Regulatory Focus™ > News Articles > Regulatory Recon: Senate Forges a Different Approach to House-Passed 21st Century Cures Bill (20 Jan

Regulatory Recon: Senate Forges a Different Approach to House-Passed 21st Century Cures Bill (20 January 2016)

Posted 20 January 2016 | By Zachary Brennan 

Regulatory Recon: Senate Forges a Different Approach to House-Passed 21st Century Cures Bill (20 January 2016)

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

In Focus: International

  • Sharing Clinical Trial Data — A Proposal from the International Committee of Medical Journal Editors ( NEJM)
  • Gavi Vaccines Alliance in deal with Merck & Co for Ebola vaccine ( PharmaLetter-$)( Reuters) ( Nature)
  • French Health Minister criticises CRO’s slow response to clinical trial accident ( Pharmafile)( Stat)
  • Two Indian states halt sales of Roche's Avastin drug ( Reuters)
  • FDA to Pull Singapore Device Firm From Import Alert List ( Focus)
  • Government of Canada partners with provinces and territories to lower cost of pharmaceuticals ( Health Canada)
  • WHO Prequalification Inspection Reports ( WHO)

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US: Pharmaceuticals and Biotechnology

  • Supreme Court Declines to Hear J&J’s Appeal of Lawsuit (Pharmalot)
  • FTC Releases Latest Staff Report on Drug Patent Settlement Agreements; Post-Actavis Trends Seem to Be Forming (FDA Law Blog)
  • Pay-For-Delay Investigations: Firms May Have To Turn Over More Documents (Pink Sheet-$)
  • Presidential memo coming on cancer 'moon shot' (Politico)
  • Controversial CRISPR history sets off online firestorm (Stat) (Washington Post)(PubMed)
  • The CRISPR Catch-22: An Innovation Series Event (MIT Forum)
  • FDA Cellular, Tissue and Gene Therapies Advisory Committee Meeting (FDA)
  • FDA Warning Letter for MasterPharm (FDA)
  • Research Center Will Focus on Consistent Manufacturing Methods for Cell-Based Therapies (GEN)
  • Cell Therapy Catapult and Synpromics to collaborate on low cost viral vector production platform (BioPharma-Reporter)
  • Sinobioway and BioAtla share CAB co-development plan (BioPharma-Reporter)
  • BluDiagnostics Continues Momentum With $600K Seed Funding Round (Xconomy)
  • Cellectis inks new deal with CELLforCURE for the cGMP manufacturing of UCART123 (PharmaLetter-$)
  • Acorda Buys Its Way Into A Parkinson's Franchise (Pink Sheet-$)
  • Lilly's Carroll Talks Innovation, Partnering And Business Development Strategy (Pink Sheet-$)
  • Martin Shkreli Seeking New Lawyers in Securities Fraud Case (Bloomberg)
  • Who are the most influential people in biopharma today? (FierceBiotech)

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

  • Zafgen Completes Beloranib Trial, Will Address Clinical Hold (WSJ-$)(Xconomy)
  • FDA warns of Unlicensed Biologic Known As "THE ANTIDOTE (Import Alert Notice)
  • FDA grants breakthrough therapy for AbbVie's venetoclax in combination with Roche's Rituxan in replased, refractory CLL (FirstWord Pharma)
  • Genmab gets US FDA approval of Arzerra to treat CLL (PharmaLetter-$)
  • Fauci: Rules Of Trials/Science Mustn't Slip In Outbreaks (SCRIP-$)
  • PETA pumps millions into scientific research (Stat)
  • GlaxoSmithKline Win Leaves Only One Avandia Injury Claim (Law360-$)
  • GenVec (GNVC) in Limbo Awaiting Novartis AG (NVS)'s Decision on Status of Lead Drug CGF166 (Press)
  • Scripps Wired for Health study results show no clinical or economic benefit from digital health monitoring (MobiHealthNews)
  • Asthma, Peanut Allergy Products Could Get Boost From FDA Advisory Panel (Pink Sheet-$)

US: Medical Devices

  • FDA Final Guidance on "Implanted Blood Access Devices for Hemodialysis” (FDA)
  • FDA is classifying the tympanic membrane contact hearing aid into class II (FDA)
  • Globus, Johnson & Johnson’s Synthes bury the hatchet (Mass Device)
  • Google's Verily, AHA, AstraZeneca team up for heart disease R&D with $75M (FierceMedicalDevice)
  • Abbott’s Absorb GT1 Bioresorbable Scaffold Gets FDA Panel Date (Gray Sheet-$)
  • Gore wins 510(k) for Synecore hernia repair biomaterial (Mass Device)
  • FDA clears HealthMyne’s medical imaging analytics (Mass Device)
  • Developing a wearable biosensor: A doctor’s story (Blog)
  • APPROVALS ANALYSIS: Big Year For PMAs, But Slower Year For Approvals Overall (Clinica-$)

US: Assorted and Government

  • FDA CVM Guidance on "Target Animal Safety Data Presentation and Statistical Analysis" (FDA)
  • National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings (Federal Register)
  • CDC Proposed Data Collection Submitted for Public Comment and Recommendations (Federal Register)

Upcoming Meetings and Events              


  • MHRA board meetings: pilot of public sessions (MHRA)
  • Wellcome Trust grants Mucosis €3.7m for clinical trials in partnership with Imperial College (Manufacturing Chemist)
  • Pfizer to launch joint production with Russia’s Polysan in St. Petersburg (TASS)
  • MEPs move to reduce permitted sugar content in baby foods (European Commission)


  • Facilitating ease of business in pharmaceutical sector (CDSCO)
  • FDA’s strict scrutiny may drag India’s drug export down (IIFL)
  • Indian Council of Medical Research hopes to spur clinical trial upswing (Fierce)


  • China's BeiGene pitches a $150M IPO to fund its cancer pipeline (Fierce)


  • Organization of the Ministry of Health, Labour and Welfare (MHLW)
  • Takeda's U.K. unit brings sales force in-house to boost efforts in oncology, IBD (Fierce)

Other International

  • Research gets increasingly international (Nature)

General Health and Other Interesting Articles

  • How the Epidemic of Drug Overdose Deaths Ripples Across America (New York Times)
  • High-Deductible Plans Don't Make Patients Smart Shoppers (MedPage Today)
  • The Genetic Key to Human Intelligence May Lie in a Fragment Called DUF1220 (Inverse)

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

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

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