Regulatory Recon: Actavis, Concordia Accused of Price Fixing; Former FDA Commissioner Weighs in on Approval Process (3 March 2017)

Posted 03 March 2017 By Michael Mezher

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

In Focus: US

  • FDA's Woodcock to Congress: Pass the GDUFA and BsUFA Reauthorizations (Focus)
  • Watch Congress Vent About PBMs on the House Floor (Drug Channels)
  • Former FDA Head Weighs In On Trump's Criticism Of Drug Approval Process (NPR)
  • Birth Defects Rise Twentyfold in Mothers With Zika, CDC Says (NYTimes) (CDC)
  • Bill To Speed ANDA Approvals Gets Cool Reception From Industry, US FDA (Pink Sheet-$)
  • Trump calls the FDA 'slow and burdensome,' but it's faster than ever (Washington Post)
  • Gates Foundation Renews Search for Male Birth Control Pill (MIT Technology Review)
  • Biosimilar Rules Likely To Survive ACA Battle, Lawyers Say (Law360-$)
  • The Demise of the BPCIA Patent Dance? (FDA Law Blog)
  • House Bill Would Incentivize Drugmakers to 'Repurpose' Drugs for Rare Diseases (Focus)
  • Coping with Escalating Drug Costs (Medpage)
  • G.O.P. Accused of Playing 'Hide-and-Seek' With Obamacare Replacement Bill (NYTimes)
  • Governors met on Obamacare replacement plan with Pence (Reuters)
  • One Democrat's Hunt For The Hidden Obamacare Replacement Bill (NPR)
  • Republican Hard-Liners Oppose Health Care Plan Led By Paul Ryan (NPR)
  • Obamacare Got Their Goat: An Illustrated Guide to Republicans' Metaphors (NYTimes)
  • Opening the FDA's History Vault (FDAVoice)
  • Valeant's New Bonus Math Puts Debt Holders in Driver's Seat (Bloomberg) (Fierce)

In Focus: International

  • Actavis, Condordia Accused of Fixing Price of Life-Saving NHS Drug (Financial Times) (The Guardian) (Pharmafile)
  • Why Now Is The Right Time For Mutual Recognition (Pink Sheet-$) (Focus)
  • UK 'Needs To Be On EU's API White List' Post-Brexit (Pink Sheet-$)
  • Sanofi pays €120M to buy into AstraZeneca RSV program (Fierce)
  • Actelion Began in a Garage—Now Its Founding Couple Has $1 Billion and a New Biotech Firm (WSJ)
  • Mexico: New Allowances for Drug Registration Renewals Likely to Apply to Medical Devices, Too (Emergo)
  • European Regulatory Roundup: EU Trade Groups Propose Criteria for Deciding EMA's New Home (Focus)
  • Venezuela's epileptic patients struggle with seizures amid drug shortage (Reuters)
  • Lilly, Chi-Med cancer drug hits phase 3 goals, eyes China NDA (Fierce) (Financial Times) (Press)
  • China Imposes Tough New Curbs On Rep Sales Activities (SCRIP-$)
  • Pharma Attacked For "Playing The System" Of EU Pediatric Rewards (Pink Sheet-$)
  • NICE expands reach of Erbitux in colorectal cancer (PharamaTimes)
  • Price cuts bring 14 Cancer Drugs Fund treatments into routine NHS use (Pharmafile)
  • NHS on 'burning platform', warns chief hospital inspector (PharmaTimes)
  • Proposals to make medicines in Europe more affordable by MEPs (PharmaLetter-$)
  • Germany Cancels Confidential Drug Pricing (Pink Sheet-$)
  • How Broad Labels May Make Market Access In Germany More Difficult (Pink Sheet-$)
  • UK patent court issues mixed decision in TAVR spat between Boston Scientific, Edwards Lifesciences (MassDevice)

US: Pharmaceuticals & Biotechnology

  • Slower than Molasses in January, FDA Moves to Provide Guidance on Product Communications by Pharmaceutical and Device Manufacturers (FDA Law Blog)
  • Gene therapy: Advanced treatments for a new era (Pharmafile)
  • Interview – Grail approaches unicorn status (EPVantage)
  • OTC Hangover Remedy Safety On Tap For FDA Advisory Committees (Pink Sheet-$)
  • Pharma Exec and Policy Scholar Spar Over High-Cost Drugs (Medpage)
  • US FDA clears Akorn's generic CellCept after Form 483 resolved (InPharmaTechnologist)
  • Ipsen appoints new Executive Vice President (Pharmafile)
  • Bioverativ adds new member to board of directors (Pharmafile)

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

  • Karyopharm AML drug fails phase 2, giving stock whiplash (Fierce)
  • Parkinson's data pump up Neuroderm (EPVantage)
  • New Results from Second Phase 3 Study Show Significant Efficacy of Guselkumab and Superiority versus Humira in Treatment of Moderate to Severe Plaque Psoriasis (Press)
  • Revance Announces BELMONT Phase 2 Clinical Data to Be Presented at the 2017 American Academy of Dermatology (AAD) Annual Meeting (Press)
  • Celgene to Present New Data from Clinical Trials on Oral OTEZLA (apremilast) at American Academy of Dermatology Congress (Press)

US: Medical Devices

  • Glaukos shares soar on Q4, FY2016 earnings Beat (MassDevice)
  • Medidata's Newest Partnership Signals Medical Device Focus (MDDI)
  • Analyst bearish on intermediate-risk TAVR uptake, but still sees market as positive (MassDevice)
  • Study: Insurers paid double for hip and knee implants (MassDevice)
  • Medtronic: Certain stent grafts may confuse during implantation (MassDevice)
  • Cydar lands Roche exec for 3D imaging software play (MassDevice)
  • Amend Surgical wins FDA nod for NanoFuse BA bone graft extender (MassDevice)
  • New Requirements for Medical EMC: IEC 60601-1-2 Edition 4 (MassDevice)
  • Philips Respironics recalls select V60 ventilators over software shut down issues (MassDevice)

US: Assorted & Government

  • Senate panel confirms Verma as CMS chief (MassDevice)
  • CDC, FDA, and states investigating multistate E. coli outbreak (CDC)
  • Tanning beds tied to U.S. health costs of $343 million a year (Reuters)
  • An Intelligent Treatment of "Mass Actions" in Pennsylvania (Drug & Device Law)
  • Concordia Pharma Gets False Ad Trial Award Upped To $2.2M (Law360-$)
  • Mudslinging After BioZone Settlement Stumps Judge (Law360-$)

Upcoming Meetings & Events

Europe

  • CQC warns online doctor services may pose risk to public (The Guardian)
  • Is the EU ready for non-biological complex drug products? (GaBI)
  • National experience with biologicals, including biosimilars (GaBI)
  • BIOCAD: The first ever biosimilar of interferon beta-1a approved in Russia (Press)
  • Synthon taps Dutch blood donor group for CD47 program(Fierce)
  • The UK High Court of Justice (Patents) Rules in Fujifilm Kyowa Kirin Biologics' Favor on Rheumatoid Arthritis, Psoriasis and Psoriatic Arthritis Dosing Regimens for Adalimumab Are Obvious and Unpatentable (Press)

Asia

  • Bangladesh to ban cold pill chemical to fight meth surge (Reuters)
  • Malaysian Government approves new generics facility (GaBI)
  • China reports four more bird flu deaths, says spread of virus is slowing (Reuters)

India

  • Indian Drugmakers Seek to Sway Trump Over Cheap Generic Imports (Bloomberg)
  • Pharma lobby cries foul on GIPC's poor ranking to India (Economic Times)
  • Maha FDA serves show cause notice to WHO-GMP unit as part of probe in narcotics drug case (Pharmabiz)
  • Coronary stents prices slashed by 85%, govt tells Delhi High Court (Economic Times)
  • HC allows Biocon, Mylan to sell their drug for three cancers (Economic Times)
  • Alembic Pharma's partner launches drug for depressive disorder (Economic Times)

General Health & Other Interesting Articles

  • Herbal medications risky in heart disease (Reuters)

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.

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