Regulatory Focus™ > News Articles > Regulatory Recon: FDA Skeptical of New Amgen Drug (27 April 2015)

Regulatory Recon: FDA Skeptical of New Amgen Drug (27 April 2015)

Posted 27 April 2015 | By Alexander Gaffney, RAC

Regulatory Recon: FDA Skeptical of New Amgen Drug (27 April 2015)

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

In Focus: US

  • FDA review challenges Amgen on a questionable T-Vec study (Fierce) (Reuters)
  • FDA Releases ICH M8 Draft Implementation Guide for Comment (FDA)
  • FDA Approves Eli Lilly’s Cyramza for mCRC (FDA) (SCRIP-$) (Press) (PharmaTimes)
  • Biosimilar Sponsors May Seek Interchangeability Before FDA Sets Rules (Pink Sheet-$)
  • How Many People Can Squeeze Into A Mid-Cycle Meeting? For Savaysa, The Number Is 70 (Pink Sheet-$)
  • Legislators Push for FDA to Implement Generic Labeling Rule (Congress)
  • Sklamberg on FDA’s New Enforcement Paradigm (RPM Report-$)
  • Pharmaceutical Companies Buy Rivals’ Drugs, Then Jack Up the Prices (WSJ-$)
  • Is Apple Waiting on FDA Clearance to Activate MedTech in its Apple Watch? (ModernHealthcare)
  • Security Experts Hack Teleoperated Surgical Robot (MIT TR)
  • FDA, Hi-Tech Remain Embroiled in DMAA Legal Battle (NPI)

In Focus: International

  • Reflection on chemical structure and properties to be considered for the evaluation of new active substance status (EMA) (EMA) (EMA)
  • ENVI Looking Into Ways to Lessen Reliance on Animal Research (EMA)
  • EU regulatory network 'takes high rate of change among national agency heads in its stride' (SCRIP RA-$)
  • Commerce ministry to talk to industry bodies to take a call on joining pharma regulator PICS (IndiaTimes)
  • Government set to cap prices of essential medical devices (India Times)
  • A Regulatory Balanced Budget in Canada (MarginalRevolution)
  • WHO's new global medtech regulatory model will change international devices scene (Clinica-$)

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US: Pharmaceuticals and Biotechnology

  • FDA Releases ICH M8 Draft Implementation Guide for Comment (FDA)
  • FDA review challenges Amgen on a questionable T-Vec study (Fierce) (Reuters)
  • FDA Approves Eli Lilly’s Cyramza for mCRC (FDA) (SCRIP-$) (Press) (PharmaTimes)
  • Biosimilar Sponsors May Seek Interchangeability Before FDA Sets Rules (Pink Sheet-$)
  • How Many People Can Squeeze Into A Mid-Cycle Meeting? For Savaysa, The Number Is 70 (Pink Sheet-$)
  • Legislators Push for FDA to Implement Generic Labeling Rule (Congress)
  • Sklamberg on FDA’s New Enforcement Paradigm (RPM Report-$)
  • Savaysa Shows The Good And Bad Of Being Late In Class (Pink Sheet-$)
  • Principles and Challenges in Access to Experimental Medicines (JAMA)
  • Is FDA’s Adverse Event Data Inferior to Health Canada’s? (AdverseEvents)
  • Brookings webcast on FDA Breakthrough Designations (MedCityNews)
  • 'Breakthrough' fees? FDA urges self-control on requests (SCRIP-$)
  • FDA revises example submission code using the new Module 1 version 2.3 (Exalon)
  • FDA Issues Final Analysis on Potential VTE-Gardasil Link (MPR)
  • From Random To Meaningful: The Evolution Of Zarxio’s Suffix (Pink Sheet-$)
  • FDA To Sandoz: Does USP Monograph Apply To Zarxio? (Pink Sheet-$)
  • A mysterious nicotine lozenge shortage that drove ex-smokers crazy is almost over (WashingtonPost)
  • Right to Try Bill Advances in California (Desert Sun)
  • Bupivacaine HCl Injection by Hospira: Recall - Iron Oxide Particulate In Glass Vials (FDA) (FDA)
  • Market Exclusivity Is Sometimes Too Much (In the Pipeline)
  • Identification Of Pharma Cases In The U.S. (RxTrace)
  • Bill would limit farmers' use of antibiotics in Oregon (Columbian)
  • Biogen's Tecfidera feeling the brunt of PML case (SCRIP-$) (BioCentury)
  • Still No Duty To Supply Drugs - In 22 States (D&D Law)

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

  • Celladon's gene therapy for heart failure bombs in PhIIb (Fierce) (Street) (Reuters)
  • Merrimack Pharmaceuticals and Baxter BioScience Announce Completion of New Drug Application Submission to U.S. FDA for MM-398 as a Treatment for Post-Gemcitabine Metastatic Pancreatic Cancer (Press)
  • Biogen blueprints a big Phase III effort for its Alzheimer's hopeful (Fierce)
  • Gilead Announces Results From Studies Evaluating Sofosbuvir-Based Regimens in Chronic Hepatitis C Patients With Genotypes 2-5 (Press)
  • BMS: ALLY-1 Trial Results Show Investigational Daclatasvir-Based Regimen Cures 94% of Post-Liver Transplant Patients with Hepatitis C and Up to 94% of Hepatitis C Patients with Cirrhosis (Child-Pugh Class A or B) (Press)
  • Merck Announces Presentation of Phase 2 Clinical Trial Results of Investigational Chronic Hepatitis C Therapy Grazoprevir/Elbasvir at the International Liver Congress 2015 (Press)
  • BioLife Solutions Submits FDA Master Files for Cell Thawing Media Products (Press)
  • MedDay reports positive pivotal Phase III study results with MD1003 in patients with Progressive Multiple Sclerosis (Press)
  • aTyr Pharma Receives U.S. FDA Orphan Designation for Resolaris (Press)

US: Pharmaceuticals and Biotechnology: General

  • Pharmaceutical Companies Buy Rivals’ Drugs, Then Jack Up the Prices (WSJ-$)
  • Prescription Pain Pill Overuse Is Leading To Thousands Of Hospitalized Newborns (Forbes) (NEJM)
  • Congressional Lawmakers Going After Pharma Industry for Part D Pricing (Congress)
  • The cost of multiple sclerosis drugs in the US and the pharmaceutical industry: Too big to fail? (PubMed) (Pharmalot) (Bloomberg)
  • Merger of Teva and Mylan Would Create Company With Control Over 25% of US Generics Market (Reuters)
  • Washington governor signs medical marijuana overhaul (Reuters)

US: Medical Devices

  • Is Apple Waiting on FDA Clearance to Activate MedTech in its Apple Watch? (ModernHealthcare)
  • Security Experts Hack Teleoperated Surgical Robot (MIT TR)
  • FDA deems all 4,000+ of troubled Maquet's left atrial appendage closure devices potentially deadly, announces major recall (Fierce)
  • Experts Recommend Requiring Randomized Trials For Flow Diverter PMAs (Gray Sheet-$)
  • FH Ortho Receives FDA 510(K) Clearance for Its Arrow Reverse Shoulder Long Keel & Short Keel Glenoid Base (Press)

US: Dietary Supplements

  • FDA, Hi-Tech Remain Embroiled in DMAA Legal Battle (NPI)
  • Point/Counterpoint: What's Next for Homeopathy (MedPageToday)
  • Despite warnings, health food stores recommend OTC dietary supplements to minors (Press)

US: Assorted And Government

  • What is the FDA Docket, and How Does it Work? (FDA)
  • CMS Submits Report to Congress on First Year of Open Payments (Policy and Medicine)

Upcoming Meetings and Events

Europe

  • Reflection on chemical structure and properties to be considered for the evaluation of new active substance status (EMA) (EMA) (EMA)
  • ENVI Looking Into Ways to Lessen Reliance on Animal Research (EMA)
  • EU regulatory network 'takes high rate of change among national agency heads in its stride' (SCRIP RA-$)
  • First HIV home test goes on sale in the UK (PharmaTimes)
  • Reporting requirements of marketing authorization holders in the EU regarding suspected adverse reactions occurring with medicinal products they donate outside the EU to public health programmes against neglected tropical diseases (EMA)
  • Guideline on good pharmacovigilance practices (GVP) - Module XVI Addendum I – Educational materials (EMA)
  • Clinigen set to lead multibillion-dollar unlicensed drugs market (FT-$)
  • NeoStem's Lead Immuno-Oncology Product Candidate, NBS20, Receives ATMP Classification From the European Medicines Agency (Press)
  • Bruker Introduces CE-marked IVD MALDI Sepsityper Solution for Rapid Identification of over 2,200 Microorganisms Directly from Positive Blood Culture (Press)

India

  • Commerce ministry to talk to industry bodies to take a call on joining pharma regulator PICS (IndiaTimes)
  • Government set to cap prices of essential medical devices (India Times)

Canada

  • Health Canada Switching up its Drug Product Database (HC)
  • A Regulatory Balanced Budget in Canada (MarginalRevolution)

Other International

  • WHO's new global medtech regulatory model will change international devices scene (Clinica-$)

Clinical Trials

  • Reviews of treatments should include clinical trial information from regulators (AllTrials)
  • TransCelerate CEO, leaders offer update on industry group’s activities (OutsourcingPharma)
  • Inaccurate reporting jeopardizing clinical trials (Press)

General Regulatory And Interesting Articles

  • What Are the Odds of Finding a Drug (And How Do You Stand Them? (InthePipeline)
  • The Importance of Literature Searches in a Regulatory Environment (DSA)
  • Will the Whill Hi-Tech Wheelchair Sell? (IEEE)
  • IdentRx Promises to Prevent Nearly All Medication Errors (MedGadget)
  • GSK responds to MSF's plea with pricing explanation--no discount (Fierce)

Regulatory Reconnaissance #544 – 27 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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