Recon: Eli Lilly to Buy Loxo Oncology for $8B

• Lilly to buy Loxo Oncology in $8 billion cancer push (Reuters) (STAT) (Endpoints) (Financial Times)
• FDA plans to create a new office to leverage cutting-edge science (STAT)
• Sanofi to exit immuno-oncology collaboration with Regeneron (STAT) (Endpoints)
• US top court rejects Amgen over cholesterol medication patent fight (Reuters) (Amgen)
• Merck loses bid to revive $200 million Gilead verdict at U.S. high court (Reuters)
• Johns Hopkins, Bristol-Myers must face $1 billion syphilis infections suit (Reuters)
• AstraZeneca picks Baselga to lead oncology R&D in growth plan (Reuters) (Endpoints) (Financial Times)
• Ironwood Pharmaceuticals Picks AstraZeneca Executive to Be Next CEO (WSJ) (Fierce)
• Genentech inks potential $2bn personalised cancer drug development deal (Pharmafile) (Endpoints)
• Generic drug maker formed by hospitals attracts a dozen more health systems (STAT)
• Sage Therapeutics pill improves postpartum depression in pivotal clinical trial (STAT) (Endpoints) (Reuters) (Press)
• Abbvie to record $4 billion impairment charges on Stemcentrx assets (Reuters)
• Allergan joins the great biopharma R&D migration to Cambridge (Endpoints)
• Trump Goes After Pharma on Twitter as Companies Increase Prices (Bloomberg)

• MDR and IVDR in 2019: up or out, sink or swim (medicaldeviceslegal)
• UK surge in cell and gene therapy trials (PharmaTimes)
• $400 billion in healthcare M&A deals expected for 2019 (Pharmafile)
• Janssen files Stelara in Europe for ulcerative colitis (PharmaTimes) (Press)
• Drug companies turn to China, Japan after pricing pressure in west (Economic Times)
• Samsung Bioepis and 3SBio enter biosimilar collaboration agreement (Biosimilar News) (Press)
• China authorities arrest 18 at TCM firm after cancer case sparks outcry (Reuters)

• A year after ‘the Michaels,’ more women will take the JPM stage — but 90 percent of presenters are still male (STAT)
• After Bristol-Myers Squibb Buys Celgene What's Next? JP Morgan's Conference Will Answer That (Forbes)
  Comparison of Sales Income and Research and Development Costs for FDA-Approved Cancer Drugs Sold by Originator Drug Companies (JAMA)
• Myriad Genetics: This Company Has Great Difficulties Telling the Truth (SIRF)
• Extreme Temperatures May Pose Risks To Some Mail-Order Meds (NPR)
• Keeping Track: US FDA Receives Submissions Galore As Year Ends (Pink Sheet-$)
• The Next New Thing In FDA Inspections: Poor Root Cause Investigations (Pink Sheet-$)
• Can Cancer Care Be Industrialized? Vanderbilt And GE Are Teaming Up To Find Out (Forbes)
• Breakthrough Designation Guidance Finalized (FDA Law Blog)
• Gilead stuffs another NASH drug discovery program into a growing portfolio (Endpoints)
• Takeda takes another step into cell therapy research (BioPharmaDive)
• This Year's Flu Vaccine Is Working Well. There's Still Time To Get It (Forbes)
• Bill Gates backs Schrödinger’s $85M venture raise for its standout computational drug discovery platform (Endpoints)
• Genentech, Adaptive Bio Join Forces on Personalized Cancer Drugs R&D (Xconomy)
• Frequency Nabs $42M for Hearing Loss Drugs, Clinical Data On The Way (Xconomy)
• Cheerful mid-stage depression drug data send Axsome stock flying (Endpoints)
• Single-Dose Zoliflodacin (ETX0914) for Treatment of Urogenital Gonorrhea (NEJM)
• Immunotherapy Combinations in Multiple Myeloma — Known Unknowns (NEJM)
• Dapagliflozin and Cardiovascular Outcomes in Type 2 Diabetes (NEJM)
• Children's hospitals more likely to give recommended antibiotics for pneumonia (Reuters)
• Lupin Pharmaceuticals, Inc. Issues Voluntary Recall of Ceftriaxone for Injection USP, 250mg, 500mg, 1g and 2g (FDA)

• Rainier Therapeutics Announces Fast Track Designation Granted by FDA for Vofatamab in Treatment of FGFR3-Positive Urothelial Cell Carcinoma (Bladder Cancer) (Press)
• Landos Biopharma Announces Final Safety Results from Phase 1 Study of BT-11 in Healthy Volunteers (Press)
• Nobilis Therapeutics Announces IND Filing for a Phase IIb Clinical Trial of NBTX-001 Drug/Device Combination for Treatment of Posttraumatic Stress Disorder (Press)
• Arrowhead Pharmaceuticals Begins Dosing in Phase 1 Study of ARO-ANG3 for Treatment of Dyslipidemias and Metabolic Diseases (Press)
• Vifor Pharma receives positive phase-I trial results for oral ferroportin inhibitor (Press)
• Solasia Initiates Phase III Program for PledOx® in Japan (Press)
• F2G Expands Investor Syndicate and Progresses Phase 2b Study for Novel Antifungal (Press)

• Sequencing Startup 10x Genomics Hits Unicorn Status With $35 Million Fundraise (Forbes)
  Endologix Voluntarily Recalls Nellix (MDDI)
• Abiomed jumps on fiscal Q3 prelims, raised outlook (MassDevice)
• Akonni Biosystems Submits Multiplex Diagnostics System to FDA (GenomeWeb)
• Novel Intrasaccular Aneurysm Treatment Device Receives FDA PMA Approval (Press)

• FDA Accuses Juul and Altria of Backing Off Plan to Stop Youth Vaping (NYTimes)
• Argument preview: Revisiting impossibility pre-emption (SCOTUS Blog)
• Poll: 68 percent of Americans support a national health plan (Politico)
• A Closer Look At New Pharmaceutical Hazardous Waste Regs (Law360-$)
• Judge Won't Gag AGs In Generics Price-Fixing Case (Law360-$) (FDANews-$)
• Eyes On FTC After Canada's Drug Sampling Probe Flops (Law360-$)
• Teva, GSK Want Lamictal Suit Paused To Appeal Class Cert. (Law360-$)
• Another Dormant Commerce Clause Win (Drug & Device Law)
• Vermont projects modest savings from a plan to import drugs from Canada (STAT)
• Pelosi Wants More Americans Subsidized To Buy Obamacare (Forbes)

• FDA Advisory Committee Calendar

• GLP Deficiency Data (MHRA)
• Committee for Advanced Therapies (CAT) Meeting Minutes October 2018 (EMA)
• What’s new in Pharmacovigilance? QPPV UPDATE (EMA)

• China moves to benefit domestic generics industry, report finds (PharmaLetter-$)

• Five-year price control exemption for new medicines to give rare disease patients access to orphan drugs (PharmaBiz)

• Consultation: Proposal to introduce a Unique Device Identification (UDI) system for medical devices in Australia (TGA)
• Consultation: Changes to a number of definitions and the scope of the medical device regulatory framework in Australia (TGA)
• Consultation: Potential reclassification of active medical devices for diagnosis and patient therapy (TGA)

• Ambulance equipment contaminated with drug-resistant superbug (Reuters)