Recon: Boehringer to Stop Development of Biosimilars Outside the US

• Roche buys US biotech Jecure in race for liver disease drugs (Reuters)
• Teva to recall certain blood pressure medicine in US (Reuters) (FDA)
• FDA promised a ‘lower-cost option’ to EpiPen, but the price isn’t any lower (STAT)
• Chronically Ill, Traumatically Billed: $123,019 For 2 Multiple Sclerosis Treatments (NPR)
• GOP infighting delaying popular health bills (Politico)
• Obamacare Sign-Ups Lag As Trump Slashes Funds For Enrollment Help (NPR)
• Humana cuts 2019 forecast for Medicare prescription drug plans (Reuters)
• Former executive at opioid maker Insys to plead guilty (Reuters)
• At FDA, a new goal, then a push for speedy device reviews (AP)
• Insulin pumps have most reported problems in FDA database (AP)
• Amazon confirms it's working on a project to mine patient records and more accurately diagnose diseases (CNBC)
• Right to Try: Access to Investigational Drugs (CRS)

• Boehringer Ingelheim abandons biosimilars outside the US (BioprocessInternational)
• Chinese geneticist reveals another "potential" gene-edited pregnancy (Reuters) (NYTimes) (WSJ)
• Amid uproar, Chinese scientist defends creating gene-edited babies (STAT)
• Pharma firm sold mesh implant despite pain warnings (The Guardian)
• First children set to receive Novartis’ Kymriah (PharmaTimes)
• Novartis HQ is pulling up its roots in the UK and moving to a new biotech campus in London (Endpoints)
• Can a $1B IPO attract leery investors on HKEX? WuXi AppTec is set to find out (Endpoints)
• New cases of HIV rise in Eastern Europe, decline in the West (Reuters)
• Drugmakers Gain More Access to China, but at a Price (WSJ)
• Powdered polio vaccine brings hope to Nigeria and Pakistan (The Guardian)
• PAHO launches campaign to prevent cervical cancer (PAHO)
• Bayer looks at options for consumer brands, animal health: sources (Reuters) (Fierce)
• European approval for Takeda's Alunbrig in ALK+ advanced non-small cell lung cancer (Pharmafile)
• Find Your EU Notified Body Now Or Risk A ‘Nasty Surprise’ (Pink Sheet-$)
• South Korea legalises medical marijuana (Financial Times)
• New WHO Public Assessment Reports (WHOPARs) published (WHO)

• An Industry Experience with Data Sharing (NEJM)
• International Plan of Mystery: ICH Guidelines for Generic Drugs (FDA Law Blog)
• Vantage View – the US FDA plays it safe (Evaluate)
• NIH to evaluate effectiveness of male contraceptive skin gel (NIH)
• GlaxoSmithKline weighs men B shot Bexsero's promise against gonorrhea (Fierce)
• Off The Clock? The New Timelines Of “Real-Time Review” (Pink Sheet-$)
• Fixed-Combination Hypertension Drugs Get Clearer Regulatory Pathway, But Will Pharma Follow? (Pink Sheet-$)
• Amarin Raises $200m Ahead Of Vascepa Push (BioCentury)
• FDA finds traces of heavy metals in kratom products (Reuters)
• Can a biotech unicorn break into the record books with a $600M IPO? Stéphane Bancel has a fortune riding on the answer (Endpoints)
• The flip side of the hot IPO market? A chill could trigger a sudden cash crunch in biotech, followed by more deals (Endpoints)
• Founded by former Pharmasset, Idenix execs, hep B company Antios nabs $25M Series A (Endpoints)
• Prometic secures $50M stock sale option to ease cash crunch (Fierce)
• Vedanta pockets $12M from Johnson & Johnson on start of microbiome drug trial (Fierce)
• Drug-screening Kronos Bio nets new chief business officer from Regeneron to develop pharma partnerships (Fierce)

• Pfizer Receives Six Months Pediatric Exclusivity for LYRICA® (pregabalin) (Press)
• Acceleron Receives FDA Fast Track Designation for ACE-083 in Charcot-Marie-Tooth Disease (Press)
• FDA Clears SpinalCyte IND Application for Universal Donor Cell Therapy to Treat Lower Back Pain (Press)
• Tiziana Announces Initiation of Phase 1 Clinical Trial with Nasal Administration of Foralumab, a Fully Human Anti-Cluster Definition 3 Monoclonal Antibody (anti-CD3 mAb), in Healthy Volunteers (Press)
• Novus Therapeutics Doses First Subjects in Phase 1 Study of OP0201 (Press)

• Emergo by UL Regulatory Recap: Global Trends November 2018 (Emergo)
• Invivoscribe Submits FLT3 Mutation CDx Assay to FDA (GenomeWeb)
• Clinical trial will explore how Sensoria's smart socks can help Parkinson's patients (mobihealthnews)
• Oscar Recalls Pacing Leads Due to a Connection Cap Malfunction (MDDI)

• Atrium Health says data of about 2.65 million patients involved in breach (Reuters)
• Indivior Inc. v. Dr. Reddy's Laboratories, S.A. (Fed. Cir. 2018) (Patent Docs)
• Hoosier Daddy, Pt. 4: Plaintiff Who Refused IME Cannot Use Absence of IME to Attack Defense Expert (Drug & Device Law)

• FDA Advisory Committee Calendar

• Notorious Noakes, £10m Guernsey GcMAF crook imprisoned (MHRA)
• Irish Genomics Research Co. Inks $400M Investment (Law360-$)

• BioHaven hopes to soothe Chinese headaches with Shanghai subsidiary (Endpoints)

• Lupin CFO quits, to pursue opportunities outside pharma (Economic Times)
• Regulatory vacuum in medical devices sector endangers patient safety; experts call for incentivising ICMED certification (PharmaBiz)

• Australian TGA sets new regulations for permanently implantable medical devices (MassDevice)
• Listed medicine compliance rating scheme (TGA)
• Use of market authorisation evidence from comparable overseas regulators / assessment bodies for medical devices (including IVDs) (TGA)

• Canada Launches Phased Program To Expedite New Drugs & IVDs For AMR (Pink Sheet-$)

• We're Living Longer ... But A Medical Journal Sees Many Causes For Alarm (NPR)