Regulatory Focus™ > News Articles > Regulatory Recon: Pfizer and Allergan Abandon Merger, First mAb Biosimilar Approved for US Market (6

Regulatory Recon: Pfizer and Allergan Abandon Merger, First mAb Biosimilar Approved for US Market (6 April 2016)

Posted 06 April 2016 | By Michael Mezher 

Regulatory Recon: Pfizer and Allergan Abandon Merger, First mAb Biosimilar Approved for US Market (6 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

  • Pfizer and Allergan abandon $160bn deal after US tax crackdown (Financial Times) (The Guardian) (Fobes) (WSJ-$) (Reuters 1, 2) (The Atlantic) (Press)
  • FDA Approves Second Biosimilar, First mAb Biosimilar for US Market (Focus) (Reuters) (WSJ-$) (SCRIP-$) (Press)
  • Cybersecurity Researcher: Recent Device Vulnerabilities Should Be a Wake-Up Call for FDA  (Focus)
  • Insulin cost in U.S. more than doubles between 2002-2013 (Reuters) (MedCityNews)
  • Supply chain fraud continues to plague companies, poll says (Outsourcing Pharma)
  • Valeant Finishes Accounting and Philidor Review With No More Problems (WSJ) (Forbes)
  • White House will dip into Ebola funding to fight Zika, possibly ending impasse (STAT) (AP)
  • Divisive CEO of Google's biotech startup turns on the charm (STAT)
  • FDA Collaborates With FTC on Mobile Health App Regulatory Tool (Focus) (FTC)
  • US Gov: Critical need for reproducible regenerative med manufacturing  (BioPharma-Reporter)
  • To Fight Antimicrobial Resistance, Allow FDA To Approve New Drugs For Limited Populations (Health Affairs Blog)

In Focus: International

  • J&J Makes Renewed Push Into Africa (WSJ)
  • Frozen yoghurt at EU congress lands Mylan in hot water (PharmaPhorum) (PMCPA)
  • Diabetes rose fourfold over last 25 years, WHO says (STAT) (Reuters)
  • GSK to Launch Free Healthcare Plan for Employees in India on World Health Day (Economic Times)
  •  Asia Regulatory Roundup: China Looks to Protect Clinical Data Integrity (Focus)
  • Ethiopia launches drive to boost drug production (PharmaLetter-$)

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US: Pharmaceuticals & Biotechnology

  • JAMA Forum: We Can't All Have It All: The Economic Limits of Pharmaceutical Innovation (JAMA)
  • FDA Drug Safety Communication: FDA adds warnings about heart failure risk to labels of type 2 diabetes medicines containing saxagliptin and alogliptin (FDA) (Focus)
  • Raising Capital As A Private Biotech: Insights From Unum Therapeutics' Series B Round (LifeSciVC)
  • Gay men follow HIV prevention regimen, if MDs prescribe it (Reuters)
  • Despite similar approval numbers, the USA continues to outpace Europe (PharmaLetter-$)
  • Merck CEO Ken Frazier Is Looking Smart For Avoiding  (Forbes)
  • More or Less – FDA Press Releases 1st Quarter 2016 (Eye on FDA)
  • Risk of Bias in Systematic Reviews of Non-Randomized Studies of Adverse Cardiovascular Effects of Thiazolidinediones and Cyclooxygenase-2 Inhibitors: Application of a New Cochrane Risk of Bias Tool (PLOS)
  • Update on Biosimilars US Regulation 1st Quarter 2016 (Policy and Medicine)
  • FDA Vs. The Three-Second Rule (PRM Report-$)
  • Continuum Labs LGD-4033 by Invisiblu International: Recall - Investigational Drug Not Approved for Use (FDA)
  • Visual Podcast: FDA/Xavier Joint Initiative Aims To Help Device Firms Predict Quality Metrics (Gray Sheet-$)
  • Visual Podcast: Applying Risk Concepts To Supply Chains And Product Lines Can Be A Snap, Expert Says (Gray Sheet-$)
  • As U.S. Pharmacy Sales Slow, Walgreens Says Rite Aid Deal On Track (Forbes)
  • Huge opportunities for premium-priced TKIs in PAH (BioSpectrum)
  • 'Boring' Bodes Well For Future Of Intercept's Ocaliva  (SCRIP-$)
  • Here's how Bellicum Pharmaceuticals answers call to change Big Pharma (MedCityNews)
  • Proteus' Digital Medicine Offering Leads To Improved Compliance And Lower Blood Pressure (Forbes)
  • Want pharma website success? Make it about your audience (PharmaPhorum)
  • Are Emerging U.S. Biosimilar Policies At Risk Of Alienating Physicians? (BioProcessOnline)
  • Biosimilar Template Revisited: Inflectra Approval Binds And Separates From Remicade (Pink Sheet 1, 2-$)
  • Vaccine Development Faces Urgency and Challenges (PharmTech)
  • FDA nitpicks Shiongi's head lice copay voucher over 'false and misleading' claims (Fierce)
  • Valeant Is a Reminder of the Peril of Outsize Executive Pay (NYTimes)
  • Beyond Protein A: Repligen continues diversification with Atoll buy (BioPharma-Reporter)
  • CrownBio develops mouse strains with human PD-1 for mAb testing (BioPharma-Reporter)
  • GE and Zenith collaborate on bioprocessing automation (BioPharma-Reporter)

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

  • "Transformative" Dupilumab Set For Third Quarter Filing In Atopic Dermatitis (Pink Sheet-$)
  • Trial drug ineffective in preventing contrast-induced kidney injury (MNT)
  • Ironwood candidate stalls in gastroparesis (BioCentury)
  • Merck to Present New Data for KEYTRUDA (pembrolizumab) at the American Association for Cancer Research 2016 Annual Meeting (Press)
  • Kamada Announces Initiation of Phase 2 Clinical Trial with Intravenous Alpha-1 Antitrypsin for the Prevention of Lung Transplant Rejection (Press)
  • Highland announces positive data for new ADHD drug (PharmaLetter-$)

US: Medical Devices

  • Moving Closer to a National Device Evaluation System (MDDI) (Focus)
  • Association Calls on FDA to Regulate Online Vision Exam as Medical Device (Focus)
  • The first "cyborg Olympics" will happen this year – featuring exoskeleton and powered wheelchair competitions (MedCityNews)
  • FDA Panel Outlines Hub For Medical Device Data (Law360-$) (Focus)
  • Banned chemical still used in hospital IVs is linked to attention deficit disorder (Washington Post)
  • Uninfected or asymptomatic? Diagnostic tests key to forecasting major epidemics (MNT)
  • Study: Diagnostic accuracy, adherence to best practices vary among virtual visit providers (mobihealthnews)
  • EnteroMedics touts study showing improved weight loss in moderate obesity patients (MassDevice)
  • Bracco wins FDA nod for liver cancer microspheres (MassDevice)
  • Sleep Profiler PSG2™ Cleared by FDA to Diagnose Sleep Apnea (Press)

US: Assorted & Government

  • The DEA will decide whether to change course on marijuana by July (Washington Post)
  • State Marijuana Legalization: DOJ Should Document Its Approach to Monitoring the Effects of Legalization (GAO)
  • Talkin Bout Your (?) Generation (Drug and Device Law)
  • SAMHSA Seeks Comment on Proposed Changes to Address Barriers to Information Sharing (National Law Review)
  • How the White House will change Medicare Advantage (Politico)
  • Purdue Asks Fed. Circ. To Revive Anti-Abuse OxyContin IP (Law360-$)
  • Eli Lilly Urges Justices To Rethink Patent-Eligibility Test (Law360-$)
  • FTC Amicus Brief Highlights Post-Actavis Challenges (Law360-$)
  • FDA Proposes TEA Framework for OTC Non-Sunscreen Ingredients (FDA Law Blog)
  • Empirical Study Confirms That No-Injury Class Actions only Benefit Lawyers (Drug and Device Law)
  • Patent Settlements Blocking Authorized Generics May Get Supreme Court Review (Pink Sheet-$)

Upcoming Meetings & Events

Europe

  • Merck receives CE Mark approval for new liquid biopsy test for colorectal cancer (Pharmafile)
  • CHMP issues positive opinion of AstraZeneca's pandemic influenza vaccine (EPR)
  • IQWiG: Added Benefit Not Proven For Elocta, But Entresto Sails Through (SCRIP-$)
  • EU Citizens Spend Over $27 Billion a Year on Drugs: Report (DD&D)
  • CHMP adopts positive opinion of Trevicta for maintenance treatment of schizophrenia (EPR)
  • Aesica adds dev-stage formulation capabilities for potent APIs and controlled drugs (In-PharmaTechnologist)
  • Eximo Medical Announces the Successful Completion of a Multi-Center First-In-Human Trial in Europe with a Hybrid Catheter for Treating Complex Lesions in Peripheral Blood Vessels (Press)

Asia

  • Drug price cuts in Japan sink in though details sparse (Fierce)
  • Turkish Manufacturing Policies Attract Servier To Local Alliances (PharmAsiaNews-$)

India

  • India should join TPP to maintain trade advantages in generics: Patent experts (PharmaBiz)
  • GSK Healthcare shifts focus from Horlicks, banks on Sensodyne, Crocin to drive growth in India (Economic Times)
  • Give exemption from drug price control for 5 years: Kiran Mazumdar-Shaw (Economic Times)
  • Members of TNCDA return banned FDCs worth Rs. 40 cr to wholesalers (PharmaBiz)
  • Health ministry launches Rotavirus vaccine as part of UIP to cut child mortality (PharmaBiz)
  • Centre reconstitutes Board of Trade to boost Indian exports (PharmaBiz)
  • Hospital blood banks do not specify MRP on blood bags despite FDA circular (PharmaBiz)
  • India Debates Gelatin Or Plant-Based Cellulose Capsules (24 Insight)

Australia

  • Stem cell treatments and regulation - a quick guide for consumers (TGA)

Zika

  • Mosquito vs. Mosquito in the Battle Over the Zika Virus (NYTimes)
  • Zika mystery deepens with evidence of nerve cell infections (Reuters)
  • What Can Science And Government Do To Prevent The Next Zika Virus? (Forbes)

Other International

  • Health needs from humanitarian emergencies at an all-time high (WHO)
  • Global push gives hemophilia patients in developing world access to vital drug (STAT)
  • Brazil IEC 60601-1-9 required Near End of 2016 – Are You Ready (Eisner)
  • Angola's yellow fever death toll rises to 225: health minister (Reuters)

General Health & Other Interesting Articles

  • Genetically engineered pig hearts survive a record-breaking two years inside baboons (Washington Post)
  • Obesity surgery linked to reduced pain, improved mobility (Reuters)
  • Addiction may explain the link between social media and depression (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 news@raps.org.

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


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