Regulatory Focus™ > News Articles > Regulatory Recon: Pfizer Beats Revenue, Profit Estimates; Study of 23andMe Data Finds New Genetic Li

Regulatory Recon: Pfizer Beats Revenue, Profit Estimates Study of 23andMe Data Finds New Genetic Links to Depression (2 August 2016)

Posted 02 August 2016 | By Michael Mezher 

Regulatory Recon: Pfizer Beats Revenue, Profit Estimates Study of 23andMe Data Finds New Genetic Links to Depression (2 August 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

In Focus: US

In Focus: International

  • Ireland calls for EU drug agency to be moved from London to Dublin (The Guardian)
  • NZ's PHARMAC to fund Merck's Keytruda, Noxafil and Isentress (PharmaLetter-$)
  • Research head urges UK to seize Brexit opportunity (BBC)
  • Brexit Shock Dodged by U.K. Pharma as Innovation Spurs Deals (Bloomberg)
  • EU drugs agency to unveil results on 'early medicines' project this week (EurActiv)
  • UK court says state health system can fund preventative HIV drug (Reuters)
  • China's 'mosquito factory' aims to wipe out Zika, other diseases (Reuters)
  • Cystic Fibrosis: EMA Considers Revisions to Guidance for Developing New Drugs (Focus)
  • EMA Revises Guidance on Developing New TB Medicines (Focus)
  • Lupin to buy 21 branded drugs from Japan's Shionogi (Economic Times)
  • TGA Urges Adverse Event Reporting for Surgical Mesh Complications (TGA)
  • UK Life Sciences ministerial post to be split (PharmaLetter-$)
  • Evaluation of Eisai's advanced thyroid cancer treatment blocked until 2018 in England (Pharmafile) (PharmaTimes)
  • Russian government to create conditions to increase drug exports (PharmaLetter-$)

US: Pharmaceuticals & Biotechnology

  • Exploring The FDA's Clarification On Biosimilar Labeling (Law360-$)
  • Disease-Modifying Anti-Rheumatic Drugs for Rheumatoid Arthritis: Effectiveness and Value(ICER)
  • Amgen And Advaxis Enter Global Cancer Immunotherapies Collaboration (Press)
  • Pioneering Interventional Cardiologist Defends Unorthodox Practices (CardioBrief)
  • How to Accelerate the Search for Alzheimer's Drugs (Forbes)
  • Pharma and tech converge in 'fantastic voyage' to fight disease (Reuters)
  • Bristol-Myers' Opdivo far outpaced Merck's Keytruda again in Q2. What gives? (Fierce)

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

  • FDA Grants Rare Pediatric Disease Designation to Regenbio Gene Therapy for Mucopolysaccharidosis Type II (Press)
  • Agilis Biotherapeutics Announces FDA Orphan Drug Designation for the Treatment of Friedreich's Ataxia (FA) (Press       )
  • ACE Inhibitor Qbrelis Gets FDA Approval (MPR)
  • RedHill Biopharma has positive results with RHB-104 for multiple sclerosis (EPR)
  • Adcetris passes Phase III CTCL test (BioCentury)
  • FDA Delivers CRL to ADMA Biologics for Inspection Issues, Deficiencies (FDA News-$)

US: Medical Devices

  • Bos Sci Exec on the Secret to Synergy's Success (MDDI)
  • Regulatory Challenges Emerge For Additive Manufacturing (MITA)
  • MITA Smart Dose Standard Enhances Patient Care (MITA)
  • Essential Medical wins FDA IDE nod for vascular sealer (MassDevice)
  • Intersect ENT files with FDA for drug-delivering sinus implant (MassDevice)
  • ReVision Optics touts Raindrop inlay study data (MassDevice)
  • Bigfoot Biomedical's Diabetes Management System Going on Trial (MedGadget)
  • First Synthetic Cartilage Implant Approved by FDA (MedGadget)
  • GORE® TIGRIS® Vascular Stent Gains FDA Approval for Treatment of Peripheral Artery Disease (Press)

US: Assorted & Government

  • President Obama Signs S. 764 into Law, Preempting the Vermont GE Labeling Law (National Law Review)
  • Female Genital Mutilation/CUTTING:Existing Federal Efforts to Increase Awareness Should Be Improved (GAO)

Upcoming Meetings & Events

Europe

  • Three Years Of EU Post-Authorization Safety Studies: Design Expectations And Trends (Pink Sheet-$)        
  • ABPI Response to Stern Review into the Research Excellence Framework (REF) (ABPI) (Review)
  • Advertising investigations: June 2016 (MHRA)
  • Clinical Trials Regulations – have your say (MHRA)
  • UK regulators OK two Oxford Biomedica sites for cell therapy processing (InPharmaTechnologist)
  • Novartis partner BioLineRx in-licenses NASH drug after joint evaluation (Fierce)
  • Medtronic wins expanded CE Mark for Evolut R TAVR system (MassDevice)
  • EMA To Beef Up Use Of PBPK Models In Drug Development And Evaluation (Pink Sheet-$)
  • GlaxoSmithKline may lose $60 million vaccine contract in Russia (PharmaLetter-$)
  • Servier invests in bioproduction in France (PharmaLetter-$)

Asia

  • PMDA August Newsletter (PMDA)
  • Takeda refocusing R&D to 'become the best in the industry' (PharmaLetter-$)
  • Chi-Med expands PhIII effort on savolitinib with AstraZeneca with amended royalty pact (Fierce)
  • AstraZeneca confident on COPD in China as nebulizer centers grow (Fierce)

India

Australia

  • Safety Advisory: PSA assay used with ADVIA Centaur systems (TGA)

Other International

  • Can A Transformed ANVISA Sustain Torrent's Brazilian Mojo? (SCRIP-$)
  • Colombian police take down counterfeit pharma ring (Securing Industry)

General Health & Other Interesting Articles

  • Omega-3 fatty acids may aid heart attack healing (Reuters)
  • What banned drugs do cheating athletes take? (Washington Post)

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 @Michael_Mezher 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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