Recon: FDA Approves Roche Combo for First-Line Lung Cancer Use; NICE OKs Yescarta for Adults With Lymphoma

• Democrats are suddenly eyeing a valuable pharma asset: its patents (STAT-$)
• Patent abuse is driving up drug prices. Just look at Lantus (STAT-$)
• Special Report: After a child's dire diagnosis, hope and uncertainty at the frontiers of medicine (Reuters)
• Special Report: Learning about targeted-therapy options (Reuters)
• Growth of Health Care Spending Slowed Last Year (NYTimes) (Reuters)
• Roche's lung cancer combo treatment wins FDA approval (Reuters) (Endpoints) (Press)
• Moderna Raises $604M and Nails Down Biotech’s Biggest IPO Ever (Xconomy) (Fierce) (Endpoints)
• With Tesaro off the block, will Clovis be the next PARP maker to get swallowed up? (Fierce)
• Sandoz prepares early 2019 launch for EpiPen alternative Symjepi at 16% discount (Fierce) (AP)
• Novartis, aiming to protect blockbuster sales, advances Xolair follow-up to phase 3 (Fierce)
• Delaware justices uphold Fresenius' Akorn Merger Drop (Law360-$)
• NIH is pressed to ensure affordable pricing before awarding a license for a CAR-T therapy (STAT)
• J&J unit to pay $360 million to US to resolve charity kickback probe (Reuters) (NYTimes) (STAT) (Law360-$) (Endpoints) (DoJ)

• EU warns of bioterror and disease risk as vaccination rates fall (Financial Times) (EC) (Vaccines for Europe)
• Nobel laureates: Despite progress, cancer won’t be wiped out (AP)
• Solving China’s Drugs-Price Problem Is Hurting Drugmakers (WSJ)
• Big Pharma’s off-patent drugs lose out in China’s new price-cutting scheme (Fierce)
• NICE give go-ahead to Gilead's Yescarta for adults with lymphoma (Pharmafile)
• UK’s genomics leadership attracts IQVIA investment, regardless of Brexit (PMLive)
• AstraZeneca's Imfinzi fails to meet main goals in head and neck cancer study (Reuters) (Pharmafile) (Endpoints)
• Novartis CEO calls for cultural shift to cater for millennial generation (Pharmafile)
• Canada’s MDSAP Transition Deadline Fast Approaching (Emergo)
• Update: Ebola virus disease – Democratic Republic of the Congo (WHO)

• The World Cup of Conferences (LifeSciVC)
• Synthorx Gets $131M In Upsized IPO For Synthetic Biology Drugs (Xconomy)
• A nonprofit biotech venture is betting on pig skin to help burn victims with first-ever clinical trial (STAT)
• Targeted Drug Plus Hormone Therapy Stops Tumor Growth In Patients With Early Breast Cancer (Forbes)
• Joining hunt for hep B cure, Brii Bio inks maiden deals featuring VBI, Vir, WuXi with a big appetite for more (Endpoints)
• Scientists Discover A Probable Cause Of 'Chemo Brain' And It May Be Treatable (Forbes)
• DiaMedica pulls off IPO to fund midphase stroke trial (Fierce)
• Tris Pharma Issues Voluntary Nationwide Recall of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, Due to Potential Higher Concentrations of Ibuprofen (FDA)

• Bio-Thera Solutions Initiates Phase I Clinical Trial for BAT4306F, an ADCC-enhanced CD20 monoclonal antibody (Press)

• How Reggie Groves reinvented Medtronic’s atrial fibrillation biz (MassDevice)
• Renal Denervation: FDA Panel, Industry Mostly on the Same Page (Medpage)
• SpeeDx Gets CE-IVD Mark for Antibiotic-Resistant Gonorrhea MDx (GenomeWeb)
• Corindus touts first-in-human coronary telerobotics study with CorPath system (MassDevice)
• FDA warns Globus subsidiary HBT over ViaCell production facility issues (MassDevice)
• FCC document suggests Apple may launch new Beddit device (mobihealthnews)
• Olympus wins FDA nod for Spiration bronchial valve (MassDevice)
• MiMedx to lay off 24% of workforce in restructuring effort (MassDevice)
• Illumina Announces a New Genotyping Array and Scientific Contribution to Three Genome Centers to Support the All of Us Research Program (Press)

• Why has ACA enrollment plunged? (Politico)
• Elizabeth Warren Stands by DNA Test. But Around Her, Worries Abound. (NYTimes)
• Spectrum Dynamics sues GE for trade theft (MassDevice)
• Children of the nation's drug crisis face long-term health effects (CBS)
• Fed. Circ. Asks Whether Endo's Opioid Patent Was Obvious (Law360-$)
• Gov't Presses Judge To Force Insys Founder To Produce Docs (Law360-$)
• 'Opioid Babies' Denied MDL Separate From Ohio Gov't Suits (Law360-$)
• Akorn fights to salvage Fresenius deal in appeal to Delaware Supreme Court (Fierce)
• Online Seller to Pay $60,000 Penalty for Violating the Contact Lens Rule (FTC)
• The Other Shoe Drops on ev3 (FDALawBlog)
• “Alter Ego” Allegations Aren’t Enough For Personal Jurisdiction (Drug & Device Law)

• FDA Advisory Committee Calendar
• Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee – 12 February 2019

• The European public-procurement opportunity: Delivering value in medtech (McKinsey)
• French Gene & Cell Therapy Trials To Get Own Fast-Track Approval Process (Pink Sheet-$)
• Brexit And Cooperation: Insights From Danish Medicines Agency Head Thomas Senderovitz (Scrip-$)

• Japan R&D Industry Presents United Front On Policy Reforms (Pink Sheet-$)
• Chinese Biopharma Stocks Plummet After Centralized Tendering Report (BioCentury)

• Database of section 19A approvals to import and supply medicines to address medicine shortages (TGA)

• Older Americans Are Flocking to Medical Marijuana (NYTimes)
• Uterine cancer on the rise, especially for black women (NBC)
• Scientists urge ban of insecticides tied to brain impairment in kids (Reuters)
• 'Narrative medicine' may help stem doctor burnout (Reuters)