Regulatory Focus™ > News Articles > Regulatory Recon: Sanofi Dengue Vaccine Approved in Mexico, FDA Panel Recommends Teva Asthma Drug (1

Regulatory Recon: Sanofi Dengue Vaccine Approved in Mexico, FDA Panel Recommends Teva Asthma Drug (10 December 2015)

Posted 10 December 2015 | By Michael Mezher 

Regulatory Recon: Sanofi Dengue Vaccine Approved in Mexico, FDA Panel Recommends Teva Asthma Drug (10 December 2015)

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

  • Mexico Approves Sanofi's Dengue Vaccine but Pricing Questions Remain (WSJ) (Reuters)
  • Treating Whole Communities for Scabies Feasible, Effective (MedpageToday)
  • Nearly two-thirds of companies not ready for EFPIA disclosure code, survey says (PharmaLetter-$)
  • China aims precision medicine plans at chronic diseases (FiercePharmaAsia) (China Daily)
  • Health Canada Safety Review Finds No Link Between Gardasil and Cardiovascular or Autoimmune Diseases (Health Canada)

US: Pharmaceuticals and Biotechnology

  • The Drug Supply Chain Security Act: Current Impact (GxP Lifeline)
  • Turning Red Blood Cells into Versatile Drug Carriers (MIT Technology Review)
  • FDA Releases Clinical Trials Demographics for Consumers (FDA)
  • Thinking With Your Gut? A Merck Vet Aims To Turn That Idea Into New Medicines (Forbes)
  • PDUFA VI "Breakthrough" Fee Unlikely; FDA Wants Fewer Obligations, Not New Metrics (RPM Report-$)
  • Anika assigned to FDA's drug eval arm for Cingal approval (MassDevice)
  • FDA Panel Set to Scrutinize Codeine Safety in Kids (MedpageToday)
  • Cancer Treatments May Need To Be Tailored To Each Tumor (NPR)
  • From 'Back' To 'Front': FDA, Industry Experts Advise Device Manufacturers On Best Inspection 'War Room' Practices – And Don't Forget The Swedish Fish (Gray Sheet-$)
  • Health App Usage Soars As Prescription For Consumer Medical Needs (Forbes)

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

  • Novo Nordisk files for regulatory approval of "faster-acting insulin aspart" in the US (Press)
  • Pfizer Announces FDA Acceptance of IBRANCE (palbociclib) Supplemental New Drug Application with Priority Review in HR+, HER2- Metastatic Breast Cancer (Press)
  • Coherus delaying Neulasta biosimilar submission (BioCentury)
  • Blincyto (blinatumomab) data shows benefit in Phase 2 trial in all patients with persistent or recurrent minimal residual disease (MNT)
  • New data for Gazyvaro demonstrate leukaemia patients can live 3 years longer without treatment vs. standard of care (MNT)
  • Merck KGaA, Darmstadt, Germany, and Pfizer Initiate Two Phase III Studies of Investigational Immunotherapy Avelumab in Advanced Gastric and Gastro-esophageal Junction Cancers (Press)
  • Ocular Therapeutix Dextenza NDA accepted by FDA (MassDevice)
  • Updated Phase III Results from German Breast Group (GBG) Demonstrate Reduced Dose of Nab-Paclitaxel (ABRAXANE) Maintains Efficacy while it Improves Tolerability in High-Risk Early Breast Cancer (Press)
  • Seattle Genetics Presents Phase 1 Data from Novel Antibody-Drug Conjugate SGN-LIV1A at San Antonio Breast Cancer Symposium (Press)
  • Puma Biotechnology Presents Interim Results of Phase II Trial of PB272 for ERBB2 Mutant, HER2 Non-Amplified, Metastatic Breast Cancer at the 2015 San Antonio Breast Cancer Symposium (Press)
  • Promedior Presents Positive Phase 2 Data for PRM-151 in Myelofibrosis at ASH Annual Meeting (Press)
  • US Food & Drug Administration Grants Orphan Drug Designation to TapImmune's TPIV 200 in the Treatment of Ovarian Cancer (Press)
  • Kadimastem Reached Agreements with the FDA Regarding the Framework of the Clinical Trials in Humans for the Treatment of ALS (Press)

`US: Medical Devices

  • CDRH Compliance Office Looks Ahead To 2016 (Gray Sheet-$)
  • Boston Scientific recalls device after pieces broke off in patients (Boston Business Journal)
  • Arsenal Medical gets $14M DoD contract to seek FDA approval of self-expanding foam (Boston Business Journal)
  • Ready or Not: Patient-Centered Device Development Is Here (MDDI)
  • Boston Scientific recalls Chariot sheaths; FDA labels it Class I (MassDevice)
  • Stimwave wins FDA 510(k) for SCS device (MassDevice)
  • Allurion wins CE Mark for weight loss balloon (MassDevice)
  • New ibuprofen patch delivers drug without risks posed by oral dose (MNT)

US: Assorted and Government

  • D. Ct. Ruling on Preliminary Injunction and 180-day Notice Issue in Amgen v. Apotex (Big Molecule Watch) (SCRIP-$)
  • Reefer Gladness? DEA OKs Catalent to supply marijuana from Missouri plant (In-PharmaTechnologist)
  • Why Do Drugs Suddenly Cost More? Because Insurance Is Covering Less Of The Costs (Forbes)
  • US Capability for Treating Ebola Outbreak Appears Sufficient but Limited (ICT)
  • Doc Groups Seek To Block CMS Biosimilars Policy Via Congress (Pink Sheet-$)
  • Wholesale Drug Distributor Charged In $100M Fraud Scheme (Law360-$)
  • Nationwide Children's accuses Silicon Valley biotech of stealing trade secrets (Columbus Business First)
  • Senators Seek Direction on Combating Opioid Abuse (MedpageToday)
  • Dems, GOP near deal on delaying medical device tax (MassDevice)
  • When They Don't Have Anything, They'll Try Anything (Drug and Device Law)
  • Class Action Issues at the Supreme Court (and Elsewhere) (Drug and Device Law)
  • Major Drug Pricing Ballot Initiatives Face 2016 Voters (Policy and Medicine)

Upcoming Meetings and Events              

Europe

  • Smarter regulation can help cut drug prices, says EU agency head (Reuters) (Focus)
  • France says found four new bird flu outbreaks (Reuters)
  • Richter's pegfilgrastim biosimilar application accepted by EMA (Biosimilar News)
  • Biocad receives bevacizumab biosimilar approval in Russia (Biosimilar News)
  • Novartis' Cosentyx Gives More Additional Benefit Than Stelara, Says German HTA (SCRIP-$)

India

  • Health Ministry to form 'Working Group' with private players (Economic Times)
  • Aurobindo Pharma gets USFDA nod for oral contraceptive tablets (Economic Times)
  • EMA grants orphan drug status for Ignyta's entrectinib to treat neuroblastoma (PharmaBiz)
  • Alembic Pharma arm ties up with Novartis for drug development (Economic Times)
  • Sun Pharma inks pact to develop nervous system drugs (Economic Times)

Canada

  • Codeine Prescription Products Indicated for Cough - Further Assessing the Risk of Serious Breathing Problems in Children and Adolescents (Health Canada)
  • BioPharma Services Inc. - Three inspections, Two sites, One company, Zero 483's! (Press)

Other International                   

  • They Helped Erase Ebola in Liberia. Now Liberia Is Erasing Them. (NYTimes)
  • Volatile Venezuela - That Sinking Feeling For Pharma? (SCRIP-$)

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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