Regulatory Focus™ > News Articles > Regulatory Recon: Are 'Right to Try Laws' Actually Helping Patients Access Unapproved Drugs? (29 Sep

Regulatory Recon: Are 'Right to Try Laws' Actually Helping Patients Access Unapproved Drugs? (29 September 2015)

Posted 29 September 2015 | By Michael Mezher 

Regulatory Recon: Are 'Right to Try Laws' Actually Helping Patients Access Unapproved Drugs? (29 September 2015)

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

  • Patient-Focused Drug Development: Is the Past Prologue? (DrugWonks)
  • Precision Medicine: Seeking Impact, Needing Champions (Forbes)
  • MedCityNews Picks 9 Potential Nominees for FDA's Patient Engagement Advisory Committee (MedCityNews)
  • FDA Proposes Amending the Definition of “Intended Use” (InsideMedicalDevices)
  • US 'right to try' laws may not help dying get unapproved drugs (Reuters)
  • Cybersecurity Concerns Grow as US FDA Sees Increasing Device Vulnerabilities (SCRIP-$) (The Register)

In Focus: International

  • New guidance to speed up development of antibiotics (EMA) (Draft Guideline)
  • French Industry Rages Over €1.7bn Drug Savings Plan (Pink Sheet-$)
  • First UK patient receives stem cell treatment to cure loss of vision (The Guardian) (Reuters) (OnMedica)
  • At Obama-Modi meeting in New York, MSF urges India to protect affordable medicines for millions (MNT)
  • Post ANZTPA, New Zealand plans new medical device regulatory system (MassDevice)

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  • 10 Essential Tips for Mastering UDI – Regulatory and Quality Solutions (R&Q) has created the ultimate UDI resource to help your UDI process run efficiently. From establishing your core team to implementing systems that are flexible, our white paper contains everything you need to know in order to optimize your process – from beginning to end. Download and share the guide today.

US: Pharmaceuticals and Biotechnology

  • How Are New Drugs Evaluated by the FDA? (Medpage Today)
  • Controlled Correspondence Related to Generic Drug Development (FDA)
  • Preparing for FDA’s Final Ruling on the Foreign Supplier Verification Program (FDAImports)
  • Sprout announces availability of Addyi REMS training (DSN)
  • Can The FDA Support Biomedical Innovation? New Report Shows Doubt (BioProcessOnline)
  • FDA Issues Priority Review Voucher to Wellstat following Xuriden Approval (FDA)
  • How much more does the U.S. pay for drugs? Up to 10 times more, report says (FiercePharma)

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

  • Second Trial Of Controversial Chelation Therapy Gains Crucial Early Support (CardioBrief)
  • New data demonstrate sustained long-term efficacy of OFEV®* on slowing disease progression and safety in patients with IPF (Press)
  • Sanofi New Drug Application for Lixisenatide Accepted for Review by FDA (Press)
  • Novavax RSV vaccine found safe for pregnant women, fetus (Reuters)
  • Baricitinib Superior to Methotrexate in Reducing Signs and Symptoms in Pivotal Phase 3 Study in Patients with Rheumatoid Arthritis (Press)
  • FDA Grants Priority Review Status TO sNDA FOR Anticancer Agent Halaven® as Treatment for Soft Tissue Sarcoma (Press)
  • Sanofi, Eli Lilly reach deal on insulin product (Reuters) (Lilly) (Sanofi)
  • New Roche Esbriet data show clinical benefits of continued and long-term treatment in patients with idiopathic pulmonary fibrosis (Press)
  • Lilly, Incyte arthritis drug found better than common treatment (Reuters)
  • Osmotica Announces FDA Acceptance of Filing for Ontinua ER for Alleviation of Spasticity Resulting from Multiple Sclerosis and Strong Advancement in the Clinical Program for Osmolex ER (Press)
  • FDA Accepts sNDA for Soft Tissue Sarcoma Tx (MPR)
  • Dextenza NDA for Ocular Pain Submitted to the FDA (MPR)

US: Medical Devices

  • Why UDI codes must be included on Medicare claims forms (FierceHealthIT)
  • Infographic: What You Need to Know about the ISO 9001:2015 Revision (MDDI)
  • Neural Implant Enables Paralyzed ALS Patient to Type Six Words per Minute (IEEE Spectrum)
  • Class 1 Device Recall PROFEMUR PLUS CoCr MODULAR NECK PHAC1254 (FDA)
  • FDA Safety Communication: Cranial Perforators with an Automatic Clutch Mechanism, Failure to Disengage (FDA)
  • ArtVentive Medical Receives FDA Clearance for Larger Size EOS™ Device (Press)
  • Intersect ENT Announces FDA Submission to Seek Expanded Indication of PROPEL Mini Steroid Releasing Implant to Treat Patients With Frontal Sinus Disease (Press)

US: Assorted and Government

  • FDA, NIH Get Just-In-Case Shutdown Ready (SCRIP-$)
  • FDA Shutdown Plans For 2015: Same As 2013, But With More People (Pink Sheet-$)
  • Clinton calls on hedge fund manager to return drug to original price (Reuters)
  • Democrats take aim at drug prices, prompting sharp drops in biotech stocks (Reuters) (Pink Sheet-$)
  • Lawmakers Seek Answers on Valeant’s Price Increases (WSJ) (SCRIP-$) (PharmaLetter-$)
  • Intervening Rights Defense Dooms Cancer Drug IP Claims (Law360-$)
  • Another Reason Biopharma Insider Trading Is A Dumb Idea (SCRIP-$)
  • A Leadership Imperative: Getting More C-Level Women In Biotech (Forbes)
  • Bayer defeats FTC in dietary supplement contempt case (Reuters)

Upcoming Meetings and Events              

Europe

  • Good laboratory practice (GLP) facilities: risk-based quality assurance (MHRA)
  • End of ISO 13485 makeover so close but EU could pose obstacle (Clinica-$)
  • NICE sees role for Cancer Drugs Fund but on a different basis, RPS conference hears (Pharmaceutical Journal-$)
  • Stentys Receives CE Mark for Self-Apposing Stent in Lower Limb Artery Disease (Press)
  • UVLrx Therapeutics Receives CE Marking for Intravenous UV Light Therapy Device (Press)
  • NICE recommends Zydelig (idelalisib) for the treatment of chronic lymphocytic leukaemia (MNT)

India

  • India needs to address major problems of adverse drug reactions (PharmaLetter-$)
  • Sampling on spurious drugs from ports to conclude by September 30 (PharmaBiz)
  • Apotex recalls cevimeline hydrochloride drugs made in India as FDA notes stability issues (FiercePharmaAsia)
  • Health ministry to recruit technical staff for implementing MvPI (PharmaBiz)
  • Pharma companies applying for patent rights must be ready to fulfil efficacy test criteria (PharmaBiz)
  • Panel on API recommends establishment of mega parks for APIs with common facilities (PharmaBiz)
  • FDA approves Lopid generic from Aurobindo (DSN)

Japan

  • Eisai Receives Additional Approval in Japan for Vascular Embolization Device DC Bead as Treatment of Hypervascular Tumors and Arteriovenous Malformations (Press)

Australia

  • Allergan Recalls Certain Batches of Ircal and Refresh Night Time Eye Ointments (TGA)
  • Aussie firm trials combination therapy for melanoma (BioSpectrum)

Other International

  • Turkey Regulatory Update: New Biotech Center, Diabetes Costs Surging (PharmAsiaNews-$)

General Health and Other Interesting Articles

  • More Evidence Chemicals Linked to Obesity and Diabetes, Group Says (NBC News)
  • Scientists might have just discovered the true origin of Hepatitis B — in a fish (Washington Post)
  • Pregnant cancer patients shouldn't terminate or delay treatment: study (Reuters)

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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