Recon: Novartis Drops Asthma Drug After More Trial Misses; Gilead NASH Combo Fails in Mid-Stage Study

• Bristol-Myers wins $752 million in US patent case against Gilead (Reuters) (Law360-$) (Endpoints)
• Axsome’s depression drug succeeds in late-stage trial (STAT) (Reuters)
• Gilead's NASH combination treatment fails mid-stage study (Reuters) (Endpoints)
• A controversial dwarfism drug, after clearing pivotal study, heads to the FDA (STAT) (Endpoints)
• Wave crashes on negative outcome of Duchenne muscular dystrophy study (STAT) (Endpoints)
• FDA approves Tandem's predictive insulin pump software (Reuters) (Press) (FDA)
• To Prevent Deadly Infections, FDA Approves the First Disposable ‘Scope’ (NYTimes) (FDA)
• FDA approves Amarin fish-oil drug to prevent heart attacks, strokes (STAT) (Reuters) (Press) (FDA)
• A Research Nonprofit Shutters TB Vaccine Effort and Lays Off Scientists (NYTimes)
• FDA panel unanimously in favor of Horizon's thyroid eye disease drug (Reuters) (Endpoints) (Press)
• Democrats box in Republicans on drug pricing (Politico)
• Trump's drug-import plan is imminent (Politico)

• BeiGene cancer drug fails in study against AbbVie: J&J's Imbruvica (Reuters) (Endpoints)
• Sackler-owned opioid maker pushes overdose treatment abroad (AP)
• UK antitrust watchdog clears Roche/Spark deal — but what is the FTC thinking? (Endpoints) (Press)
• Novartis drops asthma drug fevipiprant after trial failures (Reuters) (Fierce) (Endpoints)
• Paul Hudson seeks to write new prescription for Sanofi (Financial Times)
• US/UK trade: fear farmers, not pharma (Financial Times)
• 2019 Sees Decline In EMA Drug Approval Recommendations (Pink Sheet-$)
• India’s NPPA hikes 21 formulations’ prices by 50% (Economic Times)
• Malaysia to work with UNICEF on polio vaccination in Sabah state (Reuters)
• Samoa extends measles state of emergency, NZ to fund Pacific vaccination campaign (Reuters)

• New drug development: ‘It’s the ecosystem, stupid’ (STAT)
• Driving the next wave of innovation in CAR T-cell therapies (McKinsey)
• Inaccessible Insulin: The Broken Promise of Eli Lilly’s Authorized Generic (Warren)
• Rare skin disease biotech eyes $16 million IPO as trial results come in and cash runs out (Endpoints)
• California stem cell company halts sales after FDA warning (Washington Post)
• FDA Posts Meeting Materials for 18 December Oncologic Drugs Advisory Committee Meeting (FDA)
• Charles River Labs snaps up HemaCare, eyeing the growing cell therapy market (Fierce) (Press)
• WuXi Biologics establishes microbial fermentation in latest expansion (BioProcessInternational)
• FDA In Brief: New analysis highlights link between generic drug competition and lower drug prices, underscores importance of FDA efforts to spur generic drug development and market entry (FDA)
• Is AZ, Merck's Lynparza approvable in pancreatic cancer sans survival benefit? FDA's about to decide (Fierce) (Pink Sheet-$)
• The Hidden Drug Epidemic Among Older People (NYTimes)
• Intercept's NASH decision delayed by FDA, but don't panic: analysts (Fierce)
• Denosumab Use in Myeloma Soars for No Obvious Reason (Medpage)
• Did Sarepta Need To Tell Investors About Its Vyondys 53 Dispute Resolution Request? (Pink Sheet-$)
• Paul Biondi is jumping from Bristol-Myers to the elite team managing Flagship's startups — with newco plans of his own (Endpoints)

• Eagle Pharmaceuticals Granted Orphan Drug Designation for RYANODEX (dantrolene sodium) for Treatment of Organophosphate Exposure (Nerve Agents) (Press)
• Puma Biotechnology Presents Interim Results of Phase II CONTROL Trial of Neratinib in Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer at the 2019 SABCS (Press)
• ITF Pharma Announces FDA Approval of Supplemental New Drug Application (sNDA) for TIGLUTIK® (riluzole) Oral Suspension For The Treatment Of Amyotrophic Lateral Sclerosis (ALS) with a Percutaneous Endoscopic Gastrostomy (PEG) Feeding Tube (Press)
• Deciphera files for approval of cancer drug ahead of schedule (Fierce) (Press)
• Arrowhead Pharmaceuticals Files for Regulatory Clearance to Begin Phase 1 Study of ARO-HSD for Treatment of Alcohol and Nonalcohol Related Liver Disease (Press)
• Meiji Seika Pharma and Dong-A Socio Holdings Initiate Phase I Clinical Trial of DMB-3115, a Ustekinumab Biosimilar Candidate (Press)
• Futility Analysis Performed of the Phase II Combination Study with Birinapant and Keytruda® in Colorectal Cancer Patients (Press)
• Gilead Announces Topline Results From Phase 2 ATLAS Study in Patients With Bridging Fibrosis (F3) and Compensated Cirrhosis (F4) Due to Nonalcoholic Steatohepatitis (NASH) (Press)
• Catabasis Pharmaceuticals Announces Phase 3 PolarisDMD Trial Enrolled Expected Patient Population (Press)
• Mirum Pharmaceuticals Completes Successful Pre-NDA Meeting with FDA for Maralixibat (Press)

• DIY diabetes tech gains popularity with patients and parents fed up with clunky mainstream medical devices (Washington Post)
• Dexcom CEO on remote monitoring outage: 'No excuses. We can do better' (MedtechDive)
• Building a Better 3D Bioprinter: GE Healthcare and ASLS Combine Tech (Xconomy)
• First Patient Enrolls in STEMI DTU Randomized Controlled FDA Trial; Study Aims to Further Demonstrate Impella’s Safety and Effectiveness (Press)
• Elekta wins FDA approval for diffusion-weighted images (MassDevice)
• New trial for Abiomed’s Impella looks for heart failure reduction (MassDevice)
• Medtronic Recalls SynchroMed II Implantable Drug Infusion Pump Due to the Potential Presence of Foreign Particles Inside the Pump Motor Assembly Which May Lead to a Pump Motor Stall (FDA)
• Researchers Explore A Drug-Free Idea To Relieve Chronic Pain: Green Light (NPR)

• Reptile Research – Avoiding the Snake Pit (Drug & Device Law)
• Federal Circuit Affirms Amgen’s $70 Million Damages Award Against Pfizer Unit (Big Molecule Watch)
• Congress on the brink of banning tobacco sales to anyone under 21 (Politico)
• Prescription Drug Pricing Reduction Act May Become Law In 2020 (Forbes)
• Amazon’s PillPack Gets Closer To Health Plans In Blues Deal (Forbes)
• Trump aides hold daily meetings on vaping as White House scrambles to formulate policy (CNBC)
• E-cigarettes linked to lung problems, first long-term study on vaping finds (NBC)
• 2nd Circ. Says NY Opioid Fee Fight May Belong In State Court (Law360-$)
• Drug-Pricing Bill Threatens Robust Generics Industry (Law360-$)
• Patients Say Rescheduling Pot Would Be A Step Backward (Law360-$)
• Billionaire Electronic Health Records Pioneer Judy Faulkner Warns Of Cambridge Analytica-Type Data Risk (Forbes)

• FDA Advisory Committee Calendar

• Novartis Withdraws An Abusive Patent For An Over-Priced Cancer Medication (Medicines du Monde)
• Domperidone for nausea and vomiting: lack of efficacy in children; reminder of contraindications in adults and adolescents (MHRA)
• Class 2 Medicines Recall: Medley Pharma Limited, Ranitidine 150mg Tablets BP, PL 43870/0026, Ranitidine 300mg Tablets BP, PL 43870/0027 (EL(19)A/41) (MHRA)

• China Sets Aggressive Date for Vaccine Traceability (RxTrace)

• Sun says Halol plant cited again by the FDA (Fierce)
• Glenmark's Baddi manufacturing unit receives GMP certificate from European regulator (Economic Times)
• Violation of drug price control order: Drug cos under NPPA lens for self-exemption from price cap (Economic Times)

• Dengue fever finds breeding ground in war-weary Yemen (Reuters)

• Mailing your poop in a box may seem like a fine alternative to a colonoscopy. But it could cost you. (Des Moines Register)