Regulatory Recon: Rep. Cummings Wanted to Talk Drug Prices With Trump; ANVISA Developing New Device Regulations (17 February 2017)

Posted 17 February 2017 By Michael Mezher

placeholder+image

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

In Focus: US

  • Cummings contradicts Trump over meeting on drug prices (Baltimore Sun)
  • Mistakes at US lab force hundreds of Zika tests to be repeated (Reuters) (Forbes)
  • Trump says he'll submit healthcare reforms in early or mid-March (Reuters 1, 2)
  • House GOP Leaders Outline Plan to Replace Obama Health Care Act (NYTimes) (Reuters)
  • Republican Health Proposal Would Redirect Money From Poor to Rich (NYTimes)
  • Trump's pick to lead health agency calls EpiPen issue 'disturbing' (Reuters)
  • CMS nominee ducks pricing questions (BioCentury) (The Hill)
  • Congressman's Ties To Foreign Biotech Draw Criticism (KHN)
  • FDA Posts Q&A on ICH Q11 Development And Manufacture Of Drug Substances (FDA)
  • CDER 2016 Update for Rare Diseases (FDA)
  • DNA computer brings 'intelligent drugs' a step closer (Phys.org)
  • MicroRNA therapeutics: towards a new era for the management of cancer and other diseases (Nature)
  • Biopharma deal-making in 2016 (Nature)
  • Regulatory watch: The target product profile as a tool for regulatory communication: advantageous but underused (Nature)
  • CTTI Offers Recommendations for Pediatric Clinical Trials for Antibiotics (Focus)
  • GAO: FDA's Ability to Monitor Drug Shortages Remains a Concern (Focus)
  • House Bill Seeks to Add Mandatory Drug Recall Authority to FDA's Arsenal (Focus)
  • Industry Groups Petition FDA Over Revisions to 'Intended Use' Rule (Focus)
  • 'Tsunami' Of Alzheimer's Cases Among Latinos Raises Concerns Over Costs, Caregiving (KHN)
  • Amgen Hiding Biosimilar Info, Genentech Suit Says (Law360-$)
  • Cheaper drugs from Canada? Pharma despises the idea, but top senators are pushing HHS chief to try it (Fierce)
  • Pfizer's solo Xeljanz can't match AbbVie's Humira in big RA head-to-head miss (Fierce) (Press)
  • Alexion's Billion Dollar Deal Is Largely Wasted (The Street)
  • Baxalta buy drives huge leap in Shire's Q4 sales (PharmaTimes) (PharmaLetter-$)

In Focus: International

  • Brazil's ANVISA Developing Regulations for Custom-made Medical Devices (Emergo)
  • Canada Attempts Biosimilar Balancing Act (Pink Sheet-$)
  • EC Will Not Offer a Timeline for Phasing Out Non-Human Primate Research (Focus)
  • EMA Weighs New Guideline on Quality Requirements for Combination Products (Focus)
  • Daiichi, ArQule's struggling tivantinib fails in phase 3 liver cancer test (Fierce) (Press)
  • Martina Schüssler-Lenz elected as new chair of Committee for Advanced Therapies (EMA)
  • uniQure details three-pronged gene therapy trial program (Fierce)
  • Etanercept biosimilar submitted for approval in Japan (GaBI)
  • Takeda completes ARIAD buy (PharmaTimes)
  • Takeda and TiGenix announce successful trial of Crohn's disease drug (Pharmafile) (Fierce) (Press)
  • Mali study shows efficacy of new malaria vaccine (PharmaLetter-$) (NIH)
  • Swiss VC Launches New Fund With Orphan Drug Aspirations (SCRIP-$)
  • Health Canada approves HIV drug Odefsey (PharmaLetter-$)
  • Eisai to market Comtan and Stalevo in China (PharmaLetter-$)

US: Pharmaceuticals & Biotechnology

  • The Final Common Rule: Much Either Retained or Removed, But Not Much New Added (FDA Law Blog)
  • Oncology Practice, Doctor And Practice Manager Pay $1.7 Million To Resolve Allegations They Billed Medicare For Illegally Imported Drugs (DoJ)
  • Flu Vaccine Protects About Half the Time, CDC Says (NBC) (MedScape)
  • Amygdala acquires addiction candidate from Gilead (BioCentury) (Fierce) (Press)
  • The future of generic drugs and strategies for commercial success (Pharmafile)
  • FDA Calls for Comments on Pediatric Postmarketing Pharmacovigilance and Drug Utilization Reviews (FDA)
  • Is the return of the one-stop-shop model just a CMO marketing ploy? (InPharmaTechnologist)
  • Charles River splits off and divests CDMO business (OutsourcingPharma)
  • Targeting phospholipase D in cancer, infection and neurodegenerative disorders (Nature)
  • From basic apoptosis discoveries to advanced selective BCL-2 family inhibitors (Nature)
  • JNK inhibitors boost antifungal immunity (Nature)
  • How Sanofi blew its chance with Actelion (Drug Delivery)
  • AmpliPhi Advances Phage In Clinic To Address Microbial Infections (SCRIP-$)
  • FDA expands approval of Boehringer's asthma treatment to include children (PharmaLetter-$)
  • Sage Therapeutics fuels, then dampens, its own M&A rumors (Fierce)
  • Insulet opens manufacturing facility in Acton, Mass. (Drug Delivery)
  • Zoetis Reports Earnings Beat, So Why Are Shares Plummeting? (The Street)

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

  • AstraZeneca's drug scores positive results against chemo in breast cancer (Pharmafile) (PMLive) (Press)
  • FDA reviewing Mylan/Biocon biosimilar of Neulasta (BioCentury) (Economic Times)
  • Celgene Announces Positive Results from Phase III SUNBEAM Trial of Oral Ozanimod in Patients with Relapsing Multiple Sclerosis (Press)
  • Perrigo Announces FDA Final Approval For Hydrocodone Bitartrate And Homatropine Methylbromide Oral Solution (Press)
  • Zydus Cadila scores twin FDA approvals (Pharmafile) (Economic Times)
  • Aimmune Therapeutics Provides Update on Ongoing AR101 Phase 3 Program for Peanut Allergy Based on FDA Feedback (Press)

US: Medical Devices

  • Vascular Solutions shareholders approve $1B Teleflex takeover (MassDevice)
  • J&J touts NEJM publication of 5-year Type II diabetes bariatric surgery study (MassDevice)
  • FDA expands indication for Medtronic's Freezor Xtra cryoablation catheter (MassDevice) (Press)
  • Medtronic Introduces Signia Stapling System, Innovative Surgical Stapler for Minimally Invasive Surgery (Press)

US: Assorted & Government

  • UnitedHealth sued by US government over Medicare charges (Reuters)
  • Breast Implant Fight Should Stay In Court, Brazilian Co. Says (Law360-$)
  • Celgene Settles Patent Royalty Case for $198.5 Million (FDANews-$)
  • Treatment Gaps Persist Between Low- And High-Income Workers, Even With Insurance (KHN)
  • Something We Can All Support: H.R. 985, Picking Up Where CAFA Left Off (Drug & Device Law)
  • Align Technology claims win in ClearCorrect patent spat (MassDevice)

Upcoming Meetings & Events

Europe

  • New framework to stimulate research, innovation and growth? (Dehns)
  • Update about the procedure for authorization requests for Congresses and Meetings (AIFA)
  • EBE and EFPIA Support ARM Initiative on Hospital Exemptions and Call for Increased Transparency on All Advanced Cell, Gene and Tissue Therapies (EFPIA)

Asia

  • Hard to detect, China bird flu virus may be more widespread (Reuters)
  • Japan approves Medtronic's Micra leadless pacemaker (MassDevice) (Press)
  • Medigus wins nod to start Chinese trial for Muse transoral stapler (MassDevice)

India

  • Supportive policy needed for pharma industry to sustain growth momentum: FICCI president (PharmaBiz)
  • New stents disappear from hospitals for 're-labelling' (Economic Times)
  • Cipla, Serum Institute launch Hepatitis B vaccine (Economic Times)

Australia

  • MiniMed 640G insulin pump (TGA)
  • Prima Biomed starts new trials of lead I-O drug but needs more cash, say analysts (Fierce)

Canada

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.

Share this article:

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Regulatory Exchange: Latest Updates From the Community