Regulatory Focus™ > News Articles > 3 > Recon: Trump Selects CDC Head; AbbVie Announces Disappointing Results for Rova-T

Recon: Trump Selects CDC Head; AbbVie Announces Disappointing Results for Rova-T

Posted 22 March 2018 | By Zachary Brennan 

Recon: Trump Selects CDC Head; AbbVie Announces Disappointing Results for Rova-T

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

In Focus: US
  • More Cases Are Reported of Unusual Cancer Linked to Breast Implants (NY Times-$) (Medscape)
  • Trump Policy Change Is a Win for Drugmakers (WSJ-$)
  • Sessions issues memo on use of death penalty in drug-related cases (The Hill)
  • AbbVie will not seek faster approval for lung cancer drug (Reuters) (Fierce) (Press) (EP Vantage) (FT-$) (Forbes)
  • Trump’s pick to lead CDC both celebrated and censured (Science) (Politico) (The Atlantic) (CSPI) (Senate HELP)
  • FDA Clears Ilumya for Plaque Psoriasis (Medscape) (Press) (Fierce)
  • 12 blockbusters: The surging list of $1B-plus drugs rolling out on the market this year might surprise you (Endpoints) (BioPharmaDive) (Report)
  • Essential Components of an Adequate Response to Emerging Viral Diseases (JAMA)
  • Announcement of Medicaid Drug Rebate Program National Rebate Agreement (CMS)
In Focus: International
  • Work plan for GCP Inspectors Working Group for 2018 (EMA)
  • GSK’s move for Pfizer’s consumer arm divides market (Financial Times-$) (Fierce)
  • NHS warned on £9bn cost of Alzheimer’s breakthroughs (Financial Times-$)
  • No Revenue? No Problem—Hong Kong Draws Biotech Firms Looking to List (WSJ-$)
  • South Sudan halts spread of crippling Guinea worms (NY Times-$)
  • Accounting for risk when designing chemical safety assessments for pharmaceutical packaging systems (Euro Pharma Review)
Pharmaceuticals & Biotechnology
  • Parps prepare to surf the immuno-oncology wave (EP Vantage)
  • Third Rock debuts immunometabolism startup Rheos with $60M launch round (Endpoints) (Fierce) (Press)
  • Transparency for Decision-Making Process Coming to an Inspection Near You! (Lachman Consultants)
  • IPEC and PDA team on excipient risk assessment guidance (InPharma-Technologist)
  • Broad pharmacy availability set to boost GSK's Shingrix (BioPharma Dive)
  • Mega-mergers would mean the death of standalone PBMs. Should consumers mourn or rejoice? (Stat-$)
  • A doctor speaks, a biotech stock tanks. What happened at this invite-only health care investor conference? (Stat-$)
  • I-O newcomer’s funding now nearly $170 million (PharmaLetter-$)
  • CureVac Receives U.S. Patent Covering Entire Process for Pharmaceutical Manufacturing of RNA (Press)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • The PCSK9 of NASH? Regeneron and Alnylam join forces to tackle a promising target for severe liver diseases (Endpoints) (Fierce)
  • Mutations in Noncoding DNA Linked to Neurodevelopmental Disorders (GEN)
  • Cashing in on PhII trial success, Arena to raise $353M to fuel PhIII etrasimod/ralinepag trials (Endpoints)
  • GSK trials Benlysta/rituximab combo for lupus (PharmaTimes)
  • A Protein-Truncating HSD17B13 Variant and Protection from Chronic Liver Disease (NEJM)
  • The Proposal to Lower P Value Thresholds to .005 (JAMA)
  • Trials that say “maybe”: the disconnect between exploratory and confirmatory testing after drug approval (BMJ)
  • Gradual release of immunotherapy at site of tumor surgery prevents tumors from returning and eliminates cancer spread in mouse study (Dana Farber)
  • Takeda Announces Publication of Final Data from ICLUSIG® (ponatinib) Pivotal Phase 2 PACE Trial in Blood (Press)
Medical Devices
  • Orthofix Receives FDA 510(k) Clearance of G-Beam Fusion Beaming System (Press)
  • Edwards Lifesciences delays Sapien 3 Ultra debut in Europe until later this year (MassDevice)
  • Genentech’s pre-filled syringe for diabetic retinopathy wins FDA nod (MassDevice)
US: Assorted & Government
  • 340B is a well-intentioned drug discount program gone awry (Stat-$)
  • FDA targets anti-diarrhea pills that Pennsylvania doctor calls 'poor man's methadone' (Baltimore Sun)
  • Unintended Heating Associated with the Monteris Medical NeuroBlate Probe: Letter to Health Care Providers (FDA)
  • Drug Safety Oversight Board Meeting - January 18, 2018 (FDA)
Upcoming Meetings & Events Europe
  • EuroBiotech Report—Lundbeck-Prexton, Adaptimmune, Medicxi, Affimed and Oxford Nanopore (Fierce)
  • Learning how the USA tackles neuro research: UK–USA Partnership Symposium kicks off today (MRC)
India Australia
  • Guidance for completing the application form for an assessed listed medicine (TGA)
General Health & Other Interesting Articles
  • IVF Testing Spurs a Debate Over ‘Mosaic’ Embryos (WSJ-$)
  • Why An Imperfect HIV Vaccine Could Be Better Than None At All (NPR)
  • Omissions On Death Certificates Lead To Undercounting Of Opioid Overdoses (NPR)
  • A dietary supplement makes old mice youthful. But will it work in people? (Stat)
  • More preemies developing motor impairments (Reuters)
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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