Regulatory Focus™ > News Articles > Regulatory Recon: Califf Calls for Industry Collaboration; Obama Adds Zika to PRV Program as Congres

Regulatory Recon: Califf Calls for Industry Collaboration Obama Adds Zika to PRV Program as Congress Denies More Funds (20 April 2016)

Posted 20 April 2016 | By Michael Mezher 

Regulatory Recon: Califf Calls for Industry Collaboration Obama Adds Zika to PRV Program as Congress Denies More Funds (20 April 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: FDA can't isolate itself from industry, despite 'touchy' issues (STAT)
  • NIH Halts Some Research Amid Concerns Over Contamination And Safety (NPR) (SCRIP-$) (NIH) (Focus)
  • What A Toddler And Her Tumor Can Teach Us About Cancer Research (Forbes)
  • NIH study finds factors that may influence influenza vaccine effectiveness (NIH)
  • FDA's Foray Into Big Data Still Maturing (JAMA)
  • Obama signs Zika voucher bill into law (BioCentury) (CBS)
  • Additional Funding to Combat Zika Denied in House Markup of FDA Spending Bill (Focus) (IHP)
  • FDA approves Avedro's KXL eye treatment (Mass Device)
  • Roche Revenue Lifted by Cancer and Immunology Drugs (WSJ-$) (Pink Sheet-$)
  • What We Mean When We Talk About EvGen Part I: Laying the Foundation for a National System for Evidence Generation (FDA Voice)
  • October launch for Pfizer's Remicade biosimilar? Not if Janssen can help it (BioPharma-Reporter) (Pink Sheet-$)
  • Maker of Robotic-Assisted Surgical Systems Beats Profit Forecasts (WJS-$)
  • Form 483 Details Deficiencies at Catalent Facility Linked to Recent CRL (Focus)

In Focus: International                                                         

  • The secret of a world-class biotech sector (Financial Times)
  • WHO Removes Two APIs From Prequalified API List (WHO) (Focus)
  • Another FDA Warning Letter for an Indian Drugmaker: More Data Integrity Violations (Focus)
  • Slight Increase in Norwegian Drug Consumption in 2015 (DD&D)
  • IQWiG finds no added benefit for Xalkori in bronchial carcinoma (PharmaLetter-$)
  • EMA to review canagliflozin over amputation risks (Pharmaceutical Journal)

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US: Pharmaceuticals & Biotechnology

  • Postapproval CMC Changes: FDA Updates Guidance (Focus)
  • FDA Opinion on Proactive Response to Prescription Opioid Abuse (Policy and Medicine)
  • Will 2016 Bring US Biosimilar Reimbursement Clarity? (SCRIP-$)
  • Johnson & Johnson Beats Expectations, Boosts Guidance (WSJ-$)
  • Naltrexone cuts relapse rate and overdose among opioid-dependent offenders (Pharmaceutical Journal-$)
  • The list of cancers that can be treated by immunotherapy keeps growing (Washington Post)
  • Coming Soon to a Pharma Inspection Near You: The Program Alignment Group (PAG) Plan (GxP Lifeline)
  • Diabetes may shorten healthy years of life (Reuters)
  • Ignoring Criticism, Drug Companies Still Raising Prices, Making More Money (The Street)
  • Pharma and biotech companies: Don't just merge, innovate (STAT)
  • Biosimilar Manufacturer Reliability Is Key To Market Uptake, Amgen Says (Pink Sheet-$)
  • Pharmakon Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of All Sterile Compounded Products Due to FDA Concern of Lack of Sterility Assurance (FDA)
  • PDUFA Clock Ticks For FDA Decision On First OTC Acne Ingredient NDA (Tan Sheet-$)
  • Pace of change in CRO industry increasing, says ISR (Outsourcing-Pharma)
  • Joint Commission says its pain-management standards didn't fuel opioid epidemic (Modern Healthcare)
  • Congrats, Your Vaccine Works; Now, Who Will Buy It?  (SCRIP-$)
  • RedHill Biopharma excited at FDA positivity on 'potential blockbuster' (PharmaLetter-$)
  • BI, Lilly To Study Jardiance As Heart Failure Therapy (SCRIP-$)
  • Ten-year follow-up shows efficacy of Sanofi's MS drug Lemtrada (PharmaLetter-$)
  • HHS Sponsors New Broad-Spectrum Antibiotic Development (ICT)

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

  • Bristol-Myers' Opdivo extends survival in head and neck cancer: study (Reuters) (Press)
  • BRIEF-Biomarin provides preliminary data on first 8 patients in Hemophilia A gene therapy program (Reuters)
  • Bluebird's Gene Therapy Shows Promise in Rare Brain Disease (Xconomy)
  • Clinical trial for experimental Ebola drug publishes results (MNT) (PLOS)
  • Sucampo's cobiprostone misses Phase IIa reflux endpoint (BioCentury)
  • Marathon preps deflazacort NDA to treat DMD (BioCentury)
  • Pfizer hopes new data lead to Ibrance's full first-line approval (BioCentury)
  • Rare pediatric cancer infantile fibrosarcoma (IFS) successfully treated with new targeted therapy (MNT)
  • PD-1 Blockade with Pembrolizumab in Advanced Merkel-Cell Carcinoma (NEJM)
  • NanoCor Therapeutics Announces FDA Acceptance of Investigational New Drug (IND) for Carfostin (Press)
  • FDA Grants Orphan Drug Exclusivity to EVOMELA (melphalan) for Injection, Indicated for Multiple Myeloma (Press)
  • Acorda Announces Results from Phase 2b Clinical Trial of CVT-301 for Treatment of OFF Periods in Parkinson's Disease Published in Movement Disorders (Press)
  • Patient Dosing Initiated for OMS721 Phase 2 Program in Renal Diseases (Press)
  • SpinalCyte, LLC Announces Final Results From Phase II Animal Trials Using Human Dermal Fibroblast Transplantation for Intervertebral Disc Degeneration (Press)
  • Alnylam Reports Complete 18-Month Data from Ongoing Phase 2 Open-Label Extension Study of Patisiran, an Investigational RNAi Therapeutic Targeting Transthyretin for the Treatment of Hereditary ATTR Amyloidosis with Polyneuropathy (hATTR-PN) (Press)

US: Medical Devices

  • Internet petition wants Congress to oust CDRH head Shuren (Mass Device)
  • FDA Still Lags In Cybersecurity Game, Expert Says (Gray Sheet-$) (Focus)
  • FDA Active on Device Front for Q1 2016 (National Law Review)
  • Medtronic Announces Worldwide Voluntary Recall for Battery Pack in Covidien Oridion Labeled Capnostream(TM)20 and Capnostream(TM)20p Patient Monitors (Press)
  • Boston Scientific Corporation Recalls Fetch 2 Aspiration Catheter Due to Shaft Breakage (FDA)
  • Real-World Study Shows 72 Percent of Atrial Fibrillation Would Have Gone Undiagnosed in Stroke Patients if Cardiac Monitoring Had Been Limited to 30 Days (Press)
  • St. Jude expands EnSite Precision launch in EU, seeks FDA approval (Mass Device)
  • Patient enrolled in InVivo Therapeutics trial succumbs to injuries (Mass Device)

US: Assorted & Government

  • 340B Pricing, Penalty Alternatives Will Be Reassessed; Final Rule Delayed (Pink Sheet-$)
  • Obamacare Seems to Be Reducing People's Medical Debt (NYTimes)
  • U.S. House committee votes to smooth e-cigarette regulatory path (Reuters)
  • Express Scripts says Anthem negotiated in bad faith: court filing (Reuters) (WSJ-$)
  • Immunosyn CEO Hid FDA Hold From Investors, Jury Told (Law360-$)
  • TPPs Fail to Put Their Money Where Their (Litigation) Mouth Is and Lose (Drug and Device Law)
  • The FTC's "Pay-for-Delay" Lawsuit Against Endo: Is There a Hole in the Commission's Generic LIDODERM 180-Day Exclusivity Analysis? (FDA Law Blog)
  • Gutsy Gatekeeping: Plaintiffs' Experts Excluded in Lipitor MDL (Drug and Device Law)

Upcoming Meetings & Events

Europe

  • Illumina Shares Take Hit on Weakness in Europe (WSJ-$)
  • GSK, Others Appeal UK Watchdog's Pay-For-Delay Penalties (Law360-$)
  • Shire to construct $400m biologics plant in Ireland; create 400 jobs (BioPharma-Reporter)
  • Ortho Kinematics wins CE Mark for spinal motion analyzer (Mass Device)
  • Boston Scientific wins CE Mark for MR-safe Emblem S-ICDs (Mass Device)
  • Baxter Receives Marketing Authorization in the United Kingdom and Denmark for NUMETA G13E Ready-To-Use IV Nutrition for Preterm Newborns (Press)

Asia

  • Turkey Regulatory Update: New Vaccine Policy, Drug Protocol (PharmasiaNews-$)
  • CHAI partners with six Asian countries to initiate Hep C treatment programs (BioSpectrum)
  • Pluristem in talks with large Japanese firm interested in cell therapy pact (BioPharma-Reporter)

India

  • CDSCO to issue test license for import of small quantities of drugs online through SUGAM (PharmaBiz)
  • USFDA warns Sri Krishna Pharma for CGMP norm violations (Economic Times)

Zika

  • Chilean authorities find Zika mosquito for first time in decades (Reuters)
  • Zika: Conservative Politics Meets The Reality Of Sex (Forbes)
  • Is Crowdfunding An OK Way To Raise Money For Zika Research? (NPR)

Other International

  • Mexico's president says he is open to legalizing medical marijuana (Reuters)

General Health & Other Interesting Articles

  • Why Beneficial Epidemics Spread More Quickly than Harmful Ones (MIT Technology Review)
  • Human Experimentation: Rethinking The 'Bad Old Days' (Fobres)
  • Life expectancy for white females in U.S. suffers rare decline (Washington Post)
  • Observational Evidence of For-Profit Delivery and Inferior Nursing Home Care: When Is There Enough Evidence for Policy Change? (PLOS)

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 news@raps.org.

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


Categories: Recon, Regulatory News

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