Recon: NICE Rejects Novartis' Migraine Drug Aimovig

• Trump-Inspired Tweets Signal More Drug-Price Pressure (Bloomberg)
• Health-Care CEOs Outline Strategies at JP Morgan Conference (WSJ)
• JP Morgan's Dimon hosted a private dinner for pharma executives, and a major topic was Amazon (CNBC)
• For tiny biotechs, JP Morgan is a big opportunity — and a big cost (STAT)
• Big Pharma’s Cancer Race (WSJ)
• Former Insys CEO pleads guilty to bribery scheme (Boston Globe)
• A Drug That Eases Miscarriages Is Difficult For Women To Get (NPR)
• Merck: There’s more to us than Keytruda. Really (STAT)
• Office of Prescription Drug Promotion (OPDP) FDA-Track Metrics (FDA)
• Senior FDA Official To Head Government Affairs At CRISPR Therapeutics (BioCentury)
• AstraZeneca to shut down twin Colorado manufacturing sites, impacting over 200 jobs (Pharmafile) (Endpoints)
• As pharmas revert to regular price hikes, Azar threatens action with 'fighting words' (BioPharmaDive)
• ‘Marketers are having a field day’: Patients stuck in corporate fight against generic drugs (Washington Post)
• Amgen's Repatha hits wall at SCOTUS but presses ahead—new price breaks included (Fierce)

• Novartis migraine drug not cost effective - UK price watchdog (Reuters) (PMLive) (Endpoints) (NICE)
• EU Medicines Agency picks up its roots, embracing Amsterdam (STAT)
• Chinese biotech was big at JPM. Attendees were enthusiastic — and wary (STAT)
• China’s Junshi Prices Domestic Anti-PD-1 mAb At Deep Discount (BioCentury)
• Sanofi and Novo Nordisk press ahead with US insulin prices rises (Financial Times)
• Oncology Dominates As China Approves Record 48 New Drugs In 2018 (Pink Sheet-$)
• Monumental Year Ahead For Korean Pharmas As New US Approvals Eyed (Scrip-$)
• EU Proposes New Guidance On Allergen Products With Small Study Populations (Pink Sheet-$)

• HIV Viral Load and Transmissibility of HIV Infection (JAMA)
• The NIH is thwarting research on a poorly understood yet serious condition (STAT)
• Foundation medicine name Roche SVP as new CEO (Pharmafile)
• FDA approves record breaking 971 generic drugs in 2018 (Pharmafile)
• 2018 Complete Response Letters: Efficacy Issues Drove Most Product Rejections (Pink Sheet-$)
• J&J still sees plenty of opportunity in crowded immunology markets—starting with psoriasis (Fierce)
• JP Morgan Notebook Day 3: Biotech Feeling Government Shutdown, AstraZeneca, Denali, Allergan, Aptinyx, Sangamo (Pink Sheet-$)
• JP Morgan 2019: Industry Throws A Bonanza, With An Elephant In The Room (Scrip-$)
• US FDA Advertising Citations Remain Rare In 2018 (Pink Sheet-$)
• What They Said – A Review of FDA Press Statements for 2018 (Eye on FDA)
• Betting on allosteric mutations driving cancer, Black Diamond raises $85M in fresh round (Endpoints)
• Smartphones Could Boost OTC Drug Utilization And Numbers Of Rx-To-OTC Switches, Too (Forbes)
• Roche exec Pearl Huang rejoins biotech as CEO of Cygnal — Flagship’s bet on ‘exoneural biology’ (Endpoints)
• Novartis puts AI on the job to help reps say the right things to the right doctors (Fierce)
• Takeda’s Uloric: CV Mortality Signal Leads US FDA To Ponder Regulatory Options (Pink Sheet-$)
• Orange Book Policing May Increase, US FDA's Gottlieb Says (Pink Sheet-$)

• Cablivi gets positive results for rare blood clotting disorder (PharmaTimes) (Press)
• OncoImmune Announces Completion of Phase II Trial (Press)
• Tolero Pharmaceuticals Announces First Patient Dosed with Investigational Agent TP-1287 in Phase 1 Study in Patients with Advanced Solid Tumors (Press)
• Acceleron Announces Publication of Luspatercept Phase 2 Beta-Thalassemia Study Results in Blood (Press)
• ChemomAb Doses First Patient in Phase 1b Clinical trial of CM-101 in Patients With Non-Alcoholic Fatty Liver Disease (Press)

• FDA: Medtronic select recall of Synergy, Stealth Station S7 cranial software is Class 1 (MassDevice)
• Intuitive Surgical rises on Q4, 2018 prelim beats (MassDevice)
• Philips rejiggers, promotes image-guided therapies head van Meurs (MassDevice)
• Empatica’s pediatric seizure-predicting smartband wins FDA nod (Medical Design & Outsourcing)
• Beta Bionics raises $63m for bionic pancreas (Drug Delivery)

• FDA looks to restart safety inspections for risky foods amid shutdown (Politico)
• Government Shutdown Curtails F.D.A. Food Inspections (NYTimes)
• Courts again wrestle with birth control rules (Politico)
• Guest Post -- Linking It Up: Antibody-Drug Conjugates (Patent Docs)
• A Pair of FDC Act-Related Convictions Upheld on Appeal in the Eighth and Eleventh Circuits (FDA Law Blog)
• Albrecht Oral Argument – Better Us Than Them (Drug & Device Law)
• Conn. Judge Tosses Cities' Suits Against Opioid Makers (Law360-$)

• FDA Advisory Committee Calendar

• NHS facing early exodus of skilled consultants (PMlive)
• UK MHRA’s “No Deal” Brexit Preparations Include Role for “Responsible Person – Import” (IPQ)

• Daiichi Sankyo collaborates on iPS cell-derived insulin producing cells in Japan (PharmaLetter-$)
• China’s NMPA Launches Voluntary Device Master File Process (Emergo)

• Patient advocacy groups rap one-time assistance plan for rare disease sufferers, seek govt help to get pricey SMA drug (PharmaBiz)
• Patent experts welcome DoP's decision to deregulate prices of patented orphan and innovative drugs (PharmaBiz)
• Upgraded drug testing lab at Vadodara in Gujarat with five times capacity to become operational from Feb 2019 (PharmaBiz)
• Government revises MAI scheme related to reimbursement of expenditure for pharma exporters (PharmaBiz)

• Consultation: Proposed amendments to the Poisons Standard - ACCS meeting, March 2019 (TGA)