Regulatory Focus™ > News Articles > Regulatory Recon: Top-Selling Drugs Cost US Three Times More Than UK (13 October 2015)

Regulatory Recon: Top-Selling Drugs Cost US Three Times More Than UK (13 October 2015)

Posted 13 October 2015 | By Michael Mezher 

Regulatory Recon: Top-Selling Drugs Cost US Three Times More Than UK (13 October 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

In Focus: US

  • Transatlantic divide: how US pays three times more for drugs (Reuters)
  • FDA delays ruling on Collegium's opioid painkiller (Reuters) (Collegium)
  • Why Viagra Keeps Going Up: Pfizer's CEO On The Drug Pricing Controversy (Forbes)
  • New York Attorney General Examining Whether Turing Restricted Drug Access (NYTimes)

In Focus: International

  • 8 Year-Old Boy Dies of Rare, Vaccine-Derived Poliovirus in Laos (Washington Post) (Reuters) (WHO)
  • WHO Edges Closer To Finalizing "Biological Qualifier" Proposal (SCRIP-$)
  • Growth of Chinese Medical Device Industry Tests the Limits of its Regulators (Life Sciences Connect)
  • Cheap Medicines Disappear From China Due to "Monopolies" on Raw Materials (PharmaLetter-$)
  • IGPA becomes IGBA and chairmanship shifts to South Africa (EGA)

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US: Pharmaceuticals and Biotechnology

  • Ex-FDA inspector: How to avoid 483 observations during your next facility audit (In-Pharma Technologist)
  • INN guidance leaves FDA in catch-22 over awaited interchangeability rules, experts (BioPharma-Reporter)
  • The rise of the superbug: Paratek’s two-decade struggle to develop an antibiotic (Boston Business Journal)
  • FDA's Searchable Database of Licensing Information As Reported by Wholesale Distributors and 3PLs Now Available Online (Pharmaspective)
  • Eli Lilly's Good Cholesterol Drug Went Bad. Here's What That Means For Pharma (Forbes) (Pink Sheet-$)
  • This Drugmaker Suffered the Consequences of Price Increases (Bloomberg)
  • HIV therapy helps protect men from Hep B infection (OnMedica)
  • Lithium safe and effective in children with bipolar disorder (OnMedica) (Annals of Internal Medicine)
  • Merck cholesterol drug's odds dim after Lilly failure (Reuters)
  • HBR, NEJM and Medtronic Launch New Initiative Driving Discussion on Value-Based Healthcare (Medtronic)
  • Cosentyx demonstrates sustained efficacy in plaque psoriasis (EuropeanPharmaceuticalReview)

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

  • FDA Grants QIDP Designation to LMB for Mino-Lok™, a Novel Antibiotic Lock Therapy in Development to Treat Catheter Related Blood Stream Infection (Press)
  • FDA Lifts Hold On Biodel Diabetes Study; Shares Jump (Biodel) (SCRIP-$)
  • Microbiome drug gets Breakthrough Therapy status (pharmaphorum)
  • Results from Merck’s Phase 3 Study of Investigational Chronic Hepatitis C Therapy Elbasvir/Grazoprevir in Patients with Advanced Chronic Kidney Disease Published in The Lancet (Merck)
  • Breast cancer drug beats superbug (EurekAlert)

US: Medical Devices

  • Everolimus-Eluting Bioresorbable Scaffolds for Coronary Artery Disease (NEJM)
  • Abbott dissolving stent succeeds in pivotal U.S. trial: study (Reuters)
  • NFANT Labs gets FDA nod for smart baby bottle sensors for the NICU (MobiHealthNews)
  • FDA clears Intelesens’s zensor, a wearable vitals monitor (MobiHealthNews)
  • Medtronic CoreValve® System Demonstrates Excellent Clinical Outcomes in First Report of 'Real-World' U.S. Experience (Medtronic)
  • Medtronic Drug-Filled Stent Shows Promising Initial Results Following First Implants (Medtronic)
  • GTx Receives FDA Clearance to Initiate Clinical Trial in Stress Urinary Incontinence (Press)
  • Tryton Meets Primary Endpoint in Pivotal Confirmatory Study of Tryton Side Branch Stent in Treatment of Coronary Bifurcation Lesions (Press)
  • More 2-year data on Bard’s Lutonix DEB (MassDevice)

US: Assorted and Government

  • Judge orders Arkansas to disclose source of execution drugs (CBS News) (Boston Globe)
  • Drug Prices, Trade Deal Hot For 1st Democratic Debate (SCRIP-$)
  • US, AU and CA try to block WTO LDC drug patent waiver because PhRMA's not happy enough with the TPP (KEI)

Upcoming Meetings and Events              

Europe

  • Anti-malarial drug to be withdrawn from Irish market (Independent.ie)
  • Scottish Medicines Consortium gives the green light to three products (PharmaLetter-$)
  • Orphan designation for Can-Fite's liver cancer candidate CF102 from EMA (PharmaLetter-$)
  • No proof that 85 percent of depression treatment apps accredited by NHS actually work (EurekAlert)
  • KEYTRUDA® (pembrolizumab) Receives New Draft Recommendation from National Institute for Health and Care Excellence (NICE) in U.K. for First-Line Treatment for Advanced Melanoma (Merck)
  • Final designs for UK Gov-backed facility 'weeks away' says Cell Therapy Catapult CEO (BioPharma-Reporter)

India

  • Suven Life gets patent for neuro-degenerative drug (Economic Times)
  • One in 13 world cancer patients is Indian (Economic Times)
  • India sets out new guidelines for clinical trials with children (PharmaLetter-$)
  • DoP constitutes Inter-Ministerial Coordination Committee to address issues of pharma industry (PharmaBiz)
  • Chemists call for strike on Oct 14 against online drug sale (Economic Times)
  • TN-based Oviya Medsafe's MD to chair UK Pharmacovigilance Day programme in London on Oct 19 (PharmaBiz)

Canada

  • Health Canada approves breakthrough heart failure drug (Vancouver Sun)

Australia

  • Consultations on adoption of European Union guidelines in Australia: Outcome of previous consultation (TGA)
  • Clinical trials - migration of Clinical Trial Notifications (CTNs) from paper-based database to new online system (TGA)
  • Hazard Alert: Duracon augments tibial wedge implants - used in knee replacements (TGA)

Other International

  • Singapore develops 'embryo in a dish' to study birth defect (BioSpectrum)
  • CIMB says Malaysian pharmas have scope to adjust to TPP changes (FiercePharmaAsia)
  • Hong Kong drugstores attract Chinese customers for cancer, hep C drugs (FiercePharmaAsia)
  • Fighting New Diseases by Giving Them Blander Labels (NYTimes)

Ebola Outbreak

  • Ebola treatment beds prevented 57,000 Ebola cases and 40,000 deaths in Sierra Leone (EurekAlert)

General Health and Other Interesting Articles

  • Need an ambulance? Why you may not want the more sophisticated version (Washington Post)
  • Artificial Intelligence, You Say? (Science)

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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