Regulatory Recon: Trump Backs Medicare Drug Price Negotiations FDA Approves Amgen's Parsabiv After Rejection in August (8 February 2017)

Posted 08 February 2017 | By Michael Mezher 

Regulatory Recon: Trump Backs Medicare Drug Price Negotiations FDA Approves Amgen's Parsabiv After Rejection in August (8 February 2017)

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

In Focus: US

  • FDA approves Amgen drug for secondary hyperparathyroidism (Reuters) (PharmaTimes) (Endpoints) (Press)
  • Trump backs negotiating drug prices under Medicare: White House (Reuters) (NPR) (Endpoints)
  • Pfizer CEO On Trump, Drug Prices And The FDA (WBUR)
  • Chan Zuckerberg Biohub funds first crop of 47 investigators (Science) (Nature) (Pharmafile) (Fierce)
  • White House Backs 'Right to Try' Law for Terminally Ill Patients (WSJ)
  • US House speaker says Obamacare replacement will pass this year (Reuters)
  • Trump is considering Obamacare changes to help insurers (Politico)
  • Issues Facing Republicans in Replacing Affordable Care Act (NYTimes)
  • Biotech employee arrested, accused by US of insider trading (Reuters)
  • CDRH Warns Three Foreign Medical Device Manufacturers (Focus)
  • FTC: Shire ViroPharma Abused FDA Citizen Petition Process, Delaying Generics (Focus) (FDA Law Blog)
  • Hiring Freeze at FDA: Upton and DeGette Say it Puts Priorities at Risk (Focus)
  • More than 350 organizations write Trump to endorse current vaccines' safety (Washington Post)
  • Pharma execs expected to sign immigration letter (BioCentury)
  • Biotechnology Executives Oppose Trump Immigration Policy (Forbes) (Financial Times)
  • Gilead 2017 guidance disappoints, as 4th-qtr sales and profits fall (PharmaLetter-$) (The Street) (BioCentury)
  • HHS Pick Price Made 'Brazen' Stock Trades While His Committee Was Under Scrutiny (KHN)
  • Pharmacies Thrive Selling Opioids For Depressed Small Town Pain (KHN)
  • How the Anti-Vaxxers Are Winning (NYTimes)
  • Refining Lung Cancer Screening Criteria in the Era of Value-Based Medicine (PLOS) (Study)
  • Generic Drug Review At US FDA: Has Submission Rush Ended Or Just Paused? (Pink Sheet-$) (Lachman Consultants) (FDA 1 , 2)

In Focus: International

  • More troubles for Teva as Israeli authorities open bribery investigation (Pharmafile)
  • Treaty to stop biopiracy threatens to delay flu vaccines (Nature)
  • Preserving and boosting innovation is crucial in the age of Brexit, Trump (BioWorld)
  • Copenhagen joins crowded Brexit fight for medicines agency (Financial Times) (Danish Medicines Agency)
  • NICE restricts NHS access to Alexion's £366K-a-year bone drug (PharmaTimes) (Pharmafile)
  • NICE recommends targeted breast cancer radiotherapy treatment (EPR)
  • EMA Explains How it Supports Article 58 Applications (Focus)
  • Asia Regulatory Roundup: India Adopts New Medical Device Regulations (Focus)
  • Lundbeck gives up on Alzheimer's drug, rival to Axovant pill (Reuters)
  • AstraZeneca Works To Replicate China Success In Russia (SCRIP-$)
  • EU Close To Finalizing Revised GMP And Inspection Rules For Clinical Trials (Pink Sheet-$)
  • EMA's Multinational Approach Brings All But Two Member States Into New Drug Assessor Fold (Pink Sheet-$)
  • India scraps funding ties with Gates Foundation on immunization (Reuters)
  • New WHO Public Assessment Reports (WHOPARs) published (WHO)

US: Pharmaceuticals & Biotechnology

  • Too few U.S. teens getting flu and cancer vaccines (Reuters)
  • Adults urged to get vaccinated (Reuters)
  • Can a Researcher Studying an Alzheimer's Treatment Try It on Himself? (NYTimes)
  • Step Therapy—Clinical Algorithms, Legislation, and Optimal Prescribing (JAMA)
  • Earnings Preview: What To Expect From Regeneron On Thursday (Forbes)
  • 2017 Biosimilar Update (Policy & Medicine)
  • Male Birth Control Gel Inches Toward a Breakthrough (MIT Technology Review)
  • Scientists identify key role of divisive Alzheimer's protein (Pharmafile)
  • Draper looks to ultrasound and geometry to reduce CAR-T manufacturing costs (BioPharmaReporter)
  • Catalent running its biologics business at over 90% capacity (BioPharmaReporter)
  • Routinely Prescribed Antibiotic May Not Be Best for Treating Severe C. diff Infections (ICT)

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

  • FDA accepts Flexion's NDA for osteoarthritis steroid injection (Drug Delivery)
  • Lilly's Trulicity® (dulaglutide) Label Updated to Include Use in Combination with Basal Insulin for Adults with Type 2 Diabetes (Press)
  • Pivotal Phase 3 Data Results for TRULANCE™ (plecanatide) in the Treatment of Chronic Idiopathic Constipation (CIC) Published in American Journal of Gastroenterology (Press)
  • FDA Approves Bio Products Laboratory's Gammaplex® 10% for Treatment of Primary Immunodeficiency and Chronic Immune Thrombocytopenic Purpura (Press)

US: Medical Devices

  • Sickle cell trait skews common diabetes test (Reuters) (NPR)
  • Challenges in Designing Medical Device Materials (MDDI)
  • Stryker lands $486m DoD ortho supply contract (MassDevice)
  • Owlstone Medical launches 1,400-patient study for colon cancer 'breathalyzer' (MassDevice)

US: Assorted & Government

  • No Dearth of Legislation on Tackling High Drug Costs (Bloomberg)
  • Pfizer False Claims Act Ruling Keeps High Evidentiary Standards, Limits Employee Protections (Pink Sheet-$)
  • Cruz, Sanders face off on Obamacare (CNN)
  • Tucked Away In The Cures Act, A Better Option For Addressing Readmission Penalties For Safety-Net Providers (Health Affairs Blog)
  • One-Third Don't Know Obamacare and Affordable Care Act Are the Same (NYTimes)
  • Consumer, Environmental and Workers Groups File Legal Challenge to Trump's 'One-In, Two-Out' Executive Order on Regulations (Public Citizen)
  • More Cy Pres Abuse in California Class Action Litigation (Drug & Device Law)
  • Despite ACA 'Replace' Talk, Centene Sees Obamacare Profits In 2017 (Forbes)
  • After Officials Sign Off, Cleveland Clinic Doctor Secretly Returns Home (ProPublica)
  • How President Trump's pick to head health agency could shape Republican Medicaid reform (CNBC)
  • Contaminated medical marijuana believed to have killed cancer patient (CBS)
  • Reps Re-introduce STAR Act (McCaul)
  • Synthetic marijuana substitutes are likely not safe (Reuters)

Upcoming Meetings & Events


  • Andriukaitis: 'Rare cancers present a particular challenge' (EurActiv)
  • Update On Ireland's Framework Agreement (Big Molecule Watch) (Irish Times)
  • Health Minister Can Take Action To Increase Patient Access To Biosimilar Medicines In Ireland (Medicines for Europe)
  • Sanofi Delivers 2016 Sales And Business Eps Growth At CER (Sanofi)
  • NICE seeks to support new mothers with mental health problems (NICE)
  • Oxford men admit to illegally supplying medicines (MHRA)
  • Dr Reddy's continues European expansion (PharmaLetter-$)


  • Astellas Announces Personnel Changes and Organizational Changes  (Press)


  • CDSCO Issues Memo on Ease of Exporting Drugs (CDSCO)
  • CDSCO Updates on E-Filing Through SUGAM Portal (CDSCO)
  • India pharma exports may see near double-digit growth in FY17: Official (Economic Times)
  • Indian Pharmaceutical Alliance demands streamlining of approval of new drugs, biosimilars & revamping of CDSCO (PharmaBiz)
  • Maha FDA to serve show cause notice to Centaur Pharma as part of anti-anxiety, narcotics drug haul case (PharmaBiz)
  • India yet to achieve global goals in healthcare: Infosys founder NRN Murthy (Economic Times)

General Health & Other Interesting Articles

  • Helping Others Conquer The Mountain (LifeSciVC)
  • New Vital Signs study finds noise-related hearing loss not limited to work exposure (CDC 1, 2)

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

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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