Regulatory Recon: Drug Shortages Can Spur Price Increases for Similar Drugs (13 April 2017)

Posted 13 April 2017 By Zachary Brennan

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Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing.

In Focus: US                                          

  • Prescription-Drug Shortages Help Push Up Prices of Similar Drugs (WSJ-$) (NEJM)
  • FDA ID’s More than 70 Class I Devices Now Exempt from 510(k)s (Focus) (Federal Register)
  • US scientists still wary of Gottlieb's industry ties (PMLive)
  • Trump may halt insurer payments to force Democrats to table on healthcare (Reuters) (WSJ-$)
  • Apple has a secret team working on the holy grail for treating diabetes (CNBC)
  • FDA allows marketing of first whole slide imaging system for digital pathology (Press)
  • Fast Start for FDA Drug Approvals in 2017 (Focus)
  • On the new FDA chief’s agenda: A bipartisan bill to regulate diagnostic lab tests (Stat-$)
  • Personalized tumor vaccines keep cancer in check (Science)

In Focus: International

  • US FDA Raises Concerns over Teva’s plant in China (Reuters)
  • Japanese drug production grew in 2015, per new MHLW data (InPharma-Technologist)
  • WHO Seeks More Birth Control API Manufacturers (Focus)
  • Ten years in public health 2007-2017 for Chan (WHO)
  • Cholera spreading in Somalia, 50,000 cases foreseen: WHO (Reuters)
  • A historic yellow fever outbreak spreads in Brazil (Stat)
  • New study on Monsanto weedkiller to feed into crucial EU vote (Reuters)
  • China to tighten rules against faking clinical trial data, criminal charges possible (Fierce)
  • New innovation scorecard platform launched (UK’s NHS)
  • UK MHRA conflicts of interest annual compliance report (MHRA)
  • India’s Pricing Tussle Escalates After Regulator Names “Overcharging” Firms (SCRIP-$)

Pharmaceuticals and Biotechnology

  • Caution Urged When Using PFS as Surrogate for Overall Survival (MedPage Today)
  • Jeremy Levin spotlights a trendy new way to build a pipeline with his $86M IPO for Ovid (Endpoints)
  • We don’t know when (exactly) Lilly will announce the FDA’s baricitinib decision, but watch out for the looming pricing squabble (Endpoints)
  • Progress in Vertex talks bring cystic fibrosis drugs closer for Irish patients (PharmaLetter-$)
  • Biotech startups woo increasing numbers of crowdfunders (Nature Biotechnology-$)
  • Lyndra’s Long-Acting Drug Delivery Technology Lands $23M Investment (Xconomy)
  • PTAC OK's Alternative Payment Model for IBD (MedPage Today)
  • Thiel’s Breakout Labs fuels four new life science companies (Fierce)
  • Destiny hires CEO with IPO experience as antibiotic 2b nears (Fierce)
  • Prexton CEO on future for novel Parkinson's therapy (Pharma Intelligence)
  • CDER Offering More Concrete Advice on Continuous Manufacturing as Experience Grows (IPQ)
  • The specter of malaria that resists treatment (Novartis)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Bristol-Myers to license two drugs to Biogen, Roche (Reuters) (Press)
  • BMS links with Apexigen to test cancer immunotherapy combo (PharmaTimes)
  • University of Vienna, Berkeley appeal gene-editing patent ruling (Reuters) (Endpoints)
  • Unit of Drugmaker Shire Blasts FTC’s Lawsuit Over Use of FDA Petitions (Bloomberg)
  • Human ‘knockouts’ may reveal why some drugs fail (Science)
  • Gene silencing shows promise for treating two fatal neurological disorders (NIH)
  • Protein Degradation Time (In the Pipeline)
  • Microbiome specialist Rebiotix chalks up C. diff trial success (PMLive)
  • FDA Allows NuvOx Pharma to Run a Phase II Clinical Trial in Brain Cancer (Press)
  • Antiparasitic drug repurposed for treatment of brain tumours (Pharmafile)
  • New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults (JAMA)
  • Pfizer Can't Shake Off-Label Marketing FCA Suit (Law360-$)
  • Fed. Circ. Upholds PTAB's Ax Of Novartis MS Drug Patent (Law360-$)
  • Shire Blasts Allergan's Discovery Bid In Antitrust Suit (Law360-$)
  • Boehringer Asks DC Circ. To Stay Aggrenox Doc Production (Law360-$)
  • Novan up 21% on antifungal gel results (PharmaLetter-$)

Medical Devices

  • Hologic faces U.S. patent lawsuit over menstrual bleeding device (Reuters)
  • Public Hearing on the SCHEER Scientific Advices on the evaluation of new scientific information on the safety of PIP breast implants (EC)
  • New Simpler Parkinson's Tests Probe Walking, Talking, Typing (Scientific American)
  • EnsoData receives FDA clearance for sleep analysis software (Mobi Health News)
  • Medical Device Maker Hits Rival With Trade Secrets Suit (Law360-$)
  • Alere Wins Dismissal Of Suit Alleging Blood-Testing Errors (Law360-$)
  • MITA commends Aetna for covering CT colonography (MITA)

US: Assorted and Government

  • Cassidy Writing Rx-Price Bill; Touts Imports, Slams Sanders' Rx-Import Bill (InsideHealthPolicy-$)
  • A Hiring Freeze By A Different Name: OMB Wants Agency 'Workforce Reduction' Plans (Pink Sheet-$)
  • Form 483 for PharMerica (FDA)
  • Repeal, Replace … Revise: Your Guide To Market Stabilization (Kaiser Health News)
  • Health Reform 2.0 (PwC)
  • CMS Solicits Ideas To Improve Part D: An Opening For Co-Pay Reform And Shaping Priorities (Pink Sheet-$)
  • Public Members needed for FDA’s Institutional Review Board (FDA)

Upcoming Meetings and Events               

Asia

  • Numerous Complaints, Repeat Observations Fill FDA Warning Letter for Indoco (Focus)
  • Varicella virus on the rise in Hyderabad as more than 170 cases recorded during last one month (PharmaBiz)
  • Sixty pharma cos submit ADRs reports in XML format mandated by PvPI (PharmaBiz)

General Health and Other Interesting Articles

  • Vaccination rate jumps in California after tougher inoculation law (LA Times)
  • Doctor tells U.S. court drug not suitable for Arkansas executions (Reuters)
  • Risk of a rare but deadly mouse-borne virus increases in the spring (Washington Post)
  • Radical increase in water and sanitation investment required to meet development targets (WHO)
  • NIH scientists advance understanding of herpes virus infection (NIH)

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.

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

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