Regulatory Focus™ > News Articles > Regulatory Recon: California Bill Would Force Drug Companies to Publish Regulatory Costs (25 Februar

Regulatory Recon: California Bill Would Force Drug Companies to Publish Regulatory Costs (25 February 2015)

Posted 25 February 2015 | By Alexander Gaffney, RAC

Regulatory Recon: California Bill Would Force Drug Companies to Publish Regulatory Costs (25 February 2015)

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

In Focus: US

  • US lawmaker pushes for drug price transparency (PMLive) (Pharmalot) (BioCentury)
  • Why compounding pharmacy Downing Labs rejected FDA's recall request (CBS)
  • FDCA Preempts Maine Drug Importation Law, Court Says (Law 360-$)
  • FDA Meeting to Discuss Ethics of Sedating Children During Nonessential Interventions (FDA)
  • Antifungal Treatment Should Be Taken Off the Market, Public Citizen Tells FDA (Public Citizen) (Pink Sheet-$) (AP) (Petition)
  • US FDA Advisory Committee Reviews Pharmacy Compounding Drug Lists (Tarius) (Medscape)
  • Stanford Biodesign's New Library on Medical Technology Regulation (Stanford)
  • FDA seeks to speed updates to 'superbug' device labels (Reuters)
  • FDA panel backs Avedro eye disorder drug-device combo (SCRIP-$) (Tarius)
  • FDA Sends Plan for Electronic New Dietary Ingredient Portal to OMB (FDA)
  • NBTY, Pharmavite, Nature's Way and Nutraceutical Corp. pulled into NY AG’s probe (NI-USA) (AP)

In Focus: International

  • Three dozen hats in the ring for top EMA job (SCRIP RA-$)
  • Gilead frustrated despite final NICE Sovaldi nod (Pharmafile) (PharmaTimes)
  • Celltrion launches Remicade biosimilar in Europe (BioCentury) (Press) (Reuters)
  • Industry and campaigners split over transparency of EU trials database (SCRIP-$) (BIA)
  • Good NICE news for Pfizer, but Dendreon drug rejected (PMLive) (PharmaTimes)
  • Pharma Narrowly Defines When Compulsory Licenses Should be Used (Pharmalot)
  • Transcelerate teams to take on investigator selection bias (In-Pharma)

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US: Pharmaceuticals and Biotechnology

  • US lawmaker pushes for drug price transparency (PMLive) (Pharmalot) (BioCentury)
  • Why compounding pharmacy Downing Labs rejected FDA's recall request (CBS)
  • FDCA Preempts Maine Drug Importation Law, Court Says (Law 360-$)
  • FDA Meeting to Discuss Ethics of Sedating Children During Nonessential Interventions (FDA)
  • Antifungal Treatment Should Be Taken Off the Market, Public Citizen Tells FDA (Public Citizen) (Pink Sheet-$) (AP) (Petition)
  • Proposed ANDA and 505(b)(2) Rule Provides Codification of Long-Time Agency Practices (Lachman)
  • US FDA Advisory Committee Reviews Pharmacy Compounding Drug Lists (Tarius) (Medscape)
  • FDA Sues Compounding Pharmacy (CourtHouse News)
  • A New Variation on an Old Theme: FDA Refuses PTE Regulatory Review Period Revision Based on Filing Refusal Decision (FDA Law Blog)
  • Will The “Female Viagra” Ever Get It Up? (BuzzFeed)
  • Johnson & Johnson Loses Trial Over Risperdal And Male Breasts (Pharmalot) (Law 360-$)
  • GSK's Nonprescription Diet Pill Back in Stores After Recall (AP)
  • Adherence to risk evaluation and mitigation strategies (REMS) requirements for monthly testing of liver function (PubMed)
  • Over-the-Counter Sunscreen Drug Products-Regulatory Status of Ecamsule (FDA)
  • Over-the-Counter Sunscreen Drug Products-Regulatory Status of Enzacamene (FDA)
  • Revised FDA MAPP Covers Genetic Texicology Studies and Clinical Holds (FDA)
  • Virginia "Right to Try" Bill Sent to Governor for Signature (Thompson's)
  • Actavis Accuses NY AG Of Trying To 'Hijack' Antitrust Laws (Law 360-$)
  • Actavis Confirms Generic Uceris Patent Challenge (Press)

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

  • Phase III Trial Of Anticancer Agent Halaven In Soft Tissue Sarcoma Shows Overall Survival Benefit In Primary Endpoint (Eisai)
  • Bavarian Nordic vaccine helps prolong life in prostate cancer trial (Reuters)
  • Pfizer trumpets positive Trumenba data ahead of ACIP vote (Reuters)
  • Study That Paid Patients to Take H.I.V. Drugs Fails (NYTimes)

US: Pharmaceuticals and Biotechnology: General

  • Shire, Maker of Binge-Eating Drug Vyvanse, First Marketed the Disease (NYTimes)
  • Are we gaining more rapid access to evidence of value? (CEA Blog)
  • Antibiotic overuse targeted by specialty groups as problem persists (ModernHealthcare)
  • US legal authorities seek information on Dr Reddy's Laboratories drug pricing mechanism (India Times)

US: Medical Devices

  • Stanford Biodesign's New Library on Medical Technology Regulation (Stanford)
  • FDA seeks to speed updates to 'superbug' device labels (Reuters)
  • FDA panel backs Avedro eye disorder drug-device combo (SCRIP-$) (Tarius)
  • Hospital, FDA remain at odds on effective endoscope cleaning as 'superbug' marches on (Fierce)
  • FDA Receives Petition Against Essue (FDA)
  • Patient Groups Split On FDA's Laboratory-Developed Test Proposal (IHP-$)
  • Zimmer Says FDA Warning Letter Remains "Pending" (SEC)
  • Alfred Mann's Bioness gains first FDA nod for a chronic pain peripheral nerve implant (Fierce) (Mass Device)

US: Dietary Supplements

  • FDA Sends Plan for Electronic New Dietary Ingredient Portal to OMB (FDA)
  • NBTY, Pharmavite, Nature's Way and Nutraceutical Corp. pulled into NY AG’s probe (NI-USA) (AP)
  • Hatch, Heinrich write FDA about NYAG investigation (NewHope360)

US: Assorted And Government

  • Desperately Seeking A Leader For The FDA (Forbes)
  • PCORI awards $64.1M for research projects (BioCentury)
  • Henry Waxman, of Hatch-Waxman Act Fame, Joins Lobby Firm (The Hill)

Upcoming Meetings

Ebola Outbreak

  • BARDA funds ZMapp-like Ebola drugs from Medicago, Fraunhofer (SCRIP-$)
  • Ebola – the industry's response in antivirals (SCRIP-$)
  • Simple paper strip can diagnose Ebola and other fevers within 10 minutes (MNT)

Europe

  • Three dozen hats in the ring for top EMA job (SCRIP RA-$)
  • Gilead frustrated despite final NICE Sovaldi nod (Pharmafile) (PharmaTimes)
  • Celltrion launches Remicade biosimilar in Europe (BioCentury) (Press) (Reuters)
  • Industry and campaigners split over transparency of EU trials database (SCRIP-$) (BIA)
  • Good NICE news for Pfizer, but Dendreon drug rejected (PMLive) (PharmaTimes)
  • France's ANSM Releases 2015 Work Plan (ANSM)
  • Market surveillance top of agenda for EU competent authorities meeting (Clinica-$)
  • Dutch Antitrust Watchdog Vows Scrutiny Of Pharma Sector (Law 360-$)
  • GSK's Tyverb Upgraded to Non-Conditional Approval Status (EC)
  • Eleven arrested over bribery allegations in Lithuania's pharmaceutical industry (Lithuania Tribune)

Canada

  • Regulatory update: Health Canada’s recent initiatives for transparency and openness for marketed therapeutic products (Lexology)

Other International

  • Pharma Narrowly Defines When Compulsory Licenses Should be Used (Pharmalot)
  • Humanitarian Access to Unapproved Interventions in Public Health Emergencies of International Concern (PLoS)

Clinical Trials

  • Transcelerate teams to take on investigator selection bias (In-Pharma)
  • Clinical Trial Diversity: ‘How Much More Evidence Do We Need To Move Forward?’ (Pink Sheet-$) (FDA)

General Regulatory And Interesting Articles

  • Researchers Find Way to Harness Brain to Control Bionic Hands (WSJ-$) (MNT)
  • Common Pain Drugs Linked To More Problems After A Heart Attack (Forbes) (MPR)
  • It will take more than scientific brilliance to win the battle against dementia (Guardian)

Regulatory Reconnaissance #501 – 25 February 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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