Regulatory Focus™ > News Articles > Regulatory Recon: Ruling in Biosimilar Case Could Impact Future Launches (22 July 2015)

Regulatory Recon: Ruling in Biosimilar Case Could Impact Future Launches (22 July 2015)

Posted 22 July 2015 | By Michael Mezher 

Regulatory Recon: Ruling in Biosimilar Case Could Impact Future Launches (22 July 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

  • Court rules biosimilar 'patent dance' optional, but delays Zarxio (SCRIP-$) (PMLive) (BioPharma-Reporter) (Reuters) (Patent Docs)
  • Patent Dance May Still Be Preferable For Biosimilar Sponsors Challenging Newer Products (Pink Sheet-$ 1, 2)
  • New cholesterol-lowering medications likely to trigger fight over prices (Washington Post)
  • Gilead Combination Shows Strong Results for HCV in Patients Coinfected with HIV-1 (NEJM)
  • Bristol-Myers makes a 'breakthrough' on next-gen HIV therapy (FierceBiotech) (PharmaLetter-$) (Press)
  • openFDA: The First Year in Perspective (FDA)
  • Senators propose bill that would let patients self-pay for medical devices (GovernmentHealthIT)

In Focus: International

  • Simplified Registration Pathway for Class I Medical Devices in Russia (Emergo)
  • Ethiopia: GMP Compliant Drug and API Sector Would Yield Health and Economic Benefits (In-Pharma Technologist)
  • Emerging Markets: Pharma’s Next Challenge (McKinsey)
  • International Reference Pricing (Healthcare Economist)
  • Sanofi cholesterol drug, GSK malaria shot to get EU okay (EurActiv) (Reuters)
  • Fit for purpose MHRA can lead the way for global regulatory reforms (MHRA)
  • Amgen beats Regeneron, Sanofi to world's first big PCSK9 drug OK (FierceBiotech) (Reuters) (PharmaLetter-$)
  • EC Approves Keytruda for Patients with Advanced Melanoma (Press)
  • Aurobindo Pharma Comes Under USFDA Lens, Again (Economic Times)
  • Report Calls for Measures to Preserve India’s Brand in Global Pharma Market (Thomson Reuters)
  • Ethics In Spotlight As Scientists Jumpstart Precision Medicine In China (PharmAsiaNews-$)

US: Pharmaceuticals and Biotechnology

  • Court rules biosimilar 'patent dance' optional, but delays Zarxio (SCRIP-$) (PMLive) (BioPharma-Reporter) (Reuters)
  • Patent Dance May Still Be Preferable For Biosimilar Sponsors Challenging Newer Products (Pink Sheet-$ 1, 2)
  • New cholesterol-lowering medications likely to trigger fight over prices (Washington Post)
  • Promising Alzheimer's Drugs Disappoint With Incremental Data (Forbes)
  • IPEC calls on FDA to establish new review process for novel excipients (In-Pharma Technologist)

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

  • Gilead Combination Shows Strong Results for HCV in Patients Coinfected with HIV-1 (NEJM)
  • Bristol-Myers makes a 'breakthrough' on next-gen HIV therapy (FierceBiotech) (PharmaLetter-$) (Press)
  • Motif antibiotic secures special status from FDA (PharmaPhorum)
  • Second-Generation Investigational HIV-1 Maturation Inhibitor Demonstrates Positive New Phase IIa Results (Press)
  • In a setback, Biogen's mid-range dose of aducanumab flops in Alzheimer's study (FierceBiotech)
  • Eli Lilly offers evidence of twice-failed solanezumab's impact on Alzheimer's (FierceBiotech)
  • Big Pharma pushes new migraine drugs into Phase III with blockbuster hopes (FierceBiotech)
  • Novavax's Ebola vaccine shows promise in early-stage trial (Reuters)
  • Gilead Announces Phase 3 Results From the First Study to Evaluate Switching From TDF-Based Regimens to a TAF-Based Regimen (Press)
  • Drug for rheumatoid arthritis appears to have effect on severe eczema (OnMedica)
  • Osmotica's Osmolex ER Gets Orphan Drug Status (Press)
  • Data Using New Delayed-Start Methodology Suggested Benefit of Early Treatment with Solanezumab in Patients with Mild Alzheimer's Disease (Press)

US: Pharmaceuticals and Biotechnology: General

  • openFDA: The First Year in Perspective (FDA)
  • Use of Extrusion-Enabled Pharmaceutical Processes in Drug Development via a Streamlined Regulatory Pathway (The 505(b)(2) Blog)
  • Storming The Beach: De-risking Novel Modalities Through Innovative Translational Medicine (Life Sci VC)

US: Medical Devices

  • Roche Diagnostics strengthens its blood screening portfolio with an assay to identify Human T-lymphotropic virus I/II (Press)
  • Performance Standards for Ionizing Radiation Emitting Products; Fluoroscopic Equipment; Confirmation of Effective Date (Federal Register)
  • Technical difficulties, complications plague robotic surgeries (FierceHealthIT) (NBC News)
  • FDA wants more from Edap on Ablatherm de novo bid (MassDevice)
  • FDA Clears 2 New Propeller Health Devices That Track Respiratory Meds (Xconomy) (FierceMedicalDevices) (Press)
  • Implanting a titanium tube inside damaged bones improves procedure to ward off amputations (FierceMedicalDevices)
  • LeadCare Plus Compact Lead Testing System FDA Cleared (medGadget)
  • Abbott Submits PMA For Absorb Bioresorbable Scaffold (Gray Sheet-$)
  • First Major Advancement in Cystic Fibrosis Lung Infection Detection in 50 Years (MNT)
  • Biotronik wins FDA nod, launches Itrevia CRT-D in US (MassDevice)

US: Assorted and Government

  • 'Cures' bill, designed to speed drug approvals, could be too much of a good thing, dissenters say (FierceBiotech)
  • Senators propose bill that would let patients self-pay for medical devices (GovernmentHealthIT)
  • 21st Century Cures Act raises privacy questions (FierceHealthIT)

Upcoming Meetings and Events

Europe

  • Sanofi cholesterol drug, GSK malaria shot to get EU okay (EurActiv) (Reuters)
  • Fit for purpose MHRA can lead the way for global regulatory reforms (MHRA)
  • Amgen beats Regeneron, Sanofi to world's first big PCSK9 drug OK (FierceBiotech) (Reuters) (PharmaLetter-$)
  • European Supply Chain: A Series of New Regulations in Force (GxP Lifeline)
  • Pitfalls, Promise of EHRs Discussed at AMA Event (MedpageToday)
  • Counterfeit Medicines - Case shows medium-sized Companies are also affected (ECA)
  • HeartWare to commence CE mark trial of the world's smallest blood pump (FierceMedicalDevices)
  • Draft qualification opinion total kidney volume (TKV) as a prognostic biomarker for use in clinical trials evaluating patients with autosomal dominant polycystic kidney disease (ADPKD) (EMA)
  • EC Approves Keytruda for Patients with Advanced Melanoma (Press)
  • BMS Evotaz Authorized in Europe to Treat HIV-1 (EC)

India

  • Aurobindo Pharma Comes Under USFDA Lens, Again (Economic Times)
  • Report Calls for Measures to Preserve India’s Brand in Global Pharma Market (Thomson Reuters)
  • Aurobindo gets FDA approval for generic Tambocor (DSN)
  • FDA Warns Another Generics Maker for Skipping GDUFA Fees (FDANews-$)
  • Indian pharma cos seek faster clearance as GDUFA I nears end (PharmaLetter-$)
  • IPDA urges govt to allow e-commerce for pharma export as well as for domestic sales (PharmaBiz)

China                                                                         

  • Ethics In Spotlight As Scientists Jumpstart Precision Medicine In China (PharmAsiaNews-$)

Canada

  • Cardiome Submits Supplemental New Drug Submission for Aggrastat to Health Canada (Press)
  • Health Canada Investigates Safety of Invokana (Legal Examiner)

Australia

  • MiniMed 640G insulin pump Recalled Over Potential for Incorrect Dosing (TGA)
  • Australia Gearing Up for More Price Cuts This Year and Next (SCRIP-$)

Ebola Outbreak

  • Novavax's Ebola vaccine shows promise in human trial (BioSpectrum)

Other International

  • Simplified Registration Pathway for Class I Medical Devices in Russia (Emergo)
  • Ethiopia: GMP Compliant Drug and API Sector Would Yield Health and Economic Benefits (In-Pharma Technologist)
  • Emerging Markets: Pharma’s Next Challenge (McKinsey)
  • International Reference Pricing (Healthcare Economist)
  • Critical Path Institute Establishes the Global Pediatric Clinical Trials Network Pre-Launch Consortium (Press)
  • UN-Backed Initiative Inks Deal to Sharply Lower Price of Infant HIV Diagnosis (UN)
  • U.S. Drug Companies Should Keep A Close Eye On Cuba And Iran (Forbes)
  • Taiwan's MOHW launches biomedicine promotion website (BioSpectrum)

General Regulatory and Interesting Articles

Regulatory Reconnaissance #601– 22 July 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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