Regulatory Recon: FDA Advisers Vote Against OTC Combos for Minor Stomach Issues FDA Commissioner Nominee Faces Senate Committee (5 April 2017)

Posted 05 April 2017 | By Zachary Brennan 

Regulatory Recon: FDA Advisers Vote Against OTC Combos for Minor Stomach Issues FDA Commissioner Nominee Faces Senate Committee (5 April 2017)

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing.

In Focus: US                                          

  • With a resume that’s both asset and liability, Scott Gottlieb preps for FDA confirmation hearing (Stat) (In the Pipeline)
  • Venture Capitalist Gottlieb Has Too Many Conflicts to Run FDA (Public Citizen)
  • Trump’s Pick to Head FDA is Addicted to Opioid-Industry Cash (The Intercept) (Forbes) (WSJ-$)
  • The Senate Should Grill Trump's FDA Pick on Antibiotics (Mother Jones)
  • The FDA Can Declare War on Alzheimer's (WSJ-$)
  • High Drug Prices Remain a Conundrum, Analysts Say (MedPage Today)
  • FDA Advisers Down on OTC Combos For Tummy Trouble (MedPage Today) (Pink Sheet-$)
  • Taking Shortcuts In Drug Testing Can Put Patients At Risk (NPR)
  • EpiPen maker Mylan hit with racketeering suit over soaring drug price (Modern Healthcare)
  • Novel Biologics In US Might Not Start Getting Suffixes Until August (Pink Sheet-$)
  • FDA user fee renewal urgent, but hearing gets diverted to drug prices, NIH cuts (SNL) (Focus)
  • FDA’s Draft Biosimilar Interchangeability Guidance: Stakeholders Seek More Clarity (Focus)

In Focus: International

  • Changes to NICE drug appraisals: what you need to know (NICE)
  • UK MP: Any Repeal if EU laws on medical devices risks patient safety (Labour MEPs)
  • WHO alarmed by use of toxic chemicals as weapons in Syria (WHO)
  • India's Dr Reddy's says FDA raises fresh concerns at Srikakulam drug plant (Reuters)
  • Cell Therapies, Biosimilars Boost Biologics Clinical Trials In Korea (Pink Sheet-$)
  • EU National Agencies Prepare For ‘Rebalancing’ Of Network Post Brexit (Pink Sheet-$)
  • Lords request new body to lead NHS sustainability (PharmaTimes)
  • Medicines: March licensing time-based performance measures (MHRA)
  • How the genomics revolution could finally help Africa (Nature)
  • NJ Pharma Co. Hits Manufacturer With €3M Commissions Suit (Law360-$)
  • NAFTA tribunal fails to rule on Canada’s patent utility doctrine (PhRMA)

US: Pharmaceuticals and Biotechnology

  • Under threat of early Ampyra knockoffs, Acorda plans to chop 100 jobs (Endpoints) (Fierce) (Press)
  • Finch Therapeutics, Takeda ink new microbiome GI collab (Fierce) (Endpoints)
  • AbbVie/Janssen’s Imbruvica filed for graft-versus-host-disease (PharmaTimes) (PMLive)
  • Latest Data Show That Hospitals Are Still Specialty Drug Profiteers (Drug Channels Blog)
  • Reality and Un-Reality: Continuous Processing in Pharmaceutical Manufacturing (Contract Pharma)
  • Corbus outlines US approval path (Reuters)
  • Biogen Accused Of Stifling Neurological Drug Competition (Law360-$)
  • Sanofi, Regeneron Setting 'New Paradigm' With Dupixent Pricing In US? (Pink Sheet-$)
  • Sanofi Appoints Bill Sibold Executive Vice President Sanofi Genzyme and Member of the Executive Committee (Press) (Endpoints)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Accepts for Priority Review Bristol-Myers Squibb’s Application for Opdivo (nivolumab) in Previously Treated dMMR or MSI-H Metastatic Colorectal Cancer (Press) (PMLive) (PharmaTimes)
  • Journal editor calls for ‘culture change’ around clinical trial data (Stat)
  • Charles River launches first CRISPR-generated immunodeficient model (Outsourcing-Pharma)
  • Skin disease biotech Azitra closes $2.9M Series A for microbiome work (Fierce) (Press)
  • Takeda's largest study brings dengue vaccine step closer (Endpoints) (Reuters) (Press)
  • Biotech CEO Dodges Prison For False SEC Filings (Law360-$)
  • Strong sales and income growth for Boehringer Ingelheim in 2016 (PharmaLetter-$)
  • Stem cells plus scaffold may spur repair of torn tendons (Reuters)
  • Northwest Bio Executive Pleads Ignorance about Clinical Trial Halt, Stock Collapse (TheStreet)
  • Sosei Subsidiary Heptares to Receive US$12 Million Milestone Payment from AstraZeneca (Press)
  • Novartis AG v. Noven Pharmaceuticals Inc. (Fed. Cir. 2017) (Patent Docs)

Medical Devices

  • Drugmaker GSK recalling nearly 600,000 asthma inhalers in U.S. (Reuters) (Pharmafile)
  • Teleflex closes $9m Pyng Medical buy (Mass Device)
  • Cook Medical warns of thrombus risk with Zenith Alpha stent graft (Mass Device)
  • Medical tracer dev Shine Medical Tech raises $30m (Mass Device)
  • Appeals court upholds Medtronic win in $6m legal fees spat with Mirowski (Mass Device)

US: Assorted and Government

  • OPDP Picks Up Steam on Enforcement Letters (Policy and Medicine)
  • Upton and DeGette Urge Administration to Rethink NIH Budget Cuts (Press)
  • Cybersecurity: House Committee Looks to Build on Public-Private Partnerships (Focus)
  • New House bill to add 35% tax credit for contracted research (Fierce)
  • FDA Citizen Petition from Wilson Sonsini Goodrich & Rosati (Silvergate Pharmaceuticals, Inc.) (Citizen Petition)
  • Transcripts from FDA workshops on identification and characterization of infectious disease risks (FDA) (FDA 2)
  • Waivers from Requirements of the Sanitary Transportation of Human and Animal Food Rule (Federal Register)

Upcoming Meetings and Events               


  • Eisai agrees licensing deal for Parkinson's drug in Asia (PharmaLetter-$)
  • MHLW Releases “Blue Book” Generic Data List (Pharma Japan-$)
  • MHLW Sets Up Office for Startup Support, Starts Receiving Applications for Consultations (Pharma Japan-$)
  • AstraZeneca to announce Chennai investment as part of UK-India trade summit (PharmaLetter-$)
  • Withdrawal of "under review" GMP clearance applications that are no longer required (TGA)

General Health and Other Interesting Articles

  • One in 10 Pregnant Women With Zika in U.S. Have Babies With Birth Defects (NY Times-$) (NPR)
  • White House Offers New Health Reform Proposal (MedPage Today) (NY Times-$)
  • Report: Race and location play a big part in doctor pay (USA Today)
  • French bird flu crisis seen cutting demand for poultry feed by 330,000 tonnes (Reuters)
  • Why President Trump Needs to Name a Science Advisor (Stat)

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.

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

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