Regulatory Focus™ > News Articles > Regulatory Recon: Cancer Drug Prices Continue to Rise Despite Competition, CFDA Releases 186 Device

Regulatory Recon: Cancer Drug Prices Continue to Rise Despite Competition, CFDA Releases 186 Device Standards (3 May 2016)

Posted 03 May 2016 | By Michael Mezher 

Regulatory Recon: Cancer Drug Prices Continue to Rise Despite Competition, CFDA Releases 186 Device Standards (3 May 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

  • The contradictory reasons cancer-drug prices are going up (Washington Post) (STAT) (Pink Sheet-$)
  • J&J ordered to pay $55 million in talc-powder trial (Reuters) (The Guardian)
  • FDA Again Reviews Mandatory Training for Painkiller Prescribers (NYTimes)
  • Biosimilar User Fee Reboot: Resource Challenges Make FDA Eye New Structure (Pink Sheet-$)
  • Experts Foresee Major Role For Generic Crestor (CardioBrief)
  • The Blues Singer Who Created America's Hated Drug-Pricing Model (Bloomberg)
  • The CRISPR Way to Think about Duchenne's (NEJM)
  • Why FDA should grant accelerated approval to eteplirsen for DMD (BioCentury)
  • Confusion Pushes FDA to Change Antidepressant's Brand Name  (Focus) (Medscape) (FDA) (Press)
  • Biotech's behind-the-scenes baroness redefined how universities launch startups (STAT)
  • Critical Drugs For Hospital ERs Remain In Short Supply (NPR)
  • What the analysts are saying about Sarepta's chances at the FDA (Fierce)
  • Pharma whistleblower: Consumers must question medicines' quality (CNBC)
  • Biotech's Theranos Offers A Cautionary Tale For Silicon Valley (NPR)
  • The Commercial Market For Priority Review Vouchers (HealthAffairs)
  • IMS Health to Buy Quintiles in $9 Billion Pharma Data Deal (Bloomberg)
  • Device Groups: FDA, Industry User Fee Goals At Odds, Real-World Evidence Not Worth The Money (InsideHealthPolicy-$)
  • Biosimilar User Fees: FDA Wants Longer Review Times (Politico)

In Focus: International

  • In-depth: MSF takes on Pfizer, GSK (Pharmafile)
  • CFDA promulgates 186 industry standards for medical devices (CFDA)
  • USTR: 97% of Counterfeit Drugs in US Shipped From Four Countries (Focus)
  • Evolution of frameworks for expediting access to new drugs in Japan (Nature)
  • Genomic Data and Drug Development: EMA Offers New Draft Guidance (Focus)
  • Elsevier's 'Hive Project' to promote drug discovery (Outsourcing-Pharma)
  • EMA Finalizes Process Validation Guidance (Focus)
  • US watch list may hit affordable drug business (Economic Times)
  • Ground-breaking WEB-RADR project marks mid-point (MHRA)
  • French regulators lift manufacturing ban at Catalent softgel plant (In-PharmaTechnologist)

US: Pharmaceuticals & Biotechnology

  • FDA Slowly Chips Away at ANDA Backlog (Focus)
  • Galapagos and AbbVie expand cystic fibrosis collaboration (PharmaLetter-$)
  • Even in a Golden Age of Medical Research, Can We Quicken Progress? (Faster Cures)
  • The Pocket-Sized Lab's Killer App: Analyzing Illegal and Semi-Legal Drugs (IEEE Spectrum)
  • Lauren Levinson Named PhRMA Vice President of Communications (PhRMA)
  • Breakthrough Nears 50 Approvals: Process Improving, But "Gray Areas" Persist (RPM Report-$)
  • Psychotherapy video chats may help with 'chemo brain' (Reuters)
  • "Growing" Biosimilars: How Plants Bolster Manufacturing Efficiency (BioprocessOnline)
  • PDUFA Renewal Comments: FDA Needs to Focus on Patient Perspectives (FDANews-$)
  • As Sarepta And Valeant Exit Hearings, Biotech Steps Into M&A (Forbes)
  • Opioid Abuse Contributes To Rising Health Care Costs (Forbes) (KHN)
  • Sharpening Neuro Focus, Biogen to Spin Out Hemophilia Biz (Xconomy)
  • Advance Could Help Grow Stem Cells More Safely (DD&D)
  • Xellia and US FDA agree to modified consent decree at ex-Ben Venue site (In-PharmaTechnologist)
  • NIH Awards Seattle Startup ID Genomics with $3 Million Grant to Rapidly Choose Correct Antibiotic Treatment (Press)
  • Can Insurers Curb Opioid Abuse? CDC Puts Spotlight On Payers (Pink Sheet-$)
  • Largest Independent U.S. Psoriasis Registry to Track Safety of New Biologic Treatment (Press)
  • Low NSAID Knowledge, Satisfaction In Consumer Pain Medication Survey (Pink Sheet-$)

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

  • Novogen's ovarian cancer drug set for trials in H1 2016 (BioSpectrum)
  • Regeneron says trial drug for osteoarthritis pain meets primary endpoint in Phase II trials (Pharmafile)
  • FDA approves oral suspension of Eisai's Fycompa (DSN)
  • Fresenius Renal Therapies Announces the Introduction of Next Generation Sentinel Technology to Support Fluid Management Challenges in the End Stage Renal Disease Community (Press)
  • Trevena Announces Successful End-of-Phase 2 Meeting with FDA and Outlines Phase 3 Program for Oliceridine (Press)

US: Medical Devices

  • ICDs associated with high risk for long-term complications (MNT)
  • Proper Servicing Of Imaging Equipment Ensures Accurate And Safe Diagnoses (Mita)
  • 4 medical device M&A deals I'd like to see, with an eye to Abbott-St. Jude's Medical (MedCityNews)
  • Smiths, Fresenius Said to Bid for Pfizer's $2 Billion Pumps (Bloomberg)
  • Brigham and Women's Hospital tests Medisafe's app in hypertension patients (MobiHealthNews)
  • The Building Blocks Of A Successful Drug Delivery Device (MedDeviceOnline)
  • Medtronic wins FDA clearance for StrataMR valves (MassDevice) (Press)
  • FDA approves afib-detecting Visia ICD from Medtronic (MassDevice) (Press)
  • Another FDA win for Synaptive Medical with its ImageDrive Pro (MassDevice)
  • First Ray Receives FDA 510(k) Clearance for Stealth Staple (Press)
  • Google files for US patent to electronic eye lens (Pharmafile)

US: Assorted & Government

  • EPA takes offline report that says glyphosate not likely carcinogenic (Reuters)
  • The COMBAT Act Would Add New Brand and Generic Exclusivity-Stacking Incentives for Abuse-Deterrent Opioid Development (FDA Law Blog)
  • Not Hooked on a Feeling, the Eleventh Circuit Upholds Exclusion of Expert (Drug and Device Law)
  • Could Yogi Berra be Correct that "It Ain't Over Til It's Over"?; Supreme Court Decides Not to Review POM Wonderful v FTC Case (FDA Law Blog)
  • Texas Federal Court Says Device Manufacturer is not a Health Care Provider, but also not a Seller (Drug and Device Law)
  • NPRM Symposium: Privacy and Promises, Promises, Promises (Harvard Bill of Health)

Upcoming Meetings & Events

Europe

  • EC grants orphan designation to pSivida's Medidur (EPR)
  • New European policy recommendations on cytotoxic drugs (MNT)
  • Inaugural Meeting Of The Scientific Committee On Consumer Safety (SCCS) And The Scientific Committee On Health, Environmental And Emerging Risks (SCHEER) (EC)
  • Economic woes will see Italy's pharma industry decline to $18.6 billion by 2020 (PharmaLetter-$)
  • Novo Nordisk plans to meet entire Russian demand for insulin over the next few years (PharmaLetter-$)
  • Drugmakers oppose introduction of subsidization practice in Russia (PharmaLetter-$)
  • GM604 to Be Granted "Orphan Drug" Status in Europe (Press)
  • Essential Medical Inc. Announces CE Mark Submission for MANTA™ Large Bore Vascular Closure Device (Press)
  • Ten Years On, Access To Biosimilars Still Patchy in EU (SCRIP-$)

Asia

  • AstraZeneca 'Particularly Pleased' With Q1 China Performance (PharmasiaNews-$)

India

  • Task Force asks govt to create vision document with short & long term plan for plasma industry (PharmaBiz)
  • FDA approves Aurobindo's epilepsy drug (BioSpectrum)
  • Re-examine Sun Pharma MRs' transfer case, Bombay HC tells Industrial Court (Economic Times)
  • Teva's Indian Patent Application For Rasagiline Patch Subject Of Pre-Grant Opposition (24 Insight)
  • Alembic Receives USFDA Approval For Generic Vimpat (24 Insight)
  • USFDA OKs Marksans Pharma's Anda For Glucophage XR (24 Insight)

Australia

  • IDT Australia opens new clinical trials facility in Adelaide (BioSpectrum)
  • Updated list of 'permissible ingredients' for use in listed medicines (TGA)

Canada

  • Regulatory Decision Summary – XIGDUO (Health Canada)
  • Regulatory decision summary: DEXEDRINE TABLETS, DEXEDRINE SPANSULES (Health Canada)

Zika

  • OSHA, NIOSH Release Joint Guidance on Zika Virus Prevention (National Law Review)
  • How to Fight Mosquitoes This Summer (WSJ)

General Health & Other Interesting Articles

  • Elevated bladder cancer risk in New England and arsenic in drinking water from private wells (NIH)
  • Should The U.S. Reconsider Its Stand On Foreign Aid For Abortion Clinics? (NPR)
  • A Flu Shot During Pregnancy Protects Babies From Flu Up To 6 Months Later (Forbes)

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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