Regulatory Focus™ > News Articles > Regulatory Recon: US Rx Drug Use on the Rise, FTC Tells Mylan to Shed 7 Drugs Before Perrigo Acquisi

Regulatory Recon: US Rx Drug Use on the Rise, FTC Tells Mylan to Shed 7 Drugs Before Perrigo Acquisition (4 November 2015)

Posted 04 November 2015 | By Michael Mezher 

Regulatory Recon: US Rx Drug Use on the Rise, FTC Tells Mylan to Shed 7 Drugs Before Perrigo Acquisition (4 November 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

  • How the 'Low T' Wars Cast a Shadow Over Repros' Testosterone Alternative (Forbes)
  • Prescription Drug Use has Risen in the US (Reuters) (Washington Post)
  • Q&A: Regulatory Expert Karen Becker Provides Context for Theranos, FDA Interactions (GenomeWeb)
  • Mylan Must Sell 7 Generic Drugs Ahead Of Perrigo Deal: FTC (Law360-$) (FTC) (Mylan)

In Focus: International

  • Pfizer: No Safety Snags at China Plant Despite ‘Missing Document’ 483 (In-PharmaTechnologist)
  • Roche Blocks Indian Trastuzumab, Claiming No Room for ‘Uncertainty’ (PharmAsiaNews-$)
  • IPC to Become first WHO Collaborating Centre in SE Asia (Economic Times)
  • AHWP Releases Proposed Documents Ahead of 20th AWHP Meeting in Bangkok (AHWP)

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US: Pharmaceuticals and Biotechnology

  • American Cleaning Institute Urges FDA to Preserve Critical Antibacterial Products, Ingredients (ICT)
  • AbbVie: Humira’s patent maze will keep US biosimilars away until at least 2022 (BioPharma-Reporter)
  • ISCT: $2.4bn unregulated biologics market threatens legit industry (BioPharma-Reporter) (Report)
  • Data Mining as a Path to Better Trial Design (Geeks Talk Clinical)
  • Are doctors more willing to see pharma sales reps now? (Pharmalot)
  • Valeant’s unsavory ways are a lesson for everyone (Pharmalot)
  • Many ‘me-too’ drugs didn’t start off that way: report (Pharmalot) (Focus)
  • Scientists Find a Small Tweak May Make a Big Difference in Immune Cell Development (DD&D)
  • Anti-HIV Drug for Adults is Safe, Effective in Children Exposed to Nevirapine in the Womb (ICT)

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

  • Bi-monthly injection blocks HIV in study from J&J and GSK (Reuters)
  • Isis and GlaxoSmithKline eye Phase III with a rare disease drug (FierceBiotech)
  • GSK and Merck initiate Phase I trial of GSK3174998 with Keytruda (EPR)
  • Espero Pharmaceuticals Announces FDA Acceptance of New Drug Application for GoNitro (Nitroglycerin Powder for Sublingual Use) (Press)
  • Agilis Biotherapeutics Announces FDA Orphan Drug Designation for AGIL-AS for the Treatment of Angelman Syndrome (Press)
  • Allena Pharmaceuticals to Present Phase 2 Data on ALLN-177 Program at ASN Kidney Week 2015 (Press)
  • Merck KGaA, Darmstadt, Germany, and Pfizer Announce Initiation of Phase III First-Line Trial of Avelumab in Patients with Recurrent or Stage IV Non-Small Cell Lung Cancer (Press)

US: Medical Devices

  • Despite Clamor Surrounding Theranos, The Entrepreneur's Vision Of Transforming Diagnostics Is Near (Forbes) (MedCityNews)
  • Theranos Letter Shows Elizabeth Holmes Tried To Take Control From Shareholders (Forbes)
  • Study finds many health apps downloaded but go unused (DSN)
  • Next Step for FDA's 'Case For Quality'? 8 New Guidance Docs (Gray Sheet-$)
  • First Clinical Single Molecule Genome Sequencer Unveiled (medGadget)
  • INVO Bioscience Receives FDA Clearance for INVOcell Fertility Treatment (Press)
  • Neuromodulator and artificial kidney to be reviewed under FDA's Expedited Access Pathway (FierceMedicalDevices)
  • FDA clears Microsoft Kinect-enabled physical therapy program from Reflexion Health (MobiHealthNews) (Gray Sheet-$)
  • HHS Watchdog Will Scrutinize FDA's Handle On Device Network Security (Gray Sheet-$)
  • Reflexion Health gets FDA clearance for remote monitoring tool for physical therapy (MedCityNews)
  • Cerapedics Receives FDA Approval for i-FACTOR Peptide Enhanced Bone Graft in Cervical Spine Surgery (Press)
  • ALung Technologies Receives Expedited Access Pathway Designation from FDA for Hemolung Respiratory Assist System (Press)

US: Assorted and Government

  • HHS OIG Issues 2016 Work Plan (Policy and Medicine) (Focus)
  • Never Mind if They Work, are Supplements Safe? (Futurity) (Study)
  • Drug, Biologics Industries Lament CMS Rule Lumping Biosimilars Together (FDANews-$) (PharmaLetter-$)
  • Never Say Never to Lone Pine Orders (Drug and Device Law)
  • “Should I Stay or Should I Go” to FDA for an IND? FDA Issues a Stay for Certain Food Provisions of the Final IND Guidance (FDA Law Blog)
  • Remand Run Amok (Drug and Device Law)
  • Enzo, Applera Spar Over Fate Of DNA-Test Patent Verdict (Law360-$)
  • Ariosa V. Sequenom Signals Trouble Ahead For Life Sciences (Law360-$)

Upcoming Meetings and Events              

Europe

  • More Sleepless Nights For Pharma Over EU Labeling Rule For Investigational Drugs (SCRIP-$)
  • EMA's Medical Literature Monitoring Service Creates New Complexities For Pharma (SCRIP-$)
  • The European Medicines Verification Organisation (EMVO) and the European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe, have signed an agreement on Conformity Assessments (EDQM)
  • Elderly and those on repeat prescriptions at greatest risk of prescribing errors (OnMedica)
  • NICE u-turn for Santen's keratitis drug (PharmaTimes)
  • Merck’s Glucophage XR gets regulatory nod for type 2 diabetes patients (PharmaLetter-$)

Australia

  • Australia Targets Patients, Doctors In Biosimilar Awareness Campaign (Pink Sheet-$)

India

  • Phase I/II trials for DFU potential drug successful: NovaLead (Economic Times)

Japan

  • Japanese scientist inch closer to Toxoplasma vaccine discovery (BioSpectrum)

China

  • China State Council briefing outlines multilevel system for medical treatment (FiercePharmaAsia)
  • China developing novel Alzheimer’s drugs - by Wang Fangqing (PharmaLetter-$)

Other International

  • Mongolia Submits Membership Application to AHWP (AHWP)
  • WHO Funding Dialogue to Take Place in Geneva 5-6 November (WHO)

General Health and Other Interesting Articles

  • Early Hospitalization is Key to Survival for Ebola Victims (ICT)
  • Sorry, folks: Antibiotic-resistant gonorrhea is getting worse (Washington Post)
  • Prestigious medical journals rejected stunning study on deaths among middle-aged whites (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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