Regulatory Focus™ > News Articles > Regulatory Recon: FDA Holds Nearly 60 Sponsor Meetings on Biosimilars (15 September 2014)

Regulatory Recon: FDA Holds Nearly 60 Sponsor Meetings on Biosimilars (15 September 2014)

Posted 15 September 2014 | By Alexander Gaffney, RAC

Regulatory Recon: FDA Holds Nearly 60 Sponsor Meetings on Biosimilars (15 September 2014)

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

This fall, regulatory professionals from across the globe will come together to learn, connect and share at the Regulatory Affairs Professionals Society’s 2014 RAPS: The Regulatory Convergence, 27 September-1 October, Austin, TX.  Register here, or check out some of the mostnews-worthy sessions here.

In Focus: US

  • FDA Has Held at Least 59 Sponsor Meetings on Biosimilars (Bloomberg)
  • FDA Approves Baxter's HYQVIA for Treatment of Adults with Primary Immunodeficiency  (Press) (Pharma Times)
  • FDA Approves Baxter’s RIXUBIS [Coagulation Factor IX (Recombinant)] for Treatment of Children with Hemophilia B (Press)
  • US FDA Advisory Committee Narrowly Supports Natpara by NPS Pharmaceuticals for Hypoparathyroidism (Tarius) (BioCentury) (Pink Sheet-$) (SCRIP-$) (Reuters) (Press)
  • Twitter Not Off-Limits For Pharma, FDA Promo Chief Insists (Law 360-$)
  • IRB, HIPAA Changes To Be Folded Into 21st Century Cures Bill Next Year (Gray Sheet-$)
  • Two Apple medical trials shed light on how HealthKit will work (Reuters)
  • Time For LUFA? Lab-Developed Test Policy Will Be Key Piece Of 2017 FDA Law (RPM Report-$)

In Focus: International

  • EMA dilutes ambitious data re-analysis plans (SCRIP-$)
  • Roche Battles Counterfeit Rituxin Vials In Germany (BioSpace)
  • NICE tackles CT data issue (SCRIP-$)
  • Indian Government to hear out US pharma companies' patent fears (India Times)
  • Pharmacovigilance in China: Current Situation, Successes and Challenges (PubMed)
  • ASEAN seals deal on end-of-2015 deadline for medtech directive (Clinica-$)

US: Pharmaceuticals and Biotechnology

  • FDA Approves Baxter's HYQVIA for Treatment of Adults with Primary Immunodeficiency  (Press) (Pharma Times)
  • FDA Approves Baxter’s RIXUBIS [Coagulation Factor IX (Recombinant)] for Treatment of Children with Hemophilia B (Press)
  • US FDA Advisory Committee Narrowly Supports Natpara by NPS Pharmaceuticals for Hypoparathyroidism (Tarius) (BioCentury) (Pink Sheet-$) (SCRIP-$) (Reuters) (Press)
  • FDA Has Held at Least 59 Sponsor Meetings on Biosimilars (Bloomberg)
  • Twitter Not Off-Limits For Pharma, FDA Promo Chief Insists (Law 360-$)
  • Actavis Hypertension Combo Prompts Discussion Of “Me-Too” Drug Standards (Pink Sheet-$) (Pink Sheet-$)
  • On the Regulation of Generic Non-Biologic Complex Drugs (DrugWonks)
  • 21st Century Cures to hold antibiotic resistance meeting (BioCentury) (E&C)
  • Form 483 action looms over Sun's Halol plant (DNA India)
  • Pfizer, Ranbaxy win dismissal of lawsuit over generic Lipitor (Reuters)
  • Why URL Shorteners Matter for Pharmaceutical Marketing (RegulatoryRX)
  • Otsuka Tries To Halt Alkermes Ride On Abilify’s Coattails (Pink Sheet-$)
  • Liraglutide, aiming for new indication, gets new name (MM&M)
  • Pfizer's Testosterone Drug Poses Heart Risks, Suit Says (Law 360-$)
  • Who Is A DSCSA Dispenser? (RXTrace)

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

  • Avanir's drug succeeds in reducing Alzheimer's related agitation (Reuters)
  • Costly eye drug Avastin and far cheaper alternative have similar side effects: study (Reuters) (PMLive)
  • Evidence Flimsy For Most Experimental Treatments of ALS (NPR)
  • AbbVie and Biogen inch toward the FDA with once-a-month MS drug (Fierce)
  • Shire Announces FDA Acceptance for Filing with Priority Review of Supplemental New Drug Application (sNDA) for Vyvanse (lisdexamfetamine dimesylate) Capsules (CII) for Adults with Binge Eating Disorder (Press)
  • FDA accepts Tuzistra XR (CCP-01) NDA for full review (Press)
  • Lilly Says CYRAMZA Phase III Second-Line Colorectal Cancer Trial Meets Primary Endpoint of Overall Survival (Press) (BioCentury) (Reuters) (PMLive)
  • Merck KGaA Discontinues Clinical Development Program of Tecemotide for Stage III Non-Small Cell Lung Cancer (Press) (PMLive)
  • TG Therapeutics Reports SPA Agreement With FDA For Phase 3 Trial Of TG-1101 (RTT)
  • Synthetic Biologics Receives Orphan Drug Designation for SYN-005 Treatment for Whooping Cough (Pertussis) (Press)
  • Amgen Presents Analyses Of Phase 3 Ivabradine Data For The Treatment Of Chronic Heart Failure (Press)

US: Pharmaceuticals and Biotechnology: General

  • Gilead to raise price for new hepatitis C drug above $84,000 (Reuters)
  • Gilead signs pact with 7 firms for cheap copies of hepatitis C drug (Reuters) (NYTimes) (Press)
  • FDA, Amazon, eBay and Thwarting the Sale of Illegal Drugs (SciAm)
  • Taking the fight against the deadly prescription drug epidemic online (WonkBlog)
  • Select Drugs Cause Most Childhood Poisonings (NYTimes)
  • Dragonfly malware targeting pharmaceutical companies (Net Security)

US: Medical Devices

  • IRB, HIPAA Changes To Be Folded Into 21st Century Cures Bill Next Year (Gray Sheet-$)
  • Two Apple medical trials shed light on how HealthKit will work (Reuters)
  • Time For LUFA? Lab-Developed Test Policy Will Be Key Piece Of 2017 FDA Law (RPM Report-$)
  • Skin shocks used at Mass. school draw FDA look (AP)
  • Abbott’s Dissolving Heart Stent Clears Arteries in Trial (Bloomberg)
  • Medtronic CoreValve Data Demonstrate Favorable Cost Effectiveness Compared to Open-Heart Surgery in High Risk Patients (Press)
  • Invictus Medical Submits Application to FDA, Brands Device ‘Gel Shield' (Press)
  • FDA Approves New Styles Of The MENTOR MemoryShape Silicone Breast Implant (Press)
  • Medtronic CoreValve Data Demonstrate Favorable Cost Effectiveness Compared to Open-Heart Surgery in High Risk Patients (Press)
  • Twelve-Month Data from St. Jude Medical EnligHTN Renal Denervation System Show Continued Safety and Efficacy for Patients (Press)
  • First-in-Class Test to Predict Liver, Intestine Transplant Rejection in Children (MPR)

US: Assorted And Government

  • NJ Bill Would Shield Drug, Device Makers from Liability (NJleg)
  • Agency Growth … And Macro-Budgetary Politics (Strengthen FDA)
  • SCRIP US Capitol Capsule (SCRIP-$)
  • Chemical Industry Tries to Shape Regulations (AP)
  • Love and Regulatory Science (NYTimes)

Upcoming Meetings

Ebola Outbreak

  • BioCentury TV on the Ebola Outbreak (BCTV)
  • The Mathematics of Ebola Trigger Stark Warnings: Act Now or Regret It (Wired)
  • Black Market in Blood Serum Emerging Amid Ebola Outbreak (Bloomberg)
  • Just Who Is Leading the Fight Against Ebola? (NBC)
  • Obama Plans Major Ebola Offensive (WSJ-$)
  • Committee Leaders Request Update on Ebola Outbreak (E&C)
  • GOP wants Obama assurances on Ebola (The Hill)

Europe

  • EMA dilutes ambitious data re-analysis plans (SCRIP-$)
  • Roche Battles Counterfeit Rituxin Vials In Germany (BioSpace)
  • NICE tackles CT data issue (SCRIP-$)
  • Updates to EMA Dossier requirements (Exalon)
  • Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 9-11 September 2014 (EMA)
  • Is diclofenac a threat to European vultures? (EMA)
  • EFPIA Efforts to Block Stolen Drugs in European Supply Chain (PharmExec) (EFPIA)

India

  • Indian Government to hear out US pharma companies' patent fears (India Times)
  • More new rules for trial sponsors and CROs in India (Outsourcing Pharma)

China

  • Pharmacovigilance in China: Current Situation, Successes and Challenges (PubMed)
  • Real World Study: A Look At BMS’ China Sprycel Registry (PharmAsia-$)

Canada

  • Canadian Branded Pharma in Quiet Battle Against Generic Companies (National post)

Australia

  • TGA Releases New Guidance 23: Nonclinical studies (TGA)

Other International

  • ASEAN seals deal on end-of-2015 deadline for medtech directive (Clinica-$)

Clinical Trials

  • Voice of the Patient: Peer “Ambassadors” Help Recruitment at Aegerion (RPM Report-$)

General Regulatory And Interesting Articles

  • Assessing a Risk Management Program (BioPharm International)
  • Artificial spleen cleans up blood (Nature)
  • Some Cancer Experts See 'Overdiagnosis,' Question Emphasis on Early Detection (WSJ-$)
  • Gene-Silencing Drugs Finally Show Promise (MIT TR)

Regulatory Reconnaissance #399 – 15 September 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.

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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