Regulatory Focus™ > News Articles > Regulatory Recon: Are State Right to Try Laws Beneficial or too Risky? (16 June 2014)

Regulatory Recon: Are State Right to Try Laws Beneficial or too Risky? (16 June 2014)

Posted 16 June 2014 | By Alexander Gaffney, RAC

Regulatory Recon: Are State Right to Try Laws Beneficial or too Risky? (16 June 2014)

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

In Focus: US

  • What to Make of State "Right to Try" Laws? (BioCenturyTV)
  • Navidea wins expanded use of imaging agent Lymphoseek (SCRIP-$) (Press) (FDA) (Mass Device)
  • CDER “Sentencing Guidelines” To Provide Enforcement Clarity (Pink Sheet-$)
  • Accelerated Approval Great For “Me-Too” Products, FDA Says (Pink Sheet-$)
  • FDA’s Special Protocol Rescissions Get U.S. Capitol, Venture Capital Attention (Pink Sheet-$)
  • AbbVie says hepatitis C regimen gets nod for FDA priority review (Reuters) (BioCentury) (Pharma Times)
  • FDA Grapples with Future Regulation of 3-D Printed Medical Devices (MDDI)
  • FDA Amends Guidance on Magnetic Resonance Diagnostic Devices (FDA)

In Focus: International

  • India Defeats Attempt to Tie ICH Standards to WHO (Times of India)
  • Is the EMA Making Too Many Compromises on Transparency? (Pharmalot) (BioCentury)
  • Companies now required to update, complete and improve quality of information on authorised medicines submitted to the European Medicines Agency (EMA)
  • European Medicines Agency starts review of ibuprofen medicines (EMA) (PharmExec)
  • U.K. Cost Regulator May Reject Gilead’s Sovaldi Treatment (PharmaPhorum) (Bloomberg)
  • Spooked by probes, pharma executives ask: should I leave China? (Reuters)

US: Pharmaceuticals and Biotechnology

  • What to Make of State "Right to Try" Laws? (BioCenturyTV)
  • Navidea wins expanded use of imaging agent Lymphoseek (SCRIP-$) (Press) (FDA) (Mass Device)
  • CDER “Sentencing Guidelines” To Provide Enforcement Clarity (Pink Sheet-$)
  • Accelerated Approval Great For “Me-Too” Products, FDA Says (Pink Sheet-$)
  • FDA’s Special Protocol Rescissions Get U.S. Capitol, Venture Capital Attention (Pink Sheet-$)
  • From a Clinical Perspective: Drug development tools and the EXACT PRO initiative (FDA)
  • Genetic Diseases Could See Indication Expansions Through Accelerated Approval (Pink Sheet-$)
  • Bone events halt OncoMed early 'Wnt' studies; shares drop (SCRIP-$) (BioCentury) (Press)
  • Waiting For Biosimilars: From Manufacturing To Litigation, Stakeholders Prepare For U.S. Market (Pink Sheet-$) (Biopharma Reporter) (Forbes)
  • Teva Claims Diovan 180-Day Exclusivity, Arguing Ranbaxy ANDA Was Incomplete (Pink Sheet-$)
  • AstraZeneca’s Movantik Looks Clear After FDA Panel; Salix’ Relistor Looks Cloudy (Pink Sheet-$) (PMLive)
  • Availability of New Medicines – Characterising the Factors Influencing Drug Roll Out to Six Mature Markets (Reuters)
  • Drug and device development for localized prostate cancer: report of a Food and Drug Administration/American Urological Association public workshop (PubMed)
  • May 2014 Drug Safety Labeling Changes (FDA)
  • Granules India's paracetamol facility passes USFDA inspection (India Times)
  • A shared regulatory perspective on deferral from blood donation of men who have sex with men (MSM) (PubMed)
  • Addressing the Evidence for FDA Nicotine Replacement Therapy Label Changes: A Policy Statement of the Association for the Treatment of Tobacco Use and Dependence and the Society for Research on Nicotine and Tobacco (PubMed)
  • FDA Says It Is Taking The First Amendment "Seriously" . . . Good To Know (Forbes)

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

  • AbbVie says hepatitis C regimen gets nod for FDA priority review (Reuters) (BioCentury) (Pharma Times)
  • Actelion's heart-lung drug meets main goal in late-stage study (Reuters) (Forbes) (Bloomberg)
  • Takeda ends Affymax deal, to pull Omontys NDA (BioCentury)
  • Late-stage trial: Victoza works for weight loss (Reuters)
  • Oasmia Soars as Cancer Drug Meets Targets in Late-Stage Study (Bloomberg)
  • Intarcia's once-a-year diabetes treatment shines in early PhIII results (Fierce)
  • New Gene Therapy Rapidly Helps Patients With Rare Blood Disorder (Forbes)
  • Enanta Pharmaceuticals Announces U.S. FDA Grants Priority Review to AbbVie for Investigational, All-Oral, Interferon-Free Regimen for Genotype 1 Chronic Hepatitis C (Press)
  • GSK announces results of Phase III PETIT2 study of eltrombopag (Promacta/Revolade) in paediatric patients with chronic immune thrombocytopenia (Press)
  • Gilead Announces Phase 3 Data Showing That the Fixed-Dose Combination of Ledipasvir/Sofosbuvir Achieved 100 Percent Sustained Virologic Response (SVR12) Among Patients with Chronic Hepatitis C in Japan (Press)
  • Eli Lilly: Investigational Empagliflozin/Linagliptin Combination Tablet Showed Reduction in Blood Glucose in Two Phase III Trials (Press)
  • Lilly Opens ADA With Head-To-Head Dulaglutide/Liraglutide Data (Pink Sheet-$)
  • Sanofi's Lantus heir beats its forebear in controlling diabetes (Reuters) (Press) (Pharma Times)
  • Biogen Idec and AbbVie Announce Positive Top-Line Results from Phase 3 Study Investigating Daclizumab High-Yield Process in Multiple Sclerosis (Press)
  • Results from Phase III Study (AML-001) of VIDAZA (Azacitidine for Injection) in Acute Myeloid Leukemia Presented at EHA (Press)
  • Agios Pharmaceuticals Announces Orphan Drug Designation of AG-221 for Treatment of Acute Myelogenous Leukemia (Press)

US: Pharmaceuticals and Biotechnology: General

  • US Capitol Capsule: When drugs may cause cancer: A knotty challenge for FDA (SCRIP-$)
  • Trying to Limit Outside Influence in Prescribing Drugs (NYTimes)
  • HHS vows to fight for ‘orphan drug’ rule (The Hill) (BioCentury) (Pharma Times)
  • Product Identifier Authentication (PIA) (RxTrace)
  • House bill would increase R&D for neglected tropical diseases (BioCentury)

US: Medical Devices

  • FDA Grapples with Future Regulation of 3-D Printed Medical Devices (MDDI)
  • FDA Amends Guidance on Magnetic Resonance Diagnostic Devices (FDA)
  • Comparison of Complication Rates Associated with Permanent and Retrievable Inferior Vena Cava Filters: A Review of the MAUDE Database (PubMed)
  • Sequenom, Inc. Receives U.S. FDA Premarket Clearance (Press)
  • Valeant Pharmaceuticals Receives U.S. FDA Clearance For Restylane Silk (Press)
  • Alere Receives FDA Clearance for Alere i Influenza A and B Test (Press)
  • CDRH Unveils New "CDRH Learn" Site (FDA)
  • Captomer and Captomer-250 by Thorne Research: FDA Warning - Potential Health Risks (FDA)
  • Smiths Medical Portex Low Dead Space Connector with Sideport, 3.5mm: Class I Recall- One Lot Mislabeled (FDA)
  • Class I Recall for Convatec's Flexi Seal (FDA)

US: Dietary Supplements

  • FDA Enforces New Dietary Ingredient Notification Requirement With Import Alerts (Tan Sheet-$)
  • IND guidance unfairly restricts supplement research, VDF FutureCeuticals says (NI-USA)
  • Fabricant: FDA Focusing on NDIs, GMPs (NPI)
  • US: Assorted And Government
  • POM’s Lanham Act Claims Against Coca-Cola are Not Precluded by the FDC Act (FDA Law Blog)
  • FDA finds tennis rackets used at sprout farm linked to E.coli illnesses (FQN)

Europe

  • Is the EMA Making Too Many Compromises on Transparency? (Pharmalot) (BioCentury)
  • Companies now required to update, complete and improve quality of information on authorised medicines submitted to the European Medicines Agency (EMA)
  • European Medicines Agency starts review of ibuprofen medicines (EMA) (PharmExec)
  • European Green Paper on mHealth: a catalyst for entirely new regulation? (Clinica-$)
  • NHS England unveils plan to cut drugs waste (Pharma Times)
  • U.K. Cost Regulator May Reject Gilead’s Sovaldi Treatment (PharmaPhorum) (Bloomberg)
  • PMCPA raps Pharmaxis (Pharmafile)

India

Japan & China

  • Spooked by probes, pharma executives ask: should I leave China? (Reuters)
  • Drugmakers take an upbeat view as Viagra goesgeneric—in China (China Daily)
  • Japan Panel Calls For Greater Patient Access To Advanced Treatments (PharmAsia-$)
  • General Regulatory And Interesting Articles

Regulatory Intelligence is not... (Tim Felgate)

Regulatory Reconnaissance #337 – 16 June 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.

Did we miss a story? Send us a tweet at @RAPSorg and we'll check it out for inclusion in our next edition of Regulatory Reconnaissance. Want this in your inbox each morning? Sign up for RF Today, our morning intelligence newsletter here.

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