Regulatory Focus™ > News Articles > Regulatory Recon: White House Launches Fight Against Antibiotic Resistance (2 June 2015)

Regulatory Recon: White House Launches Fight Against Antibiotic Resistance (2 June 2015)

Posted 02 June 2015 | By Alexander Gaffney, RAC 

Regulatory Recon: White House Launches Fight Against Antibiotic Resistance (2 June 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

  • White House announces forum to fight antibiotic overuse (Reuters) (NatGeo) (White House)
  • FDA staff: Women's libido drug has small benefit, safety issues (Reuters) (AP) (Bloomberg)
  • Woodcock Weighs in on FDA Pharmaceutical Quality Oversight (PubMed)
  • Woodcock: FDA Wants Mutual Inspection Program With Europe (FDAnews-$)
  • Senators Complain FDA Guidelines May Restrict use of Roche’s Avastin (Pharmalot)
  • Novel government cancer study will test precision medicine (AP) (Washington Post) (WSJ-$) (SCRIP-$)
  • Hospitals tell feds that they can do more to support unique device ID (Fierce)
  • Moving on Medical Device Surveillance (MDDI)
  • FTC to Host Workshop to Examine Advertising for OTC Homeopathic Products (FTC) (Tan Sheet-$)

In Focus: International

  • What a new executive director could mean for EMA's innovative direction (BioCentury-$)
  • Work kicks off on new EU code of conduct and standards/guidelines for mHealth (Clinica-$)
  • Roche, Novartis and Bayer gain NICE recommendations (PMLive)
  • NICE says AZ' ovarian cancer drug is too expensive (PharmaTimes) (Pharmafile) (SCRIP-$) (PharmaPhorum)
  • Draft guideline on epidemiological data on blood transmissible infections (EMA)
  • Getting better all the time for drug, medical device safety in China? (Fierce)

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US: Pharmaceuticals and Biotechnology (In-Pharma)

  • White House announces forum to fight antibiotic overuse (Reuters) (NatGeo) (White House)
  • FDA staff: Women's libido drug has small benefit, safety issues (Reuters) (AP) (Bloomberg)
  • Woodcock Weighs in on FDA Pharmaceutical Quality Oversight (PubMed)
  • Woodcock: FDA Wants Mutual Inspection Program With Europe (FDAnews-$)
  • Senators Complain FDA Guidelines May Restrict use of Roche’s Avastin (Pharmalot)
  • Remsima's US FDA review held back by contradictory demands, says Celltrion (BioPharma Reporter)
  • Novel government cancer study will test precision medicine (AP) (Washington Post) (WSJ-$) (SCRIP-$)
  • FDA Advisory Committee Does Not Support New Blood Donor Deferral Policy Related to the Risk of Mad Cow Disease (Tarius)
  • Pazdur: Transition to gene-based cancer treatment may not be simple (Reuters)
  • “Breakthrough” Dose-Finding In Oncology (RPM Report-$)
  • Four key questions about FDAMA Section 114 (CEA)
  • How 21st Century Cures Act would fund innovation at NIH, FDA (BioCentury-$)
  • HHS Funding $20M Competition to Develop Antimicrobial Resistance Rapid, Point-of-Care Diagnostics (DHHS)
  • Evaluate Ltd and AdverseEvents, Inc. Team Up to Create New Insight on FDA Adverse Event Reporting (Press)

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

  • FDA priority review for Opdivo/Yervoy combo in skin cancer (PharmaTimes) (SCRIP-$)
  • FDA Accepts Supplemental Biologics License Application (sBLA) for KEYTRUDA (pembrolizumab) in Advanced Non-Small Cell Lung Cancer, Grants Priority Review (Press)
  • Gilead submits new drug application to U.S. FDA for Zydelig (Reuters)
  • Insys Therapeutics Submits NDA for Dronabinol Oral Solution (Press)
  • FDA Accepts Biologics License Application For Anthim (Obiltoxaximab) (Press)

US: Pharmaceuticals and Biotechnology: General

  • Patients Get Extreme to Obtain Hepatitis Drug That's 1% the Cost Outside U.S. (Bloomberg)
  • Foster Farms backs away from using human antibiotics in poultry (Reuters)

US: Medical Devices

  • Hospitals tell feds that they can do more to support unique device ID (Fierce)
  • Moving on Medical Device Surveillance (MDDI)
  • Cyberonics Announces FDA Approval Of The AspireSR Generator For VNS Therapy (Press)
  • Clinical-grade wearable for posture, movement tracking gets second FDA clearance (MobiHealthNews)
  • InvisionHeart wins FDA nod for InvisionECG (MassDevice) (MedGadget)
  • Medical Informatics Corp Sickbay Clinical Platform Receives FDA 510(k) Clearance (Press)
  • Carestream Health’s Ultrasound Systems Receive FDA 510(k) Clearance (Press)
  • Wright Hip Implant Faulty, Jury Told In First Of 1,200 Cases (Law 360-$)

US: Dietary Supplements

  • FTC to Host Workshop to Examine Advertising for Over-the-Counter Homeopathic Products (FTC) (Tan Sheet-$)

US: Assorted And Government

  • New FDA Guidances for May 2015 (Ask Cato)

Upcoming Meetings and Events

Europe

  • What a new executive director could mean for EMA's innovative direction (BioCentury-$)
  • Work kicks off on new EU code of conduct and standards/guidelines for mHealth (Clinica-$)
  • Roche, Novartis and Bayer gain NICE recommendations (PMLive)
  • NICE says AZ' ovarian cancer drug is too expensive (PharmaTimes) (Pharmafile) (SCRIP-$) (PharmaPhorum)
  • Draft guideline on epidemiological data on blood transmissible infections (EMA)
  • Concept paper on the revision of the guideline on quality of herbal medicinal products/traditional herbal medicinal products (EMA) (EMA)
  • The European Commission Approves Helsinn's Akynzeo (netupitant/palonosetron) for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) in the European Union (Press)

Japan

  • Japanese Companies Attack Neglected Diseases (NYTimes)

China

  • Getting better all the time for drug, medical device safety in China? (Fierce)

Other International

General Regulatory And Interesting Articles

  • Tests for new cancer drugs not reliable enough, doctors say (Reuters)
  • Advanced Biopharmaceutical Manufacturing: An Evolution Underway (Deloitte)
  • Do certain medicines raise murder risk? (CBS)
  • MERS Virus Kills 2 in South Korea as Infections Rise to 25 (Bloomberg)

Regulatory Reconnaissance #567 – 2 April 2015

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 @AlecGaffney 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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