Regulatory Recon: Califf Responds to Senate Inquiries, China Precision Medicine Plan Expected in March (8 January 2016)

Posted 08 January 2016 | By Michael Mezher 

Regulatory Recon: Califf Responds to Senate Inquiries, China Precision Medicine Plan Expected in March (8 January 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

  • Califf Suggests Large Trials Using EHRs, Small Precision Trials To Lower Costs (Inside Health Policy-$)
  • A Biosimilar Must Say It's A Biosimilar: PhRMA/BIO (SCRIP-$)
  • ANDA Submission Boost May Dampen New Approval Record (Pink Sheet-$)
  • Sanofi, Regeneron say US FDA accepts review of sarilumab BLA (PharmaLetter-$) (Press)
  • House Committee Requests Drug Pricing Information From Valeant, Turing (FDANews-$)

In Focus: International

  • WHO approves third cholera vaccine producer (Reuters)
  • How Valeant Tripled Prices, Doubled Sales of Flatlining Old Drug (Bloomberg)
  • India will be self-reliant in bulk drugs by 2020: Government (Economic Times)
  • Indian Drug Quality Reports – 12 Drugs Fail CDSCO Quality Standards (24 Insight)
  • Factors affecting the uptake of 'similar biologics' in India (GaBI)
  • German HTA Rejects 'Major Added Benefit' Claim For Celgene's Imnovid (SCRIP-$)
  • 5 Key Indian Trial Regulation Play-Outs Anticipated in 2016 (SCRIP-$)
  • Precision medicine plan in China may be announced in March (FiercePharmaAsia)

US: Pharmaceuticals and Biotechnology

  • What's Next for the National Committee for Quality Assurance? (MedCityNews)
  • 2015 FDA Wrap-Up and 2016 Regulatory Priorities (National Law Review)
  • Heartburn pills may help grow infection-causing bacteria in gut (Reuters)
  • Parexel: 2016 prescribing decisions to be driven by clinical and real-world data (Outsourcing-Pharma)
  • Bad data: new methods needed to catch errors in clinical trials (Outsourcing-Pharma)
  • Personalised tissue will change drug development, says researcher (BioPharma-Reporter)
  • Oral contraceptive use early in pregnancy not tied to defects (Reuters)
  • Cancer drug shows promise for treating Duchenne muscular dystrophy (OnMedica)
  • Cepheid, USAID to Partner on Multidrug-Resistant TB National Action Plan (GenomeWeb)
  • FasterCures Comments on Federal Policy for the Protection of Human Subjects (FasterCures)

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

  • Roche says encouraged by cancer drug atezolizumab study (Reuters)
  • FDA gets into Rhythm with a 'breakthrough' title for orphan obesity drug (FierceBiotech)
  • TetraLogic Ends Birinapant MDS Trial After No Clinical Benefit Seen Over Placebo (SCRIP-$)
  • ViiV and Janssen to test new HIV regimen in Phase III trial (Pharmafile)
  • OSE Pharma announces initiation of its pivotal Phase 3 trial of Tedopi in non-small cell lung cancer (MNT)
  • Positive top-line Phase IIa trial results for DS107 as a treatment for atopic dermatitis (EPR)
  • Roche presents updated results for investigational cancer immunotherapy atezolizumab in advanced bladder cancer (Press)
  • Global Genomics Group (G3) and GNS Healthcare Report Preliminary Results of Largest-Ever Study Linking Biomarkers with Coronary Artery Disease (Press)
  • Roche prepares to file atezolizumab for bladder cancer (PMLive)
  • AcelRx Completes Protocol Review with FDA and Plans to Initiate Phase 3 Open-Label Study (IAP312) for Zalviso in 1Q 2016 (Press)

US: Medical Devices

  • Zombie Laboratory Company Sics Bill Collectors On Patients Promised Free Tests (CardioBrief)
  • FDA approves Integra Omnigraft Dermal Regeneration Matrix to treat diabetic foot ulcers (FDA)
  • FDA Issues Draft Guidance for Notifying the Public of Emerging Postmarket Medical Device Signals (FDA Law Blog) (Focus)
  • What's the CEO of Medtronic Doing At CES? (MDDI)
  • NeuroMetrix jumps on next-gen Quell FDA nod, but can't hold momentum (MassDevice)
  • PA rep Fitzpatrick wants FDA to launch criminal probe into morcellator deaths (MassDevice)
  • The Future of Wearables: Can Companies Avoid The Pitfalls Threatening Healthcare Wearables? (Forbes)

US: Assorted and Government

  • FDA 2015: A Look Back (and Ahead) – Part 3: Food, Tobacco, and Antimicrobial Resistance (FDA Voice)
  • New York opens marijuana clinics with emphasis on 'medical' (Reuters)
  • U.S. says 11.3 million Americans have signed up for 2016 Obamacare plans (Reuters)
  • Post-Grant Challenges In Life Sciences: 2015 In Review (Law360-$)
  • Drug distributors under fire in West Virginia painkiller epidemic (CBS)
  • Judge Cold To Otsuka's Exclusivity Claims In FDA Row (Law360-$)
  • The 'new' economics of drug pricing (PharmaPhorum)
  • New Dietary Guidelines Urge Americans to Eat Less Sugar (WSJ-$) (Washington Post) (Reuters)
  • Fitbit's heart rate monitoring accuracy questioned in class action suit (mobihealthnews)
  • Apotex Allies: Amgen's Views Distort Congress' Biosimilars Goals (SCRIP-$)

Upcoming Meetings and Events              


  • What Is The Starting Point For The Next Round Of EU Medical Device And IVD Trilogues? (Clinica-$)
  • Cardiome/SteadyMed's PAH Drug Approved for Review in EU (Press)
  • Novo Nordisk (NVO) Submits MAA for Nonacog Beta Pegol to EMA (Press)


  • Glenmark Pharmaceuticals starts studies on new drug aimed at cancer treatment (Economic Times)
  • Lupin gets USFDA nod to market oral contraceptives (Economic Times)
  • International funds to inject new life in government's vaccine drive  (Economic Times)
  • Mylan launches generic Hepatitis C drug in India (Economic Times)
  • Manus Pharma of Canada No Longer Interested In Indian Patent After Section 3(D) Objections (24 Insight)
  • Indian healthcare system needs 'antibiotic policy' for its prescription and use: IPA-RAD (PharmaBiz)
  • Pharmexcil to facilitate & resolve trade disputes of pharma exporters and importers (PharmaBiz)
  • Centre working to ensure Pharma R&D gets total IT exemption to drive innovation & drug discovery at faster pace (PharmaBiz)


  • Japan Industry Frets Blockbuster Price Slash Proposals (Pink Sheet-$)
  • Positive top-line results from the Japanese Phase II study of Traumakine® for the treatment of ARDS (EPR) (BioSpectrum)
  • Novocure Submits PMA Partial Amendment Application to Japanese Pharmaceuticals and Medical Devices Agency for Treatment of Newly Diagnosed Glioblastoma Patients (Press)

Other International

  • Turkey Regulatory Update: Reimbursement Case, New Early Trials Site (PharmAsiaNews-$)
  • Brazil to hire doctors, nurses to help in Rio health crisis (Reuters)

General Health and Other Interesting Articles

  • Last-Ditch Drug Resistance: China and Europe Respond (National Geographic)
  • Calorie cutting may help older obese people with thinking problems (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

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

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