Regulatory Focus™ > News Articles > Regulatory Reconnaissance: EMA Transparency Plan Due for Release in June (25 March 2014)

Regulatory Reconnaissance: EMA Transparency Plan Due for Release in June (25 March 2014)

Posted 25 March 2014 | By Alexander Gaffney, RAC 

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In Focus: US

  • FDA Approvals for Tweaked High-Risk Devices Need Revamping (Medscape) (Study) (MedPage Today) (Mass Device)
  • DexCom Receives FDA Warning Letter for Administrative Deficiencies in its MDR Reporting (Press)
  • AARP Questions If FDA Has Resources To Implement Generic Labeling Reg (IHP-$)
  • ASCO creating scorecard to value cancer drugs, influence their use (BioCentury-$)

In Focus: International

  • NICE refuses to back Zaltrap as Sanofi exhausts its options (PMLive) (Pharmafile) (Pharma Times) (Bloomberg)
  • EMA's Final Transparency Plan Due to be Presented in June 2014 (EMA) (SCRIP-$) (BioCentury)
  • Why U.K. scheme to fast track breakthrough drugs to patients may be underused (BioCentury-$)
  • Groups Challenge Gilead Filing in Delhi Patent Office For Hep-C Drug (PharmAsia-$)
  • Additional E14 Q&As available on the ICH website (ICH)
  • ASEAN device directive on track, but medtech firms unclear over scope of benefits (Clinica-$)

US: Pharmaceuticals/Biotechnology

  • FDA staff review recommends against Novartis heart failure drug serelaxin (Reuters) (Bloomberg)
  • AARP Questions If FDA Has Resources To Implement Generic Labeling Reg (IHP-$)
  • Generic Drug Industry Urges High Court To Limit Scope Of False Advertising Ruling To Avoid Drug Implications (IHP-$)

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

  • Rockwell seeks FDA nod for Triferic in CKD (SCRIP-$) (Pink Sheet-$) (BioCentury)
  • Genocea's Therapeutic Vaccine for Herpes Simplex-2 Infection Shows Highly Significant Reductions in Clinical Symptoms at 6 Months (Press)
  • Afinitor/Aromasin combo disappoints in breast cancer trial (Pharma Times) (BioCentury)
  • Pfizer Reports Positive Phase 3 Study Outcome Of XALKORI (crizotinib) Compared To Chemotherapy In Previously Untreated Patients With ALK-Positive Advanced Non-Small Cell Lung Cancer (NSCLC) (Press)

US: Pharmaceuticals and Biotechnology: General

  • The 10 best-selling drugs of 2013 (Fierce)
  • J&J releases more Doxil, its popular cancer med that has been dogged by supply issues (Fierce)
  • ASCO creating scorecard to value cancer drugs, influence their use (BioCentury-$)
  • How ICER concluded new HCV drugs Sovaldi, Olysio not worth their costs (BioCentury-$)
  • How payers hope to gain price leverage over new HCV drugs like Gilead's Sovaldi (BioCentury-$)
  • Double Dip: Doctors Paid to Advise, Promote Drug Companies That Fund Their Research (ProPublica)
  • In biotech, 24 years without selling a single pharmaceutical isn't that unusual (MedCity News)
  • Should Prisoners Get Expensive Hepatitis C Drugs? (Stateline)
  • Op-Ed: Scare Tactics Over Foreign Drugs (NYTimes)
  • Biotech stocks down for second straight day as bubble fears escalate (BioFlash)

US: Medical Devices

  • FDA Approvals for Tweaked High-Risk Devices Need Revamping (Medscape) (Study) (MedPage Today) (Mass Device)
  • DexCom Receives FDA Warning Letter for Administrative Deficiencies in its MDR Reporting (Press)
  • False positives a concern in new colon cancer test (AP)
  • Health IT Advocates Prepare for Battle over Potential New FDA Safety Regulations (Policy and Medicine)
  • FDA posts briefing docs for colorectal cancer tests (BioCentury) (Gray Sheet-$)
  • Advancing Regulatory Science for High Throughput Sequencing Devices for Microbial Identification and Detection of Antimicrobial Resistance Markers (FDA)
  • Why the FDA's recent approval of brain biomarkers may help Alzheimer's efforts (BioFlash)
  • Case: Preemption Applies Even Though the Device Was Cleared under §510(k) and Used Off-Label (D&D Law)
  • Easing Epilepsy With Battery Power (NYTimes)
  • Quest wins U.S. nod for rapid Dx test that helps identify encephalitis (Fierce) (GenomeWeb) (Press)
  • FDA Grants Diazyme 510(k) Clearance to Market Its Vitamin D Assay for Clinical Chemistry Analyzers (Press)
  • EndyMed Medical Receives FDA Clearance for the Intensif - Its Breakthrough 3DEEP Fractional RF Microneedle Applicator (Press)
  • FDA clears 532 nm laser for Stellaris system (Press)

US: Dietary Supplements

  • Garcinia cambogia weight-loss pill is no miracle (Consumer Reports)
  • Legal Brief: What Happens if Your Supplement Delivers a Lawsuit? (NPI)

US: Assorted And Government

  • Participation of Minorities in US cancer trials "woefully inadequate" (Pharma Times)
  • District Court's Attorney-Client Privilege Ruling Counteracts Incentives to Perform Internal Investigations (WLF)

Europe

  • NICE refuses to back Zaltrap as Sanofi exhausts its options (PMLive) (Pharmafile) (Pharma Times) (Bloomberg)
  • EMA's Final Transparency Plan Due to be Presented in June 2014 (EMA) (SCRIP-$) (BioCentury)
  • Why U.K. scheme to fast track breakthrough drugs to patients may be underused (BioCentury-$)
  • EMA Concept paper on the revision of the guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins (EMA)
  • EMA Draft concept paper for a guideline on user safety of topically administered products (EMA)
  • Exelixis Receives Approval for COMETRIQ (Cabozantinib) in the EU for Treatment of Progressive, Unresectable Locally Advanced or Metastatic Medullary Thyroid Carcinoma (Press)
  • Cost watchdogs demand efficacy data on new Bayer cancer drugs (Fierce)
  • The color purple knocks back Novartis' Advair rival in Germany (Fierce)

India

  • Groups Challenge Gilead Filing in Delhi Patent Office For Hep-C Drug (PharmAsia-$)
  • Merck In Multiple Partnerships To Finance Hep C Treatment In India (PharmAsia-$)

Other International

  • Additional E14 Q&As available on the ICH website (ICH)
  • ASEAN device directive on track, but medtech firms unclear over scope of benefits (Clinica-$)
  • Health Canada falling short on trial transparency (Pharma Times) (The Star) (Study)
  • The TGA - a watchdog with dentures? (Crikey)
  • South Africa Mulls New Policy Tightening New-Drug Patent Standards (PharmAsia-$)
  • GMiA welcomes the release of Australian Pharmaceutical Patent Review (Pharma Letter-$) (GMiA)

General Regulatory And Interesting Articles

Regulatory Reconnaissance #283 - 25 March 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.

Did we miss a story? Send us a tweet at @RAPSorg and we'll check it out for inclusion in our next edition of Regulatory Reconnaissance. Want this in your inbox each morning? Sign up for RF Today, our morning intelligence newsletter here.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at news@raps.org.


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