Regulatory Recon: FDA Approves AbbVie's Venclexta for Rare Form CLL, Industry Groups to Coordinate BsUFA Negotiations (12 April 2016)

Posted 12 April 2016 | By Michael Mezher 

Regulatory Recon: FDA Approves AbbVie's Venclexta for Rare Form CLL, Industry Groups to Coordinate BsUFA Negotiations (12 April 2016)

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

  • FDA Approves AbbVie's BCL-2 Targeting Drug for CLL (MedpageToday) (Reuters) (Press) (FDA)
  • Clinical Trials Need More Subjects (WSJ) (NYTimes)
  • Biosimilar User Fee Talks Begin with Industry Negotiating Amongst Itself (Pink Sheet-$)
  • This Nonprofit is Playing a Valuable Role in Framing the Drug Price Discussion (STAT)
  • Search for New Medical Treatments Zeroes in on Genetic Superheroes (MIT Technology Review) (NYTimes) (Nature)
  • Anavex Plays the Orphan Drug Stock Promotion Game (The Street)
  • In Medical Research, Financial Conflicts of Interest do Matter (Boston Globe)
  • Small Molecules, Big Targets: Drug Discovery Faces the Protein–Protein Interaction Challenge (Nature)
  • Unpredictable Precedent: Bread, Circuses, and the Termination of Pfizer-Allergan (Forbes)
  • Senate Committee on Aging Calls Meeting to Initiate Contempt Proceedings Against Valeant CEO (Senate)
  • USPSTF Updates Aspirin for Primary Prevention Recommendation (CardioBrief) (Reuters) (WSJ-$)

In Focus: International

  • ISO 13485 Update: Worries About Firms Missing 2019 Deadline; Quality Systems Standard Handbook in the Works; Suppliers now Eligible for Certs – And More (Gray Sheet-$)
  • For Polio Vaccines, a Worldwide Switch to New Version (NYTimes)
  • WHO Inspection Finds HALMED, KPC Pharmaceuticals Labs in Compliance (WHO)
  • Several Large Indian Pharma Companies Under US FDA Scrutiny (Manufacturing Chemist)
  • Points to be considered by applicants to the Horizon 2020 topic: New therapies for rare diseases (EMA)
  • Scalped: At China's creaking hospitals, illegal ticket touts defy crackdown (Reuters)
  • PAHO Offers Technical Support for Pilot Studies of New Mosquito Control Technologies (ICT)

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US: Pharmaceuticals & Biotechnology

  • New Data: How Outrageous Hospital Markups Hike Drug Spending (Drug Channels)
  • FDA Biosimilars Guidance Not Conducive To Preemption (Drug and Device Law)
  • CRISPR Developer Intellia Deals With Regeneron, Jumps Into IPO Queue (Xconomy)
  • USFDA Approved 60 ANDAS In March – Aurobindo Leads With 8 Approvals (24 Insight)
  • Hydromorphone could prevent opioid addicts from using street heroin (Pharmaceutical Journal-$)
  • Sometimes Pain Is a Puzzle That Can't Be Solved (NYTimes)
  • 7 tips for cancer patients worrying about the cost of their care (NYTimes)
  • FDA Issues Updated Draft Guidance for Emergency Use Authorizations: Emphasis on IVDs and Government Agencies (FDA Law Blog)
  • GE, Mayo launch software startup to scale gene therapy (MedCityNews)
  • A New Day for Process Validation and Regulatory Review (Pharmaceutical Manufacturing)
  • Hormone Therapy for Prostate Cancer Tied to Depression (NYTimes)
  • New program to expedite clinical trials through data sharing (In-PharmaTechnologist)
  • Hepatitis B and C Could be Eliminated as Public Health Problems in U.S., Report Says (ICT)
  • Vaccines and biologics driving Charles River investments (BioPharma-Reporter)
  • NIH Sequences Genome of a Fungus That Causes Life-Threatening Pneumonia (ICT)
  • ICER casts doubt on cost-effectiveness of newer MM drugs (BioCentury)
  • Clinical studies point to consistent efficacy in AstraZeneca's treatment for drug-resistance bacteria (Pharmafile)

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

  • Catabasis Pharmaceuticals Initiates Part B of the MoveDMDSM Trial of CAT-1004 for the Treatment of Duchenne Muscular Dystrophy (Press)
  • GW Pharma starts Phase III trials for Tuberous Sclerosis Complex drug (Pharmafile) (MNT)
  • Roche to present new data at AAN showing superior efficacy of investigational medicine ocrelizumab versus comparators on disease activity and progression in two forms of multiple sclerosis (Press)
  • Redhill initiates Phase II study of Bekinda in IBS-D (EPR)
  • Paratek presents new trial data for antibiotic as late-stage trials continue (Boston Business Journal)

US: Medical Devices

  • Joint FDA/ASQ Case For Quality Library Launched (Gray Sheet-$)
  • FDA clears Nephros after 2015 warning letter (MassDevice)
  • Dexcom Inc. Recalls G4 Platinum and G5 Mobile Continuous Glucose Monitoring System Receivers Due to Audible Alarm Failure (FDA 1, 2)
  • Boston Scientific recalls Fetch 2 thrombectomy catheters (MassDevice) (FDA)
  • Vascular Solutions initiates voluntary recall of Guardian II valve (MassDevice) (FDA)
  • Profusa wins $1.75m NIH grant for tissue-integrated biosensors (MassDevice)

US: Assorted & Government

  • Rep. Susan Brooks: U.S. needs incentives, leader to battle Zika, biological weapons (Indy Star)
  • How the Surgeon General plans to fight the opioid crisis (Politico)
  • What States Can Do on Birth Control (NYTimes)

Upcoming Meetings & Events

Europe

  • European Medicines Agency IT systems unavailable from 16 April to 17 April 2016 (EMA)
  • SMC accepts three new medicines for use by NHS Scotland; rejects two (EPR)
  • Profound Medical wins CE Mark for Tulsa-Pro ablation device (MassDevice)
  • New test aims to see how well cancer drugs work within days (OnMedica)
  • Bayer to consider selling animal health if unable to bulk up: CEO (Reuters)
  • Medical devices deal promises to save UK millions (OnMedica)

Asia

  • Singapore's NMT pumps equity into CAO TCM-derived oncology play (Fierce)
  • Genetic tests identify 6 types of liver cancer among Japanese patients (Fierce)
  • Juno Therapeutics and WuXi AppTec Announce New Company to Develop Novel Cell-Based Cancer Immunotherapies in China (Press)

India

  • IPCA Laboratories will not supply anti malaria meds to the Global Fund (In-PharmaTechnologist)
  • Three months' time given to return banned FDCs pose regulatory challenge for enforcement officials in Kerala (PharmaBiz)
  • Orchid Pharma antibiotic API plant passes US FDA inspection (In-PharmaTechnologist)
  • Two generics makers end battle to copy drugs amid patent debate (Economic Times)

Australia

  • ACPM meeting statement, Meeting 308, 5 February 2016 (TGA)

Zika

  • U.S. officials warn Zika 'scarier' than initially thought (Reuters)
  • Emergency Funding for Puerto Rico Department of Health, Zika Virus Outbreak (CDC)
  • Rubio endorses Obama's $1.9B request to fight Zika (Miami Herald)
  • Officials sound alarm on Zika funding (The Hill)

Other International

  • Yellow fever outbreak kills 21 in Congo, WHO says (Reuters)

General Health & Other Interesting Articles

  • A Simple Tool to Ease Cancer's Side Effects (WSJ-$)
  • Brain scans reveal how LSD affects consciousness (Nature)
  • Legionnaires' death tally in Flint area rises by 2, to 12 (Reuters)
  • Short sleep may be tied to cold or infection risk (Reuters)
  • Social Support of Marriage May Improve Cancer Survival (NYTimes)
  • This 85-Year-Old Chemist Has Made Deciphering Marijuana's Medical Secrets His Life's Work (WSJ-$)
  • Doctors Hear Patients' Calls for New Approaches to Hypothyroidism (WSJ)

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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