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

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• FDA Advisory Committee Calendar
• 2018 Center for Biologics Evaluation and Research Science Symposium (Federal Register)

• 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)

• Alembic receives FDA 483, but no repeat observations (InPharma-Technologist)

• Guidance for completing the application form for an assessed listed medicine (TGA)

• 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)