Regulatory Focus™ > News Articles > Regulatory Recon: Draft Drug Pricing Order Proposes to Ease Regulations; FDA Approves Shire's Long-A

Regulatory Recon: Draft Drug Pricing Order Proposes to Ease Regulations FDA Approves Shire's Long-Acting ADHD Drug (21 June 2017)

Posted 21 June 2017 | By Michael Mezher 

Regulatory Recon: Draft Drug Pricing Order Proposes to Ease Regulations FDA Approves Shire's Long-Acting ADHD Drug (21 June 2017)

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

In Focus: US

  • A decade behind schedule, Shire finally gets an FDA OK for long-acting ADHD drug (Endpoints) (Reuters) (Pharmafile) (Press)
  • Draft Order on Drug Prices Proposes Easing Regulations (NYTimes)
  • Will Trump's FDA relax standards for drug approval? We'll get a clue soon with decision on Portola's anticoagulant (STAT)
  • No choice, no free market (Bioworld)
  • Landmark FDA approval bolsters personalized medicine (STAT)
  • Walgreens, Theranos Reach Tentative Settlement (The Street)
  • FDA Commissioner Vows to Eliminate Backlog of Orphan Drug Designation Requests (Focus)
  • FDA to Clear Path for Drugs Aimed at Cancer-Causing Genes (Bloomberg)
  • CBER Director Offers a Peek Into the Complexities of Where the Center is Headed (Focus)
  • FDA Issues Draft Q&A on Electronic Systems in Clinical Investigations (Focus)
  • Scientists Call For Tighter Limits On Use Of Ubiquitous Antimicrobial Chemicals (Forbes)
  • Drugmaker Mylan gets boost from unlikely source: coal (Reuters)
  • Mylan, embattled maker of EpiPen, faces a crucial test as angry investors plot to oust CEO (STAT)
  • US Supreme Court ruling threatens massive talc litigation against J&J (Reuters)
  • In just one year, nearly 1.3 million Americans needed hospital care for opioid-related issues (Washington Post)
  • Senate GOP wants Obamacare repeal vote next week (Politico) (Reuters)
  • GOP Rift Over Medicaid and Opioids Imperils Senate Health Bill (NYTimes)
  • GOP Health Plan is Really a Rollback of Medicaid (NYTimes)

In Focus: International 

  • EU can't decide how to relocate agencies marooned by Brexit (Politico) (Luxemburger Wort)
  • Worldwide drug sale forecasts fall as pricing pressures mount (Reuters) (STAT) (Fierce) (PharmaTimes) (Evaluate)
  • Top 20 blockbuster drugs in the late-stage pipeline — EvaluatePharma (Endpoints)
  • Asia Regulatory Roundup: J&J, Medtronic Lead Pushback Against TGA Device Priority Review Proposal (Focus)
  • Better consultations, better evidence (MHRA)
  • Early access to medicines scheme (EAMS) scientific opinion: Raxone to treat the decline of respiratory function in patients with Duchenne Muscular Dystrophy (MHRA)
  • Consultation on Risk Management Plans for Opioid-containing Products (Health Canada)
  • AstraZeneca gets marketing nod for asthma drug Symbicort in India (Economic Times)
  • Midsummer Madness: EMA Headquarters Rumors Fly At BIO (Pink Sheet-$)
  • UK watchdog reviews travel insurance for cancer patients (Reuters)
  • Merck Ventures, CRUK launch new immuno-oncology spinout biotech iOnctura (Fierce)

Pharmaceuticals & Biotechnology

  • FDA-approved drugs in combination could provide new antibiotics (Pharmafile)
  • GSK's Bexsero, Shingrix to pass $1B sales mark by 2022: report (Fierce)
  • The small, virtual team at Syntimmune bags a $50M round in the march toward a pivotal test (Endpoints)
  • Egalet Receives Complete Response Letter from U.S. Food and Drug Administration for Prior Approval Supplement for 10 mg and 15 mg Dosage Strengths of OXAYDO (Press)
  • Patient Voices: A.L.S. (NYTimes)
  • FDA, Ahead of GDUFA II Enactment, Starts the Ball Rolling with Pre-Submission Facility Correspondence Guidance (FDA Law Blog)
  • Running out of cash and cited on fraud charges, ImmunoCellular retreats on PhIII and cries for help (Endpoints)
  • Ionis' Akcea closes in on $125M IPO to fund phase 3 trials (Fierce)
  • Flagship-backed Rubius raises $120M to take off-the-shelf red blood cell cancer therapeutics into the clinic (Fierce)
  • Alzheimer's Drug Pipeline Analysis: Have We Hit Peak Amyloid? (Xconomy)
  • A lymphoma survivor became a Pfizer scientist. Now she's starring in a TV ad (Fierce)
  • 100 Breakthrough Cancer Inventions from 100 Companies? BIO and CAI are Betting On It (BIO)
  • MA Gov. puts money behind science (BioPharmaDive) (Mass.gov)
  • FDA issued 47 Product Recalls, Import Alerts, and Consent Decrees in May 2017 (FDAZilla)
  • FDA Informs Veterinarians about Important Labeling Changes to Critical Care Medications for People (FDA)
  • How 21st Century Cures Act Affects Combination Products (Law360-$)
  • Wyeth Pharmaceuticals Inc. et al.; Withdrawal of Approval of 121 New Drug Applications and 161 Abbreviated New Drug Applications (FDA)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Pfizer kicks off human testing with maternal GBS vaccine (Fierce) (Press)

Medical Devices

  • VNS Therapy Receives FDA Approval for Expanded MRI Labeling (Press)
  • ClearFlow, Inc. Receives FDA Clearance for FlowGlide Technology for Cardiac Surgery Patients (Press)
  • New Data Reveal Medtronic CRT Devices Improve Therapy Delivery and Reduce Healthcare Costs (Press)
  • Class 1 Device Recall Venture RX Catheter,Venture OTW Catheter,Venture CS Catheter (FDA)
  • FDA clears Conformis' iTotal hip replacement (MassDevice)
  • Intuitive Surgical wins FDA nod for inguinal hernia repairs with da Vinci Xi (MassDevice)
  • BD wins FDA nod for customizable mini-laparoscopic instruments (MassDevice)
  • Report: Apple partners with Health Gorilla to integrate iPhone with hospital, lab data (MassDevice)
  • Hologic Receives 510(k) Clearance for Herpes Simplex Virus Assay (GenomeWeb)

US: Assorted & Government

  • With Health Law in Flux, Insurers Scramble to Meet Filing Deadline (NYTimes)
  • Actavis At 4: Pay-For-Delay Lawsuits Receding (Law360-$)
  • Merck Gets Out Of Patent Suit Over QR Codes (Law360-$)
  • Six linked to CanadaDrugs.com face extradition to US (Securing Industry)
  • Ninth Circuit En Banc Panel Holds that Central Hudson Survives Sorrell (Drug & Device Law)
  • Webinar, 6/28: Procedural aspects of compulsory licensing under TRIPS (Harvard Bill of Health)

Upcoming Meetings & Events

Europe

  • MHRA chair recognised in 2017 Queen's Birthday Honours (MHRA)
  • Why does the UK lag far behind much of Europe for patient access to new innovations, asks Novartis' MD for UK and Ireland (PharmaLetter-$)

India

  • Department of Pharmaceuticals sets up facilitation cell to help firms shift to GST (Economic Times)
  • India's largest medical device park launched in Hyderabad (PharmaBiz)
  • Make in India programme for SMEs in pharma sector a mirage: Anjan K Roy (PharmaBiz)
  • Cadila receives audit closure report (Economic Times)
  • Glenmark, APC Therapeutics ink licensing pact for cancer drug (Economic Times)
  • GST rollout: Drug retailers go slow on stockpiling (Economic Times)
  • GST may not impact essential drugs stock (Economic Times)
  • Zydus Cadila gets USFDA nod to market anti-inflammatory drug (Economic Times)

Australia

  • GMP clearance process – Fees for compliance verification GMP clearance applications (TGA)

General Health & Other Interesting Articles

  • WHO says child from Raqqa among 15 new polio cases in Syria (Reuters)
  • Chemotherapy, Then the U.S. Championships, for Gabriele Grunewald (NYTimes)
  • More U.S. counties are finding Zika-carrying mosquitoes (Washington Post)

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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