Recon: EMA Loses Bid to End London Lease; Merck’s Keytruda Fails Late-Stage Liver Cancer Study

• CVS Needs More Expensive Drugs (WSJ) (Forbes)
• US top court rejects bid to block Indivior opioid drug copycat (Reuters)
• Indivior launches generic version of its Suboxone opioid drug (Reuters)
• Merck's Keytruda fails late-stage study in liver cancer patients (Reuters) (Endpoints) (Press)
• FDA chief says feds might intervene if states continue allowing vaccine exemptions (The Hill)
• Drug pricing fight centers on insulin (The Hill)
• ‘Everyone is at fault’: With insulin prices skyrocketing, there’s plenty of blame to go around (STAT)
• Insulin pricing lawsuit against Sanofi, Novo Nordisk and Eli Lilly moves forward (Fierce)
• Here’s how prosecutors say generic drug makers schemed to fix prices (STAT)
• Alexion agrees to pay $13 million for illegally using charities to pay kickbacks to Medicare patients (STAT)
• Joining a clinical trial is too hard for many cancer patients (Reuters) (Forbes)
• With one manufacturer and little money to be made, supplies of a critical cancer drug are dwindling (STAT)
• Don’t villainize the biopharma industry. It offers hope to people like me (STAT)
• FTC gives the go ahead to Fresenius, NxStage merger (MassDevice) (FTC)

• EU medicines agency loses bid to end London lease over Brexit (Reuters)
• Scientists Release Controversial Genetically Modified Mosquitoes In High-Security Lab (NPR)
• Public Spending on Health: A Closer Look at Global Trends (WHO)
• Chinese Biotech Stock Soars After Tipping Profit Doubled in 2018 (Bloomberg)
• What are Brexit contingency plans for pharmaceutical industry? (The Guardian)
• AstraZeneca adjusts supply chain for no-deal Brexit (BioPharmaDive)
• Former AstraZeneca UK plant back up for sale, putting 270 jobs at risk (Fierce)
• Mexico's ruling party lawmakers urge capping drug prices (Reuters)
• Germany To Increase Data Requirements For Pricing Orphan And Other Drugs (Pink Sheet-$)
• Germany Could Introduce Biosimilar Substitution By Pharmacists In Three Years (Pink Sheet-$)
• French Patients To Get Pre-Approval Access To Bayer’s Vitravki (Pink Sheet-$)
• Israeli biopharma firm BiomX raises $32 million in private funding (Reuters)
• Measles outbreak in Canada's British Columbia province affects (Reuters)

• Developers are scrambling for the next Kendall Square. Where will it be? (STAT)
• Monthly buprenorphine injections effective for opioid use disorders (NIH)
• Bristol-Myers Squibb Provides Update on Pending Transaction with Celgene (Press)
• Sandoz Inc. launches authorized generic version of buprenorphine and naloxone sublingual film (Press)
• Suzette Kox Nominated as Secretary General of the International Generic and Biosimilar Medicines Association (IGBA)
• FDA Issues Handful Of New PDUFA Dates (BioCentury)
• Common yeast infection pill tied to miscarriages (Reuters)
• Pfizer, Merck, J&J well-positioned for M&A and Biogen and BioMarin are prime targets: report (Fierce)
• Under-pressure Allergan backs a CEO-chairman job split—just not right now (Fierce)
• Annuity Payment Model For Cures May Get Test Drive In Massachusetts (Pink Sheet-$)
• FDA Provides Interim Response to Pfizer on Citizen Petition (FDA)
• Beximco expands US portfolio with buy of eight ANDAs (PharmaLetter-$)
• Darrin Disley takes CEO role at cell therapy startup (Fierce)
• MorphoSys CEO Simon Moroney announces his retirement (Fierce)
• How Health Plans Profit—and Patients Lose—From Highly-Rebated Brand-Name Drugs (Drug Channels)
• FDA approves Indian firm Alembic's generic of Teva's Diamox (Pharmafile)
• Deaths spur partial hold for Xencor’s CD3 bispecific for leukemia, partnered with Novartis in $2.5B deal (Endpoints) (Press)
• Stem cell therapies for space missions? Pluristem joins forces with NASA to combat space-related ailments (Endpoints)
• GenCure Plans Adult Stem Cell Lab at San Antonio “Innovation Center” (Xconomy)
• Peloton raises a monster $150M in latest round, as lead drug heads for pivotal trial (Endpoints) (Xconomy)
• IP trouble defers launch of Novo’s long-acting hemophilia therapy (Endpoints)
• Taking a Risk-Based Approach to Drug Inspections (QualityDigest)
• Backed by OrbiMed and J&J to build precision bacteria-killing tool, BiomX adds a slate of investors in $32M Series B (Endpoints)
• Pfizer drops 10 mg dose of best-selling Xeljanz as study spotlights cardio safety issue, higher rate of deaths (Endpoints)
• Strike 3: Vical axes its only remaining clinical program, completing a trifecta of disasters (Endpoints)

• Koutif Therapeutics Announces FDA Acceptance of IND Application for Novel New Treatment of IBD (Press)
• Sangamo Announces FDA Acceptance of IND Application for ST-920 Gene Therapy Candidate for Fabry Disease (Press)
• FDA Grants Priority Review to Merck’s Supplemental Biologics License Application for KEYTRUDA® (pembrolizumab) Monotherapy for Third-Line Treatment of Patients with Advanced Small Cell Lung Cancer (SCLC) (Press)
• Ocular Therapeutix™ Announces Dosing of First Patient in OTX-TKI (tyrosine kinase inhibitor implant) Phase 1 Clinical Trial for the Treatment of Wet Age-related Macular Degeneration (AMD) (Press)
• Biohaven Enrolls First Patient In Phase 3 Generalized Anxiety Disorder (GAD) Trial Of Troriluzole (Press)
• Mallinckrodt Announces Interim Analysis Results for Therakos® Platform Phase 3 Clinical Trial in Treatment of Pediatric Patients with Steroid Refractory Acute Graft-versus-Host Disease (Press)
• DelMar Pharmaceuticals Achieves Halfway Enrollment Point for Phase 2 Clinical Trial of VAL-083 in Newly Diagnosed MGMT-unmethylated GBM (Press)
• Achieve Life Sciences Announces Completion of Enrollment in 254-Subject Phase 2b Trial of Cytisinicline for Smoking Cessation (Press)
• Phase 1 Data Published in Nature Communications Show Potential of mRNA Encoding VEGF-A as a Regenerative Therapeutic (Press)

• Balancing Benefit and Risk in Medical Device Regulation (FDA Law Blog)
• A Tangled Webb: Sham Affidavit Knocks Over Knee Implant Case (Drug & Device Law)
• Medical Devices; Dental Devices; Classification of the Auto Titration Device for Oral Appliances (FDA)
• Intuitive Surgical wins FDA clearance for robotic-assisted lung biopsy system (MassDevice)
• Phillips-Medisize is expanding in Wisconsin (MassDevice)
• Apollo Endosurgery touts results of stomach-stapling study (MassDevice)
• Medtronic Announces U.S. Commercial Launch of Deep Brain Stimulation for Medically-Refractory Epilepsy (Press)

• Troubling outlook for rural hospitals (Politico)
• The Difference Between a ‘Public Option’ and ‘Medicare for All’? Let’s Define Our Terms (NYTimes)
• Generics Cos. To Face Most State Claims In Price-Fixing MDL (Law360-$)
• Justices Reject Mylan's Challenge To 'Tactical' Drug Patenting (Law360-$)
• DOJ Says Shuttered Abbott Unit Engaged In Kickback Scheme (Law360-$)
• 'Absurd' To Argue PTAB Wins Bar Patent Cases: Generics Cos. (Law360-$)
• Can Government Petition PTAB To Review Patents? Supreme Court Seems Skeptical (Pink Sheet-$)
• ONC’s Proposed Rule is a Breakthrough in Patient Empowerment (Harvard Bill of Health)

• FDA Advisory Committee Calendar

• The NHS: The Rise Of The Robotic Workforce (Forbes)
• MHRA Issues Guidance on Marketing Biologics in No-Deal Brexit (FDANews-$)
• Professional use monitor/defibrillator: LIFEPAK 15 – risk of device failure during patient treatment and possible failure to deliver therapy (MHRA)
• Notify MHRA about a clinical investigation for a medical device (MHRA)

• Indian pharma companies set to mark double digit sales growth in FY'19, profit may remain flat (PharmaBiz)