Regulatory Recon: Congress Takes Summer Vacation Without Addressing Zika (15 July 2016)

Posted 15 July 2016 | By Zachary Brennan 

Regulatory Recon: Congress Takes Summer Vacation Without Addressing Zika (15 July 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                                      

  • Congress Takes a Vacation Without Doing Anything About Zika (NY Times-$) (AP) (NBC) (Time)
  • Inaction on Zika Funding Likely to Delay Vaccine Testing (AP)
  • Zika Epidemic May Have Peaked But Will Threaten U.S. For Years (NPR)
  • Appropriators to Obama: Act Aggressively to Use Existing Funds to Combat Zika (Senate Committee on Appropriations)
  • For cancer patients on experimental immunotherapy drugs, it’s been an emotional week (STAT)
  • Brain Tumor Patient Dies After Ziopharm Gene Therapy Injection (TheStreet) (Reuters)
  • CMS and FDA advocate for device identifiers on claims forms (Modern Healthcare) (Mass Device) (InsideHealthPolicy-$)
  • The Seventh Circuit Rejects First Amendment Protection for Commercial Speech Related to an Unapproved Product (FDA Law Blog)
  • House E&C Committee Clears New Priority Review Voucher Program (Focus) (BIO)
  • FDA Offers New Draft Guidance on How to Co-Develop IVDs, Therapeutics (Focus)
  •  19 July 2016 Meeting Materials, Dermatologic and Ophthalmic Drugs Advisory Committee for Valeant (FDA) (Reuters)
  • PhRMA Welcomes Five New Member Companies (Press)

In Focus: International

  • Celgene’s Revlimid (Lenalidomide) Approved by the European Commission for the Treatment of Relapsed/Refractory Patients with Mantle Cell Lymphoma (Press)
  • Yellow fever situation report (WHO)
  • NHS spends £780,000 a day on antidepressants (PharmaTimes)
  • Wales confirms £80m treatment fund (PharmaTimes)
  • Science's status shifts in new Brexit government (Nature)
  • Bruises from Brexit start to show in U.K. chemistry enterprise (C&EN)
  • Indonesia orders overhaul of drug agency after fake vaccine scandal (Reuters)
  • UK charity pockets $150 million from Merck cancer immunotherapy drug (Reuters)
  • Scheduling committees meeting dates and decisions timeframes (Australia’s TGA)
  • New Class III Medical Device Licence Application Form (Health Canada)
  • Saudi Arabia’s pharmaceutical market set to hit $6 billion by 2020 (PharmaLetter-$)

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US: Pharmaceuticals and Biotechnology

  • Layoffs at Medimmune in Maryland (In the Pipeline)
  • Plant That Won’t Glow Shows DIY Biohacking Is Overhyped (MIT Technology Review)
  • Biotech VC: On track for second-highest year in 2016 (Fierce)
  • US venture funding falters (EP Vantage)
  • Biotech's Paradox: A Robustly Valued, Highly Active And Seemingly Terrible IPO Market (Forbes)
  • Juno Therapeutics Adds Adenosine Receptor Antagonist Through Acquisition of RedoxTherapies (Press) (Fierce)
  • HIV pill could cut infections in gay, bisexual men by a third (Reuters)
  • Fecal Transplants Can Be Life-Saving, but How? (NY Times-$)
  • GSK licenses respiratory disease target from Five Prime (PharmaTimes)
  • Teva looking at up to $25 billion in bond sale to fund Allergan’s generic-unit buy (Pharmafile)
  • Biotech Roundup: Hellos, Goodbyes, “Cures” Delays And Trial News (Xconomy)
  • Atty Sues Firms Over Share Of $30M Bristol-Myers Settlement (Law360-$)
  • Fed. Circ. Affirms Celgene Win In Bone Cancer Drug IP Case (Law360-$)
  • Drug Companies Dispute FTC’s Authority Over Pay-For-Delay Cases (FDANews-$)
  • PARPs for course: BRCA test advancing, handful of players push research (BioWorld-$)

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

  • Who's Running The Trials: Top Industry Sponsors (In Vivo-$)
  • Twenty years on: the impact of fragments on drug discovery (Nature)
  • Worldwide collaboration for orphan drug designation (Nature)
  • Reducing the risk of failure: biomarker-guided trial design (Nature)
  • Xbiotech Responds to ESMO, Other Critics of Phase 3 Cancer Data (Xconomy)
  • Ultragenyx posts broadly positive data for small rare disorder trial (Fierce)
  • Upfront Immunotherapy for Lung Cancer? Not Yet (Medscape)

Medical Devices

  • FDA Information Collection Activities; Submission for OMB Review; Comment Request; Clinical Laboratory Improvement Amendments Act of 1988 Waiver Applications (Federal Register)
  • Spirox wins FDA nod for Latera nasal implant (Mass Device)
  • Ability Dynamics wins CE Marks for Rush foot prostheses (Mass Device)
  • Cambridge start-up expands its genetic test offering (PHG)

US: Assorted and Government

  • CMS discusses VBP's effects on Medicaid best price (BioCentury)
  • The FDA versus the Tooth (Marginal Revolution)
  • Senators Introduce Bill to Expand Research into Medical Benefits of Marijuana (Press)
  • Herbalife Will Restructure Its Multi-level Marketing Operations and Pay $200 Million For Consumer Redress to Settle FTC Charges (FTC)

Upcoming Meetings and Events             


  • Scientific Committee on Health, Environmental and Emerging Risks Meeting of the Working Group on Sunbeds (European Commission)
  • Guide to Electronic Submissions - Human Medicines (Ireland’s HPRA)


  • Report: Boston Scientific opens largest OUS R&D shop in India (Mass Device)
  • Glenmark Expects Cash Surge From License Deals in Next 18 Months (Bloomberg)
  • Floating Medical Clinic In India Delivers Aid To Millions (Quartz)


  • China National Adverse Drug Reaction Monitoring report shows 5.3% increase in ADR cases (PharmaLetter-$)


  • Zika Virus-Associated Microcephaly and Eye Lesions in the Newborn (Study)

General Health and Other Interesting Articles

  • At Least 130 People Have Overdosed on K2 in New York in the Past 3 Days (New York Mag)
  • Fighting a Hospital Superbug Reveals an Unexpected Benefit (National Geographic)
  • The Rise and Fall of Theranos: A Cartoon History (KQED)
  • E-cigarettes could cut smoking-related deaths by 21 percent: study (Reuters) (Bloomberg)
  • Hospitals gird for party conventions, with surgeons on call and enough supplies for a siege (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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