Regulatory Focus™ > News Articles > Regulatory Recon: Not Enough Funding in 'Cures' Bill, FDA Chief Warns (14 September 2015)

Regulatory Recon: Not Enough Funding in 'Cures' Bill, FDA Chief Warns (14 September 2015)

Posted 14 September 2015 | By Zachary Brennan 

Regulatory Recon: Not Enough Funding in 'Cures' Bill, FDA Chief Warns (14 September 2015)

In Focus: US

  • Not Enough Funding in 'Cures' Bill, FDA Chief Warns (MedPage Today)
  • Senators may use biomedical research bill to address anxiety over drug costs (CQ-$)
  • Price critiques set off alarms in drug industry (Boston Globe)
  • Senators Take Another Stab at Passing the Preserve Access to Affordable Generics Act (FDA Law Blog)
  • FDA Panel Likes New Abuse-Deterrent Opioid (MedPage Today) (Reuters)(SAC Tracker)

In Focus: International

  • EU court ruling toughens regulations on chemicals of 'very high concern' (EurActiv)
  • EFPIA Seeks More Efficient Pathway for Drugs for Unmet Needs (FDANews-$)
  • Guidelines for the prudent use of antimicrobials in veterinary medicine (European Commission)

US: Pharmaceuticals and Biotechnology

  • Big Pharma Hands Out Fitbits to Collect Better Personal Data (Bloomberg News)
  • Priority Review Vouchers Keep Coming, But Expiration Deadline Looms (Pink Sheet-$) 
  • A Biotech Education, In Progress (In the Pipeline)
  • Pharma Plays The “Value” Card: Drug Spending Then And Now (Xconomy)
  • Podcast from Dr Duncan Emerton highlighting the latest in biosimilars (Biotech Due Diligence)
  • Buckle Up, Drug Makers: Bumpy Pricing Roads Ahead (SCRIP-$)
  • Again, A Closer Look At The Six-Year Record-Keeping Requirement (RxTrace)
  • Letter to the editor: Inflated drug prices (New York Times)
  • Will Amgen, Sandoz Tango Across Old Ground? (SCRIP-$)
  • Amgen Heads To High Court Over Handling Of Worker Stock (Law360-$)

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

  • Catabasis Receives Rare Pediatric Disease Designation from FDA for DMD treatment (Press)
  • Raptor Pharma says may discontinue development of liver drug, stock down (Reuters)(Press)
  • Sanofi's combination diabetes drug hits goal in second late-stage trial (Reuters)
  • FDA grants Roche’s alectinib priority review for lung cancer (PMLive)
  • Lower Blood Pressure Guidelines Could Be ‘Lifesaving,’ Federal Study Says (New York Times)(CardioBrief)
  • Tetraphase Executive Profits Hours Before Stock Plummets (TheStreet)
  • Aeglea BioTherapeutics Announces FDA Acceptance of Investigational New Drug Application for AEB1102 (Press)
  • Eisai Announces FDA Acceptance of NDA for the Review of FYCOMPA (Press)
  • Actos Settlement In Sight As First Threshold Crossed (PharmAsiaNews)
  • New Novartis Heart-Failure Drug Should Cost 17% Less, Research Group Says (WSJ)
  • UPDATED: Melinta's CEO steps down amid a big Phase III push (FierceBiotech)
  • Gene therapy player Dimension catches the biotech IPO wave, files $115M offering (FierceBiotech)(Xconomy)
  • Lion Biotechnologies Opens Enrollment in Phase 2 Study (Press)

US: Medical Devices

  • Insulet OmniPod Recall Tagged As Class I (Gray Sheet-$)
  • SEC fines trio for insider trading on a GE med tech acquisition (FierceMedicalDevices)
  • Class 2 Device Recall Hemocor High Performance Hemoconcentrator (FDA)
  • Class 2 Device Recall XGAUZE Trauma Dressing (FDA)
  • Class 2 Device Recall UCLA Abutment Hexed Castable Cylinder 3.4mm (FDA)
  • Fasetto Raises $5m, Will Start Selling 1TB Wearable In 2016 (Xconomy)

US: Assorted and Government

  • Medical Innovation Bill Passed the House With 344 Votes; Now It’s On Life Support (National Journal)
  • Milken, of junk bond notoriety, back as medical legislative advocate on Cures(Boston Globe)
  • Chimerix and BARDA Announce Contract Extension of $13.0 Million for the Continued Development of Brincidofovir for Smallpox (Press)
  • Biosimilar Workload At FDA: Policy Development Far Exceeds Application Review (Pink Sheet-$)

Upcoming Meetings and Events              

Europe

  • MHRA guidance on DEHP phthalates in medical devices (MHRA)
  • Parallel import licences granted in August 2015 (MHRA)
  • Diabetes: Dexcom wins CE Mark for G5 CGM (Mass Device)
  • Valtech Cardio wins CE Mark for Cardioband mitral repair device (Mass Device)
  • Acacia looks to a $230M IPO in London as it steers through PhIII (FierceBiotech)
  • Shire Weighing Options to Sweeten All-Stock Offer for Baxalta (WSJ)(SCRIP-$)
  • EMA grants orphan drug status to Stemline Therapeutics' acute myeloid leukaemia drug (PharmaBiz)

India

  • Exclusive: Abbott tangles with regulators over Indian cough syrup complaint (Reuters)
  • Dr Reddy’s inks $198 million pact with Hatchtech to market head lice product (Live Mint)
  • Prioritize anti-cancer drive: WHO to India (Economic Times)
  • Significant progress in stem cell research taking place in India (Pharma Letter-$)

China

  • U.S., China, UK experts to tackle vexed issue of gene editing (Reuters)
  • Asia Spotlight: FDA’s New China Director Looks To Strengthen CFDA Ties (Pink Sheet-$)
  • Ex-NYU researcher avoids prison in China bribery case (Mass Device)

Ebola Outbreak

  • Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Ebola Zaire Virus (FDA)
  • How to Eradicate Political Panic (Politico)

Other International

  • FDA Philippines issues warning on unregistered breast cancer drug (Inquirer)

General Health and Other Interesting Articles

  • One Symptom in New Medical Codes: Doctor Anxiety (New York Times)
  • Accountable Care Organizations, Explained (Kaiser Health News)
  • 4 Pentagon Labs Face Inquiry on Handling of Deadly Germs (New York Times)
  • California Approves Physician-Assisted Suicide (NPR)
  • Prosthetic limb used to restore 'near-natural' sense of touch, claims DARPA (The Verge)

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

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe