Regulatory Focus™ > News Articles > Regulatory Reconnaissance: Massive J&J Legal Judgement Reversed due to Warning Letter (21 March 2014

Regulatory Reconnaissance: Massive J&J Legal Judgement Reversed due to Warning Letter (21 March 2014)

Posted 21 March 2014 | By Alexander Gaffney, RAC

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In Focus: US

In Focus: International

  • FDA Of India State Cites Wockhardt For Horrifying GMP Violations At Three Plants (PharmAsia-$) (DNA India)
  • EMA's CHMP Recommends Approval for Nine New Medicines (EMA)
  • Boehringer, Lilly Diabetes Drug Wins EU Panel's Backing (Bloomberg) (Press)
  • Takeda Inflammatory Bowel Drug Wins EU Regulatory Backing (Bloomberg) (EMA)
  • Merck, Endocyte score crucial EMA OK for conditional approval of vintafolide (Fierce) (EMA) (Press)
  • St. Jude Medical nails CE mark for 'burst' neurostim treatment of chronic pain (Fierce) (Mass Device)
  • China's Top Prosecutor Vows More Crackdowns On Drug-Making Violations (PharmAsia-$)

US: Pharmaceuticals/Biotechnology

  • 2013 Was An Across-the-Board Record Breaker for Orphan Drugs (FDA Law Blog)
  • FDA Warning Letter Is Inadmissible Hearsay, Arkansas Supreme Court Says In Tossing $1.2 J&J Judgment (Pink Sheet-$) (SCRIP-$) (PMLive) (Reuters) (Guardian) (AP) (Pharma Times) (NYTimes) (Law 360-$) (Bloomberg)
  • FDA OK's Piramal's PET imaging agent Neuraceq (SCRIP-$) (Press) (BioCentury)
  • California Drug Take-Back Bill Faces Opposition (California Healthline)
  • Pfizer 'breakthrough' gain may speed needed meningococcal B vaccine (SCRIP-$)
  • FDA review of new sunscreen ingredients has languished for years, frustrating advocates (Washington Post)
  • States Adopt Variety of Oversight Strategies in Wake of NECC Disaster (Bloomberg BNA)
  • New Data Linking Bisphosphonates and Atrial Fib: Should FDA Revisit? (Medscape)
  • Sentinel: Harnessing the Power of Databases to Evaluate Medical Products (FDA) (FDA)
  • Stephen Ostroff FDA's New Acting Chief Scientist (FDA)
  • Manufacturers Struggle with FDA's "Breakthrough Drug" Development (PharmTech)
  • So Why Don't We Speed Up Approvals And Save More Lives? (NCPA)
  • Meetings: Anesthetic and Analgesic Drug Products Advisory Committee: ZRxPharma's MoxDuo Painkiller(FDA)
  • When Government Bureaucracy Proves To Be More Than Annoying -- Perhaps Even Fatal (HuffPo) (Roll Call)
  • Comments Roll in Regrding FDA Gene Therapy Guidance (FDA)
  • KV Pharma Reaches $12.8M Deal To Settle Shareholder Action (Law 360-$)
  • Sanofi Sues Alkem Over Generic Heart Medication (Law 360-$)
  • Opinion: Triclosan Must Go (Scientific American)

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

  • Janssen halts schizophrenia study early on good efficacy (SCRIP-$) (Press) (Pharma Letter-$) (BioCentury)
  • J&J to submit schizophrenia drug in 2014 (MM&M)
  • Forest, Gedeon Announce Positive Phase IIb Results for Major Depressive Disorder Drug (Press)
  • Novo says Tresiba's down but not out of the blockbuster diabetes race (Fierce)
  • Common statin drug may help those with advanced MS (USA Today)

US: Pharmaceuticals and Biotechnology: General

  • Drug Makers and Antitrust: Is Cash All That Matters? (WSJ-$)
  • Arizona 'Abortion Pill' Rule Faces Challenge (WSJ-$)
  • J&J blazes a new pharma trail with industry's first designer-in-chief (Fierce)
  • Democratic reps want details on Sovaldi's cost (BioCentury)
  • Texas obtains new batch of drugs used in executions (AP)

US: Medical Devices

  • Medical Device Recalls Nearly Doubled in a Decade (WSJ-$)
  • Cochlear lands breakthrough FDA win for Nucleus Hybrid L24 hearing aid (Mass Device) (FDA) (MedPage Today) (Press)
  • Ex-CMS Louis Jacques On Partnering With FDA And Keeping It Local (Gray Sheet-$)
  • UCLA researchers create Google Glass app for instant medical diagnostic test results (Press)
  • Deadline Today for Northwestern to Respond to Senate Judiciary Hearing on Device Testing Inquiry (Press)
  • HealthInterlink gets FDA clearance for remote patient monitoring system (MobiHealthNews)

US: Dietary Supplements

  • Kratom Import Alert Clarifies FDA Deems The Botanical An Unsafe NDI (Tan Sheet-$)

US: Assorted And Government

  • Homeopathy Company Recalls Products due to Undeclared Penicillin (FDA)
  • How a PepsiCo flavor partner fooled Wall Street and the press (Al Jazeera)
  • The Onion on FDA Conspiracy Theories (Onion)

Europe

  • EMA's CHMP Recommends Approval for Nine New Medicines (EMA)
  • Boehringer, Lilly Diabetes Drug Wins EU Panel's Backing (Bloomberg) (Press)
  • Takeda Inflammatory Bowel Drug Wins EU Regulatory Backing (Bloomberg) (EMA)
  • Merck, Endocyte score crucial EMA OK for conditional approval of vintafolide (Fierce) (EMA) (Press)
  • EMA recommends authorisation of first medicine for Castleman's disease (EMA)
  • Novartis Gets Labeling Expansion for Diabetes Drugs Tresiba and Victoza (Press)
  • NICE plans OK for Velcade in multiple myeloma (Pharma Times) (Pharmafile) (Pharma Letter-$)
  • St. Jude Medical nails CE mark for 'burst' neurostim treatment of chronic pain (Fierce) (Mass Device)
  • AB Science loses appeal over EU rejection of cancer drug (Reuters)
  • EMA issues recommendations for 2014/2015 seasonal flu vaccine composition (EMA)
  • France Issues Notice on the Regulation of Fecal Microbiota (ANSM)
  • UK to be first country to vaccinate children against meningococcal B (OnMedica) (Reuters) (UK) (UK) (Guardian)
  • CMDh endorses recommendations to restrict the use of diacerein-containing medicines (EMA)
  • Generics Manufacturing, Stockpiling Before IP Expiries Could Boost EU (Pink Sheet-$)

India

  • FDA Of India State Cites Wockhardt For Horrifying GMP Violations At Three Plants (PharmAsia-$) (DNA India)

Japan & China

  • China's Top Prosecutor Vows More Crackdowns On Drug-Making Violations (PharmAsia-$)
  • Hisun Pharmaceutical Submitted For Sirolimus To China FDA (PharmAsia-$)

Other International

  • Biogen Idec wins Canadian approval for hemophilia drug Alprolix (Reuters) (Press)
  • Genzyme's Lemtrada Approved in Brazil for Treatment of Multiple Sclerosis (Press)

General Regulatory And Interesting Articles

  • Are biosimilars worth it? (GABI)
  • How the Military's Bomb-Detecting Lasers May One Day Protect You From the Flu (Defense One)
  • Dutch company Bioneedle is working on the tiniest vaccine you've ever seen (MedCityNews)
  • New hepatitis C drugs must be affordable worldwide, say campaigners (Guardian)
  • Did You Know St. John's Wort Might Neutralize Hormonal Contraceptives? (Forbes)
  • Drug Dealers Aren't to Blame for the Heroin Boom. Doctors Are. (New Republic)

Regulatory Reconnaissance #281 - 21 March 2014

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.

Did we miss a story? Send us a tweet at @RAPSorg and we'll check it out for inclusion in our next edition of Regulatory Reconnaissance. Want this in your inbox each morning? Sign up for RF Today, our morning intelligence newsletter here.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at news@raps.org.


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