Regulatory Focus™ > News Articles > Regulatory Recon: Forest, Actavis Sued Over Withdrawal of Alzheimer's Drug (16 September 2014)

Regulatory Recon: Forest, Actavis Sued Over Withdrawal of Alzheimer's Drug (16 September 2014)

Posted 16 September 2014 | By Alexander Gaffney, RAC 

Regulatory Recon: Forest, Actavis Sued Over Withdrawal of Alzheimer's Drug (16 September 2014)

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

This fall, regulatory professionals from across the globe will come together to learn, connect and share at the Regulatory Affairs Professionals Society’s 2014 RAPS: The Regulatory Convergence, 27 September-1 October, Austin, TX.  Register here, or check out some of the mostnews-worthy sessions here.

In Focus: US

  • NY attorney general sues Actavis and Forest Labs over Alzheimer's drug (Reuters) (NYTimes) (CBS)
  • Using Twitter to study pharmaceutical drug side effects (iMedicalApps)
  • US FDA Posts Advisory Committee Materials for Pediatric-Focused Safety Reviews for 16 Products (Tarius)
  • Attorneys Mixed On Whether FDA Should Make 180- Day Exclusivity Process Public (IHP-$)
  • St. Jude Medical hits 'pause' on Portico TAVI device (Mass Device) (Gray Sheet-$)
  • CDRH Posts First Customer Satisfaction Ratings (FDA)
  • How to Hack Your Own Medical Device (MDDI)
  • Lawyer grills DePuy executive over safety studies for Pinnacle hips (Reuters)

In Focus: International

  • Drug-testing rules broken by Canadian researchers (The Star)
  • Why new Ebola vaccines, treatments won't be ready in time for current crisis (BioCentury-$)
  • EMA guideline on pharmacovigilance inspections comes into effect (In-Pharma) (EMA) (EMA)
  • EMA Releases Draft guidance on the classification of MUMS veterinary products (EMA)
  • India approves Epirus' Remicade biosimilar (BioCentury) (Reuters) (BioFlash) (Press)
  • No quality control for life-saving generic drugs, government apathetic (Economic Times)

US: Pharmaceuticals and Biotechnology

  • NY attorney general sues Actavis and Forest Labs over Alzheimer's drug (Reuters) (NYTimes) (CBS)
  • Using Twitter to study pharmaceutical drug side effects (iMedicalApps)
  • US FDA Posts Advisory Committee Materials for Pediatric-Focused Safety Reviews for 16 Products (Tarius)
  • Attorneys Mixed On Whether FDA Should Make 180- Day Exclusivity Process Public (IHP-$)
  • Keep the FDA in charge of American drug safety, not the Alabama Supreme Court (Alabama)
  • FDA shouldn’t fall for latest ruse to derail biosimilars competition (The Hill)
  • Hospira again reports a human hair discovered in a product (Fierce) (In-Pharma)
  • The need for open clinical trial data for FDA approval (Pharma Letter-$)
  • Combination Products Coalition Wants FDA to Improve its Guidance Practices (FDA)
  • NYU Forms Working Group on Compassionate Use (NYU)
  • UCERIS (budesonide) 2mg Rectal Foam for the Induction of Remission of Mild-to-Moderate Distal Ulcerative Colitis Granted Tentative Approval by FDA (Press)
  • Wisconsin Pharmacist and Nevada Pharmacologist Charged with Smuggling Counterfeit Pharmaceuticals Using a Costa Rican Internet Pharmacy (DOJ)
  • Which body parts warrant the biggest biotech venture investments? (Fierce)

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

  • Safety concerns cloud odanacatib PhIII as Merck steps back from FDA filing (Fierce) (Press) (PharmaPhorum)
  • NovaBiotics Receives Orphan Drug Status from the US Food and Drug Administration (FDA) for Lynovex for the Treatment of Cystic Fibrosis (Press)
  • Study shows Novo's new diabetes drug effective and safe for children (Reuters) (Press)
  • EYLEA (aflibercept) Injection Receives FDA Breakthrough Therapy Designation for Diabetic Retinopathy in Patients with Diabetic Macular Edema (Press)
  • Amarin Says It Will Complete Cardiovascular Outcomes Trial For Its Fish Oil Pill (Forbes)
  • BI's  Investigational empagliflozin/linagliptin combination tablet shows sustained reduction in blood glucose in Phase III study (Press)

US: Pharmaceuticals and Biotechnology: General

  • The TTIP Prescription: Expanding Trade Can Speed The Flow Of New Medicines (Forbes)
  • US' Only Supplier of Smallpox Drugs, Siga, Declares Bankruptcy (Bloomberg) (Reuters)

US: Medical Devices

  • St. Jude Medical hits 'pause' on Portico TAVI device (Mass Device) (Gray Sheet-$)
  • CDRH Posts First Customer Satisfaction Ratings (FDA)
  • How to Hack Your Own Medical Device (MDDI)
  • Lawyer grills DePuy executive over safety studies for Pinnacle hips (Reuters)
  • Cochlear Announces the FDA Approval of True 2.4 GHz Wireless Connectivity With the Cochlear Nucleus 6 Sound Processor (Press)
  • Flowonix Submits PMA Supplements for Prometra(R) Implantable Pump System (Press)
  • TCT 2014 Roundup (Mass Device) (Mass Device)
  • Trice Medical Receives FDA 510(k) Clearance for mi-eye (Press)

US: Dietary Supplements

  • Dietary Supplements – International Regulators Respond to a New and Growing Industry (USP)
  • FDA's Taylor Stresses Industry / Government Cooperation to Enforce FSMA (Food Safety)

US: Assorted And Government

  • House passes bill to crack down on anabolic steroids (The Hill) (NPI)

Upcoming Meetings

Ebola Outbreak

  • Why new Ebola vaccines, treatments won't be ready in time for current crisis (BioCentury-$)
  • Hiccups Were The Clue That Led Researchers To Ebola (NPR)
  • Obama Dispatching 3,000 Troops, Medical Aid to Stem Ebola Spread (Bloomberg) (SCRIP-$)

Europe

  • EMA guideline on pharmacovigilance inspections comes into effect (In-Pharma) (EMA) (EMA)
  • Movement in the Commission – medical devices policy back to DG Enterprise (MDL)
  • Draft guidance on the classification of veterinary medicinal products indicated for minor use minor species (MUMS) / limited market (EMA)
  • Switzerland takes on its top drugmakers in price row (Reuters)
  • EU OKs Gardasil update on long-term HPV protection (Fierce)
  • Breathe Technologies receives CE Mark approval for Non-Invasive Open Ventilation (NIOV) system (MNT)

India

  • India approves Epirus' Remicade biosimilar (BioCentury) (Reuters) (BioFlash) (Press)
  • No quality control for life-saving generic drugs, government apathetic (Economic Times)
  • Draft Guidelines could lead to unnecessary bias against pharma patent applications: USIBC (Pharmabiz)
  • India's price cap axe may be held back for now (SCRIP-$)

Japan

  • PMDA Warns Again On ARBs, ACE Inhibitors In Expectant Mothers (PharmAsia-$)

Canada

  • Drug-testing rules broken by Canadian researchers (The Star)
  • Health Canada approves Yervoy (ipilimumab) for first-line treatment of adults with metastatic melanoma, the most deadly form of skin cancer (Press)

Other International

  • 'Ambitious' Asean supplements harmonisation process nearing its goal (Nutra-Ingredients)

General Regulatory And Interesting Articles

  • "Side Effects May Include Spontaneous Poetry…" (The Daily Beast)
  • Antibiotics Prescribed For Children Twice As Often As Needed (NPR)
  • Cheaper Generic Statins Beat Brand-Name Statins in Adherence and Outcomes (Forbes) (MedPage Today)
  • Combining epilepsy drug, morphine can result in less pain, lower opioid doses (Press)

Regulatory Reconnaissance #400 – 16 September 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.

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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