Regulatory Focus™ > News Articles > Regulatory Recon: Obama’s Precision Medicine Initiative Launches; New WHO Guidance on Zika; (25 Febr

Regulatory Recon: Obama’s Precision Medicine Initiative Launches New WHO Guidance on Zika (25 February 2016)

Posted 25 February 2016 | By Zachary Brennan 

Regulatory Recon: Obama’s Precision Medicine Initiative Launches New WHO Guidance on Zika (25 February 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

In Focus: International

  • Assessment of infants with microcephaly in the context of Zika virus (WHO Guidance)
  • Identification and management of Guillain-Barré syndrome in the context of Zika virus (WHO Guidance)
  • Breastfeeding in the context of Zika virus (WHO Guidance) (AP)
  • After the Ebola crisis, can the WHO rise to the challenge of Zika? (STAT)
  • Ebola 'devastates long-term health' (BBC)
  • French drug trial scandal: 'dogs died in pre-clinical test' (Guardian)
  • India’s Drugmakers Step Up U.S. Investment (WSJ-$)
  • US prosecutors say corrupt Chinese officials behind Glaxo pharma secrets theft, but defence says that’s ‘fantastical’ (AP)

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US: Pharmaceuticals & Biotechnology

  • Bankrupt KaloBios Pursuing Deal to Buy Rights to Tropical Disease Drug (WSJ-$)
  • AstraZeneca's $4 billion Acerta deal endorsed by orphan drug status (Reuters)(PharmaFile)
  • GPhA Hopes To Gain Champions In Congress By Educating Lawmakers (InsideHealthPolicy-$)
  • In CRISPR patent fight, all eyes turn to the judge, a former scientist (STAT)
  • Bayer reports another record year (PharmaLetter-$)(PharmaTimes)(Bloomberg)
  • Investors gobble half of Stanford's 'don't-eat-me' cancer-focused spinout (San Francisco Business Times)
  • GSK, Teva Ask Justices To Take Lamictal Pay-For-Delay Case (Law360-$)
  • Costco, Apotex Get Generic Lipitor Labeling Suit Tossed (Law360-$)
  • Kyle Bass' Coalition Gets PTAB Review Of Anacor Patents (Law360-$)
  • Pharma Groups, Economists Knock Effexor Antitrust Appeal (Law360-$)
  • Pharmedium Services 483 (FDA)
  • Johnson & Johnson fights $72M cancer claim verdict (CBS News)
  • Baxalta and Precision BioSciences form Global Genome Editing Collaboration in Immuno-Oncology (Press)

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

  • Novartis claims FDA breakthrough status for leukaemia treatment (PMLive)
  • CRUK starts trial of Amgen's cancer immunotherapy (PharmaTimes)
  • Pancreatic cancer 'breakthrough' hailed (CNBC)
  • Flu Vaccine 60 Percent Effective So Far, CDC Says (NBC News)
  • ViiV and Janssen take long-acting HIV regimen to Phase III (PMLive)
  • Juno, Fred Hutch Launch Clinical Trials Unit (GEN) (Outsourcing-Pharma)
  • Better biomarkers needed to assess OA therapies, but patient voice still missing (BioWorld-$)
  • Merck and TissueGene will transform future osteoarthritis market, says analyst (PharmaLetter-$)
  • Esteve and UAB expand research to two new gene therapies for Sanfilippo B and Hunter syndromes (PharmaLetter-$)
  • Effect of antihypertensive treatment at different blood pressure levels in patients with diabetes mellitus: systematic review and meta-analyses (BMJ)
  • How did NEJM respond when we tried to correct 20 misreported trials? (Ben Goldacre)

US: Medical Devices

  • FDA Wants To Connect Payers And Sponsors Earlier In Device Development Process (MedDeviceOnline)
  • FDA Status Report Medical Devices Single Audit Programme (ECA)
  • BioFire Receives FDA Clearance for FilmArray Torch with FilmArray Respiratory Panel and Submits Special 510(k) Applications for Use with additional FilmArray Panels (Press)
  • Medical device superstars: where innovation happens in the US (MassDevice)
  • Brazilian authorities raid Boston Scientific’s offices (Mass Device)
  • Boston Scientific co-founder Peter Nicholas to step down a year ahead of plan (Mass Device)
  • DARPA: Minimally Invasive Implant Could Unlock Thought-Controlled Prosthetics (MedDeviceOnline)

US: Assorted & Government

  • US governors seek to limit opioid prescribing (BMJ-$)(NY Times)
  • Six states sue Obama administration over Affordable Care Act (AP)
  • Senate Finance Pushes 'Lock In' Legislation To Address Opioid Crisis (InsideHealthPolicy-$)
  • Burwell Expects To Update Congress On Part B Drug Demo Soon (InsideHealthPolicy-$)
  • The Food and Drug Administration Food Safety Modernization Act: Prevention-Oriented Import System Regulations and Implementation; Public Meeting (Federal Register)
  • Oncologists Urge Congress To Stay The Course On Site-Neutral Pay (InsideHealthPolicy-$)
  • Committee Renewals: Gastrointestinal Drugs Advisory Committee (Federal Register)
  • Enforcement in Brief (Gold Sheet-$)
  • Weight Loss Supplement Maker Can't Trim FTC Suit (Law360-$)

Upcoming Meetings & Events


  • Acerta's acalabrutinib leaps closer to EU orphan status (PharmaTimes)
  • MHRA expands use of MSD's Ezetrol (PharmaTimes)
  • EU Unannounced Audits: A Primer (Gray Sheet-$)
  • New blockbusters in pharma - German experience (PharmaLetter-$)
  • Warning - Capsules sold on the website of "The Diennet Institute" (SwissMedic)
  • Member states contact points for translations review (EMA)
  • Will the EMA keep PTC's failed/spurned ataluren on the market for Duchenne MD? (FierceBiotech)
  • Seqirus to build £22m vaccine production facility in Liverpool (Manufacturing Chemist)
  • Cobra Biologics links up with CPI in £1.8m project to advance development of regenerative medicines (Manufacturing Chemist)


  • China’s WuXi PharmaTech tapping banks for $1.5b IPO for biologics arm (Bloomberg)
  • China API Plant Has Deficiencies, Polish Regulators Find (EudraGMDP)
  • MSF slams 'ridiculously high price' of Otsuka's TB drug delamanid (PharmaLetter-$)
  • Booming WuXi eyes $1.5B IPO for biologics unit — Report (FierceBiotech)



  • Australia’s Consultation Forecast (TGA)

Zika Virus

  • Zika exposes class differences in Brazil, where most victims are poor (Washington Post)
  • NIH Says Zika Vaccine Could Be Ready For Trials By Summer (Law360-$)
  • Fauci: Good Zika Synergy, But Pharma No NIH Substitute (SCRIP-$)

Other International

  • The Medicines Patent Pool - five years on (Pharmafile)

General Health & Other Interesting Articles

  • Embryo Viability Predicted by Squishiness (GEN)
  • Living With Cancer: A Farewell to Legs (NY Times)
  • Why More Americans Don't Get IVF Treatment (Forbes)
  • Vermont could become the first state to legalize marijuana through the legislature (Vox)

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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