Regulatory Focus™ > News Articles > Regulatory Recon: Drug Pricing Takes the Spotlight Again (20 October 2015)

Regulatory Recon: Drug Pricing Takes the Spotlight Again (20 October 2015)

Posted 20 October 2015 | By Michael Mezher 

Regulatory Recon: Drug Pricing Takes the Spotlight Again (20 October 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

  • Drug Makers Sidestep Barriers on Pricing (NYTimes)
  • Valeant, Under Pressure About Price Increases, Plans Changes (WSJ-$) (SCRIP-$)
  • FDA Finds Deficiencies in Neos' Marketing Application for ADHD Drug (Reuters)
  • Economic Proof That the FDA's Drug Regulation Makes us All Poorer (Forbes)
  • Califf, Sherman Contributed To Report Pushing Alternative Informed Consent Policies (InsideHealthPolicy)

In Focus: International

  • A Bitter Pill: Can the Access to Medicines Movement Score Another Victory? (Foreign Affairs)
  • Russian secret service to vet research papers (Nature)
  • WHO Offers Technical Assistance To China On Joining PIC/S And Other Regulatory Issues (SCRIP-$)
  • Irish compounder Fannin recalls chemo drugs (Outsourcing-Pharma) (The Irish Times)
  • Cipla gets FDA's nine observations and issues noticed memo for Indore unit (Economic Times)

Sponsored Content

  • Regulatory Strategy Cheat Sheet - Want the most efficient pathway to market? Regulatory and Quality Solutions (R&Q) has crafted 10 tips that will ensure a well-researched and documented regulatory strategy. Download the white paper and you will learn how to:
  • Examine and align with key company stakeholders
  • Consider/assess markets and timelines for entering them
  • Determine the impact your device will have on your quality system
  • Incorporate current FDA thinking and data into the regulatory strategy

US: Pharmaceuticals and Biotechnology

  • FDA-Accelerated Ca Drugs Don't Get Adequate Follow-Up (MedpageToday) (Focus)
  • Clinton urges U.S. regulators to examine Daraprim price hike (Reuters)
  • Taking on the Superbugs (NYTimes)
  • Better communication about sex is just as effective as "Female Viagra" (Medical University of Vienna)
  • Talking Drug Prices, Pt 4 Drug pricing is out of control, what should be done? (PLoS) (Part 1, 2, 3)
  • More Questions About Nonprofit Groups And Industry Support (CardioBrief)
  • Antibiotic resistance threatens surgical procedures and chemotherapy, study warns (Pharmaceutical Journal)
  • Bluebird shares dented after gene therapy patient experiences a setback (FierceBiotech) (Press)
  • Florida Transdermal Patch Maker Lands 483 for Testing, Complaint Issues (FDANews-$)
  • Bayer's Corporate Reports About Their YAZ / Yasmin Settlement Program Show Progress Continues To Be Made, Albeit At A Slow Pace (Drug Injury Watch)

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

  • Johnson & Johnson's Stelara succeeds in Phase III Crohn's disease trial (Reuters)
  • Genocea stops pneumonia vaccine development after study fails (Reuters)
  • FDA approval for LEO Pharma’s Enstilar (PharmaLetter-$)
  • Pfizer’s Inotuzumab Ozogamicin Receives FDA Breakthrough Therapy Designation for Acute Lymphoblastic Leukemia (ALL) (Pfizer)
  • NDA for Progressive Eye Conditions Resubmitted to the FDA (MPR)
  • Atara Bio Receives FDA Orphan Drug Designation for STM 434, Atara Bio's Activin Inhibitor for Ovarian Cancer (Press)
  • Corbus Pharmaceuticals Announces FDA Orphan Drug Designation and Fast Track Status of Resunab(TM) for the Treatment of Cystic Fibrosis (Press)
  • Oncolytics Biotech® Inc. Announces Phase 1b Study in Advanced Pancreatic Cancer (Press)
  • Avedro Resubmits New Drug Application to FDA for Corneal Cross-Linking (Press)
  • Cold Genesys Announces FDA Acceptance of a Phase I/II Clinical Trial Using CG0070 Plus an Anti-CTLA-4 Checkpoint Inhibitor as a Neo-Adjuvant Immunotherapy for Muscle Invasive Bladder Cancer (Press)
  • Naia Rare Diseases Inc. Receives Orphan Drug Designation From U.S. FDA For NB1001 For Short Bowel Syndrome Treatment (Press)
  • Experimental Treatment Regimen Shown to be Effective Against HIV (ICT)

US: Medical Devices

  • Johns Hopkins, Microsoft to develop technology to improve patient safety in the ICU (Johns Hopkins)
  • To Best Oversee Physiological Closed-Loop Devices, FDA Need Regulators Who ‘Get’ Algorithms (Gray Sheet-$)
  • Injured Device Patients Blitz CDRH’s Shuren (MDDI)
  • Roche Gets FDA Approval for Cobas MDx Systems; HBV, HCV Viral Load Tests (GenomeWeb)
  • U.S. Supreme Court patent cases could affect devicemakers (ModernHealthcare)
  • More Resources Sought For Using Patient-Preference Data In US Device Reviews (SCRIP-$)
  • FDA approves expanded trial for InVivo Therapeutics spinal cord treatment (MassDevice)

US: Assorted and Government

  • Califf Nomination CO-OPed By Sen. Sasse In Fight Over Obamacare (Pink Sheet-$) (The Hill)
  • Does FDA Need a Dietary Supplement User Fee Act? (Harvard Bill of Health)
  • You Win Some, You Lose Some: Federal Circuit Denies En Banc Review in BPCIA Dispute & Otsuka Files Suit Over 3-Year Exclusivity (FDA Law Blog)
  • The Supreme Court to Review Enhanced Damages -- Octane Revisited, or Something Entirely Different? (Patent Docs)
  • Millennium Health to pay $256 million to resolve U.S. allegations: Justice Department (Reuters)
  • Drug Prices Now A Bipartisan Campaign Prop (SCRIP-$)
  • Jurisdiction In Hatch-Waxman Actions Against Foreign Entities (Law360-$)
  • NC Jury Hands Boston Scientific Win In Pelvic Mesh Case (Law360-$)
  • Amgen Calls For Halt To Neulasta Biosimilar Marketing (Law360-$)
  • Getinge: Resolving FDA beef less costly than thought (MassDevice)
  • Supreme Court to review Stryker’s patent infringement spat with Zimmer (MassDevice)
  • MDL Judge Allows Manufacturing Defect Claim to Go to Trial with No Direct Evidence of a Defect in the Device Actually Implanted in Plaintiff (Drug and Device Law)

Upcoming Meetings and Events              

Europe

  • EMA's Updated Guidance On Monitoring Off-Label Use Of Medicines Expected By Year End (SCRIP-$)
  • EU Notified Bodies Under Spotlight For Offering Consultancy Services (Clinica-$)
  • Luminex Receives CE-IVD Mark for Respiratory Pathogen Panel (GenomeWeb)
  • Lightpoint Medical Wins CE Mark Approval For World's First Intra-Operative Molecular Imaging Device (MedDeviceOnline)

India

  • Jubilant Life Sciences gets USFDA nod for migraine treatment drug (Economic Times)
  • India says no trade talks with EU until GVK issue 'resolved' (The Hindu)
  • UP government to focus on promoting pharma sector (Economic Times)
  • ICMR issues national ethics guidelines for biomedical research involving children (PharmaBiz) (Focus)
  • Pharma companies team up to clean industry’s image (ET Health World)

Japan

  • Takeda presents efficacy and cost-effectiveness data on vedolizumab (PharmaLetter-$)
  • Japan’s Agency for Medical Research and Development, AMED, Selects Certara’s Phoenix WinNonlin Software to Assess New Drug Candidates (Press)
  • Government to promote use of older drugs (The Japan News)

China

  • LeMaitre wins Chinese clearance for Trivex phlebectomy system (MassDevice)
  • Unleashing China's innovators (BioCentury 1, 2-$)

Other International

  • First Gene-Edited Dogs Reported in China (MIT Technology Review)
  • AstraZeneca opens new $224 million drug factory in Russia (Reuters)
  • WHO chief says US, Saudi discussing MERS vaccine (Reuters)
  • Argentina's Ministry of Health Approves MediWound's NexoBrid (Press)
  • Merck and UNESCO partner to build research capacity in Africa (PharmaLetter-$)
  • PM Lee Hsien Loong inaugurates new R&D hub in Singapore (BioSpectrum)

General Health and Other Interesting Articles

  • Blood thinners reduce angioplasty mortality (OnMedica)
  • Having more than 11 moles on your right arm may signal increased risk of skin cancer (Washington Post)
  • The Heterogeneity of Acute Myelogenous Leukemia: Gene Variants in Clinical Trials (Thomson Reuters)

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

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe