Regulatory Recon: Teva Settles Foreign Bribery Charges for $519M; Former HHS Officials on Trump’s Pick for HHS (22 December 2016)

Posted 22 December 2016 By Zachary Brennan

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

In Focus: US                                      

  • SEC, DOJ fine Teva Pharmaceutical $519 million to settle foreign bribery charges (SEC) (DOJ) (MarketWatch) (Reuters)
  • Care for the Vulnerable vs. Cash for the Powerful — Trump’s Pick for HHS (NEJM)
  • Exclusive: U.S. regulator poised to approve Abbott purchase of St Jude – sources (Reuters)
  • 52 weeks, 52 faces: Obituaries narrate lives lost to the opioid epidemic (Stat) (CSPAN)
  • 14 For ’17: Key Clinical Data to Watch For Next Year (Part 1) (Xconomy)
  • Alleged Scheme To Fix Generic Drug Prices Started At Dinners And ‘Girls Nights Out’ (Kaiser Health News)
  • How hospitals, nursing homes keep lethal ‘superbug’ outbreaks secret (Reuters)
  • Senators Look to Halt Price Spikes of Off-Patent Drugs (Focus) (Report)
  • Drug Firms Make Millions By Sending Opioid Pills To W.Va., Report Says (NPR)
  • Year in Review 2016 (C&EN)
  • Woodcock Tries To Calm US FDA Staff Fears About Trump (Pink Sheet-$)
  • AML Master Protocol For Precision Medicine Developed By Nonprofit And US FDA (Pink Sheet-$)
  • Congress needs to turn its attention to medical device safety (Stat)
  • Manufacturing questions delay yet another FDA drug approval in 2016 (FiercePharma) (Xconomy)
  • Editor’s Corner: Drug approval delays due to manufacturing are a troubling trend in the industry (FiercePharma)
  • Medical detectives raced to save a man from a rare, ‘universally lethal’ disease (Washington Post)

In Focus: International

  • Fatal French clinical trial failed to check data before raising drug dose (Nature News)
  • Clinical data for two more medicines now available online (EMA)
  • Report on the activity of scientific committees from 2013-2016 (European Commission)
  • Blockbuster Competitors Figure Large Among Biosimilars Under Review in EU (Pink Sheet-$)
  • Brexit: Biotech awaits impact of slow shuffle to EU exit (FierceBiotech)
  • MHRA advertising investigations: November 2016 (MHRA)
  • Special investment contract to strengthen AstraZeneca’s position in Russia (PharmaLetter-$)

US: Pharmaceuticals and Biotechnology

  • Actelion, J&J Are Back in Exclusive Talks a Week After Breakup (Bloomberg) (NY Times-$)
  • Allergan’s CEO Has Struck an Insane Number of Biotech Deals (Fortune)
  • Markets slowly wise up to Sarepta’s “elegant placebo” (EP Vantage-$)
  • CRISPR Screen IDs Human Host Genes for HIV (GEN)
  • Biotech Stocks: Rate Expectations Matter (WSJ-$)
  • ACOG on FDA anesthesia warning (ACOG)
  • 21st Century Cures Act: HP&M to Offer Two Complimentary Webinars on Topics of Interest (FDA Law Blog)
  • Biotech IPO market slowdown—will it continue into 2017? (FierceBiotech)
  • As the dust settles on Cures, what will it mean for biopharma R&D? (FiercePharma)

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

  • Critics Assail Paper Claiming Harm from Cancer Vaccine (Nature News)
  • The Top 10 Health Affairs Articles Of 2016 (Health Affairs)
  • The disgrace of cancer clinical trials (The Hill)
  • Study Suggests Alzheimer and Parkinson Disease Are Not Transmitted Through Blood Transfusion (JAMA)
  • The Microbiome and Risk for Obesity and Diabetes (JAMA)
  • Alexion adds a failed pivotal Soliris trial to an air of crisis. The perfect time to talk buyout (Endpoints) (Press)
  • Roche readies a hunt for marketing OK on hemophilia blockbuster hopeful emicizumab after PhIII success (Endpoints)
  • Merrimack shutters a failing PhII breast cancer study for MM-302 (Endpoints) (Boston Globe)
  • OvaScience nose dives, as CEO and CFO departures and staff cuts announced (PharmaLetter-$) (Press)

Medical Devices

  • Mad cow disease remains a threat. New blood tests could detect it (Science)
  • Adverse Events Involving Radiation Oncology Medical Devices: Comprehensive Analysis of US Food and Drug Administration Data, 1991 to 2015 (Study)

US: Assorted and Government

  • Medicare Penalizes Hospitals In Crackdown On Antibiotic-Resistant Infections (NPR)
  • Trump's budget director pick: “Do we really need government-funded research at all” (Vox)
  • What the new HealthCare.gov numbers are (and aren't) telling us (Politico)
  • Researchers race to copy Obamacare data for fear it will vanish (Politico)

Upcoming Meetings and Events             

Europe                                                                                

  • Medicines and Healthcare products Regulatory Agency’s staff survey results 2016 (MHRA)

General Health and Other Interesting Articles

  • Aging And Addicted: The Opioid Epidemic Affects Older Adults, Too (California Healthline)
  • You’re an Adult. Your Brain, Not So Much. (NY Times-$)
  • Street Hustle: The Truth Behind the ‘New’ Police Tool for Confronting Fentanyl Menace (ProPublica)
  • Snickers Maker Criticizes Industry-Funded Paper on Sugar (AP)

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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