJ)

Upcoming Meetings & Events


  • Veterinary medicines: highlights of 2016 (EMA)
  • Building A 21st Century Regulatory Environment For Better Patient Access To Medicines (Medicines for Europe)
  • EU names star panel of innovation advisors (ScienceBusiness)
  • Call for Expression of Interest Multi HTA Early Dialogues – Pharmaceuticals *EUnetHTA)
  • UK Child health 'in jeopardy' because of inequalities, warns report (PharmaTimes)
  • Endologix wins CE Mark reinstatement for AFX, AFX2, touts 3-year post market Ovation study (MassDevice)
  • Jardiance® (empagliflozin) becomes first type 2 diabetes medicine in the EU to include cardiovascular death reduction data in label (Press)
  • Neural Analytics wins CE Mark for next-gen Lucid transcranial ultrasound (MassDevice)


  • 'Donald Trump's push for lower drug prices to benefit Indian pharma' (Economic Times)

General Health & Other Interesting Articles

  • World's foremost institute on death and disease metrics gets massive cash boost (Nature)
  • Neuroscience: Big brain, big data (Nature)

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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