Regulatory Recon: Pediatric OxyContin Approval Draws Scrutiny, AstraZeneca Pauses Two Cancer Trials and Senators Call on CMS to Delay Biosimilar Policy (9 October 2015)

Posted 09 October 2015 | By Michael Mezher 

Regulatory Recon: Pediatric OxyContin Approval Draws Scrutiny, AstraZeneca Pauses Two Cancer Trials and Senators Call on CMS to Delay Biosimilar Policy (9 October 2015)

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

  • FDA Approval of OxyContin Use for Children Continues to Draw Scrutiny (NYTimes)
  • Senator Calls for FTC Investigation of Drug Price Increases (FDANews-$) (Letter)
  • Senators urge CMS to delay biosimilar reimbursement policy (BioCentury) (Letter) (SCRIP-$)
  • AstraZeneca pauses two lung cancer drug combination trials (Reuters) (FierceBiotech) (Bloomberg)
  • CDC's Flawed Opioid Efforts. Attention must be paid. (DrugWonks)

In Focus: International

  • A love story that cost GVK its international reputation (The Hindu)
  • Low- and middle-income countries lack assistive devices for elderly (Reuters)
  • ENVI Committee to Hear Statement from Guido Rasi Following Nomination (ENVI)
  • Glenmark evaluating legal options over diabetes drugs setback (Economic Times)
  • EFPIA Highlights Europe ‘Lessons’ As Japan Ponders Policies (PharmAsiaNews-$)

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US: Pharmaceuticals and Biotechnology

  • Earning The Right To Say FDA Registered Outsource Facility (Pink Sheet-$)
  • Blog: Our day at the FDA: Who’s being protected? (The Inquirer)
  • When It Comes To Cancer Drugs, What Is A Year Of Life Worth? (Forbes)
  • Pharma execs talk innovation challenges, evolution of trials (MobiHealthNews)
  • How will biosimilars be affected by the TPP (GaBI)
  • Data Integrity Issues Cited in All Eight FDA Warning Letters to API Makers in FY15 (FDANews-$)

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

  • Institute of Human Virology Begins Phase 1 Clinical Trials of HIV Vaccine Candidate (Press)
  • FDA Accepts Supplemental New Drug Application (sNDA) for DALVANCE (Press)
  • FDA grants Fast Track designation to avelumab for Merkel cell carcinoma (EuropeanPharmaceuticalReview)
  • Treatment for rare bleeding disorder effective and well-tolerated, studies show (MNT)

US: Medical Devices

  • FDA allows marketing of the first nucleic acid-based test to detect multiple pathogens from a single sample of cerebrospinal fluid (FDA)
  • Proposed Intended-Use Amendments Invite Questions About FDA's Off-Label Intentions (Gray Sheet-$)
  • The Retrospective Approach To Companion Diagnostics (Law360-$)
  • US FDA: Functional Equivalence for Reformulated Sterilization Product from DuPont (Emergo)
  • Watchdog Verifies FDA Review Of Disputed Device Approvals (Law360-$)
  • The social cost of FDA’s bias against new technology (MobiHealthNews)
  • StimGuard wins another IDE nod for bladder treatment trial (MassDevice)
  • FDA clears Medtronic’s Tyrx envelope for DBS devices (MassDevice)
  • CDC-Funded Study Proves Germ-Killing Robot Can Help Hospitals Reduce HAIs (MedDeviceOnline)
  • Carestream Obtains FDA Clearance for Diagnostic Reading of ECG Waveforms on Mobile Tablets Using Vue Motion Viewer (Press)
  • Ambry Genetics presents groundbreaking TP53 gene data at ASHG; TP53 linked to breast cancer (MNT)
  • FDA approves expanded label for InSightec’s ultrasound uterine fibroid device (MedCityNews)
  • Neurocrine's neurological disorder drug effective in late: stage study (Reuters)

US: Assorted and Government

  • A Quarter Century of Groundbreaking Science: The Forensic Chemistry Center (FDAVoice)
  • Supreme Court Must Act Fast On IPR Questions: Petitioner (SCRIP-$)
  • Finance Chairman Bristles At TPP's Drug, Tobacco Provisions (Law360-$)
  • Impossibility Preemption Is Possible In 510(k) Drug Cases (Law360-$)
  • Sun Pharma withdraws lawsuit filed by Ranbaxy against USFDA (Economic Times)
  • Sheller To Appeal Suit Over FDA Inaction On Risperdal Docs (Law360-$)
  • Bernie Sanders Opposes Califf Nomination To Lead FDA, Cites Pharma Industry Ties (Forbes)

Upcoming Meetings and Events


  • Friends Or Foes? The Changing Regulator/Industry Relationship In Europe (SCRIP-$)
  • NICE recommends Keytruda for advanced skin cancer (PMLive)
  • Clarification on Software Among Revisions In EU Manual On Borderline Devices (SCRIP-$)
  • Teva's thrice-weekly Copaxone approved in Russia (PharmaLetter-$)
  • Epilepsy: Vimpat EU positive monotherapy Phase 3 results (MNT)


  • India improves processes for clinical trials (PharmaPhorum)
  • DoP again extends voluntary implementation of UCPMP by pharma companies till December 2015 (PharmaBiz)
  • Unichem gets USFDA nod for generic asthma treatment tablets (Economic Times)
  • India setting up chain of high-tech viral diagnostic labs (Economic Times)


  • Notice: Clarification of bioanalytical method validation procedures (Health Canada)


  • Advertising health services with Schedule 3, Schedule 4 or Schedule 8 medicines (TGA)

Other International

  • Eisai Receives Approval FOR Anticancer Agent Lenvima® in South Korea (Press)

Ebola Outbreak

  • Ebola's persistence in survivors fuels concerns over future risks (Reuters)
  • J&J starts vaccine trial in Sierra Leone, even as Ebola fades (Reuters)
  • Ten quarantined in Nigeria over Ebola scare (Reuters)

General Health and Other Interesting Articles

  • Should a patient have a right not to know genetic information about him or herself? (Harvard Bill of Health)
  • The first ancient African genome reveals complex human migrations (Washington Post)

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

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

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