Regulatory Focus™ > News Articles > Regulatory Recon: FDA Advisory Committee Takes Second Look at Birth Control Implant (24 September 20

Regulatory Recon: FDA Advisory Committee Takes Second Look at Birth Control Implant (24 September 2015)

Posted 24 September 2015 | By Zachary Brennan 

Regulatory Recon: FDA Advisory Committee Takes Second Look at Birth Control Implant (24 September 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 , @Zachary Brennan and @RAPSorg on Twitter.

In Focus: US

  • How a Facebook Group Got the FDA to Reconsider a Type of Birth Control (Wired) (Kaiser Health News)(MedPage Today)
  • FDA hiring top official to improve lab safety in wake of smallpox incident (USA Today)
  • The little-known FDA program that's driving drug prices higher (LA Times)
  • FDA Nominee Driven by "Data, Data, Data" (GEN)
  • Patients Assume 'Breakthrough' Drugs Are Better (MedPage Today)
  • What does development of the FDA’s new patient engagement committee actually mean for patients? (MedCity News)
  • Assisted Suicide and Lethal Injection: FDA’s Regulatory Dilemma? (Harvard Law Blog)
  • AdvaMed CEO Rumored To Become Top Drug Lobbyist (Gray Sheet-$) (SCRIP-$) (Pink Sheet-$)
  • FDA Looks To Mini-Sentinel Again For Answers On Seasonal Flu Vaccine Safety (Pink Sheet-$)
  • Report: FDA Has Spent $65.9 Million on Biosimilars Work (Focus) (FDANews-$)

In Focus: International

US: Pharmaceuticals and Biotechnology

  • Federal Prosecutors Target Martin Shkreli in a Criminal Investigation (Newsweek-$)
  • BIO boots Martin Shkreli's Turing out after pricing controversy erupts (FierceBiotech)
  • Shkreli Implodes And Provides Hillary A Perfect Medicare Moment (Xconomy)
  • Turing boss says Daraprim price drop 'might curtail research for lethal diseases' (Guardian)
  • Drug-price hikes don't lead to better cures. We must find another way forward (Guardian)
  • Trump: Drug CEO that raised prices 4000% is 'spoiled brat' (The Hill)
  • A Timeline of the Turing Pharma Controversy (Forbes)
  • Video: Curing Rare-Drug Prices (NY Times)
  • New poll finds majority of voters oppose government price-setting for prescription drugs (PhRMA)
  • Amgen Wants Patent Dance Redo and a Halt to Hospira’s EPOGEN Biosimilar (FDA Law Blog) (FDANews-$)
  • Biosimilar drug development and the importance of analytical characterization (GaBI)
  • Munich Re, Marsh Seeking ‘Next Blockbuster’ With Pharma Coverage (Bloomberg)
  • Should A Clinical Mastermind Run The FDA? (Outsourced Pharma)
  • Novartis launches portfolio for low and low-middle-income countries (Reuters)
  • Vaccine-maker IDT Biologika launches in US (Outsourcing-Pharma)

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

  • Conatus Data First Step In Liver Drug Pivotal Trial Design (SCRIP-$)
  • Arrowhead Reports Peak Reduction in HBsAg of Up to 99% (1.9 log) After a Single Dose with Hepatitis B Candidate ARC-520 in Treatment Naïve Cohort of Phase 2a Study (Press)
  • Lilly awaits results for alternative amyloid drug in Alzheimer's (Pharmaphorum)
  • PCCA Supports House of Representatives Members Asking FDA to Improve Access to a Critical Compounded Medication, Domperidone (Press)
  • BIND Therapeutics Announces Pfizer Inc. Exercises Option to Advance Nanoparticle-Based Kinase Inhibitor for Treatment of Solid Tumors (Press)
  • New study questions clinical trial data for kidney cancer drugs (PharmaLetter-$)
  • 3rd Circ. Won't Rethink Lamictal Pay-For-Delay Ruling (Law360-$)
  • Perrigo Gets Claims Over CMS Drug Reimbursements Tossed (Law360-$)
  • GSK Gets Wellbutrin Pay-For-Delay Antitrust Suit Nixed (Law360-$)
  • Takeda Manipulated Gout Drug Clinical Trial, FCA Suit Claims (Law360-$)

US: Medical Devices

  • Stemina, Eyeing Boston VC, Launches Large Autism Diagnostic Study (Xconomy)
  • Peter Thiel-backed Auris Surgical Robotics raises $150M (MedCity News)
  • Penumbra clears $125m in IPO (Mass Device)
  • Xenios claims ‘significant’ 8-figure funding round (Mass Device)
  • Class 2 Device Recall Stryker Orthopaedics (FDA)
  • Class 2 Device Recall Bard Access Marketing Brochures (FDA)
  • Class 2 Device Recall Synthes Cranial Flap Tube Clamp and Crimping Device for Cranial Tube Clamp (FDA)
  • Class 2 Device Recall MicroScan LabPro Information Manager System (FDA)
  • Growing Concerns With Cybersecurity Hacks of Devices (Gray Sheet-$)
  • CLIA Waiver Granted To Roche For Quick Flu Test (Gray Sheet-$)
  • Researchers create antimicrobial biofilm to protect medical implants from infection (MNT)

US: Assorted and Government

  • Measles Outbreak as a Catalyst for Stricter Vaccine Exemption Legislation (JAMA)
  • NIH researchers find role for soft palate in adaptation of transmissible influenza viruses (Press)

Upcoming Meetings and Events              

Europe

  • Keryx wins EU approval for  FEXERIC (FERRIC CITRATE COORDINATION COMPLEX) (Press)
  • Germany's Merck Seeks Global Growth In Fertility Drugs And Technologies (SCRIP-$)

Australia

  • TGA participation in the IMDRF Table of Contents (ToC) pilot (TGA)
  • Australia’s opportunity to lead the TPP forward (PhRMA)

India

  • Govt panel on GVK Bio data issue to submit report soon (Financial Express)
  • India to supply generic cancer drug to US (Economic Times)
  • Pfizer withdraws notice to close Thane plant (Economic Times)
  • Sub-committee on online pharmacy invites comments and suggestions from stakeholders (PharmaBiz)

China

Japan

  • Bayer’s Xarelto Approved in Japan for the Treatment and Secondary Prevention of Pulmonary Thromboembolism and Deep Vein Thrombosis (Press)

Ebola Outbreak

  • Ebola more complicated than many doctors realized (USA Today)

Other International

  • MENA Changing Population Dynamics: Prospects Accelerating Dealmaking (Reuters)

General Health and Other Interesting Articles

  • Science Nobel Prize predictions (Reuters)
  • It’s time to consider the bigger picture around acetaminophen (Toronto Star)
  • "Massive reset" needed in how we think about autism, book says (CBS)
  • Obesity Maps Put Racial Differences On Stark Display (NPR)

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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