Regulatory Focus™ > News Articles > Regulatory Recon: UK Legislators Kill Controversial Medical Innovation Bill (2 March 2015)

Regulatory Recon: UK Legislators Kill Controversial Medical Innovation Bill (2 March 2015)

Posted 02 March 2015 | By Alexander Gaffney, RAC 

Regulatory Recon: UK Legislators Kill Controversial Medical Innovation Bill (2 March 2015)

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

In Focus: US

  • Companies' tests used in 'superbug' scope cleaning flawed: FDA (Reuters)
  • Scopes in UCLA superbug case linked to unreported deaths in other states (Crain's)
  • FDA gets feedback on next-generation sequencing (BioCentury)
  • U.S. judge denies Ranbaxy bid to reinstate approvals for Valcyte, Nexium copies (Reuters) (LiveMint)
  • Efficiency indicators for new drugs approved by the FDA from 2003 to 2013 (Nature-$) (Press)
  • Deaf or Death? In Drug Trial, Parents Weigh Life vs. Hearing Loss (WSJ)
  • Form 483 for Hospira Facility Located in Visakhapatnam, India (SEC)
  • ANDA Submission Lull Is Now A Trend, As Are Sluggish Approval Numbers (Pink Sheet-$)
  • How To Save A Drug After A Negative Panel Review? Narrow The Indication (Pink Sheet-$)
  • FDA Says Supplement Company USPlabs has Undeclared Prozac in Product (FDA)
  • Cost Of FDA Reforms Is Big Challenge For ‘Cures’ Legislation (Pink Sheet-$)

In Focus: International

  • UK's Expanded Access "Saatchi" Medical Innovation Bill Scrapped (Telegraph) (Telegraph)
  • China says to implement drug distribution reforms (Reuters) (GlobalTimes) (BioSpectrum)
  • GSK annual report says China bribery case spawned surge in compliance 'contacts' (Fierce)
  • Australian Drugmakers Press for Reforms to Speed Access to Cancer Drugs (FDAnews-$)
  • Access to medications and conducting clinical trials in LMICs (Nature-$)
  • Roche says EU agency recommends Avastin for cervical cancer (Reuters) (Press)
  • Safety of 3D-printed devices needs addressing, says EU working group head (Clinica-$)

As the EU Gears up for Major Device Changes, What do Regulatory Pros Need to Know?

  • In Europe, medical devices currently are regulated much the same way they have been since the 1990s. Now, almost 20 years and several major scandals later, EU officials are preparing a massive overhaul of the region's medical device regulatory directives in the hopes of modernizing the system—if only they could agree on what those changes should look like. (Regulatory Focus)
  • Find out what changes are likely to affect medical devices and IVDs next year in this 11 March 2015 webcast featuring expert Erik Vollebregt. (RAPS Webcast)

US: Pharmaceuticals and Biotechnology

  • U.S. judge denies Ranbaxy bid to reinstate approvals for Valcyte, Nexium copies (Reuters) (LiveMint)
  • Efficiency indicators for new drugs approved by the FDA from 2003 to 2013 (Nature-$) (Press)
  • Deaf or Death? In Drug Trial, Parents Weigh Life vs. Hearing Loss (WSJ)
  • Fake Press Release Targets Company, Citing Regulatory Developments That Never Happened (Press) (CBC)
  • Form 483 for Hospira Facility Located in Visakhapatnam, India (SEC)
  • ANDA Submission Lull Is Now A Trend, As Are Sluggish Approval Numbers (Pink Sheet-$)
  • How To Save A Drug After A Negative Panel Review? Narrow The Indication (Pink Sheet-$)
  • Congressman Urges FDA to Abandon Electronic Package Insert Proposal (SJValley)
  • Advancing Antibiotic Development in the Age of 'Superbugs' (Pew)
  • FDA Announces Two-Day Meeting on Pediatric Therapeutics and Neurocognitive Outcomes (FDA)
  • Analytical Quality by Design: A Tool for Regulatory Flexibility and Robust Analytics (NCBI)
  • Opioid Compounding Restrictions Could Create New Headaches For FDA (Pink Sheet-$)
  • California Drug Donation Bill introduced (CA)
  • Antibiotics Currently in Clinical Development (Pew)
  • A Battle Rages Over Whether an Old Drug Can Be New Again (The Street)
  • Congress could help solve antibiotic resistance. This Congresswoman explains why it won't. (Vox)
  • Drug Safety Perspectives on Hepatitis C (AdverseEvents)
  • MAPPing out the timing of a Complete Response submission (Drug Kennel)
  • Sandoz fires back in Zarxio suit (BioCentury)
  • FDA Can't Track Whether Pharmacists Compound For Specific Uses (IHP-$)
  • Biosimilar Substitution Bill Introduced in Illinois (Scout)
  • Biosimilar Substitution Bill Introduced in California (CA)
  • A Weird Duo: Health Insurance Lobby Joins New York AG’s Battle Against Pharmaceutical Company (BuzzFeed)
  • FDA Posts New Drug Trial Snapshots to its Website (FDA)
  • Rare Diseases at FDA: A Successful Year for Orphan Products (FDA) (SCRIP-$)
  • Bill allowing experimental drugs for terminally ill goes to Wyoming House (WyomingNews)
  • Access to Confidential Business Information by the Food and Drug Administration, Office of Foods and Veterinary Medicine (FDA)

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

  • Amgen Sees Positive Results From Kyprolis Study (WSJ-$) (Forbes) (Reuters) (The Street)
  • FDA Grants Priority Review for Asfotase Alfa as a Treatment for Patients with Hypophosphatasia (Press)
  • FDA rejects Pacira's application for expanded use of pain drug (Reuters) (Press)
  • US priority review for B-MS' Opdivo in lung cancer (PharmaTimes) (Press)
  • Boehringer Ingelheim Submits Biologics License Application to FDA for Idarucizumab, Investigational Specific Reversal Agent for Pradaxa® (dabigatran etexilate mesylate) (Press)
  • Shire Submits Application to the U.S. FDA for Approval of Lifitegrast for Treatment of Dry Eye Disease in Adults (Press)
  • Bristol Already Preparing Daclatasvir Supplemental Filings In HCV (Pink Sheet-$)
  • TaiMed's ibalizumab gets breakthrough designation (BioCentury)
  • Novartis treatment for vision loss meets goals in study (Reuters) (PharmaTimes)
  • FDA Grants Breakthrough Therapy Designation to Epstein-Barr Virus (EBV) Targeted T-Cells for Treatment of EBV-Associated Lymphoproliferative Disease (Press)

US: Pharmaceuticals and Biotechnology: General

  • Kyle Bass Files Second IPR Petition (BIO)
  • CDC panel drops preference for MedImmune's FluMist  (SCRIP-$)
  • Study: Over-the-counter birth control could reduce unplanned pregnancies by one-quarter (The Hill)
  • Psychiatric Drug Overuse Is Cited by Federal Study (NYTimes)

US: Medical Devices

  • Companies' tests used in 'superbug' scope cleaning flawed: FDA (Reuters)
  • Scopes in UCLA superbug case linked to unreported deaths in other states (Crain's)
  • St. Jude Medical Settles, Closing Out Riata Suits (MDDI) (Mass Device)
  • More lawsuits planned as infected endoscope safety scare grows (Fierce)
  • FDA gets feedback on next-generation sequencing (BioCentury)
  • With FDA Nod, Nonprofit Drug Firm Launches New IUD—And New Model (Xconomy)
  • FDA Proposal to Regulate LDTs Raises Legal Liability Questions for Labs (InsideMedicalDevices)
  • AMA: FDA Should Have Authority Over 'Black-Box' Tests, But Not All LDTs (IHP-$)
  • In-Depth: Anticipating FDA Regulation of Pharmaceutical Apps (MobiHealthNews)
  • New Quality Management Software Designed Specifically For Medical Devices (MedDeviceOnline)
  • Akili Labs collaboration will evaluate video game to treat autism (MedCityNews) (Fierce)
  • Burwell presses Congress for more ONC, precision medicine funding (Fierce)

US: Dietary Supplements

  • FDA Says Supplement Company USPlabs has Undeclared Prozac in Product (FDA)
  • FDA Asked To Clear Air After New York Supplement Enforcement Cloud (Tan Sheet-$)
  • Illinois Bill Would ban Sale of Powdered Caffeine to Those Under 18 Years of Age (Scout)
  • Additional Actions Needed To Help FDA's Foreign Offices Ensure Safety Of Imported Food (GAO)

US: Assorted And Government

  • Cost Of FDA Reforms Is Big Challenge For ‘Cures’ Legislation (Pink Sheet-$)
  • Hamburg to Testify Before Congress This Week, Likely for the Last Time (Strengthen FDA)
  • FDA's Home-District Senator Barbara Mikulski to Retire (Washington Post)
  • Former Senator Tom Coburn Joins the Manhattan Institute's "Project FDA" (Press)
  • GOP Chair of House Science and Tech Subcommittee: I Didn't Vaccinate My Kids (MotherJones)
  • Making Regulations Readable (Federal Register)
  • FDA's Office of Criminal Investigations Seeking Automated Investigative Management System (FDA)
  • Deadly bacteria release sparks concern at Louisiana lab (USAToday)

Upcoming Meetings

Ebola Outbreak

  • ZMapp's 'moment-of-truth' efficacy trial starts (SCRIP-$) (Reuters)
  • It Kills Germs For Up To 6 Hours. Can It Wipe Out Ebola? (NPR)

Europe

  • UK's Expanded Access "Saatchi" Medical Innovation Bill Scrapped (Telegraph) (Telegraph)
  • Regulatory Requirements Pose Clinical Challenges – Regulatory Summit Highlights (Accenture)
  • Medical device and health software standards in state of flux? (Clinica-$)
  • Roche says EU agency recommends Avastin for cervical cancer (Reuters) (Press)
  • Safety of 3D-printed devices needs addressing, says EU working group head (Clinica-$)
  • The First Paediatric Use Marketing Authorisation -- A Case Study (TIRS-$)
  • European Medicines Agency Accepts Santen's Marketing Application Filing for Intravitreal Sirolimus for the Treatment of Noninfectious Uveitis of the Posterior Segment (Press)
  • EPHA Weighs in on Clinical Trials Transparency (EPHA)
  • Taiho Submits TAS-102 Marketing Authorisation Application to the European Medicines Agency for the Treatment of Refractory Metastatic Colorectal Cancer (Press)
  • Spain claims best hep C drug prices in Europe (SCRIP-$)

India

  • Insight On India – A Call To Review All Price Controls By NPPA (24 Insight)
  • India plans to impose price controls on medical device makers and distributors (PharmaLetter-$)

Japan

  • Introducing Internet Retailing of OTC Drugs in Japan: Revision of the Pharmaceutical Affairs Law (TIRS-$)

China

Australia

  • Australian Drugmakers Press for Reforms to Speed Access to Cancer Drugs (FDAnews-$)

Other International

  • Actions of the National Regulatory Authorities in 10 Low- and Middle-Income Countries Following Stringent Regulatory Authority Safety Alerts on Rosiglitazone (TIRS)
  • KEI: TRIPS Doesn't Require Compulsory Licenses to be used Only in Cases of Emergency (KEI)
  • PHARMAC in negotiations over rare disorders medicines (PharmaLetter-$)
  • Pakistani Officials Issue Arrest Warrants Over Refusals of Polio Vaccine (NYTimes)

Clinical Trials

  • Access to medications and conducting clinical trials in LMICs (Nature-$)
  • ClinicalTrials.gov: An Underutilized Source of Research Data About the Design and Conduct of Commercial Clinical Trials (TIRS-$)
  • Investigating the Efficacy of Clinical Trial Monitoring Strategies (TIRS-$)
  • A Trial Activation Initiative to Accelerate Trial Opening in an Academic Medical Center (TIRS-$)

General Regulatory And Interesting Articles

  • VICE's New Special, "Killing Cancer" (VICE)
  • Innovation In Bayer HealthCare's Quality Management (LifeSciLeader)
  • General Principles for the Education and Training of GCP Inspectors (TIRS-$)
  • Parents Choose A Simple Device To Reshape A Baby's Ear (NPR)
  • Study on biology of chronic fatigue illness stirs debate (Reuters) (NYTimes)
  • Relevant to Anyone Who's Even Been to a Conference (TIE)
  • Hepatitis C: Hunting the silent killer (Guardian)
  • Most Doctors Give In to Requests by Parents to Alter Vaccine Schedules (NYTimes) (Reuters)

Regulatory Reconnaissance #504 – 2 March 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.


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