Regulatory Focus™ > News Articles > Regulatory Recon: Congress Considers Different Reimbursement Rates for Biosimilars (6 August 2015)

Regulatory Recon: Congress Considers Different Reimbursement Rates for Biosimilars (6 August 2015)

Posted 06 August 2015 | By Michael Mezher 

Regulatory Recon: Congress Considers Different Reimbursement Rates for Biosimilars (6 August 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 and @RAPSorg on Twitter.

In Focus: US

  • Focus on Precision Medicine Distracting From Efforts Seeking Healthier Population (GenomeWeb)
  • Why Are Generics So Pricey? Pharmacy Practice News (MedpageToday)
  • FDA backs cannabis-based medicine for in-danger newborns (Business Weekly)
  • The Future of Clinical Pathways (The Catalyst)
  • FDA Warns of Serious Adverse Events with Ventricular Assist Devices (FDA) (MedpageToday)
  • US FDA amends refuse to accept policy for 510(k) medical device submissions (MassDevice) (Gray Sheet-$)
  • Six preliminary FDA refuse-to-accept screening questions any 510(k) submission must pass (MassDevice)
  • House seek unique reimbursement rates for biosimilars (BioCentury)
  • With 21st Century Cures Act, the House Got it Right (MDDI)
  • CDC study: Lack of coordination among health facilities undermines antibiotic resistance efforts (MedCityNews)

In Focus: International

  • Podcast: CE Marking for Medical Devices in Europe (Emergo)
  • NICE calls the shots on Harvoni – but NHS England eyeing price controls (PharmaPhorum)
  • Britain raps Pfizer over huge jump in epilepsy drug price (Reuters) (BBC)
  • China gets tougher for Western drugmakers (Reuters)
  • Glenmark move to clear sitagliptin stocks denied by India's top court (FiercePharmaAsia)
  • Trans-Pacific Partnership could pose risk to public healthcare, leaked draft shows (The Guardian)
  • How to beat the next Ebola (Nature)

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US: Pharmaceuticals and Biotechnology

  • US Officials: Global Crises Require Accelerated Drug Evaluation (SCRIP-$)
  • Focus on Precision Medicine Distracting From Efforts Seeking Healthier Population (GenomeWeb)
  • Why Are Generics So Pricey? Pharmacy Practice News (MedpageToday)
  • Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs; Revised Draft Guidance for Industry (Federal Register) (FDA)
  • Latest Safety Warning For Novartis's Gilenya Won't Hurt Sales (SCRIP-$)
  • Oncology constitutes biggest therapy area in terms of pipeline (PharmaLetter-$)
  • FDA backs cannabis-based medicine for in-danger newborns (Business Weekly)

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

  • Phase III results for Vanda’s Hetlioz published in The Lancet (European Pharmaceutical Review)
  • Experimental gel partially protects against genital herpes (Reuters)
  • Enrollment Begins in Cytori U.S. Phase III/Pivotal Scleroderma Trial (Press)
  • Gammaplex® Approved for Use in Pediatric Patients (Press)
  • Rosetta Genomics Receives Conditional Approval from New York State for Lung Biomarker (Press)
  • Perrigo Omeprazole Magnesium PPI Approval Includes 180-Day Exclusivity (Tan Sheet-$)

US: Pharmaceuticals and Biotechnology: General

  • The Future of Clinical Pathways (The Catalyst)
  • Did Express Scripts Just Save the Healthcare System an Additional $107.8 Million? (RxViewBlog)

US: Medical Devices

  • FDA Warns of Serious Adverse Events with Ventricular Assist Devices (MassDevice) (FDA) (MedpageToday)
  • US FDA amends refuse to accept policy for 510(k) medical device submissions (MassDevice) (Gray Sheet-$)
  • Six preliminary FDA refuse-to-accept screening questions any 510(k) submission must pass (MassDevice)
  • Overview of FDA Approved Obesity Treatment Devices (FDA)
  • Apollo Endosurgery, Inc. Announces FDA Approval of the ORBERATM Intragastric Balloon (Press)
  • Expert Calls On Professional Societies to Step Up On Robotic Surgery (Gray Sheet-$)
  • Use of Ultrasound to Promote Faster Healing of Wounds (medGadget)
  • FDA Approves 28 Additional Styles of Allergan's Natrelle® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Press)
  • FDA Hikes Medical Device User Fees For FY 2016 (Med Device Online)
  • J&J working with nonprofit to enable open-source software to combine diabetes device data (FierceMedicalDevices)
  • Cook recalls 95,000+ angiographic catheters due to complaints of tip separation (FierceMedicalDevices) (FDA) (FDA) (FDA)
  • Medical device cybersecurity: The Internet of Things could kill you (MassDevice)
  • Samsung’s Latest Enhanced Digital Radiography System Receives 510(k) FDA Clearance (Press)
  • Class 1 Device Recall Medtronic EnVeo R Loading System (FDA)
  • What’s the best approach to medical device Design Reviews? (MedCityNews)
  • Tackling the Tough Issues Related to Flexible Endoscopes: A Q&A with Sharon Van Wicklin (ICT)
  • FDA Panel Seeks Answers About Effective Reprocessing of Endoscopes (ICT)

US: Assorted and Government

  • Biosimilars Face Uncertain Market If CMS Payment Plan Proceeds (SCRIP-$) (BioCentury)
  • Industry View On Biosimilar Reimbursement Draws Congressional Support (Pink Sheet-$)
  • With 21st Century Cures Act, the House Got it Right (MDDI)
  • GAO: Prescription Drugs Are Just 2% of Medicaid Spending (The Catalyst)
  • FDA Bans 3 Supplement Companies Over GMP Issues (DSN)

Upcoming Meetings and Events                                                            

Europe

  • Podcast: CE Marking for Medical Devices in Europe (Emergo)
  • NICE calls the shots on Harvoni – but NHS England eyeing price controls (PharmaPhorum)
  • IQWIG Finds No Added Benefit With Novo’s Xultophy Or Lundbeck’s Brintellix (Pink Sheet-$)
  • Britain raps Pfizer over huge jump in epilepsy drug price (Reuters) (BBC)
  • Two Reports on hGH-CTP Pediatric Phase 2 Clinical Data Accepted for Oral Presentation at the 54th Annual Meeting of the European Society for Paediatric Endocrinology (Press)
  • The Brexit Effect: Clinical Trials And New Drug Approvals (SCRIP-$)
  • Lundbeck Baffled After German Assessment Snub, Novo Also Hit Again (SCRIP-$)
  • Russia may start production of patented imported drugs without owners’ permission (PharmaLetter-$)
  • AstraZeneca officially receives license for production of drugs in Russia (PharmaLetter-$)

Canada

  • Sorin’s Perceval heart valve wins Health Canada nod (MassDevice)
  • Regulatory Decision Summary: Eperzan (Health Canada)

India

  • Glenmark move to clear sitagliptin stocks denied by India's top court (FiercePharmaAsia)
  • GVK India Row: Stalled EU Trade Talks And "Vendetta" Claims (SCRIP-$)
  • Dr Reddy's Tests Financing Model For Sofosbuvir In India (SCRIP-$)

China

  • China gets tougher for Western drugmakers (Reuters)

Ebola Outbreak

  • How to beat the next Ebola (Nature)
  • Lessons From Ebola: FDA Floats New Paradigm For Testing Drugs In Emergencies (Pink Sheet-$)

Other International

  • Trans-Pacific Partnership could pose risk to public healthcare, leaked draft shows (The Guardian)
  • Hanmi’s Licensing Success Driven By Strong Clinical Strategy (PharmAsiaNews)

General Health and Other Interesting Articles

  • An Intern’s Tale of Discovery & Development (LillyPad)
  • CDC study: Lack of coordination among health facilities undermines antibiotic resistance efforts (MedCityNews)
  • Contraceptives May Lower Endometrial Cancer Risk Long-Term (NYTimes)

Regulatory Reconnaissance #612– 6 August 2015

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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