Regulatory Focus™ > News Articles > Regulatory Recon: Drug Pricing Fight Heats Up; 23andMe Abandons Next-Gen Sequencing (27 October 2016

Regulatory Recon: Drug Pricing Fight Heats Up 23andMe Abandons Next-Gen Sequencing (27 October 2016)

Posted 27 October 2016 | By Zachary Brennan 

Regulatory Recon: Drug Pricing Fight Heats Up 23andMe Abandons Next-Gen Sequencing (27 October 2016)

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                                      

  • Allergan’s executive team orchestrates a $200M buyout to beef up gastroenterology pipeline (Endpoints) (Press)
  • 23andMe Has Abandoned The Genetic Testing Tech Its Competition Is Banking On (BuzzFeed)
  • Disconnect Between Silicon Valley and Regulators Over Health Technologies, 23andMe CEO Says (WSJ-$)
  • US, EU Look to Mutually Recognize GMP Inspections by January 2017 (Focus)
  • In Washington’s Drug Price Fight, Plenty of Blame to Go Around (Bloomberg)
  • Liberal groups call for delaying Cures bill to next year (The Hill)
  • How the next president can lower drug prices with the stroke of a pen (Washington Monthly)
  • Grassley Sets Judiciary Committee Hearing on EpiPen Settlement (Bloomberg) (Press)
  • Drug Prices, Not The Health Law, Top Voters’ Health Priorities For 2017 (Kaiser Health News)
  • AARP, MSF and Others Pen Letter to Obama on Biologics Exclusivity (Letter) (The Hill)
  • FDA Approval Changes Could Affect Drug Prices (Roll Call)
  • The U.S. Is Standing in the Way of Cheaper Drugs for the Poor (NY Times-$)
  • FDA Issues Four Emergency Use Authorizations for in vitro diagnostic devices for detection and/or diagnosis of Zika virus (Federal Register)
  • FDA Seeks Public Comments on Updating Tolerances for Residues of New Animal Drugs in Food (FDA)

In Focus: International

  • Sanofi partners with Brazil to accelerate Zika vaccine work (Reuters)
  • Over 1 million treated with highly effective hepatitis C medicines (WHO) (Report)
  • Ireland Looks to Host New EMA Headquarters Following Brexit (Focus)
  • Expect Zika virus to reach India and Africa, medical research charity warns (Guardian)
  • NICE nods for Tagrisso, Cimzia and Zepatier (PharmaTimes)
  • Novo Nordisk's Tresiba backed for use on NHS Wales (PharmaTimes)
  • Evotec makes offer to acquire Cyprotex (PharmaLetter-$)
  • Report: Australia 60% Cheaper for Trials Than US (Outsourcing-Pharma)
  • Health Canada Warns of Complications With Soliris and Bexsero (Focus)

US: Pharmaceuticals and Biotechnology

  • Buy or build – big pharma’s freshness dilemma (Evaluate)
  • Teva teams up with IBM to tackle two challenges facing the pharma industry (Pharmafile)
  • Generics Group Urges Justices To Hear Patent Locale Dispute (Law360-$)
  • BIO comments on FDA compounding guidance (Comment)
  • MIT launches venture capital fund (Boston Globe)
  • Space is at a premium for Cambridge startup Intellia (Boston Globe)
  • Biopharma supplants med tech for top 2017 health care innovations (BioWorld)
  • We have the technology to fast-track drug development, but we're not using it yet (Business Insider) (Report)
  • Universal Child FH Screening Proposed (CardioBrief)
  • Donald Trump’s ‘Access Hollywood’ tape may have cost biotech investors $50 billion (MarketWatch)
  • Stanford biochemist Peter Kim leads the Chan Zuckerberg Biohub project on infectious disease (Stanford News)
  • Bowel Drug False Ad Suit Kept Alive (Law360-$)

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

  • Gene therapy shows promise for treating Niemann-Pick disease type C1 (NIH)
  • Remission of Follicular Lymphoma after Treatment for Hepatitis C Virus Infection (NEJM) (In the Pipeline)
  • Turning pharma castoffs into an instant fortune, Vivek Ramaswamy’s Myovant bags a $218M IPO (Endpoints)
  • ProQR shares spike on positive PoC study for lead CF drug (Endpoints)
  • Data Sharing — Is the Juice Worth the Squeeze? (NEJM)
  • Bristol-Myers Squibb Reports Third Quarter Financial Results (Press) (Financial Times) (Endpoints)
  • Celgene's third-quarter sales up 28 percent, with Revlimid growing 30 percent (First Word Pharma)
  • Sarepta Therapeutics Announces Third Quarter 2016 Financial Results and Recent Corporate Developments (Press)
  • Vertex Presents Long-Term Data Demonstrating that ORKAMBI (lumacaftor/ivacaftor) and KALYDECO (ivacaftor) Show the Potential to Modify the Progression of CF (Press)
  • Inclusion of the First Patient in the Phase II Clinical Study That Aims to Test THN102 in Patients Affected by Narcolepsy (Press)
  • Immune Pharmaceuticals Receives FDA Guidance for Phase III Pivotal Trial of its AML Therapy Ceplene In Combination with Low Dose IL-2 (Press)
  • Alexion Reports Third Quarter 2016 Results (Press)
  • Alexion Initiates Simultaneous Registration Trials of ALXN1210 for Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) and Atypical Hemolytic Uremic Syndrome (aHUS) (Press)

Medical Devices

  • MDUFA IV to add $50-75 Million Annually in new User fee Revenue for FDA (Focus)
  • St. Jude Medical’s shareholders OK $25B Abbott buyout (Mass Device)
  • Zimmer Biomet picks up tele-rehab provider RespondWell (Mass Device)
  • Helix, The Closely Watched DNA Startup, Makes Uncertain Debut (BuzzFeed)
  • Class 2 Device Recall da Vinci Xi" Surgical System (FDA)
  • Fed. Circ. Won’t Lift Early Sales Ban In Qiagen Patent Case (Law360-$)

US: Assorted and Government

  • FDA AdCom on Human Research Protections (Tarius)
  • National Cancer Institute Extends Scope of Seven Bridges Cancer Genomics Cloud Pilot (Press)
  • Aetna profits bolstered by Medicare, Medicaid business lines (Modern Healthcare)

Upcoming Meetings and Events             


  • Sun Pharma Acquires Ocular Technologies (Economic Times)
  • Dr Reddy's inks new deal with Gland Pharma in the US market (PharmaLetter-$)

General Health and Other Interesting Articles

  • HIV’s Patient Zero exonerated (Nature News) (Letter) (Editorial)
  • The kids are all right: Children with 3-way DNA are healthy (AP)
  • WHO and partners gear up to safeguard lives of displaced persons fleeing Mosul (WHO)

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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