Regulatory Focus™ > News Articles > Regulatory Recon: Novartis Acromegaly Drug Approved by FDA (16 December 2014)

Regulatory Recon: Novartis Acromegaly Drug Approved by FDA (16 December 2014)

Posted 16 December 2014 | By Alexander Gaffney, RAC

Regulatory Recon: Novartis Acromegaly Drug Approved by FDA (16 December 2014)

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

In Focus: US

  • Novartis Gets FDA Approval For Signifor LAR To Treat Acromegaly (RTT) (PharmaTimes) (Press) (Pharmafile) (Reuters) (Fierce)
  • FDA Ruling Blocking Celebrex Generics Reversed in Win For Mylan (Bloomberg)
  • Senators Warren, Feinstein and Gillibrand Ask Interagency Task Force About Efforts to Combat Antibiotic Overuse in Food Animals (Senate) (Letter)
  • Legislators Call on HHS to End Discriminatory Blood Donation Policy, Implement Risk-Based Policies (Senate) (Letter)
  • PhRMA, Pew: Compounders Need to Comply With 2013 Law, Not Seek Exemptions (PhRMA) (Letter)
  • Purdue's 'New' Oxycodone Pills Are Copycats, Acura Says (Law 360-$) (Acura)
  • How FDA Approved Hysterectomy Tools It Now Disfavors (WSJ-$)
  • FDA clears test that helps predict the risk of coronary heart disease (FDA) (MedPageToday)
  • FDA allows marketing of the first newborn screening test to help detect Severe Combined Immunodeficiency (FDA)
  • FDA grants CLIA waiver expanding the availability of rapid screening test for syphilis (FDA) (MedPageToday)

In Focus: International

  • New EMA expert group to support veterinary novel therapies (EMA)
  • USFDA vigilance on Chinese drug companies may benefit Indian counterparts (India Times)
  • Top five China regulatory changes 2014 (SCRIP-$)
  • China tightens codeine control over addiction concerns (Global Post)
  • Adaptive pathways: a future approach to bring new medicines to patients? (EMA)
  • Guideline on the use of minimal residue disease as an endpoint in chronic lymphocytic leukaemia studies (EMA)

US: Pharmaceuticals and Biotechnology

  • Novartis Gets FDA Approval For Signifor LAR To Treat Acromegaly (RTT) (PharmaTimes) (Press) (Pharmafile) (Reuters) (Fierce)
  • FDA Ruling Blocking Celebrex Generics Reversed in Win For Mylan (Bloomberg)
  • Senators Warren, Feinstein and Gillibrand Ask Interagency Task Force About Efforts to Combat Antibiotic Overuse in Food Animals (Senate) (Letter)
  • Legislators Call on HHS to End Discriminatory Blood Donation Policy, Implement Risk-Based Policies (Senate) (Letter)
  • PhRMA, Pew: Compounders Need to Comply With 2013 Law, Not Seek Exemptions (PhRMA) (Letter)
  • Purdue's 'New' Oxycodone Pills Are Copycats, Acura Says (Law 360-$) (Acura)
  • What Makes A “Breakthrough”? (RPM Report-$)
  • Addressing prescription opioid overdose: data support a comprehensive policy approach (JAMA)
  • Actavis to Appeal Injunction Requiring Continued Distribution of NAMENDA IR (Press)
  • The Food and Drug Administration's role in promoting consistent labels for generic drugs (JAMA)
  • Industry traceability activity ramps up, with some companies already preparing for 2017 (PharmaCommerce)
  • Feinstein, Grassley Bill to Combat Transnational Drug Trafficking Passes Senate (Congress) (Bill)
  • The End of the Hard Switch? What the Judge Says About an Actavis Tactic (Pharmalot)
  • Two Olathe residents plead guilty to operating multimillion-dollar designer drug business (KCKansan)
  • Head-to-Head Trials: Is This The Future Of Late-Stage Drug Development? (Forbes)
  • FTC Urges Court Not To Nix AbbVie Pay-For-Delay Suit (Law 360-$)
  • FDA Posts November 2014 Orange Book Cumulative Supplement (FDA)
  • Baxter has yet another recall of sodium chloride (Fierce) (FDA)

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

  • CSL Behring Submits Biologics License Application for FDA Approval of Recombinant Fusion Protein Linking Coagulation Factor IX with Recombinant Albumin (rIX-FP) for Hemophilia B Patients (Press)
  • Sophiris plummets on doubts its prostate drug can clear Phase III (Fierce)
  • Prothena Receives FDA Fast Track Designation for NEOD001, a Monoclonal Antibody for the Treatment of Patients With AL Amyloidosis (Press)
  • Salix NDA Review of Zifaxan 550 for IBS Delayed (Press)
  • Relypsa's patiromer under FDA review; shares jump (SCRIP-$)
  • Cyclacel lead drug likely to fail trial, says safety board (Reuters)

US: Pharmaceuticals and Biotechnology: General

  • New USPTO thinking on patent subject matter eligibility (BioCentury) (SCRIP-$)
  • CA panel: Gilead's Harvoni cost-effective at $95K, but only affordable at half the price (Fierce)
  • As Controlled Substance Use Rises in Medicare, Prolific Prescribers Face More Scrutiny (ProPublica)
  • How Pfizer is executing patient-centric drug development (BioCentury)

US: Medical Devices

  • How FDA Approved Hysterectomy Tools It Now Disfavors (WSJ-$)
  • FDA clears test that helps predict the risk of coronary heart disease (FDA) (MedPageToday)
  • FDA allows marketing of the first newborn screening test to help detect Severe Combined Immunodeficiency (FDA)
  • FDA: Stop Taking Selfies of Your Fetus (FDA)
  • 8 FDA Guidance Documents for Devices You Need to Know (MDDI)
  • FDA grants CLIA waiver expanding the availability of rapid screening test for syphilis (FDA) (MedPageToday)
  • Brainsway wins FDA nod for PTSD test (Mass Device)
  • FDA clears laser-based comb to combat hair loss (Fierce)
  • Improving the 510(k) FDA process for cardiac troponin assays: in search of common ground (PubMed)
  • EOS imaging Obtains FDA Approval for hipEOS, the First 3D Stereoradiographic Planning Software for Hip Arthroplasty (Press)
  • CVRx Granted Humanitarian Device Exemption Approval from FDA for Barostim neo legacy Hypertension Therapy Device (Press)
  • FDA Clears Olympus' Narrow Band Imaging (NBI) for Effective Targeting of Bladder Cancer Biopsies and Improved Visualization of Tumor Margins (Press)
  • Bovie Medical Receives FDA 510(k) Approval for Bovie Ultimate Generator (Press)

US: Dietary Supplements

  • Dallas-based maker of supplements linked to deaths is facing federal mail fraud investigation (Dallas Morning News)

US: Assorted And Government

  • FDA Funding Helped By Ebola Emergency Spending, But Opioid Issue Still Rankles Appropriators (RPM Report-$)
  • Publication Procedures for Federal Register Documents During a Funding Hiatus (Federal Register)
  • Enforcement Report - Week of December 10, 2014 (FDA)
  • Congress Passes Historic Medical Marijuana Protections In Spending Bill (Huffington Post)
  • Cassidy given HELP Committee seat (The Hill)

Upcoming Meetings

Ebola Outbreak

  • BioCryst Ebola drug BCX4430 enters safety testing (SCRIP-$)
  • Endless Ebola Epidemic? That's The 'Risk We Face Now,' CDC Says (NPR)

Europe

  • New EMA expert group to support veterinary novel therapies (EMA)
  • Adaptive pathways: a future approach to bring new medicines to patients? (EMA)
  • Guideline on the use of minimal residue disease as an endpoint in chronic lymphocytic leukaemia studies (EMA)
  • Stada, Dr. Reddy's and others dodge German drug suspensions with appeals (Reuters)
  • Reviving the personalized medicine space for IVD and drug makers (Clinica-$)
  • Early Access: the ground rules for communicating with physicians and patients (PharmaPhorum)
  • NICE backs Pfizer drug Inlyta in kidney cancer (PMLive) (PharmaPhorum)
  • NHS cost watchdog in favour of Bayer's Xofigo (PharmaTimes)
  • Germany's IQWiG delivers bad news for Bayer’s Eylea (PMLive)
  • Poland starts CESP pilot (Exalon)
  • Research and Generic/Biosimilar Industries Call for Integrated Life Sciences Strategy for Europe (EFPIA)

India

  • USFDA vigilance on Chinese drug companies may benefit Indian counterparts (India Times)
  • CDSCO says Indian hospital charged for stem cell treatments given during unapproved trial (Outsourcing Pharma)
  • Three cancer drugs get clinical trial waiver for importing, marketing in India (PharmaBiz)
  • Drug Smuggling from China: CBI Special Court Remands 12 (Indian Express)

China

  • Top five China regulatory changes 2014 (SCRIP-$)
  • China tightens codeine control over addiction concerns (Global Post)
  • Domestic partners may help MNCs avoid newest delays in China clinical trials (BioCentury-$)

General Regulatory And Interesting Articles

  • Drug-resistant malaria: the world's next big health crisis? (Reuters)
  • Potential Drug-Drug Interactions Occur in Nearly Half of Pediatric Hospitalizations (MPR)
  • Why is so Much Published Science Not Reproducible? (BCTV)

Regulatory Reconnaissance #460 – 16 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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