Regulatory Recon: Pharma Execs Criticize PBMs UK to Invest £100m in Biomedical Catalyst program (3 October 2016)

Posted 03 October 2016 | By Zachary Brennan 

Regulatory Recon: Pharma Execs Criticize PBMs UK to Invest £100m in Biomedical Catalyst program (3 October 2016)

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

In Focus: US                                      

  • Drugmakers Point Finger at Middlemen for Rising Drug Prices (WSJ-$)
  • Court Rules that FDA's FOIA Expedited Processing Procedures Are Legal but Requires FDA to Immediately Produce Certain Records (FDA Law Blog)
  • Glaxo to Pay $20 Million SEC Fine Over Bribery in China (Bloomberg) (WSJ-$)
  • New Drug for Severe Eczema is Successful in 2 Trials (NY Times)
  • A silent liver disease epidemic (C&EN)
  • AstraZeneca hands off another Amgen-partnered drug in a $1.5B deal with an acquisitive Allergan (Endpoints) (Reuters) (Press)
  • Par Sues FDA For Yanking Gout Drug's 180-Day Exclusivity (Law360-$)
  • When is a REMS Necessary: FDA Explains in Draft Guidance (Focus)
  • FDA Is Redefining The Term 'Healthy' On Food Labels (NPR)
  • Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients Final Guidance for Industry (FDA)
  • Short-Term PRV Authorization Signed, Program User Fees Drop (InsideHealthPolicy-$) (White House)
  • FDA Seeks Methods to Better Regulate NGS Products (GEN)
  • FDA letter prompts Tute to cancel genome sequencing crowdfunding campaign (FierceBiotech)
  • FDA warns against the use of homeopathic teething tablets and gels (FDA) (Reuters)
  • Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) April - June 2016 (FDA)

In Focus: International

  • UK pledges £220m tech fund for life science and university sectors (PMLive) (ABPI)
  • Chinese FDA Update List of Medical Devices Exempt from Clinical Trial Requirements (Emergo)
  • Medicine Nobel for cell recycling work (BBC News) (NY Times) (Nobel PR) (JAMA)
  • Thailand considers Zika tests for all pregnant women (Reuters)
  • WHO to Add $20m in Industry Fees to Keep Prequalification Program Sustainable (Focus)
  • Ukraine’s Competition Authority Issues Major Decision on Drug Pricing Practices (National Law Review)

US: Pharmaceuticals and Biotechnology

  • J&J’s Skin Drug Beats Humira in Final-Stage Psoriasis Study (Bloomberg) (Endpoints) (Reuters)
  • Novo Nordisk Bets on Riskier Insulin Research (WSJ-$)
  • Gene therapy offers hope for treatment of sickle cell anaemia (Guardian)
  • Depomed Gets Favorable Nucynta Patent Decision (WSJ-$)
  • Cellular Dynamics Spinoff Aims to Develop Vision-Restoring Therapies (Xconomy)
  • CTI BioPharma Announces Retirement Of President And CEO (Press)
  • Blockbuster performance: Regeneron, Sanofi add stellar PhIII dupilumab data on display at EADV (Endpoints) (Fierce) (Press) (NEJM)
  • Presto! Wall Street magician Vivek Ramaswamy has another instant biotech IPO to sell you (Endpoints)

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

  • FDA approval of 44 new drug applications (NDAs) and 158 abbreviated new drug applications (ANDAs) from multiple applicants as products are no longer marketed (FDA)
  • AbbVie's Investigational HCV Regimen Receives U.S. FDA Breakthrough Therapy Designation (Press)

Medical Devices

  • Manufacturer failed to disclose faulty device in rivaroxaban trial (BMJ)
  • Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting (FDA)
  • Classification of the Evoked Photon Image Capture Device (Federal Register)
  • Mergers, IP, risk assessment among trends in medtech (Mass Device)
  • FDA Grants Valencia Technologies IDE Approval for U.S. Pivotal Study of Bioelectronic Device for Hypertension (Press)
  • BD’s CareFusion lands $100m contract with U.S. Defense Dept. (MassDevice)

US: Assorted and Government

  • Emergent BioSolutions gets $1.6 billion BARDA contract for NuThrax development (PharmaLetter-$)
  • Pharma CEO Charged in $100 Million Fraud Scheme (Department of Justice)

Upcoming Meetings and Events             


  • India Specifies Terms For Ceasing Supplies Of Essential Drugs (SCRIP-$)
  • Phase III success for Sun Pharma and Almirall’s tildrakizumab in psoriasis (PharmaLetter-$)
  • AstraZeneca Cuts 50 Sales Reps in India (Economic Times)
  • Thermo Fisher Scientific Expands Global Footprint to Support Cell and Gene Therapy Clinical Trials in Japan (Press)


  • $95M mega-round in hand, Elaine Sullivan sets out to build a European oncology player (Endpoints)
  • Does breast cancer care in Europe include psychological support? (European Commission)
  • EMA Committee on Herbal Medicinal Products Minutes of the meeting on 11-12 July 2016 (EMA)

General Health and Other Interesting Articles

  • Report: Medical Record Mix-ups Are A Common Problem (NPR)
  • Children Who Get Zika After Birth Tend Not to Fall Seriously Ill, Study Finds (NY Times)
  • Inside Venezuela’s Crumbling Mental Hospitals (NY Times) (NY Times)
  • MSF urges world leaders to act over bombing of hospitals in Aleppo (BMJ)

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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