Regulatory Focus™ > News Articles > Regulatory Recon: States Pushing "Right to Try" Laws (19 May 2014)

Regulatory Recon: States Pushing "Right to Try" Laws (19 May 2014)

Posted 19 May 2014 | By Alexander Gaffney, RAC

Regulatory Recon: States Pushing

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know: news@raps.org.

In Focus: US

  • States Push "Right to Try" Drug Laws (WSJ-$) (AP) (Washington Post) (SCRIP-$)
  • More Clarifications on Some Significant Changes re: Generic Stability Program Implementation (Lachman)
  • Hamburg: Avastin Decision Was the Toughest of her Term (Bloomberg)
  • FDA Dangles Golden Ticket To Spur Drugs For Neglected Diseases (NPR)
  • Feds analyze risk-based approach to health IT regulation (GovHealthIT)
  • Proposing a Generic Labeling Change Could Land FDA With More Work (RPM Report-$)
  • Compounder Inspections: States Press FDA For Greater Frequency (Pink Sheet-$)

In Focus: International

US: Pharmaceuticals/Biotechnology

  • States Push "Right to Try" Drug Laws (WSJ-$) (AP) (Washington Post)
  • More Clarifications on Some Significant Changes re: Generic Stability Program Implementation (Lachman)
  • Hamburg: Avastin Decision Was the Toughest of her Term (Bloomberg)
  • Compounder Inspections: States Press FDA For Greater Frequency (Pink Sheet-$)
  • FDA Generic Director Post Is Officially Open; Uhl May Be Only Candidate (Pink Sheet-$)
  • FDA Dangles Golden Ticket To Spur Drugs For Neglected Diseases (NPR)
  • Proposing a Generic Labeling Change Could Land FDA With More Work (RPM Report-$)
  • Antimicrobial Drug Development: Few Incentives, Many Task Force Meetings (Pink Sheet-$)
  • FDA’s Patient-Focused Drug Development Meetings Inspire Imitators (Pink Sheet-$)
  • Pulmonary Arterial Hypertension Endpoint May Need Replacing (Pink Sheet-$)
  • FDA Scores an Initial Win in COPAXONE Litigation; When Will the Other Shoe Drop? (FDA Law Blog)
  • Serelaxin Rejection Shows “Breakthrough” Status Doesn’t De-Risk Programs (Pink Sheet-$)
  • U.S. Marshals seize unapproved drugs from Ohio distributor  (FDA)
  • BMJ Commentator Hits Flomax for Lack of Data Transparency (BMJ)
  • New Number for Reporting Drug Shortages to CBER (FDA)
  • Update: FDA Postlicensure Rapid Immunization Safety Monitoring (PRISM) study demonstrates no statistically significant association between Trivalent Inactivated Influenza Vaccine and Febrile Seizures in Children during the 2010-2011 influenza season (FDA)
  • Another Hospira Recall due to Visible Iron Oxide Particulates (FDA) (FDA)
  • Former FDA Medical Policy Head Joins Greenleaf, Will Highlight FDA As “Resource” (Pink Sheet-$)

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

  • Pfizer to submit breakthrough breast cancer drug for FDA approval in Q3 (Reuters) (Pharmafile) (AP) (SCRIP-$) (Press)
  • Shire to Submit New Drug Application to FDA for Lifitegrast for Dry Eye Disease in Adults (Press) (BioCentury) (Reuters)
  • Bristol-Myers Squibb and AbbVie Receive U.S. FDA Breakthrough Therapy Designation for Elotuzumab, an Investigational Humanized Monoclonal Antibody for Multiple Myeloma (Press)
  • NovoNordisk Weight Management Drug Excels in Phase 3a (Press)
  • PTC Therapeutics Posts Positive Results for CF Drug (Press)
  • Sanofi C. diff vaccine shows immune response in PhII trial (Fierce)
  • Kamada tanks as its lead drug can't top placebo (Fierce) (Reuters)
  • IPF Phase III results published in NEJM show nintedanib slows disease progression (Press)
  • Disappointing Results For Statins In Two NIH Trials (Forbes) (NEJM)

US: Pharmaceuticals and Biotechnology: General

  • Robbery Suspect Tracked by GPS-Equipped Decoy Prescription Bottle and Killed (NYTimes)
  • Thousands of Toddlers Are Medicated for A.D.H.D., Report Finds, Raising Worries (NYTimes)
  • Sure, We'll (Eventually) Beat Cancer. But Can We Afford To? (Forbes)
  • To Pay For Hepatitis C Drugs, Medicare Might Face A Steep Bill (NPR)
  • NCATS advisers set translational science goals (SCRIP-$)

US: Medical Devices

  • Requesting an Extension/Exception to the U.S. FDA UDI Rules (RxTrace)
  • Feds analyze risk-based approach to health IT regulation (GovHealthIT)
  • FDA panel votes 'yes' on Advanced Circulatory's new CPR tech (Mass Device)
  • Medtronic's Infuse Moves From Operating Room to Courtroom (MedPage Today)
  • Ventlab, LLC. Issues a Nationwide Recall of Ventlab Resuscitator Bags Due to Possible Health Risk (FDA) (FDA)
  • FDA Recall for Datascope's Intra-Aortic Balloon Pumps (FDA)

US: Dietary Supplements

  • Herbal Testosterone Supplement Makers Face RICO Action (Law 360-$)

US: Assorted And Government

  • A Q&A About FDA's Funding Expectations for FY 15 (Strengthen FDA)
  • US Capitol Capsule (SCRIP-$)
  • Connecticut Requires Pharmaceutical and Device Companies to Report Payments and Transfers of Value Made To Nurse Practitioners and other APRN's (Policy and Medicine)
  • NIH's NCCAM Wants a Name Change (NIH)

Europe

  • EU Ombudsman concerned about change of policy at EMA on clinical trial data transparency (Pharma Letter-$) (Science Times)
  • Europe approves J&J hepatitis C drug Olysio (Pharma Times) (BioCentury) (Press) (SCRIP-$)
  • EC Releases New Device Standard for Medical Gloves for Single Use  (EC)
  • European Medicines Agency and German Society for Transfusion Medicine and Immunohaematology to co-organise workshop on advanced therapies (EMA)

Japan & China

  • Xinhua: Multinationals, beware--or end up like Glaxo (Fierce)
  • CEO of China Drug Maker Jumps to Death Amid Probe (AP)

General Regulatory And Interesting Articles

  • Pregnant women get sick too, so is there a case for medication? (Guardian)
  • Scientists Battle it Out Over Testosterone Effects on the Heart (Medpage Today)
  • Clinical trial casts doubt on routine fluconazole treatment for premature infants (PJO)
  • Canines’ Cancer-Sniffing Snouts Showing 90%-Plus Accuracy (Bloomberg)

Regulatory Reconnaissance #321 – 19 May 2014

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.

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


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