Recon: Amgen's Osteoporosis Drug Evenity Approved First in Japan

• Trump summons advisers to White House over drug price hikes (Politico)
• Democrats seek early victories on drug prices (The Hill)
• Shutdown drags on (Politico)
• FDA employees think shutdown could be deadly (CNN)
• Where’s Big Tech at biopharma’s big bash? (STAT)
• Investors get dose of government shutdown as FDA chief loses audio while delivering keynote speech via video call at J.P. Morgan conference (CNBC)
• Shutdown has Aimmune waiting on FDA on multiple fronts — a sign of broader delays for biopharma (STAT)
• Allergan CEO: We stuck to the spirit of our social contract with recent price hikes (STAT)
• Cramer: Jamie Dimon should bring Apple into his joint health venture with Bezos and Buffett (CNBC)
• IBM isn’t retreating from using Watson in health care, CEO Rometty says (STAT)
• With its stock in a slump, Moderna makes the case for its big-money valuation (STAT)
• Akorn gets FDA warning letter for Illinois plant (Reuters) (Press)
• ‘Nominal pricing’ can help prisons and jails treat hepatitis C without breaking the bank (STAT)

• Amgen gets first OK for Evenity in Japan as FDA panel looms (Fierce) (PharmaLetter-$)
• GlaxoSmithKline to look for early-stage assets: CEO (Reuters)
• Norway Drugmaker Turns Oil Trader And Quickly Loses Millions (Bloomberg) (Financial Times)
• New Ebola-like virus is discovered in China (STAT)
• Pfizer to stop manufacturing in its Chennai and Aurangabad facilities (Economic Times) (Pharmafile)
• Stivarga final NICE recommendation for hepatocellular carcinoma (PharmaTimes)
• As it digests Shire, Takeda plans to shed $10B in non-core assets to relieve debt burden (Endpoints) (Financial Times)
• EU Pharma Slams ICH Proposal For Selective Adoption Of Quality Guideline (Pink Sheet-$)
• Brazil Tightens Outsourcing Restrictions Just Months After Easing Them (Pink Sheet-$)
• ABPI Code “Tidy Up” Reflects Digital Developments (Pink Sheet-$)
• Ramping up in-house drug development, API maker BrightGene bags $80M round led by Sequoia China (Endpoints)

• Opinion: Price Drugs According to What They Do (WSJ)
• Botox May Help Prevent Migraines (NYTimes)
• J.P. Morgan Notebook Day 2: Biogen, GSK, Bluebird, Roche, Amgen, Biohaven And Lilly (Pink Sheet-$)
• JP Morgan 2019 day two roundup – after the party a harsh reality (Evaluate)
• Lupin recalls over 23,000 bottles of antibiotic drug in US (Economic Times)
• Digitization, automation, and online testing: The future of pharma quality control (McKinsey)
• The FDA is investigating stem cell clinics that peddle unproven treatments (Vox)
• Can The Record Breaking Number Of FDA New Drug Approvals Continue? (Forbes)
• ERC-USA Initiates Therapy Under Right to Try Law With First Patient In California Using Investigational Compound ERC1671 for Treatment of Glioblastoma (Press)
• How Miniature Human Hearts Will Revolutionize Drug Testing (Forbes)
• Nektar confirms BMS deal for NKTR-214 is on track (PMLive)
• US FDA's Brexit: One Staffer Moving, But Impact Still May Loom Large (Pink Sheet-$)
• With pivot to less-rare diseases, Alexion needs a new sticker-price plan, CEO says (Fierce)
• Gene Therapies: Accelerated Approval Open For Some, But Not All, Neurodegenerative Disease Treatments (Pink Sheet-$)
• Breakthrough Denial Doesn't Mean US FDA Won't Bring Full Resources To Application (Pink Sheet-$)
• ‘It’s us against the world’: And George Yancopoulos wants you to know they are beating the world (Endpoints)
• Tetra Inks Deal with Shionogi to Support Fragile X, Alzheimer’s R&D (Xconomy)
• How to build a biotech unicorn: Get the star team in place, attract deep-pocket VCs, paint a big picture and raise up to $1B (Endpoints)
• Anti-aging startup Unity dives into eye diseases as partnership with Ascentage bears fruit (Endpoints)
• Denali broadens tech to infiltrate the blood-brain barrier with Sirion deal (Endpoints)
• Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of Vecuronium Bromide for Injection Due to the Presence of Particulate Matter Identified as Glass (FDA)
• Happy Together, Inc. Issues Voluntary Nationwide Recall of Product Due to Presence of Undeclared Sildenafil and Tadalafil (FDA)

• Seattle Genetics Announces Publication of North American Subgroup Data from ECHELON-1 Phase 3 Clinical Trial of ADCETRIS® (Brentuximab Vedotin) in Newly Diagnosed Advanced Hodgkin Lymphoma (Press)
• UroGen’s UGN-101 clears 57% of tumors in pivotal trial (Fierce)
• NantKwest Announces Launch of Merkel Cell Carcinoma Phase II Trial Deploying Novel Triple Combination of off-the-Shelf Natural Killer haNK Cell Therapy with Superagonist IL-15 Cytokine Therapy and PD-L1 Checkpoint Inhibitor Therapy (Press)
• Basilea Announces Positive Interim Results from Registrational Phase 2 Study with Oncology Drug Candidate Derazantinib in Intrahepatic Cholangiocarcinoma (iCCA) (Press)

• Medtronic CEO pushes back on critics who claim the medical device giant has a 'spotty record' (CNBC)
• Amgen touts lowered prices for Repatha delivery devices (Drug Delivery)
• Sandoz, Pear launch digital therapy for opioid use disorder (Drug Delivery)
• Insulet taps former Medtronic finance exec McMillan as CFO (MassDevice)

• New York City launches $100 million universal health insurance program (Reuters)
• US health care industry spends $30 billion a year on marketing (Reuters)
• FDA Focus: What Venable's Practice Chair Is Watching (Law360-$)
• Third Circuit Affirms Dismissal of Avandia Failure-to-Warn Claims (Drug & Device Law)

• FDA Advisory Committee Calendar

• bluebird bio reveals new UK General Manager (Pharmafile)
• Letters and drug alerts sent to healthcare professionals in December 2018 (MHRA)
• Ipilimumab (Yervoy): reports of cytomegalovirus (CMV) gastrointestinal infection or reactivation (MHRA)
• Tapentadol (Palexia): risk of seizures and reports of serotonin syndrome when co-administered with other medicines (MHRA)

• China issues new IVD medical device clinical trial guidelines (Pacific Bridge Medical)
• China drug procurement pilot scheme reduces drug prices (Pacific Bridge Medical)

• Health ministry to amend MD Rules to do away with mandatory submission of TSE, BSE certificates by medical device makers (Pharmabiz)