Regulatory Recon: HHS Rejects House Democrats' Push on Drug Prices; More Theranos Quality Questions (8 March 2016)

Posted 08 March 2016 By Zachary Brennan

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

In Focus: US

  • Theranos Ran Tests Despite Quality Problems (WSJ-$)
  • Commitment of CDER Central Funds to Support Intercenter Science Projects (FDA)
  • ‘Leaning in’ on Combination Products (FDA Voice)
  • DNA Barcodes Could Streamline Search for New Drugs to Combat Cancer (NIH Director’s Blog)
  • American company bungled Ebola response (AP)
  • Fixing Erroneous FDA Guidance Can Take a Decade – and Persistence (FDA Law Blog)
  • Reducing Drug Waste Could Save Billions of Dollars (New York Times)
  • US Vaccine Officials Weigh In At The Midpoint Of The Decade Of Vaccines (Health Affairs)
  • FDA In Vitro Diagnostic Chief: Industry Exploits Loophole On Waived Tests (InsideHealthPolicy-$)
  • HHS rejects Dems' push on high drug prices (The Hill)

In Focus: International

  • U.S. industry body says India agreed to not issue 'compulsory' drug licences ( Reuters)
  • Whistle-Blower of Unsafe Medicines Takes on `Made in India' ( Bloomberg)
  • Performance data on collaborative registration of medicines in Africa ( WHO)
  • The Making Of Nepal’s Immunization Law ( Health Affairs)
  • Sanofi and Merck pull the plug on European vaccines venture ( Reuters) ( PR)
  • Better together? Five takeaways on the proposal for a WHO pooled fund ( GHTC)
  • IMDRF Agenda for Meeting in Brazil 8-10 March ( DITTA)
  • ANSM Bans Production at Theravectys’ Paris Facility Until Sept. ( BioPharma-Reporter)( Focus)
  • Man who died in French drug trial had ‘unprecedented’ reaction, say experts ( Guardian)
  • US FDA backlog holding up revamp of inactive ingredients database ( InPharma-Technologist)

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US: Pharmaceuticals and Biotechnology

  • Promise of Immuno-Oncology Therapies Is Boosting R&D Funding and Alliances ( Tufts CSDD)
  • CRISPR: gene editing is just the beginning ( Nature News)
  • How the US CRISPR patent probe will play out ( Nature News) ( STAT)
  • BIO amicus brief in The Medicines Company v. Hospira ( BIO)
  • TransCelerate webinar on shared investigator platform ( TransCelerate)
  • Inside the ad blitz for Gilead’s Hep C drug ( STAT)
  • Illumina CEO Jay Flatley Built The DNA Sequencing Market. Now He's Stepping Down ( Forbes)
  • Up to Speed on Meldonium ( In the Pipeline) ( Forbes)
  • Abbott's IT layoffs draw fire from Sen. Durbin ( Chicago Tribune)
  • Past free trade agreements provide valuable lessons for future success ( PhRMA)
  • Bristol-Myers Squibb says stops some initiatives in China ( Reuters)
  • Amgen sues Sandoz over biosimilar patent talks ( Law360-$)

Clinical Study Results, Filings and Designations

  • Patients, Scientists Fight Over Research-Data Access ( WSJ-$)
  • Oncologic Drugs Advisory Committee Recommendations and Approval of Cancer Drugs by FDA ( JAMA) ( Editorial)
  • Statisticians issue warning over misuse of P values ( Nature News) ( PR)
  • US fast-track for AZ flu drug ( PharmaTimes)
  • Bayer links with academia on TB research ( PharmaLetter-$)
  • PatientsLikeMe and M2Gen Announce Partnership and Plans for Cancer Experience Study ( PR)

US: Medical Devices

  • Warning about magnetic interference between breast tissue expanders with magnetic ports and implantable cardioverter-defibrillators (ICDs) or pacemakers ( FDA)
  • Protease-Activated Fluorescent Probe Shows Promise as a Cancer Imaging Device ( JAMA)
  • Jury Acquits Medical Device CEO Charged With FDA Crimes ( Lexology)
  • Senseonics sets terms for $64m offering ( MassDevice)
  • BD Receives FDA Approval For New Automated Cervical Cancer Screening System ( Med Device Online)
  • J&J’s Ethicon touts Evarrest in study of aortic repair ( MassDevice)

US: Assorted and Government

  • AMCP Forum Issues Recommendations for FDA Guidance on FDAMA Section 114 ( PR)
  • Missouri House approves prescription monitoring program ( AP)
  • Drugmakers would pay for tossing cancer patient waste under RI bill ( STAT)
  • Policy: NIH push to stop sexual harassment ( Nature)

Upcoming Meetings and Events              

Europe

  • Three new drugs cleared for use on NHS Scotland ( PharmaTimes)
  • EFPIA on the Country Reports in the European Semester 2016 ( PR)
  • No variation for change of QPPV and/or PSMF location ( MEB)
  • MEPs approve updated rules to help contain transmissible animal diseases ( EU Parliament)

India

  • Takeda, AZ say Indian Co. Infringed Daliresp Petent ( Law360-$)
  • CDSCO Notice on Compliance Reports ( CDSCO)

Zika Virus

  • Monitoring and managing insecticide resistance in Aedes mosquito populations ( WHO)
  • States worry they don’t have money to fight Zika ( Washington Post)
  • HHS ships blood products to Puerto Rico in response to Zika outbreak ( HHS)

Other International

  • JP drafts for public comments, March 1 - 31, 2016 ( PMDA)

General Health and Other Interesting Articles

  • Retail Health Clinics Result in Higher Spending, Survey Finds ( New York Times)
  • How cancer cells fuel their growth ( MIT)
  • Hopeful start for first uterus transplant in US ( New York Times)

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.

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

  

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