Regulatory Focus™ > News Articles > Regulatory Recon: Bayer to Buy Monsanto for $66B; House Oversight Committee to Grill Mylan’s CEO Nex

Regulatory Recon: Bayer to Buy Monsanto for $66B House Oversight Committee to Grill Mylan’s CEO Next Week (14 September 2016)

Posted 14 September 2016 | By Zachary Brennan 

Regulatory Recon: Bayer to Buy Monsanto for $66B House Oversight Committee to Grill Mylan’s CEO Next Week (14 September 2016)

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

In Focus: US                                      

  • Bayer clinches Monsanto with improved $66 billion bid (Reuters) (WSJ-$) (Press)
  • Oversight Committee to Hold Hearing on EpiPen Price Increases (Oversight)
  • EpiPen Maker Dispenses Outsize Pay (WSJ-$)
  • House E&C Committee Letter on EpiPens (Letter)
  • Memo To The President: The Pharmaceutical Monopoly Adjustment Act Of 2017 (Health Affairs)
  • Why drug prices in America are so high (Economist)
  • How Congress Can Make Drug Pricing More Rational (Forbes)
  • GAO Report: 315 Generics More Than Doubled in Price Since 2010 (Focus)
  • Drug manufacturers are gaming the Orphan Drug Act (Incidental Economist) (Health Affairs)
  • FDA's Califf Clarifies Real-World Data Use (BNA)
  • Court Rejects FDA on Ferring's Prepopik Exclusivity (BNA)
  • FDA Issues Updated Draft Guidance Regarding 510(k) Third Party Review Program (FDA Law Blog)
  • Riding higher on Celgene filing, Agios proposes $150M offering to fund late-phase trials (FierceBiotech)
  • Guest Commentary: A call to change incentives (BioCentury)
  • Biosimilars Face Repercussions of Drug Pricing Debate (PharmTech)
  • FDA to Hold One Advisory Committee for Each Initial Biosimilar (Focus)
  • Biosimilar Interchangeability May Be Losing Luster As Approval Goal (Pink Sheet-$)

In Focus: International

  • UK pharma industry welcomes Department of Health investment into biomedical research (ABPI)
  • EU nod for Exelixis’ kidney cancer drug (PharmaTimes)
  • GlaxoSmithKline Takes Its Medicine (Forbes)
  • Teva recalling all lots of 4 drugs made at troubled Hungary plant (FiercePharma)
  • Nigeria Has To Wipe Out Polio — Again (NPR)
  • Kuwait plans to create a huge DNA database of residents and visitors. Scientists are appalled. (Washington Post)
  • Ireland’s Health Products Regulatory Authority Publishes 2015 Annual Report (Report)
  • Novartis Eager to See More 1st Approvals in Japan despite Pricing Headache (Pharma Japan)
  • Japan approves Medtronic’s Reveal Linq cardiac monitor (Mass Device)

US: Pharmaceuticals and Biotechnology

  • Sarepta Soars After Reports of FDA Drug Reviewer’s Departure (Bloomberg)
  • Allergan to Purchase Vitae for $639M, Building Dermatology Portfolio (GEN) (EP Vantage)
  • Atlas partner Saha takes the helm at Delinia, looking to disrupt autoimmune R&D (Endpoints)
  • The lab breakthrough that paved the way for today’s pricey hepatitis C cures (STAT)
  • All that pharmaceutical advertising may be a ‘mixed bag,’ after all (STAT)
  • Valeant’s New CFO Will Review 2016 Numbers, CEO Papa Says (Bloomberg)
  • Actavis Wants False Ad Claims Dismissed With Prejudice (Law360-$)
  • Value Vs. Values: ICER’s Review Of Opioid Abuse-Deterrent Formulations (Pink Sheet-$)
  • BIO Submits Comments Re: ICER Value Framework (BIO)
  • Catalent to Buy Pharmatek Laboratories (InPharma-Technologist)
  • With its software, TraceLink capitalizes on drug counterfeiting crackdown (Boston Globe)
  • AbbVie’s Battle Royale (TheStreet)
  • Genentech-partnered AC Immune tees up $68M IPO to bankroll Alzheimer's R&D (FierceBiotech)
  • Otsuka sees Bluetooth pill container as a weapon against Pletal generics (FiercePharma)
  • Takeda sets aside $15B for U.S. buys after topsy-turvy R&D week: FT (FierceBiotech) (Endpoints)
  • Interview – Respicardia looks to the US (EP Vantage)

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

  • Ebola virus lingers longer than scientists thought (Nature News)
  • Roche's MS hopeful Ocrevus banks more data for fierce market-share combat (FiercePharma) (Reuters)
  • Can easier dosing propel AstraZeneca's severe asthma med past Glaxo's Nucala? (FiercePharma)
  • GSK files RA drug in the EU (PharmaTimes)
  • Sanofi trumpets new IGlarLixi data after regulatory delay (PMLive)
  • Novo Nordisk Presents Positive Phase III Results from Semaglutide and Xultophy (FDANews-$)

Medical Devices

  • Want A BRCA Test? Some Insurers Require Genetic Counseling First (NPR)
  • FDA Gives Nod to Medtronic Drug-Coated Balloon (MedPage Today)
  • Laboratory Testing in the Era of Precision Medicine: Senate HELP Hearing (Hearing)
  • Visumax approval information (FDA)
  • Light-based arrhythmia treatment skips the shocks (Mass Device)
  • Why Upgrading the Medical Imaging Archives System Is a Must (MDDI)
  • Titan Medical sets $8m to $12m range on overnight offering for Sport surgical bot (Mass Device)
  • Plaintiff’s loss overturned in Boston Scientific pelvic mesh lawsuit (Mass Device)

US: Assorted and Government

  • FDA Logo Modernization Aims For Uniform 'Look And Feel' (Pink Sheet-$)
  • FDA MAPP on Drug Safety Oversight Board (FDA)

Upcoming Meetings and Events             

Europe                                                                                

  • Important safety information regarding GlucaGen® Hypo-Kit (SwissMedic)
  • MHRA Marketing Authroisations Granted in August 2016 (MHRA)

India

General Health and Other Interesting Articles

  • Cholera in the Americas - Situation summary (PAHO)
  • Harnessing the amazing work of the 40 trillion chemists in your gut microbiome (STAT)
  • Pathways for Oxygen Regulation and Homeostasis (JAMA)

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? Send him an email at news@raps.org.

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


Categories: Recon, Regulatory News

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