Regulatory Focus™ > News Articles > Regulatory Recon: Thanksgiving Roundup Edition (1 December 2014)

Regulatory Recon: Thanksgiving Roundup Edition (1 December 2014)

Posted 01 December 2014 | By Alexander Gaffney, RAC 

Regulatory Recon: Thanksgiving Roundup Edition (1 December 2014)

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

In Focus: US

In Focus: International

  • Novartis flu vaccine suspended following deaths in Italy (BioPharma Reporter) (Reuters) (EMA)
  • Novartis' heart failure drug on EMA's fast track (PMLive)
  • NICE Approves Alexion's $340,000-per-year Drug Soliris (BioPharma Reporter) (MNT) (Pharma Times)
  • First gene therapy drug sets million-euro price record (Reuters) (Fierce) (BioCentury)
  • Unfavorable EU scrutiny procedure for high-risk devices may be scrapped by Council of EU (Clinica-$)
  • EU Council also thinks genetic testing amendment in IVD regulation proposal is outside competence EU (MDL)
  • China: China Issues Draft Guidance On Multi-Regional Clinical Trials (Mondaq) (PharmaAsia-$)
  • China’s NDRC Said to Consider Lifting Price Caps on Most Drugs (Bloomberg)
  • AdvaMed Applauds Japan’s New Device Regulatory Framework (AdvaMed) (Fierce)
  • BSI suspended from conformity assessment role in Malaysia (Clinica-$)

US: Pharmaceuticals and Biotechnology

  • FDA Releases DSCSA Data Exchange Guidance (TraceLink) (FDA) (RxTrace) (FDA Law Blog) (SCRIP-$)
  • FDA Gene Therapy Branch Head Leaves for Private Sector (Press) (MedCityNews)
  • BMS proposed HCV therapy gets cold shoulder from regulators (MM&M) (Fierce) (Press) (BioCentury) (Reuters) (SCRIP-$) (Press)
  • Mandatory FDA Review Of Pivotal Trial Protocols Urged In JAMA (JAMA) (MNT) (Pink Sheet-$) (Pharmalot) (Forbes)
  • Panel Rejects Sternest FDA Warning for Steroid Shots (NYTimes) (Tarius) (Medscape) (MedPage Today)
  • FDA Piloting Oncology Supplement Review Using Only Data Summaries (Pink Sheet-$)
  • Off-Label Tensions: FDA’s Contraindication Authority Questioned At Advisory Committee (Pink Sheet-$)
  • FDA extends review of Novartis' panobinostat (BioCentury) (SCRIP-$)
  • This Week: FDA weighs lifting ban on blood donations from gay men (The Hill) (WaPo)
  • Blood users’ groups seek safeguards before lifting of gay-donor ban (Washington Times)
  • FDA Sends 483 to Dr Reddys Over Vizag Plant (MoneyControl) (DNA India) (LiveMint) (BioPharma Reporter)
  • FDA Breakthrough Designation Standards Revealed (Kind Of) (Pink Sheet-$)
  • FDA Quietly Consults Patients To Understand Vimizim's Six-Minute Walk Significance (Pink Sheet-$)
  • FDA Approves Valeant’s ONEXTON Acne Gel (Press)
  • Label changed on Biogen's top MS drug to reflect patient death (BioFlash) (FDA) (FDA) (Fierce)
  • Lilly on navigating the regulatory pathway for its insulin glargine (PMLive)
  • Designing drug trials: considerations for pregnant women (PubMed)
  • Adverse Events Uncovered with New Antibiotics, Antivirals (MPR) (PubMed)
  • Allergic reactions after egg-free recombinant influenza vaccine: reports to the US Vaccine Adverse Event Reporting System (PubMed)
  • Global and national initiatives to facilitate studies of vaccines in pregnant women (Press)
  • Assessment of congenital anomalies in infants born to pregnant women enrolled in clinical trials (PubMed)

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

  • Baxter Submits Application for U.S. FDA Approval of BAX 855, Extended Half-Life Recombinant FVIII Based on ADVATE for Hemophilia A (Press)
  • Ipsen Announces FDA Acceptance of Filing for Dysport in the Treatment of Upper Limb Spasticity in Adult Patients (Press)
  • EYLEA (aflibercept) Injection Accepted for Priority Review by FDA for Diabetic Retinopathy in Patients with Diabetic Macular Edema (Press)
  • Amgen, AstraZeneca's brodalumab beats J&J's Stelara in 2nd PhIII psoriasis showdown (Fierce) (Press)
  • Momenta Pharmaceuticals' Necuparanib Receives Fast Track Designation From the FDA for the Treatment of Patients With Metastatic Pancreatic Cancer (Press)
  • Novartis’ Gilenya fails in difficult-to-treat form of MS (PMLive) (Reuters) (SCRIP-$)
  • AstraZeneca and Lilly move Alzheimer's drug into big trial (Reuters)

US: Pharmaceuticals and Biotechnology: General

  • Using Doctors With Troubled Pasts to Market a Painkiller (NYTimes)
  • Nasal Naloxone Price Set to Jump (MedPage Today) (NYTimes)
  • Last of 5 Men Pleads Guilty in 2010 Drug Theft at a Connecticut Warehouse (NYTimes)
  • Most Americans With HIV Missing Treatment, CDC Says (NBC)

US: Medical Devices

  • FDA Approves New Noninvasive Technology To Assess Heart Vessels (Forbes) (FDA) (Press)
  • FDA Says No To Avanir Pharma's Migraine Drug-Device AVP-825 (RTT) (Reuters) (SCRIP-$)
  • What to Expect When Implementing UDI (MDDI)
  • Opponents of FDA's LDT regulations lawyer up, get in combat mode (Fierce)
  • FDA Tries to Get Ahead of New Era of Cyber-Terrorism (PCM)
  • Philips receives FDA 510(k) clearance for IQon Spectral CT (Press) (Mass Device)
  • Vascular Solutions wins FDA nod for Gel-Block embolization foam (Mass Device)
  • Cepheid Receives FDA Clearance for Xpert Norovirus, the First On-Demand Molecular Test for Detection of Norovirus (Press)
  • Warburg Pincus' Silk Road gets pivotal stroke prevention data, FDA up next (Fierce)
  • Plaintiffs in Bard's pelvic mesh MDL want cases tried together (Mass Device) (Law 360-$)
  • Trial shows new imaging system may cut X-ray exposure for liver cancer patients (Press)
  • Synthes Recalls Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws (FDA)

US: Dietary Supplements

  • Drug Claim Symptoms Spread Among Supplement Marketers Targeting Ebola Fears (Tan Sheet-$)

US: Assorted And Government

  • CBO Scores Ebola Voucher Bill (CBO)

Upcoming Meetings

Ebola Outbreak

  • Phase I success for GSK Ebola vaccine in sped-up trial (BioPharma Reporter) (Press) (Reuters) (NEJM) (MedPageToday)
  • China drafts policy on emergency Ebola diagnosis, approves products (Reuters)
  • U.K. and Wellcome Trust back trial of new, 15-minute Ebola test in West Africa (Fierce) (Reuters)
  • Italy's Ebola Patient Gets Experimental Treatment (AP)

Europe

  • Novartis flu vaccine suspended following deaths in Italy (BioPharma Reporter) (Reuters) (EMA)
  • Novartis' heart failure drug on EMA's fast track (PMLive)
  • Unfavorable EU scrutiny procedure for high-risk devices may be scrapped by Council of EU (Clinica-$)
  • EU Council also thinks genetic testing amendment in IVD regulation proposal is outside competence EU (MDL)
  • New EU guideline on development of modified-release formulations (SCRIP-$)
  • Eli Lilly Gets European Approval to Sell Trulicity, a Type 2 Diabetes Drug (NYTimes) (Reuters)
  • NICE Approves Alexion's $340,000-per-year Drug Soliris (BioPharma Reporter) (MNT) (Pharma Times)
  • NICE recommends Lundbeck's Selincro for alcohol dependence (BioCentury) (MNT) (PMLive)
  • NICE overturns negative Glivec guidance (PMLive)
  • Entyvio first biologic to get NICE backing for UC (Pharma Times)
  • It was not easy - EMA policy chief on new data disclosure policy (SCRIP-$)
  • MHRA helps to create new cancer medicine facility (Press)
  • UK: Saatchi Innovation Bill Still Divisive (PharmExec)
  • Guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms (EMA)
  • Concept paper on revision of the addendum to the note for guidance on evaluation of medicinal products indicated for treatment of bacterial infections to specifically address the clinical development of new agents to treat disease due to Mycobacterium tuberculosis (EMA)
  • Vargatef (nintedanib) approved in the EU for lung cancer patients with advanced adenocarcinoma after first-line chemotherapy (Press)
  • Exclusive: First gene therapy drug sets million-euro price record (Reuters) (Fierce) (BioCentury)
  • Shared and Dedicated Facilities: EMA's final Guideline on Setting health based exposure limits (PDEs) (ECA)
  • Karyopharm Announces Additional Orphan Designations Granted for Selinexor (KPT-330) by European Commission (Press)

India

  • India: Of Bad Drugs, Deaths And Promises Of Reforms (PharmAsia-$)
  • MNCs deprive India of vital drugs despite getting monopoly rights (India Times)
  • Gujarat FDCA plans to set up medical device testing lab in the state (PharmaBiz)
  • Insight On India – Highlights For The Week Of Nov 23-29, 2014 (Two-Four Insight)
  • No increase in prices of essential medicines: Government (India Times)
  • Government making efforts to bring down price of drugs: Health Minister JP Nadda (India Times)
  • IPC to submit proposal to CDSCO regarding advisory note/label change for certain medicines soon (PharmaBiz)

China

  • China: China Issues Draft Guidance On Multi-Regional Clinical Trials (Mondaq) (PharmaAsia-$)
  • China’s NDRC Said to Consider Lifting Price Caps on Most Drugs (Bloomberg)
  • China prescription drugs market to go online (Companies and Markets)
  • Chinese excipient market set to more than double by 2017 (In-Pharma)

Japan

  • AdvaMed Applauds Japan’s New Device Regulatory Framework (AdvaMed) (Fierce)
  • Nippon Kayaku launches biosimilar Remicade in Japan (PharmaLetter-$)

Canada

  • Apotex suing health minister over refusal to license Parkinson’s drug (Toronto Star)

Australia

  • TGA business plan 2014-2015 (TGA)
  • TGA Warns About St Jude Neurostimulators (TGA)

Other International

  • BSI suspended from conformity assessment role in Malaysia (Clinica-$)
  • ACCESS ALL ASIA: China intensifies notarization demands; new leadership at AHWP; more on ANZTPA’s demise (Clinica-$)
  • Nigerian Regulators End Strike (WorldStageGroup)
  • Philipines FDA Deals With Dengue Drug Scandal (Rappler)
  • Eisai Submits Marketing Authorization Application For Anticancer Agent Lenvatinib In South Korea (Press)

Clinical Trials

  • 3 Reasons to Share Data from Unsuccessful Clinical Trials (BioClinica)
  • The Role of the Patient Voice in Clinical Trial Design (Thompson Reuters)
  • The Power Behind the ‘P’: PROs, Patient Preference, and Patient-Centered Outcomes Research (FasterCures)
  • Designing drug trials: considerations for pregnant women (PubMed)
  • Global and national initiatives to facilitate studies of vaccines in pregnant women (Press)
  • Assessment of congenital anomalies in infants born to pregnant women enrolled in clinical trials (PubMed)
  • Making The Decision To Implement Adaptive Trials Across A Portfolio (LifeScienceLeader)
  • China: China Issues Draft Guidance On Multi-Regional Clinical Trials (Mondaq)
  • How C-Path turbocharges fight against serious illness (Tuscon)

General Regulatory And Interesting Articles

  • Mind The Gap: Are Training Gaps Preventing You From Closing The Quality Loop? (Master Control)
  • AbbVie adds children's AIDS drugs to shared patent pool (Reuters)
  • Powdered measles vaccine found safe in early clinical trials (Press)
  • GSK announces 14 winners of Discovery Fast Track Challenge (MedCityNews) (Press)

Regulatory Reconnaissance #449 – 1 December 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.


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