Regulatory Focus™ > News Articles > Regulatory Recon: Kythera's Chin Fat Drug Gets Panel Support for FDA Approval (10 March 2015)

Regulatory Recon: Kythera's Chin Fat Drug Gets Panel Support for FDA Approval (10 March 2015)

Posted 10 March 2015 | By Alexander Gaffney, RAC

Regulatory Recon: Kythera's Chin Fat Drug Gets Panel Support for FDA Approval (10 March 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

In Focus: International

  • 25 years of the EU's medical device directives (Clinica)
  • Germany’s IQWiG finds no added benefit for Novartis’ Galvus (PharmaLetter-$)
  • Gilead faces tough Harvoni reimbursement discussions in Germany (SCRIP-$)
  • Health ministry to amend Rule 96 of D&C Rule to make labelling of drugs with storage conditions mandatory (PharmaBiz)
  • Germany's Boehringer loses India patent on lung drug to Cipla (India Times)
  • Canadian Thalidomide victims to receive funding for variety of expenses (Globe and Mail) (Press)
  • 2014 a Record-Breaking Year for New Drug Launches (SCRIP-$)

[Tomorrow] As the EU Gears up for Major Device Changes, What do Regulatory Pros Need to Know?

  • In Europe, medical devices currently are regulated much the same way they have been since the 1990s. Now, almost 20 years and several major scandals later, EU officials are preparing a massive overhaul of the region's medical device regulatory directives in the hopes of modernizing the system—if only they could agree on what those changes should look like. (Regulatory Focus)
  • Find out what changes are likely to affect medical devices and IVDs next year in this 11 March 2015 webcast featuring expert Erik Vollebregt. (RAPS Webcast)

US: Pharmaceuticals and Biotechnology

  • FDA panel backs Kythera's double chin-fighting shot (Fierce) (Reuters) (Pink Sheet-$) (Tarius) (WSJ-$) (SCRIP-$) (BioCentury)
  • U.S. FDA warns of seizure, alcohol risk with Pfizer's Chantix (Reuters) (FDA) (Pharmafile) (Press)
  • USFDA officials to visit India this month; to sign pact (India Times)
  • Opdivo's survival benefit inspired FDA to act fast on NSCLC approval: Pazdur (Fierce)
  • Why Shionogi wants FDA to create a pathogen-based development pathway (BioCentury-$)
  • Drug Quality and Security Act does not apply to veterinary compounding (Duane Morris)
  • BIO To Senate Health Panel: More Exclusivity Needed To Spur Innovation (IHP-$)
  • Early Lessons From The REMS Battlefield (Law 360-$)
  • FDA Elepsia XR Nod Clears Clouds Over Sun’s Halol Unit? (PharmAsia-$)
  • APIs in banned sex supplements sold openly online says regulator (In-Pharma)
  • Senate bill would legalize medical marijuana in some states (The Hill) (Vox)
  • Hagens Berman Sanctioned For Bad Thalidomide Suits (Law 360-$)
  • Hagens Berman Slaps Merck With Lawsuit Over Suicide Allegedly Linked To Hair Loss Drug (RTT) (Law 360-$)
  • Ariad Directors Beat Investor Suit Over Failed Leukemia Drug (Law 360-$)

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

  • AcelRx hammered (again) after FDA demands a new Zalviso study after all (Fierce) (SCRIP-$) (WSJ-$) (The Street) (BioCentury) (Reuters)
  • Eyeing an FDA filing, Ocular Therapeutix drug hits PhIIIa goals (Fierce) (Press)
  • Vanda's PhII 'itch' trial fails on 'high placebo effect' (SCRIP-$)
  • NCI-sponsored Phase III Blincyto study on hold for funding (SCRIP-$)

US: Pharmaceuticals and Biotechnology: General

  • Hepatitis Pills Spark Biggest Jump In Drug Costs In A Decade (Forbes) (WSJ-$) (CNBC) (Reuters)
  • A Bitter Pill for DEA: GAO Releases its Report on Drug Shortages and DEA’s Management of the Quota System (FDA Law Blog)
  • The Purpose (and Probability) of Mandating E-Prescribing (MedPage Today)
  • Widespread Use of Prescription Drug Monitoring Programs to Reduce Opioid Abuse and Overdoses (Harvard BOH)

US: Medical Devices

  • FDA approves CPR devices that may increase chance of surviving cardiac arrest (FDA) (Fierce) (MedPage Today)
  • Apple's ResearchKit to give scientists ready access to study subjects (Reuters) (MedCityNews) (MobiHealthNews) (BuzzFeed) (Politico) (Modern Healthcare)
  • FCC/FDA Joint Workshop on Wireless Medical Device Test Beds (FDA)
  • FDA Launches New Case Studies for Choosing the Right Medical Device Pathway (FDA)
  • FDA Corrects Electronic Medical Device Reporting Rule To Re-Include UDIs (IHP-$)
  • Edap bails on Ablatherm PMA, to seek de novo clearance from FDA (Mass Device)
  • Women’s Health Devices Taken to Task by Citizen Petitions (MDDI)
  • Sunshine clouds over after patient deaths (EP Vantage)
  • Study: FDA-cleared biomarker can reduce ADHD overdiagnosis (Fierce)
  • Miraculins Provides Pre-Submission De Novo Documentation to the FDA for Its Scout Diabetes Technology (Press)
  • TomTec receives FDA 510(k) clearance for its latest version of TomTec-Arena software (Press)

US: Dietary Supplements

  • Safety of Herbal Supplements Pulls Prosecutors Together (NYTimes)
  • Examine Tighter Supplement Industry Regulation, Hamburg Tells Congress (Tan Sheet-$)
  • How NY AG Supplement Case Affects Congress (NPI)
  • Industry finds new supporter in meeting with Rep. Ted Lieu, D-CA (NI-USA)

US: Assorted And Government

Upcoming Meetings

Ebola Outbreak

  • Corgenix and Fio Combine Rapid Ebola Test with Automated Analysis and Data Capture to Improve Frontline Care and Case Tracking (Press)

Europe

  • 25 years of the EU's medical device directives (Clinica)
  • Germany’s IQWiG finds no added benefit for Novartis’ Galvus (PharmaLetter-$)
  • Gilead faces tough Harvoni reimbursement discussions in Germany (SCRIP-$)
  • Advanced Bionics Receives CE Mark Approval for Cochlear Implant Use in Patients With Single-Sided Deafness (Press)
  • Scotland OKs seven new drugs for NHS use (PharmaTimes)
  • Cancer Drugs Fund cull ‘won’t save NHS money’ (PMLive)

India

  • Health ministry to amend Rule 96 of D&C Rule to make labelling of drugs with storage conditions mandatory (PharmaBiz)
  • Germany's Boehringer loses India patent on lung drug to Cipla (India Times)
  • India unveils Rotavirus vaccine, claimed to be cheapest (India Times)

China

  • Rising China Payer Agency Screaming For Drug Cost Control (PharmAsia-$)

Canada

  • Canadian Thalidomide victims to receive funding for variety of expenses (Globe and Mail) (Press)

Other International

  • 2014 a Record-Breaking Year for New Drug Launches (SCRIP-$)
  • WMA warns against making essential anaesthetic a controlled drug (WMA)
  • Sovaldi counterfeits in the market? (Securing Industry)
  • Natco Pharma launches hepatitis C drug in Nepal (India Times)
  • Sri Lanka poised to launch mandatory generics-first policy (Fierce)

Clinical Trials

  • Patients Want Docs to Disclose Ties to Pharma Before They Enroll in Trials (Pharmalot)
  • Most information in drug development is lost (Press)

General Regulatory And Interesting Articles

  • Watch Heart Tissue Twitch on a Chip When Drugged (IEEE)
  • Protection Without a Vaccine (NYTimes)
  • DeuteRx's novel approach to chiral switching for racemic drugs (Press)

Regulatory Reconnaissance #510 – 10 March 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 @AlecGaffney 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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