Regulatory Recon: CDC Issues Long Awaited Opioid Guidelines, UK NSCLC Patients to get Early Access to Keytruda (16 March 2016)

Posted 16 March 2016 | By Michael Mezher 

Regulatory Recon: CDC Issues Long Awaited Opioid Guidelines, UK NSCLC Patients to get Early Access to Keytruda (16 March 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

  • Former FDA chief Margaret Hamburg speaks out about Califf, Cruz, and Congress (STAT)
  • Xavier University & PwC Pharmaceutical Quality Metrics White Paper (PwC)
  • FDA panel OKs Abbott's Absorb stent (MassDevice) (MedpageToday)
  • CDC Releases Guideline for Prescribing Opioids for Chronic Pain (CDC) (WSJ-$) (NYTimes) (Reuters) (House E&C)
  • Confusion In The Age Of Genetic Information (CardioBrief)
  • How Gut Bacteria Are Shaking Up Cancer Research (Bloomberg)
  • A Road Map To Strategic Drug Pricing (InVivo-$)
  • Report: A new sign Obamacare is helping the people who really need it (Washington Post) (Express Scripts)

In Focus: International

  • Keytruda Gets Positive UK Early Access to Medicines Opinion for NSCLC (MHRA)
  • EDQM Cancels EU, Chinese Pharmacopoeia Workshop (EDQM)
  • Sanofi signs deal worth up to $2.3 billion with DiCE Molecules (Reuters) (Bloomberg)
  • Experts urge more cautious dosing after fatal French drug trial (Reuters) (BJCP)
  • FDA Warns Indian Pharma Company Over Repeat Data Manipulation Violations (Focus)
  • European drug regulator suspends Anuh Pharma's three drugs (Economic Times)
  • List of WHO Prequalified Quality Control Laboratories (WHO)

US: Pharmaceuticals & Biotechnology

  • Roche Commits Up To $1bn For Blueprint's Immunokinase Inhibitors (SCRIP-$)
  • A Conversation with FDA's OPQ Director Michael Kopcha (RPM Report-$)
  • Template for Public Assessment Summary Information for Biosimilar (PASIB) (IPRF)
  • Pfizer Moves To Block Unichem Over Xeljanz Patent (SCRIP-$)
  • FDA Announces Grant Award Opportunity for Antimicrobial Use and Resistance Data Collection (FDA)
  • Vaccine refusal tied to increased risk of measles and pertussis (Reuters)
  • PhRMA: Transparency and confidentiality in FDA's proposed quality metrics proposal is key (The Catalyst)
  • Collaboration in pre-clinical and clinical development: interview with Dalvir Gill (Health Business Blog)

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

  • Allergan gets Complete Response Letter from FDA for Restasis bottle (PharmaLetter-$)
  • Circassia Uses Adaptive Design For Phase III And Advances Commercial Plans (SCRIP-$)
  • Electronic Study Data Submission; Data Standards; Support End Date for Case Report Tabulation Data Definition Specification Version 1.0 (FDA)
  • Publication in Retrovirology of the results of Biosantech's phase IIA clinical trial for the anti-HIV candidate vaccine (Press)
  • Provectus Biopharmaceuticals Amends Protocol for Phase 3 Study of PV-10 in Treatment of Locally Advanced Cutaneous Melanoma (Press)
  • OPKO Health Announces Dosing of First Subject in Phase 1 Clinical Study of a Long-Acting Oxyntomodulin for the Treatment of Obesity and Type II Diabetes (Press)
  • Cerus Receives FDA Approval for Use of the INTERCEPT Blood System for Platelets Suspended in 100% Plasma (Press)
  • Halozyme Doses First Patient In Phase 3 Clinical Trial Of PEGPH20 In Combination With ABRAXANE And Gemcitabine (Press)
  • First-in-Class ChemoTx Granted Orphan Drug Status for Pediatric Brain CA (MPR)
  • Pfizer to Present New Data on Investigational Tofacitinib in Inflammatory Bowel Disease at the 11th Congress of ECCO (Press)
  • Bird Rock Bio Nears Pivotal Trial of New Biologic Drug for RA (Xconomy)
  • Baxter Enrolls First Patient in U.S. Clinical Trial for VIVIA Investigational Home Hemodialysis System (Press)

US: Medical Devices

  • The Road To Restoring Credibility: How Maintaining A Good Reputation With FDA Can Be An Uphill Battle For Manufacturers – But It's Possible (Gray Sheet-$)
  • Q&A: As IoT becomes more prominent, what increasing dangers do medical devices manufactures face? (MedCityNews)
  • User-Fee Sticker Shock? Industry Pursues Trimmed-Down MDUFA IV Proposal (Gray Sheet-$)
  • Duodenoscope Models TJF-160F and TJF-160VF by Olympus: Safety Communication - Reprocessing Instructions Validated (FDA)
  • CardiacAssist wins 510(k) for TandemLung (MassDevice)
  • InfoBionic Receives FDA 510(k) Clearance for MoMe Kardia (Press)
  • Baxter launches trial for Vivia home hemodialysis system (MassDevice)

US: Assorted & Government

  • 5 Major Hospital Hacks: Horror Stories from the Cybersecurity Frontlines (IEEE Spectrum)
  • Sanofi Underplayed Dangers Of Chemo Drug, Suit Says (Law360-$)
  • Out to the Woodshed in Louisiana (Drug and Device Law)
  • U.S. agency pushes reforms to protect drug-dependent babies (Reuters)
  • Breaking Good? The Arc Of Antitrust Policy In The Health Sector (Health Affairs Blog)
  • Massachusetts Adopts Comprehensive Legislation To Curb Opioid Abuse (National Law Review)
  • A bill to direct the NIH to intensify and coordinate fundamental, translational, and clinical research with respect to the understanding of pain, the discovery and development of therapies for chronic pain, and the development of alternatives to opioids for effective pain treatments (Congress)

Upcoming Meetings & Events


  • Already 13 EMA GMP Non-compliance Reports in 2016 published (ECA)
  • EU Orphan Law A 'Remarkable Success' But Approval Speed and Patient Access Still Poor (SCRIP-$)
  • Seven Types Of Scrutiny: A Tangled And Costly Web Ahead For Device Makers (SCRIP-$)
  • Allergan's UK Generics Business Up For Sale Under EC Merger Condition (SCRIP-$)
  • EFPIA: Protecting the European Meds Verification System from fakers is vital (In-PharmaTechnologist)
  • NeMaura wins CE Mark for sugarBEAT wearable CGM (MassDevice)


  • Asia Regulatory Roundup: India Reverses Opposition to Off-Label Ophthalmic Use of Avastin (15 March 2016) (Focus)
  • 'China is hungry,' as drug innovation push continues (Outsourcing-Pharma)
  • Study confirms BETADINE efficacy for foot&mouth disease (BioSpectrum)
  • Routine Pediatric Enterovirus 71 Vaccination in China: a Cost-Effectiveness Analysis (PLOS)


  • Banning FDCs a right move by govt as it help to reduce unwanted intake of medicines: Experts (PharmaBiz)
  • Drug ban: Pharma market to see immediate loss of Rs 1,000 crore (Economic Times)
  • 'Banned drugs cannot be returned promptly' (Economic Times)
  • Delhi High Court grants interim stay on ban of Abbott's Phensedyl (Economic Times)
  • MSF expresses concern over India's verbal assurance to US groups to not to use compulsory licence option (PharmaBiz)
  • Bill to set up biotechnology centre introduced in Lok Sabha (Economic Times)
  • After Pfizer, Delhi High Court grants relief to Abbott and Macleods (Economic Times)


  • Regulatory requirements for in-house IVDs (TGA)
  • Idelalisib (Zydelig) 100 mg and 150 mg tablets (TGA)

Zika Virus

  • Thermo Fisher Scientific offers EUROIMMUN anti-Zika virus test kits (BioSpectrum)
  • Cuba reports first case of Zika contracted in the country (Reuters)
  • Study strengthens Zika-microcephaly link, women and babies at risk (Reuters)
  • Study of Zika Outbreak Estimates 1 in 100 Risk of Microcephaly (NYTimes)

General Health & Other Interesting Articles

  • Robotic sampling devices find pharma compounds in marine water (In-PharmaTechnologist)
  • Woman Says Cancer Test Company Fired Her For Having Cancer (Forbes)
  • No evidence that genetic tests change people's behavior (MNT)

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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