Regulatory Focus™ > News Articles > Regulatory Recon: Novartis Data Shows Potential Megablockbuster Heart Drug (2 September 2014)

Regulatory Recon: Novartis Data Shows Potential Megablockbuster Heart Drug (2 September 2014)

Posted 02 September 2014 | By Alexander Gaffney, RAC

Regulatory Recon: Novartis Data Shows Potential Megablockbuster Heart Drug (2 September 2014)

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

This fall, regulatory professionals from across the globe will come together to learn, connect and share at the Regulatory Affairs Professionals Society’s 2014 RAPS: The Regulatory Convergence, 27 September-1 October, Austin, TX.  Register here.

In Focus: US

In Focus: International

US: Pharmaceuticals and Biotechnology

  • UCB’s epilepsy drug approved as monotherapy in US (PharmaPhorum) (Press) (SCRIP-$)
  • An analysis of FDA-approved drugs for oncology (Elsevier)
  • HHS Mulls Lifting Gay Blood Donor Ban (MedPage Today)
  • Naloxone Behind-the-Counter? Petition Could Help Push Action (RPM Report-$)
  • India, U.S. Set High-Level Talks Over Drug Quality, IP Issues (PharmAsia-$)
  • Poll: Americans Skeptical About Generic Drugs (Consumer Reports)
  • Merck Suvorexant Scheduled, But DEA Delays Remain an Issue (RPM Report-$)
  • $3B Lilly Case Spotlights Drug Promoters' Labeling Quandary (Law 360-$)
  • Wockhardt recalls same drug for third time in the US since May (DNA India) (PharmAsia-$) (Fierce)
  • 6 New England governors urge painkiller reversal (AP)
  • OGD Management Review Results in Forfeiture of Generic ACTONEL 180-Day Exclusivity Eligibility (FDA Law Blog)
  • Rivaroxaban and Liver Injury: Case Studies Add to Safety Questions (MPR) (Pharmalot)
  • Feds Rip PhRMA's Free Speech Claims In FCA Off-Label Suit (Law 360-$)
  • ‘Dear Healthcare Professional’ letters may not be effective REMS communication tool (PubMed)
  • Cipla Targets U.S. With Glaxo’s Advair, Anti-AIDS Drugs (Bloomberg)
  • On Patient Safety and Class II Drug Recalls (People's Pharmacy)
  • Compounding the problem: US warns two more pharmacies (In-Pharma)
  • Upcoming events: FDA panels take on liraglutide and Natpara (EP Vantage)
  • FDA Approval Summary: Crizotinib for the Treatment of Metastatic Non-Small Cell Lung Cancer With Anaplastic Lymphoma Kinase Rearrangements (PubMed)
  • The US Food and Drug Administration's Efforts to Support Ophthalmology Clinical Trials (PubMed)
  • Protecting the pipeline of science: Openness, scientific methods and the lessons from ticagrelor and the PLATO trial (PubMed)
  • Cardiac Safety Research Consortium: Can the thorough QT/QTc study be replaced by early QT assessment in routine clinical pharmacology studies? Scientific update and a research proposal for a path forward (PubMed)
  • FDA warns consumers about pets' tear stain meds (WTSP) (FDA)
  • Lipitor Diabetes Claims Start Piling up in Federal Case (Press)

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

US: Pharmaceuticals and Biotechnology: General

  • Which Countries Excel in Creating New Drugs? It’s Complicated (Xconomy)
  • Pricing is key for new heart drugs challenging cheap generics (Reuters)
  • Public Citizen Comes out Against TPP (Citizen)

US: Medical Devices

  • Boston Scientific nerve device no help in heart failure study (Reuters) (EP Vantage) (Press)
  • St. Jude Quartet quadriploar lead delivers positive results in trial (EP Vantage) (Press)
  • Cyberonics device improves heart function after Boston flop (Reuters) (EP Vantage)
  • CDRH Recall Chief On Social Media Notifications And Conducting Recall ‘Post-Mortems’ (Silver Sheet-$)
  • FDA clearance of Medtronic's scoliosis implant a much-needed victory for pediatric devices (Fierce) (MedGadget)
  • Does Apple's HealthKit prove FDA guidance is working? (GovHealthIT)
  • Medtronic warns on insulin pump overdose (Mass Device)
  • J&J’s Pinnacle Hips Face First Trial on Poisoned Patients (Bloomberg)
  • FDA Research Indicates Women Fare Better Than Men After CRT-D Implantation (PubMed)
  • New Clinical Trial Results Demonstrate Importance of St. Jude Medical Fractional Flow Reserve in Guiding Treatment of NSTEMI Patients (Press)
  • Smiths Medical Issues Urgent Medical Device Recall of Certain Portex Endotracheal Tube Holders, 2.5mm and 3.0mm (Press)
  • Attorney: Latest UDI guidance unhelpful, many questions left unanswered (Fierce)
  • Report: Boston Scientific wins 2nd pelvic mesh bellwether (Mass Device) (Law 360-$)
  • Vital Connect’s home monitoring patch gets FDA clearance (MedCity News)
  • On the Regulatory Risks of Crowdfunding a Device (Regdy)

US: Dietary Supplements

  • FTC Wants Supplement Executives Jailed After Judge Imposes $40 Million in Sanctions (NPI)
  • NBTY sued over allegedly pumping up protein claims for whey product (NI-USA)
  • Regeneca Worldwide, a Division of Vivaceuticals, Inc Expands the Voluntarily Recall of Regeneslim Appetite Control Capsules Due to the Presence of DMAA that May Pose Possible Health Risk (FDA)

US: Assorted And Government

  • More Data to Be Kept from Doc Payments Database (ProPublica)

Upcoming Meetings

Ebola Outbreak


  • GE Healthcare Announces European Union Approval of VIZAMYL in Suspected Alzheimer’s Disease (Press)
  • European Medicines Agency updates guidance on European Union periodic-safety-update-report single assessment for nationally authorised medicines (EMA)
  • Germany’s IQWiG denies Astellas’ incontinence drug (PMLive)
  • Insufficient Postage Leads to Bust of Fake Drugs (AP)
  • EMA Hires New Comms Head (EMA)
  • Allergan Announces OZURDEX (dexamethasone 700 mcg intravitreal implant in applicator) Now Approved in the European Union for the Treatment of Diabetic Macular Edema (Press)
  • U.K. Cancer Drug Fund May Shift To ‘Coverage With Evidence Development’-Style Approach (Pink Sheet-$)
  • Claiming Pressure From European Regulators, Trial Leaders Cancel Press Conference (Forbes)
  • Numbers of clinical trials in Denmark have stabilized (Pharma Letter-$)
  • Sophia Genetics Becomes the First European Company to Obtain CE-IVD Mark for Clinical use of Next Generation Sequencing Bioinformatics Pipeline for Routine Genetic Testing (Press)


  • India To Exempt Certain Drugs From Trials (PharmAsia-$) (India Times)
  • With regulatory action on rise, pharma liability cover takes prominence (Business Standard)
  • 'Patients back-out from trials fearing Audio/Video consent' (BioSpectrum)
  • 59 new drug applications pending review at CDSCO (BioSpectrum)
  • Gardasil Studies in India Faulted for Improper Consent, Potential Side Effects (India Times)
  • Consecutive drug reactions: Doctors puzzle over why patients in 14 other hospitals were not hit by antibiotics (Times of India)


  • Fujian releases new policies to support pharmaceutical industry (Xiamen)
  • Survey: Pharmaceutical and Other Foreign Companies in China Feel 'Targeted' (AP)



  • Canada bans citronella-based bug spray (CBC)

Other International

  • Taiwanese urge for Orphan Drug Act (BioSpectrum)
  • Brazil plans shake-up of clinical trial approval process (SCRIP-$)
  • Nigeria: NAFDAC Raids Kano Markets, Seizes Fake Drugs Worth Millions of Naira (AllAfrica)
  • Mexico first country to launch Novo Nordisk’s Ryzodeg (Pharma Letter-$) (PMLive)

Clinical Trials

General Regulatory And Interesting Articles

  • Fear of opioid addiction keeps some cancer patients from seeking pain relief (Reuters)
  • Company tests a way to deliver vaccines by a skin 'patch' (BioFlash)
  • Clockwork heart pacemaker does away with batteries (Reuters)
  • Electronic nose ‘smells’ C-diff (OnMedica)
  • Bioelectronic medicine: Milestones on the way to medical revolution (Eye for Pharma)
  • UK cancer death rate for children drops 22% in a decade (Pharma Times)
  • More Evidence That ADHD Drugs Don't Curb Ultimate Height (NPR)

Regulatory Reconnaissance #390 – 2 September 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

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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