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Regulatory Recon: Senate to Hold Procedural Vote on Califf Nomination Today, Taiwan FDA Approves Record 170 New Drugs in 2015 (22 February 2016)

Posted 22 February 2016 | By

Regulatory Recon: Senate to Hold Procedural Vote on Califf Nomination Today, Taiwan FDA Approves Record 170 New Drugs in 2015 (22 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

  • Review Times Remain A GDUFA II Topic (Pink Sheet-$)
  • Break Up the Insulin Racket (NYTimes)
  • FDA Calls for New Opioid Hearings as Califf Readies for Monday's Senate Vote (Focus) (STAT)
  • Side Effects Vary (The New Yorker)
  • Pentax Updates on FDA-Cleared Scope Labeling to Fight "Superbugs" (MassDevice) (FDA)
  • Evolving Industry Structures in Biosimilar Development (Harvard Bill of Health)
  • Vaccine has Sharply Reduced HPV in Teenage Girls, Study Says (NYTimes)
  • Big Pharma's Delicate Dance on Drug Prices (WSJ)
  • The Many Faces of the FDA (RxTrace)

In Focus: International

  • Eurasian Countries Agree to Harmonized Medical Device Framework (Emergo)
  • The Contribution of Mutual Recognition to International Regulatory Co-Operation (OECD)
  • Taiwan FDA Approved a Record Breaking 170 New Drugs in 2015 (PharmaLetter-$)
  • MHRA concerned about pharma's preparedness for excipient risk assessments (In-PharmaTechnologist)
  • Zika Virus and Microcephaly: Why is This Situation a PHEIC? (The Lancet)
  • China Research Highlights Country's Excess use of Antibiotics (Reuters)
  • China Suspends Ali Health-Run Online drug Monitoring Platform (Reuters)
  • EU Approves Bayer's Kovaltry for Haemophilia A (Reuters)

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US: Pharmaceuticals & Biotechnology

  • Hopes rise for a liver cancer breakthrough in 2016 (EP Vantage)
  • An example of how healthcare transparency fails: The battle against superbugs (MedCityNews) (KHN)
  • Edge's Aneurysm Drug Cuts Hospital Stays, Improves Outcomes (SCRIP-$)
  • FDA's Generic Drug Workload, Productivity Beating Budget Estimates (Pink Sheet-$)
  • Breakthrough Pace Shows No Signs Of Slowing (Pink Sheet-$)
  • New therapy could double chances of recovery from bleeding stroke for some patients (Washington Post)
  • 5 Steps to Forming a Consensus to Mitigate Adverse Events (RxView Blog)
  • Short shelf-life poses problems for cell therapy makers, Chiesi (BioPharmaReporter)
  • Making Cells Do Your Work (Also, The Revenge of the Yeast) (In The Pipeline)
  • Alliance Seeks $2.85 Billion for FDA for FY 17 (Alliance for a Stronger FDA)
  • FDA's OPQ Adapts ANDA Risk-Ranking Model for Drug Substance Reviews (IPQ)
  • How to Make the Most of Drugs We Already Have (NYTimes)
  • Pediatric Priority Review Voucher Designations Near 30; How Many Can Beat Sunset Date? (Pink Sheet-$)
  • Growing biosimilar pipelines pose long-term threat to branded pharma companies (PharmaLetter-$)
  • Stakeholders shaping FDA plan for patient perspectives (BioCentury)

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

  • Amgen, UCB say osteoporosis drug meets main goal in late-stage trial (Reuters)
  • After Failed Trial, Chimerix Shuts Down Two More Phase 3 Tests (Xconomy)
  • Merck's Investigational Once-Daily Formulation of ISENTRESS (raltegravir) Meets Primary and Secondary Endpoints in Pivotal Phase 3 Study (Press)
  • FDA Accepts Sanofi New Drug Application for Once-Daily Fixed-Ratio Combination of Insulin Glargine and Lixisenatide (Press)
  • Trevena, Inc. Receives FDA Breakthrough Therapy Designation for Oliceridine for the Management of Moderate-to-Severe Acute Pain (Press)
  • FDA Grants Orphan Drug Designation to Bellicum's BPX-501 for the Treatment of Immunodeficiency and GvHD Following Stem Cell Transplant (Press)
  • Pfizer Receives Expanded FDA Approval For IBRANCE (palbociclib) In HR+, HER2- Metastatic Breast Cancer (Press)
  • vTv Therapeutics Reports Preclinical and Clinical Results on its Diabetes Candidate TTP273 (Press)
  • Mylan's ANDA for Generic Advair Diskus Accepted for Filing by FDA (Press)
  • Spectrum Pharmaceuticals Announces FDA's Acceptance of NDA Filing for EOquin (apaziquone for intravesical instillation) (Press)
  • Shionogi preparing naldemedine submissions (BioCentury) (BioSpectrum)
  • Strategia Therapeutics Initiates a Phase 1 Clinical Trial of the Anti-cancer Agent "FF-10502" For FUJIFILM in Patients with Advanced Cancers (Press)
  • Seattle Genetics Initiates Phase 1/2 Trial of Vadastuximab Talirine (SGN-CD33A) Combination Therapy for Patients with Untreated Myelodysplastic Syndrome (MDS) (Press)
  • Lannett Receives FDA Approval For Sumatriptan Nasal Spray USP, 5mg And 20mg (Press)
  • Remedy Pharmaceuticals announces FDA orphan drug designation in two CNS indications (MNT)
  • Oral ozanimod 72-week phase 2 results from RADIANCE trial in relapsing multiple sclerosis presented (MNT)

US: Medical Devices

  • FDA panel votes against Medtronic's DIAM spine stabilization system (MassDevice)
  • Medicare contractor won't cover St. Jude Medical's CardioMEMS heart monitor (MassDevice)
  • FDA clears ScandiDos radiation dose monitor (MassDevice)
  • Paper Skin Mimics the Real Thing (IEEE Spectrum)
  • Blood test detects all known genes for inherited heart conditions (MNT)
  • Pharma companies looking at using video games for healthcare (Financial Times)
  • Critics say FDA medical device interoperability plan lacks teeth (Health Data Management)
  • Hospitech Respiration Ltd. Announced Clearance of a 510(k) Pre-Market Notification for the AnapnoGuard System (Digital Journal)

US: Assorted & Government

  • Markey blasts FDA opioid policy (BioCentury) (Letter to HHS)
  • FTC Requires Drug Marketer Hikma Pharmaceuticals PLC to Divest Rights to Five Generic Injectable Drugs as a Condition of Acquiring Certain Drug Products from Ben Venue Laboratories, Inc. (FTC)
  • Federal Regulators Propose Increase to Medicare Advantage Rates (WSJ-$)
  • Medicaid premium hikes may leave many children uninsured (Reuters)
  • GSK Ruling Raises Bar For Pharma On Brand Label Warnings (Law360-$)
  • Lupin, Gavis to sell 2 drugs to fulfil US FTC condition (Economic Times)
  • Governors Devise Bipartisan Effort to Reduce Opioid Abuse (NYTimes)
  • Breaking News - Bauman Trumps Jurisdiction By Consent in Second Circuit – and New Post-Bauman Cheat Sheet on General Personal Jurisdiction (Drug and Device Law)
  • 48 Hours in New Orleans: Food, Drugs, and – Oh, Right – Law (FDA Law Blog)
  • NuVasive wins a round in patent battle with Medtronic (MassDevice)

Upcoming Meetings & Events


  • UK Industry Survey Underlining Notified Body Flaws To Provide Ammo For EU Action (Clinica-$)
  • New fully-liquid pediatric hexavalent vaccine Vaxelis cleared in EU (PharmaLetter-$)
  • Generics Firms Advised To Engage Early In Europe's Referral Process (Pink Sheet-$)
  • European advice launched on heart failure (OnMedica)
  • AZ's Gout Drug PASS-ed In Europe (SCRIP-$)
  • Ciproflaxin resistance spreading says taskforce calling on drug industry for new antibiotics (In-PharmaTechnologist)
  • Medtronic Receives CE Mark for Full Line of Cardiac Resynchronization Therapy-Defibrillators Compatible with MRI Scans (Press)
  • GenDx Receives CE Mark for HLA Typing Software (GenomeWeb)


  • Data Presented at APASL from First Completed Phase 3 Trial of All-oral Chronic Hepatitis C Regimen in Chinese Patient Population Shows Daclatasvir and Asunaprevir DUAL Therapy Demonstrated High Cure Rates Among HCV Genotype 1b Patients (Press)
  • Japan's MHLW to review 3 drugs, 2 devices for Sakigake list (FiercePharmaAsia)
  • Korea To Expand Drug Support Incentives, Ease Listing Requirements (PharmAsiaNews-$)
  • Restaurant air poisons FDA staff (Taipei Times)


  • Prices of essential drugs to be cut by 3% from April (Economic Times)
  • Zydus Cadila's Ahmedabad Sez Unit Goes Online With Generic Monodox (24 Insight)
  • Top drug makers like Sun Pharma, Torrent, Cipla working on quality standards at manufacturing (Economic Times)
  • India, Canada soon to begin joint research to develop portable diagnostics & analysers (PharmaBiz)
  • Expert View: Recent Cases Lift Pharma Confidence In India's IP Protection (SCRIP-$)
  • India to Change Its Decades-Old Reliance on Female Sterilization (NYTimes)
  • IPC launches benefit-risk assessment cell for drugs under PvPI (PharmaBiz)
  • Maharashtra govt all set to adopt Clinical Establishment Act after 5 years (PharmaBiz)
  • Adverse event reporting format of MvPI put under stakeholder review for effective implementation (PharmaBiz)

    Zika Virus

    • WHO Advises Caution, but Not a Halt, in Blood Collection in Zika-Affected Areas (NYTimes)
    • Sanofi Set To Jump Zika Vaccine Scientific and Regulatory Hurdles (Pink Sheet-$)
    • South Africa confirms first case of Zika virus (Reuters)
    • Proof of Zika's Role in Birth Defects Still Months Away, WHO Says (NYTimes) (Reuters)
    • Zika Will Take A $664 Million Bite Out Of Cuban Tourism, World Bank Estimates (Forbes)
    • Updated Guidelines for Caring for Infants or Children with Possible Zika Virus Infection (CDC)
    • CDC, Brazil start big study to test Zika link to birth defects (Reuters)
    • Philanthropist Paul Allen announces $2 million in grants for Zika diagnostic, mosquito control (Washington Post)
    • How a tiny mosquito became one of the world's 'most efficient killers' (Washington Post)
    • Zika Spike Overwhelms Colombia Doctors (NPR)

    Other International

    • Iran, Russia sign 3 medical MOUs (Tehran Times)
    • New Zealand Favors EU SmPC Format For Drugs; Considers Data Sheets For Devices (SCRIP-$)

    General Health & Other Interesting Articles

    • Researchers find link between death of tumor-support cells and cancer metastasis (NIH)
    • Sleep apnea may be bad for kidneys (Reuters)
    • What Makes a Bacterial Species Able to Cause Human Disease? (ICT)

    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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