Regulatory Focus™ > News Articles > Regulatory Recon: FDA Spells Out Biosimilar Naming Rules, Second PCSK9 Inhibitor Approved (28 August

Regulatory Recon: FDA Spells Out Biosimilar Naming Rules, Second PCSK9 Inhibitor Approved (28 August 2015)

Posted 28 August 2015 | By Michael Mezher 

Regulatory Recon: FDA Spells Out Biosimilar Naming Rules, Second PCSK9 Inhibitor Approved (28 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

In Focus: International

  • The French defy pharma over drug pricing (Politico) (SCRIP-$)
  • EMA Warns of Heart Risks With Newer HCV Drugs and Amiodarone (Pharmaceutical Journal)
  • MHRA uncovers $1m illegal ED drug haul (In-Pharma Technologist)
  • Wales approves Celgene's Imnovid despite NICE 'no' (PharmaTimes)
  • UK clears first use of e-consent tech in clinical trial (Outsourcing-Pharma)
  • Cipla Chief: Don't Dilute India's Patent Laws (SCRIP-$)
  • Government to soon remove duty anomalies in medical devices sector (Economic Times)
  • Medical devices and IVDs: Cancellations of certain devices within an entry (TGA)
  • China’s Big And Small Next-Gen Sequencing Players Ride The Precision Medicine Wave (Clinica-$)

US: Pharmaceuticals and Biotechnology

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

  • FDA approves Repatha to treat certain patients with high cholesterol (Press) (FDA) (CardioBrief) (NYTimes) (Washington Post) (WSJ-$)
  • Edurant Label Updated With New Pediatric Indication, Warning (MPR)
  • Clinuvel/FDA To Discuss NDA For Phototoxicity Drug Scenesse (SCRIP-$)
  • Novel Antibiotic Fast Tracked for Bacterial Vaginosis (MPR)
  • Roche/Exelixis Get First Cobimetinib Approval (SCRIP-$)
  • Predicting the Outcome of the Biomarin and Sarepta FDA Drug Reviews (The Street)
  • US nod for BI/Lilly's diabetes combo pill (PharmaTimes) (Press)
  • Letairis/Tadalafil Combo Demonstrates Efficacy for Pulmonary HTN (MPR)
  • FDA clears Jardiance combo for type 2 diabetes (PMLive)
  • Sunovion Announces FDA Approval of a New Indication for Aptiom® (eslicarbazepine acetate) as Monotherapy for Partial-Onset Seizures (Press)

US: Pharmaceuticals and Biotechnology: General

  • Manufacturers Say 340B Penalties Proposal Could Punish Actions Outside Their Control (Pink Sheet-$)
  • 340B Patient Definition Gets Much-Needed Update In Omnibus Guidance (Pink Sheet-$) (Law360-$)
  • ‘Good Publication Practice’ guidelines call for all clinical trials to be reported (AllTrials)
  • Fuse data, randomized clinical trials to reduce problems (FierceHealthIT)

US: Medical Devices

  • FDA gives PMA approval to Minerva's ablation device to treat heavy menstrual bleeding (FierceMedicalDevices)
  • Smart Oxygen Solutions' Supplemental Oxygen Delivery Device Achieves FDA Regulatory Pathway Milestone (Press)
  • Therapy System for Treating Major Depressive Disorder Receives FDA Clearance (Press) (MassDevice)
  • Class I Recall of CareFusion Alaris Syringe Pump (FDA) (FDA) (FDA) (MassDevice)

US: Assorted and Government

  • Amgen Files Emergency Motion To Block Zarxio's Launch (SCRIP-$)
  • Takeda Hid Link Between Actos And Cancer, Nev. Jury Told (Law360-$)
  • State exemption levels low, national vaccination rates high (CDC) (NBC News) (Reuters)
  • FDA Warns Tobacco Companies Advertising 'Natural' Cigarettes (NPR) (Reuters)

Upcoming Meetings and Events              

Europe

Canada

Australia

  • Medical devices and IVDs: Cancellations of certain devices within an entry (TGA)

India

  • Cipla Chief: Don't Dilute India's Patent Laws (SCRIP-$)
  • Government to soon remove duty anomalies in medical devices sector (Economic Times)
  • HvPI generates 2700 adverse transfusion reaction reports through its reporting system (PharmaBiz)
  • FDA OKs Baraclude generic from Aurobindo (DSN)

China

  • China’s Big And Small Next-Gen Sequencing Players Ride The Precision Medicine Wave (Clinica-$)

Japan

Ebola Outbreak

  • CDC Clarifies Ebola PPE Guidance for U.S. Healthcare Personnel (ICT)
  • Ebola Vaccine Clinical Trial Opens at Sanford Health (ICT)
  • Ebola: Where are we now? (IRIN)

Other International

  • USAID begins construction of warehouse for essential drugs in Lagos, Nigeria (PharmaAfrica)
  • UPDATED: ANVISA Changes to Impact Class I, II Medical Devices and IVDs in Brazil (MassDevice)
  • Cancer, transplant patients protest Venezuela's medicine shortages (Reuters)
  • WHO Strengthens Focus on Water, Sanitation and Hygiene to Eliminate Neglected Tropical Diseases (ICT)
  • Europe, US, Japan: The recall round-up (In-Pharma Technologist)

General Health and Other Interesting Articles

  • UCSB Researchers Demonstrate How Gram-Negative Bacteria Deliver Toxins to Kill Neighboring Bacteria (ICT)
  • HIV Particles Do Not Cause AIDS, Our Own Immune Cells Do (ICT)

Regulatory Reconnaissance #628 – 28 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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