Regulatory Focus™ > News Articles > Regulatory Recon: Theranos Gets More Time to Respond to CMS Inspection, Patient in Halted Akashi DMD

Regulatory Recon: Theranos Gets More Time to Respond to CMS Inspection, Patient in Halted Akashi DMD Trial Dies (8 February 2016)

Posted 08 February 2016 | By Michael Mezher 

Regulatory Recon: Theranos Gets More Time to Respond to CMS Inspection, Patient in Halted Akashi DMD Trial Dies (8 February 2016)

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

In Focus: US

  • Theranos Gets Additional Week to Respond to US Inspection (Bloomberg)
  • Drug Industry Launches Ad Campaign Aimed at Lawmakers (WSJ)
  • Give Up Your Data to Cure Disease (NYTimes)
  • How Do Pharmaceutical Companies Establish Drug Prices? (NPR)
  • Akashi Investigating Duchenne Patient Death (SCRIP-$) (FierceBiotech)

In Focus: International

  • Biotrial Says It 'Rigorously Complied' With Standards In Phase I Study (SCRIP-$)
  • Biologics Naming: WHO Final Plan, FDA Draft Guidance Incompatible (Pink Sheet-$)
  • Evolving Japanese regulations on companion diagnostics (Nature-$)
  • Mexican Regulators Boosting Third-Party Review Process for Medical Devices (Emergo)
  • We Have the Technology to Destroy All Zika Mosquitoes (MIT Technology Review)

Sponsored Content: The Ohio State University Masters of Applied Clinical and Preclinical Research

US: Pharmaceuticals and Biotechnology

  • Final Guidance: Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays (FDA)
  • Is It Time To Stop Using Race In Medical Research? (NPR)
  • High Costs For Drugs Used By A Few Are Starting To Add Up (NPR)
  • J&J, AbbVie Shares Drop on Potential Biosimilar Competition (WSJ-$)
  • Study: Characteristics of FDA drug recalls: A 30-month analysis (AJHP-$) (Abstract)
  • AbbVie: 'We have entered a new phase in our biosimilar strategy' (BioPharma-Reporter)
  • Letters to the Editor: Getting to the Root Causes of Drug Shortages (NYTimes)
  • Sandoz, Pfizer and regulators back biosimilar data extrapolation (BioPharma-Reporter)
  • PRVs Revisited During Drug Pricing Hearing: FDA Still Doesn't Like Them (RPM Report-$)
  • GPhA responds to Congressional hearing on BCPIA (DSN)
  • FDA Aims To Tap Sentinel Data Network For Drug Effectiveness Studies (Pink Sheet-$) (Focus)
  • Biosimilar Committee Roster Shows More Focus On Analytics For Inflectra (Pink Sheet-$)
  • Call Martin Shkreli Whatever You Want, But Not A Pharma CEO (Forbes)
  • Biogen joins international effort to share preclinical data (Boston Business Journal)
  • The value of surrogate endpoints for predicting real-world survival across five cancer types (Healthcare Economics)

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

  • Amgen's Repatha Meets Endpoints In GAUSS-3 Trial (SCRIP-$)
  • BioCryst's genetic disorder drug fails study, shares slump (Reuters)
  • Phase III Blincyto TOWER Study Stopped Early After Endpoint Met (SCRIP-$) (DD&D)
  • FDA Approves Expanded Use of Bristol-Myers Squibb's Daklinza (daclatasvir) for Additional Challenging-to-treat Patients with Genotype 1 or Genotype 3 Chronic Hepatitis C (Press)
  • Reneuron gets US patent for non-toxic cell cryopreservation system (BioPharma-Reporter)
  • FDA Grants Breakthrough Therapy Designation to Immunomedics for Sacituzumab Govitecan for the Treatment of Patients With Triple-Negative Breast Cancer (Press)
  • Sarepta Therapeutics Receives Notification of PDUFA Extension for Eteplirsen (Press)
  • FDA grants Orphan Drug status to Asterias Biotherapeutics' AST-OPC1 to treat acute spinal cord injury (PharmaBiz)
  • Promius Pharma™ Receives FDA Approval for Sernivo (betamethasone dipropionate) Spray, 0.05% (Press)
  • CTI BioPharma Provides Update On Investigational Agent Pacritinib (Press)
  • Sangamo BioSciences Announces FDA Clearance Of Investigational New Drug Application For ZFN-Mediated Genome Editing Treatment Of MPS I (Press)
  • Epizyme Announces Tazemetostat Granted Orphan Drug Designation for Malignant Rhabdoid Tumors by U.S. FDA (Press)
  • Atara Bio Receives FDA Orphan Drug Designation for EBV-CTL to Treat Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disorder (Press)
  • Cartiva, Inc. Announces Tentative Date of FDA Advisory Panel Review of Cartiva SCI (Press)
  • Cytori Reports Interim Data On U.S. Phase II Osteoarthritis Trial - Quick Facts (RTTnews)

US: Medical Devices

  • Spectranetics Receives FDA 510(k) Clearance for Bridge™ Occlusion Balloon for Lead Extraction Procedures (Press)
  • Short battery life of pacemakers puts patients at risk of serious complications (OnMedica)
  • FDA Issues Draft Guidance Regarding Interoperable Medical Devices (FDA Law Blog) (Focus)
  • Technology Provides Opportunities for Medical Device Companies (Life Science Leader)
  • scPharmaceuticals' drug/device combo aims at replacing IVs in antibiotic drug delivery (MedCityNews)

US: Assorted and Government

  • Amgen Urges No Exceptions To Biosimilar Notice At Fed. Circ. (Law360-$) (SCRIP-$)
  • 6th Circ. Told Pliva Can't Dodge FDA's Stance On Warnings (Law360-$)
  • Supernus Gets Partial Win In Drug Patent Row With Actavis (Law360-$) (Reuters)
  • Fed. Circ. Affirms Validity Of Vascular Stent Patent (Law360-$)

Upcoming Meetings and Events

Europe

  • NICE says 'no' to alirocumab in draft guidance (EPR)
  • NICE rejects cholesterol drug Praluent in draft guidance (Pharmafile)
  • Review of information technology in NHS (GOV.UK)

India

  • Medical device industry urges govt to stop insisting on US FDA certification in tendering process (Pharmabiz)
  • Drug firm Strides acquires controlling stakes in Kenyan, Australian cos (Economic Times)
  • Dr Reddy's Laboratories gets USFDA approval to market Sernivo spray (Economic Times)
  • Government withdraws customs exemption on 74 drugs (Economic Times)
  • Withdrawing customs duty may lead to hike in medicine prices: DG Shah (Economic Times)
  • The pill that costs $9,000 in US sells for $70 in India (Economic Times)
  • Strides Shasun Receives Positive WHO Inspection Report For Formulation Facility (24 Insight)

China

  • Understanding Regs Key As CFDA Toughens GMP Enforcement (Pink Sheet-$)

Canada

  • AngioDynamics wins Health Canada nod for new Celerity device (MassDevice)

Zika Virus

  • Zika Messes with Texas (Harvard Bill of Health)
  • CDC: Link between Zika, microcephaly looks "stronger and stronger" (Reuters)
  • Condom makers step up to help with Zika effort (Reuters)
  • White House seeks $1.8 billion from Congress to combat Zika (Reuters)
  • Doctors puzzle over severity of defects in some Brazilian babies (Reuters)
  • Puerto Rico declares public health emergency over Zika virus (Reuters)
  • Zika Virus Transmittable Through Sex; Unclear Risk From Saliva, Urine (Forbes)
  • Brazil finds Zika in saliva, urine; expert warns against kissing (Reuters)
  • France restricts blood transfusions over Zika virus (Reuters)
  • CDC widens Zika virus guidelines for pregnant women (Reuters) (CDC)
  • Developing vaccine for Zika to take time: Johnson & Johnson's Paul Stoffels (Economic Times)
  • Lawyers see limited legal options for workers sent in Zika's way (Reuters)
  • More than 3,100 pregnant women in Colombia have Zika virus: government (Reuters)
  • U.S. athletes should consider not attending Olympics if fear Zika – officials (Reuters)
  • Athletes weigh gold lust against Zika health fears (Reuters)

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.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @Michael_Mezher or send him an email at news@raps.org.

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


Categories: Recon, Regulatory News

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