Regulatory Recon: House Republicans Unveil Plan to Replace Obamacare; PTC Files DMD Drug Over Protest With FDA (7 March 2017)

Posted 07 March 2017 By Michael Mezher

placeholder+image

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

In Focus: US

  • Republicans unveil plan to dismantle Obamacare, critics pounce (Reuters) (Politico) (NYTimes) (Forbes) (KHN) (Health Affairs Blog) (Wyden Statement)
  • Republican governors request radical change in Medicaid drug coverage (Politico)
  • How the world's richest doctor gave away millions — then steered the cash back to his company (STAT 1, 2, 3)
  • Snubbed at the FDA, PTC files their three-time loser for Duchenne MD over protest (Endpoints) (BioCentury)
  • Drugs that lack single-agent activity: are they worth pursuing in combination? (Nature)
  • How Pharma Can Get Trump Off Its Back (Bloomberg)
  • R&D Costs For Pharmaceutical Companies Do Not Explain Elevated US Drug Prices (Health Affairs Blog)
  • Reports Of Medical Breakthroughs Often Don't Prove Out (NPR)
  • FierceBiotech's Rotten Tomatoes (Fierce)
  • Drained Swamps and Quackery: Some Thoughts on Efficacy (Harvard Bill of Health)
  • Mystery solved: Addiction medicine maker is secret funder of Kennedy-Gingrich group (STAT)
  • Senators Ask GAO to Probe Orphan Drug Act as Questions Pile up Over Marathon's Pricey Steroid (Focus) (WSJ) (NPR) (KHN)
  • J&J's legal costs surge in wave of product lawsuits (Financial Times)
  • Cadila and Supernus settle patent dispute over epilepsy generic (Pharmafile) (Economic Times)
  • Allergan and Serenity to terminate deal on Noctiva, just as it gets US approval (PharmaLetter-$)
  • Shaping A Shkreli Bill: Voucher Abuse Solution May Stumble On FDA Effects (Pink Sheet-$)
  • Biosimilar Trade Secrets: Coherus Hiring Of Amgen Exec Leads To Theft Suit (Pink Sheet-$)
  • Public Citizen Warns 'Right to Try' Gives Patients False Hope (Focus)
  • Trump Tells Planned Parenthood Its Funding Can Stay if Abortion Goes (NYTimes)

In Focus: International

  • Japan Joins Trump in Drug Price War Crimping Pharma Profits (Bloomberg)
  • Modi Backs Stent Price Controls; More Drugs To Join List (Bloomberg)
  • GSK's vaccines access leads the pack, report says, as lagging Pfizer disputes findings (Fierce) (Report)
  • Personalised medicines – focus on patients and healthcare professionals (EMA) (Meeting)
  • Illegally imported medicinal products in 2016: major risk among prescription-only medicines (Swissmedic)
  • Brazil ANVISA: Half of Some High-risk Medical Device Registration Submissions Rejected in 2016 (Emergo)
  • IMDRF Offers a Preview of Next Week's Vancouver Meeting (Focus)
  • Pharma Inspection Co-operation Scheme Criticizes Plan to Lower GMP Requirements for ATMPs (Focus)
  • Lupin CFO Says $1 Billion M&A Warchest May Be Just The Start (Bloomberg)
  • How To Make A Global First-In-Class Drug In China (SCRIP-$)
  • The difficult road ahead for clinical trials in India (PharmaLetter-$)
  • UK life sciences sector productivity double national average (EPR)
  • TiGenix says it's on track for 2017 EMA decision on Cx601 (PharmaLetter-$)
  • Pharma responsible for 200,000 jobs in Spain, figures show (PharmaLetter-$)
  • Merck's Allergopharma opens €42m biopharmaceutical plant (Pharmafile) (InPharmaTechnologist)

US: Pharmaceuticals & Biotechnology

  • The First LPAD? Cempra May Try New Pathway For MRSA Antibiotic, Could Retrofit Solithromycin (SCRIP-$)
  • Rare Disease Week Recap: HP&M's Frank Sasinowski Briefs the Rare Disease Congressional Caucus (FDA Law Blog)
  • Data Shows Americans Hold Similar Views of Drugmakers, PBMs (Morning Consult)
  • EpiPen competition grows: Alternatives to anti-allergy device see big jump in prescriptions in 2017 (CNBC)
  • Epistemic Injustice, Procedural Fairness, and the Real Weight of Medical Evidence (Harvard Bill of Health)
  • Getting real about NCI-designated Cancer Center advertising (Nature)
  • ​Ex-Vice President Biden to Speak About Cancer Moonshot at SXSW (Xconomy)
  • How Vivek Ramaswamy Plans To Speed Drug Research And Cure Alzheimer's Disease (Forbes)
  • Ionis slips as safety concerns offset efficacy in FCS phase 3 (Fierce)
  • NIH extends PPD HIV research support contract until 2024 (OutsourcingPharma)
  • Sponsors Flesh Out Profiles of New Dermatology Drugs At AAD Meeting (SCRIP-$)
  • Researchers discover worrying new antibiotic-resistance gene variant (Pharmafile)

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

  • Bristol-Myers Squibb and Pfizer to Present New Analyses of Eliquis (apixaban) Clinical and Real-World Data at the American College of Cardiology 2017 Scientific Session (Press)
  • Aimmune Therapeutics Presents Clinical Data on Phase 3 Screening and Phase 2 Adherence for AR101 for Peanut Allergy at the 2017 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting (Press)
  • Revance Completes Enrollment in Phase 3 Pivotal Trials of RT002 Injectable for the Treatment of Glabellar (Frown) Lines (Press)
  • GlycoMimetics Completes Enrollment of Newly Diagnosed AML Patient Cohort in Phase 2 Clinical Trial of GMI-1271 (Press)
  • Swedish Orphan Biovitrum AB - FDA Approves in-use Storage at Room Temperature for Orfadin® Capsules (Press)

US: Medical Devices

  • Nephros wins FDA nod for EndoPur endotoxin dialysis filter (MassDevice)
  • Study evaluates drug-device combo therapy for deep vein thrombosis (Drug Delivery)

US: Assorted & Government

  • Alzheimer's $250B Cost Could Break Medicare (Forbes)
  • "Eggshell Plaintiffs" Meet Administrative Deference: Ninth Circuit Affirms Dismissal of Proposed Chicken Shed Rule (FDA Law Blog)
  • JPML Refuses MDL for Proton Pump Inhibitor Kidney Injury Cases (Drug & Device Law)
  • Los Angeles Biomedical Research Institute v. Eli Lilly & Co. (Fed. Cir. 2017); Eli Lilly & Co. v. Los Angeles Biomedical Research Institute (Fed. Cir. 2017) (Patent Docs)
  • Orthofix's foreign corruption woes: Here's what you can learn (MassDevice)
  • Stakeholders Agree: Modernize the legal framework to support move to value-driven health care (PhRMA)
  • 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties; Delay of Effective Date (Regulations.gov)
  • Texas law would allow pharmacists to order antibiotics, other drugs (Modern Healthcare)
  • More advertising pushback: Vermont Senate seeks restraint on 'beautiful' drug ads (Fierce)
  • Building the Pipeline: African Women in Health and Science (USP)

Upcoming Meetings & Events

  • FDA Advisory Committee Calendar
  • EMA Human Scientific Committees' Working Parties with Patients' and Consumers' Organisations (PCWP) and Healthcare Professionals' Organisations (HCPWP) joint meeting – 15 March 2017
  • Seventh Framework Programme (FP7) small-population research methods projects and regulatory application workshop – 29-30 March 2017
  • 4th Meeting of the International Generic Drug Regulators Programme, Mexico City, Mexico - 17-20 October 2016

Europe

  • Actelion's Ledaga approved in EU for the treatment of MF-CTCL (PharmaLetter-$)
  • The potential consequences for cancer care and cancer research of Brexit (eCancer Journal)
  • Therapy focus – Roche looks ready to rule another cancer niche (EP Vantage)
  • UK online carer-patient matchmaker HomeTouch expands nationwide (Reuters)
  • How the Chancellor can support the UK's world-class pharmaceutical industry in his budget for a proper industrial strategy (ABPI)
  • Aeterna Zentaris Announces EMA Pediatric Committee Agreement on the Pediatric Investigation Plan for Macrilen (Press)
  • BTG wins CE Mark for DC Bead Lumi radiopaque drug-eluting bead (Drug Delivery)
  • Mithra CDMO signs up a second Estrogen drug in 20-year Fuji deal (Outsourcing Pharma)

Asia

  • Takeda partnership 'enables more agile drug development and manufacturing' (PharmaLetter-$)
  • WuXi subsidiary HD to use Irish cell-based assays to monitor Mitochondria (OutsourcingPharma)

India

  • Ranbaxy's Singh brothers must seek permission to sell assets: High Court (Economic Times)
  • Lupin launches generic anti-depression drug in US (Economic Times)
  • CDSCO to go online for all services in six months (PharmaBiz)
  • How Indian Firms Are Rebooting For Quality Transformation (Pink Sheet-$)
  • Maha FDA steps up its vigilance on hospitals for overcharging coronary stents (PharmaBiz)
  • Announcement: Date of the 22nd AHWP Annual Meeting & Capacity Traning in India (AHWP)

Canada

  • Gore wins Health Canada approval for Tigris vascular stent (MassDevice)

Australia

  • Hazard Alert - Medtronic StrataMR Valves and Shunts (TGA)

General Health & Other Interesting Articles

  • Medicine with a side of mysticism: Top hospitals promote unproven therapies (STAT)
  • First he had penile cancer. Then he got a transplant. (Washington Post)
  • Studies highlight gender, racial inequalities in medical profession (Reuters)
  • Exercise better than drugs for cancer fatigue (Reuters)
  • Soy tied to longer life after breast cancer (Reuters)
  • U.S. reports low pathogenic bird flu outbreak in Wisconsin: OIE (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.

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