Recon: Novartis Considers Reinsurance Model to Cover Ultra-Expensive Drugs

• Shutdown watch (Politico) (Alliance for a Stronger FDA)
• Can precision medicine rescue a multibillion-dollar pharma debacle? (STAT)
• J&J knew for decades that asbestos lurked in its Baby Powder (Reuters)
• Reuters stands by J&J report, says it was based ‘entirely’ on Johnson & Johnson documents (CNBC)
• Trump Officials Say Drug Prices Are Inflated. So Are Some of Their Claims on a Solution. (NYTimes)
• BrainStorm gets FDA okay for stem cell trial in MS patients (Reuters)
• Lilly says Taltz superior to Humira in late-stage psoriatic arthritis trial (Reuters)
• Evofem's birth control gel meets main study goal; shares rise (Reuters)
• Texas Judge Strikes Down Obama’s Affordable Care Act as Unconstitutional (NYTimes) (Politico) (NYTimes) (The Hill)
• Amazon has explored getting into consumer health diagnostics (CNBC)
• Pharma sales growth is being crimped as price hikes diminish (STAT)
• Versant partners gear up for a $700M bonanza of biotech bets (Endpoints) (Xconomy)
• Eli Lilly has anted up for its next big bet on a next-gen pain drug, buying Hydra assets (Endpoints)
• Proteostasis finds shelter in $100M cash Roche deal (Endpoints) (Press)
• Bristol-Myers, H3 Biomedicine explore RNA splicing drugs for cancer (Fierce) (Press)
• Seer Launches to Develop Liquid Biopsy for Cancer, Brain Disease (Xconomy)

• Novartis weighs reinsurance tie-up to fund ultra-expensive drugs (Financial Times)
• Teva to move global HQ to Tel Aviv amid $3B cost-cutting drive (Fierce)
• Nicox teams up with Chinese firm to develop and sell glaucoma drug (Reuters)
• Pfizer's cut-price version of Avastin wins EU panel greenlight (Reuters)
• The CRISPR shocker: How genome-editing scientist He Jiankui rose from obscurity to stun the world (STAT)
• European VC firm Kurma sets its sights on €150 million fund, its biggest ever (Endpoints)
• EU Drug Filings To Fall Slightly In 2019, But Scientific Advice On The Up (Pink Sheet-$)
• Novartis withdraws EU filing for canakinumab (PMLive)
• Roche gains EU PRIME status for Spinraza rival (PMLive) (Press)
• No-deal Brexit stockpiling puts pressure on supply chain (Pharmafile)
• Novartis Wins EU Authorization for Self-Administration of Xolair (PharmaNewsEU)
• Junshi wins the race for first made-in-China PD-1 approval as execs reap $394M IPO harvest (Endpoints)
• Novo Nordisk grabs a $486M buyout option on an anti-apoC3 antibody for its cardio R&D group (Endpoints) (Fierce)
• Why Advicenne's Kidney Disease Drug Reverted To Standard EU Review (Pink Sheet-$)
• Largest vaccine manufacturing plant in South America to be commissioned in March 2019 (PharmaLetter-$)

• OGD Ties Its 128 Approval Actions Record in November Plus October Stat Update (Lachman)
• AbbVie Announces Executive Leadership Changes (Press)
• FDA must act to increase naloxone availability (The Hill)
• FDA to facilitate access to unapproved drugs (BioCentury)
• Imugene ‘encouraged’ by data for HER2 vaccine in gastric cancer (Fierce)
• Flu shots tied to lower risk of premature death with heart failure (Reuters)
• Improving patient adherence through data-driven insights (McKinsey)
• Warnings Up As US FDA Trims List Of Uninspected OTC Drug Manufacturers (Pink Sheet-$)
• Interchangeable Insulin: One Step Forward, Two Steps Back? (Pink Sheet-$)
• Drug Development Tool Qualification: US FDA Offers Three-Step Review Process (Pink Sheet-$)
• Arnold Foundation Will Retain Drug Pricing Focus As Health Care Agenda Grows (Pink Sheet-$)
• Pfizer again supplying pain drugs to veterinarians shunted aside because of hospital shortages (Fierce)
• Tesaro execs split $304M windfall from $5.1B GlaxoSmithKline buyout (Endpoints)
• Broadening its oncology focus, Innovent adds three Incyte drugs to portfolio for $40M cash (Endpoints)
• Harvard prof Omid Farokhzad heads west, setting up a new Bay Area biotech on a mission to start a revolution in pre-symptomatic disease detection (Endpoints)

• Celltrion and Teva Announce FDA Approval of HERZUMA® (trastuzumab-pkrb), a Biosimilar to HERCEPTIN®, for the Treatment of HER2-Overexpressing Breast Cancer for Certain Indications (Press)
• Sangamo Announces Treatment Of First Patient In Phase 1/2 Clinical Trial Of In Vivo Genome Editing Therapy For Hemophilia B (Press)
• FDA Approves Nplate® (Romiplostim) For Use In Pediatric Patients With Immune Thrombocytopenia (Press)
• Teva Announces Positive Topline Phase IIIb Results with Fremanezumab in Adults with Migraine Who Did Not Respond to Multiple Classes of Preventive Treatments (Press)
• Ayala Pharmaceuticals Announces First Patient Enrolled in Phase 2 Study of Lead Product Candidate AL101 for Adenoid Cystic Carcinoma with Notch Activated Mutations (Press)
• HOOKIPA Doses First Patient in a Phase 2 Clinical Trial of Prophylactic Vaccine Candidate HB-101 against Cytomegalovirus (Press)
• Vedanta Biosciences Initiates Phase 2 Study for Lead Rationally-Defined Bacterial Consortium Product Candidate, VE303 (Press)
• Exicure Announces Top-line Patient Data for Phase 1 Inflammation Program in Psoriasis (Press)
• Concert Pharmaceuticals Initiates Phase 1 Clinical Program of CTP-692 for the Treatment of Schizophrenia (Press)
• Bridge Biotherapeutics Announces FDA Clearance of IND for its BBT-877, an Autotaxin Inhibitor for IPF (Press)

• How a Tiny Device Is Making a Big Difference for Pediatric Transplant Patients (MDDI)
• Moody’s: Outlook strong for medical devices in 2019 (MassDevice)
• Here’s how Intuitive Surgical is innovating to stay competitive (Medical Design & Outsourcing)
• Medtronic wins FDA nod for InterStim sacral neuromod programmer (MassDevice)
• Aortica Corp. Announces FDA Approves Medtronic Valiant NAVION™ for Inclusion in Starnes' Physician-Sponsored IDE (Press)
• FDA Approves Smart Programmer for the InterStim System (Press)

• The US government is asking industry to help identify ‘emerging technologies’ (STAT)
• FDA Generic Labeling Proposal – Six, Two, and Even, Over and Out (Drug & Device Law)
• New Data Integrity Guidance Imposes Significant Burdens, Yet FDA Claims It Does Not Regulate by Guidance (FDA Law Blog)
• AstraZeneca Sues Again Over Breast Cancer Drug Patents (Law360-$)
• Sanofi Fires Back Against Mylan In Its Bid To Exit EpiPen MDL (Law360-$)
• Texas Justices Won't Hear Ranbaxy's Patent Arbitration Row (Law360-$)
• Fed. Circ. Reins In Reach Of Double-Patenting Doctrine (Law360-$)
• Feds Fight To Keep Insys Grand Jury Instructions Secret (Law360-$)
• MiMedx escapes Osiris trade theft suit (MassDevice)

• FDA Advisory Committee Calendar

• Swissmedic laboratory publishes test method for nitrosamines in sartans (Swissmedic)
• EMA Draws On 12 Years' Experience To Revise Environmental Risk Assessment Guide (Pink Sheet-$)
• New Russian Quality Assurance Rules Could Push Up Costs & Delay Product Launches (Pink Sheet-$)

• Hospitals get tax notices for implants (Economic Times)
• Indian Drugmaker Warned After Refusing FDA Inspection (FDANews-$)
• USFDA completes Biocon's Telangana plant inspection (Economic Times)
• India drafts first national essential diagnostics list; vector-borne diseases, NCDs given high priority (Pharmabiz)

• Consultation: Remaking Therapeutic Goods Order No. 78 (TGA)

• Big Tongues and Extra Vertebrae: The Unintended Consequences of Animal Gene Editing (WSJ)