Regulatory Recon: Pfizer to Buy Cancer Biotech Medivation in $14 Billion Deal (22 August 2016)

Posted 22 August 2016 | By Michael Mezher 

Regulatory Recon: Pfizer to Buy Cancer Biotech Medivation in $14 Billion Deal (22 August 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 to Buy Medivation for $14 Billion (WSJ-$) (The Atlantic) (Financial Times) (NYTimes) (Press)
  • Why Did Mylan Hike EpiPen Prices 400%? Because They Could (Forbes)
  • From Nightmare Drug to Celgene Blockbuster, Thalidomide Is Back (Bloomberg)
  • D.A. Henderson, who led effort to eradicate smallpox, dies at 87 (Reuters)
  • ICER Releases Draft Evidence Report on Treatments for Non-small Cell Lung Cancer (ICER)
  • Chewable Tablets: Companies Seek Clarity on FDA Draft Guidance (Focus)
  • Manufacturing Dopamine in the Brain with Gene Therapy (MIT Technology Review)
  • Comparing individual papers from journals with different journal impact factors (ScienceMag)
  • FDA approves Pfizer's abuse-deterrent opioid painkiller (Pharmafile) (PharmaTimes) (Press)
  • In Florida, Pregnant Women Cover Up and Stay Inside Amid Zika Fears (NYTimes)
  • Are "Pay for Delay" Settlements in Patent Litigation Collusive? (
  • An Immuno-Oncology Target You've (Probably) Never Heard of – Releasing the Brakes on the Innate Immune System (Oncology Discovery)
  • Up to 270 microcephaly cases expected in Puerto Rico due to Zika: officials (Reuters)
  • US doctors waste millions of dollars on branded medicines (Financial Times)
  • The Profit and Peril of Cancer Drugs (WSJ-$)
  • New FDA Draft Guidance Helps Define the Scope of §510(k) Medical Device Preemption (Drug and Device Law) (Inside Health Policy) (Focus)
  • Portola 'surprised' with CMC concerns in FDA rejection of anticoagulant candidate (BioPharmaReporter)
  • Pharmaceuticals: Staying power (Financial Times)

In Focus: International

  • Updates to the Brazilian Food and Drug Administration OTC Drug Guidelines (National Law Review)
  • Valeant Taps Zoetis Executive for CFO Role (WSJ-$)
  • Stada faces showdown with activist investor AOC (Financial Times)
  • EU Bans Non-Critical, Sterile Products from a Pfizer Site in India Following Joint Inspection (Focus)
  • EMA Releases List of Medical Events for Pharmacovigilance Monitoring (Focus)
  • Making Ranbaxy units cGMP compliant time consuming: Sun Pharma (Economic Times) (Times of India)
  • US judge upholds UN immunity in Haiti cholera case (Reuters 1, 2)
  • EU to review Portola's blood-thinner antidote (PharmaTimes)
  • NICE Reassessing Old CDF Drugs On Value-For-Money Basis – Some Fail (SCRIP-$)
  • Medical Technology Development in Israel Diversifies (MDDI)
  • Australia's PBAC rejects application for Gilead's HIV PrEP (PharmaLetter-$) (The Guardian)

US: Pharmaceuticals & Biotechnology

  • FDA delays decision on Sanofi, Zealand's diabetes drug, handing lead to Novo Nordisk (Fierce) (BioCentury) (Press)
  • FDA Needs Plan To Regulate Clinical Software, Group Says (Law360-$)
  • PPMD asks FDA to clarify DMD decisions (BioCentury)
  • Biotech sentiment not helped by Auris and Cerulean setbacks (EP Vantage)
  • FDA Barred From Shutting Down Tissue Therapy Co. (Law360-$)
  • How Obama's FDA Keeps Generic Drugs Off the Market (WSJ-$)
  • Raptor Soars After Retrophin Is Said to Consider Bid (Bloomberg)
  • How Headlines About Research On Marijuana, Sex And Pain Misled Readers (Forbes)
  • Honeywell Issues Voluntary Nationwide Recall Of One Lot Of Eyesaline Eyewash Solution Due To Microbial Contamination (FDA)
  • Innovators Employ Labyrinthine Defenses To Fend Off Biosimilars (SCRIP-$)
  • First Anniversary Of FDA's Approval Of Addyi To Boost Women's Sex Drive: A Reason To Celebrate? (Forbes)
  • Oxacillin for Injection, USP, 10g by Sagent: Recall - Iron Oxide Particulate Matter (FDA)
  • Patient Recruitment and Retention for Healthier Studies (Bioclinica Blogs)
  • Digital Health: The Convergence Of Consumer Devices And Clinical Applications (LifeSciVC)

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

  • Lilly and AstraZeneca Receive FDA Fast Track Designation for AZD3293, an Investigational Treatment for Early Alzheimer's Disease (Press)
  • Xenetic Biosciences Announces FDA Acceptance of Investigational New Drug Application to Initiate Phase 2 Clinical Trial of Virexxa® in Endometrial Cancer (Press)
  • DeuteRx Enters Clinical Stage Development with DRX-065 (Press)

US: Medical Devices

  • Class 1 Recall: Alere INRatio2 Devices (FDA 1, 2, 3, 4, 5, 6, 7, 8)
  • Joe Robinson Named Vice Chair Of MITA Board Of Directors (MITA)
  • 5 Shocking Medical Device Crimes (MDDI)
  • 3D Printer Hacked to Perform Fast and Cheap DNA Sequencing (medGadget)
  • 'Born to be bad' or 'Born to be benign' - Testing cells for oesophageal cancer risk (MNT)

US: Assorted & Government                                                                                  

  • U.S. Officials Move to End Duplicate Health Care Coverage (NYTimes)
  • Reporting Associated With Designated New Animal Drugs for Minor Use and Minor Species (FDA)
  • FDA Investigates Outbreak of Hepatitis A Illnesses Linked to Raw Scallops (FDA)
  • J&J Fights $500K Risperdal Verdict At Pa. Appeals Court (Law360-$)
  • Intuitive Surgical sues J&J's Ethicon for 'legal gymnastics' over sales rep's non-compete (MassDevice) (Law360-$)

Upcoming Meetings & Events


  • Trek Therapeutics buys rights to Medivir's hep C candidate MIV-802 (PharmaLetter-$)
  • How GlaxoSmithKline Is Changing the World (Fortune)
  • NHS to spend £365m on perinatal mental health (PharmaTimes)
  • Puma Biotechnology Announces European Medicines Agency Validation of Marketing Authorization Application for PB272 (Neratinib) as Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer in Europe (Press)


  • How Japan Is Dealing With Impacts Of Supporting The Oldest Population In The World (NPR)
  • China over-reliant on hospitals, needs more family doctors: WHO (Reuters)
  • China vows to tighten up food and drug legislation (Securing Industry)


  • India's healthcare expenditure lowest in the world: KPMG (BioSpectrum)
  • Lupin gets CDSCO nod for indigestion treatment tablets (Economic Times)
  • Amgen's Repatha India Trial Waiver Plan Trips Up (SCRIP-$)
  • Made in India drugs safe & effective: Survey (Economic Times)
  • With price cap, 22 drugs get cheaper (Economic Times)
  • DoP earmarks Rs 300 crore for common facilities in medical parks (Economic Times)


  • Astral 100 and Astral 150 ventilators (TGA)


  • Summary Safety Review - GILENYA (fingolimod) - Assessing the Potential Risk of a Rare Brain Infection (Progressive Multifocal Leukoencephalopathy (Health Canada)


  • Man Dies From Zika-Related Paralysis in Puerto Rico (NBC)
  • Health official warns Zika could spread across U.S. Gulf (Reuters)
  • Additional area of active Zika transmission identified in Miami Beach (CDC)
  • CDC Updates Guidance for Care of Infants Born to Mothers with Possible Zika Virus Infection During Pregnancy (CDC)

Other International

  • WHO Director-General addresses the Regional Committee for Africa (WHO)

General Health & Other Interesting Articles

  • Whose Lives Should Be Saved? To Help Shape Policy, Researchers in Maryland Ask the Public (NYTimes)

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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