Regulatory Recon: Senate HELP Committee to Vote on Califf Nomination Next Week (5 January 2016)

Posted 05 January 2016 | By Michael Mezher 

Regulatory Recon: Senate HELP Committee to Vote on Califf Nomination Next Week (5 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

  • Senate HELP Committee to Vote on Califf Nomination Next Week (The Hill) (BioCentury) (SCRIP-$)
  • Which Drugs are Going Off-Patent in 2016? (MedCityNews)
  • Gilead Gets FDA Priority Review of Hepatitis C Combo Drug (WSJ-$)
  • US Emergency Departments Face Serious Drug Shortages (MNT) (Study)

In Focus: International

  • India MoH Proposes Steep Fee Hike for Drugs Licenses, Registration, Manufacturing  (Economic Times)
  • Teva, Active Biotech Halt Higher Doses of Oral MS Drug in Trials (Reuters) (Pink Sheet-$)
  • We Need Clinical Trials But Must Remain Vigilant Against Their Abuse (The Guardian)
  • Japan's Push on Innovative Drugs Gets a Budget Boost (FiercePharmaAsia)
  • Japan's Import Notification Requirements for Medical Devices Changing in 2016 (Emergo)

US: Pharmaceuticals and Biotechnology

  • 2015: Another Strong Year for Patients in Need of New Drug Therapies (FDA Voice)
  • FDA cautions about dosing errors when switching between different oral formulations of antifungal Noxafil  (FDA)
  • Navigating biosimilar approvals: start conversations early, says IP lawyer (BioPharma-Reporter)
  • FDA's bioequivalence rules are out of date and need to be modernized (In-PharmaTechnologist) (Focus)
  • Promise Of High Prices Now Driving Biopharma R&D Investments (Forbes)
  • 2015 New Drug Approvals Hit 66-Year High! (If you Include CBER Approvals) (Forbes)
  • FDA's Rx Promotion Citation Drought Continued In 2015 (Pink Sheet-$)
  • Risk of heart damage follows some childhood cancer survivors (Reuters)
  • Infertility treatment not inherently tied to developmental problems (Reuters) (NIH)
  • New class of blood pressure meds as effective as old, analysis shows (Washington Post)
  • Otiprio OK'd for Use in Children Undergoing Tympanostomy Tube Surgeries (MPR)
  • Listen up, pharma marketers--to patients' social media posts, that is (FiercePharmaMarketing)
  • Patients with chronic condition open to DTC advertising, survey reveals (FiercePharmaMarketing)
  • Gene Editing Could Yield New Muscular Dystrophy Therapy (DD&D)

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

  • Gilead Announces Top-Line Results From Two Phase 3 Studies Evaluating Tenofovir Alafenamide (TAF) for Patients With Chronic Hepatitis B Infection (Press)
  • SteadyMed Receives Orphan Drug Designation for Trevyent for the Treatment of Pulmonary Arterial Hypertension (Press)
  • Ionis Pharmaceuticals Receives Orphan Drug Designation from the US FDA for IONIS-HTT Rx for the Treatment of Patients with Huntington's Disease (Press)
  • DHEA vaginal suppository good alternative to estrogen creams (Reuters)
  • Clearside Biomedical, Inc. Announces Positive Topline Data from Phase 2 Clinical Trial for the Treatment of Macular Edema Associated with Non-Infectious Uveitis (Press)
  • Allegro Ophthalmics Announces Last Patient Enrolled in DEL MAR Phase 2b Clinical Trial of Luminate® for the Treatment of Diabetic Macular Edema (Press)

US: Medical Devices

  • US FDA Revisits UDI Requirements for "Convenience Kits" (Emergo)
  • 2016 Will Be A Big Year For Combo Product Reform, US FDA Says (SCRIP-$)
  • NOWDiagnostics is using quick fingertip-prick blood testing to identify disease, and it's fully approved (MedCityNews)
  • At Theranos, Many Strategies and Snags (WSJ)
  • Wearable device works to predict lactate threshold (Reuters)
  • iHear Medical gains FDA approval for OTC hearing test (DSN)
  • Should you worry about the radiation from CT scans? (Washington Post)
  • FDA warns of Class 1 recalls from Boston Scientific, Draeger and Insulet (FierceMedicalDevices)
  • Artificial pancreas from UVA heads to trials (MassDevice)
  • Gore touts bioabsorbable hernia mesh study data (MassDevice)
  • InVivo Therapeutics wins FDA approval for pivotal trial of spinal scaffold (MassDevice)
  • Class 1 Recall: The Fuhrman Pleural/Pneumopericardial Drainage Set (FDA)

US: Assorted and Government

  • GMP Problems No Excuse for Caraco's Lack of WARN Act Layoff Notifications (FDA Law Blog)
  • FDA Rejected Warnings Sought In $140M Motrin Case: J&J (Law360-$)
  • Pathway Genomics To Pay $4M In FCA Settlement (Law360-$)
  • 5 Of The Top Drug And Device Developments In 2015 (Law360-$)
  • US Lawmakers Hit FDA Over 'Inadequate' Scrutiny of Indian, Chinese Sites (PharmAsiaNews-$)
  • Endocyte Dodges Class Action Over Cancer Drug Claims (Law360-$)
  • Plaintiff Tries To Amend Under Fed. R. Civ. P. 15 But Is Denied Under Fed. R. Civ. P. 59 & 60 (Drug and Device Law)
  • Pacira Settlement and the Future (Policy and Medicine)
  • US refocuses on testing to fight deadly hog virus (Reuters)
  • Spotlight vs Blind Spot (in Drug Cost Reporting) (DrugWonks)

Upcoming Meetings and Events              


  • UK regulators license BAT e-cigarette as quit-smoking medicine (Reuters) (OnMedica)
  • France Leads Europe In Reimbursing Truvada For HIV Prophylaxis (SCRIP-$)
  • Britain set for first mass strike by doctors in 40 years (Reuters)
  • AXIM bags pot discount for gum to treat multiple sclerosis (Reuters)
  • Celyad's CAR-T shows safe profile in early trials (PharmaPhorum)


  • Government plans Rs 500 crore pharma technology upgradation fund (Economic Times)
  • State FDA seizes huge stocks of codeine containing cough syrups from unlicensed traders (PharmaBiz)
  • FDA set to add inspectors to India, report says (FiercePharmaAsia-$)


  • Questions and Answers Document: Ethnic Factors in the Acceptability of foreign Clinical Data - ICH Topic E5(R1) (Health Canada)
  • Rx&D Becomes Innovative Medicines Canada (SCRIP-$)

Other International

  • Asia 2015: A Tale Of Regulation, Reform And Restructuring (PharmAsiaNews-$)
  • Study finds West Africa at highest risk of bat-to-human virus spread (Reuters)
  • Indonesia pharma investment cap eyed as top firms plan new plants (FiercePharmaAsia)
  • B. Braun seeks World Bank loan to support construction of Indonesia parenterals plant (In-PharmaTechnologist)

General Health and Other Interesting Articles

  • Regular Use of Aspirin May Lower Men's Risk of Advanced Prostate Cancer (WSJ-$)
  • US Becomes More Vulnerable to Tropical Diseases Like Zika (NYTimes)
  • The big chill: Cryotherapy may be trendy, but does it work? (Washington Post)
  • You just heard another alarming health report. Should you be scared? (Washington Post)
  • Periodic table gains four new superheavy elements, filling up the seventh row (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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