Regulatory Focus™ > News Articles > 2019 > 1 > Recon: Eli Lilly to Buy Loxo Oncology for $8B

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

Posted 07 January 2019 | By Michael Mezher 

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

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • 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)
In Focus: International
  • MDR and IVDR in 2019: up or out, sink or swim (medicaldeviceslegal)
  • UK surge in cell and gene therapy trials (PharmaTimes)
  • $400 billion in healthcare M&A deals expected for 2019 (Pharmafile)
  • Janssen files Stelara in Europe for ulcerative colitis (PharmaTimes) (Press)
  • Drug companies turn to China, Japan after pricing pressure in west (Economic Times)
  • Samsung Bioepis and 3SBio enter biosimilar collaboration agreement (Biosimilar News) (Press)
  • China authorities arrest 18 at TCM firm after cancer case sparks outcry (Reuters)
Pharmaceuticals & Biotechnology                                              
  • A year after ‘the Michaels,’ more women will take the JPM stage — but 90 percent of presenters are still male (STAT)
  • After Bristol-Myers Squibb Buys Celgene What's Next? JP Morgan's Conference Will Answer That (Forbes)
    Comparison of Sales Income and Research and Development Costs for FDA-Approved Cancer Drugs Sold by Originator Drug Companies (JAMA)
  • Myriad Genetics: This Company Has Great Difficulties Telling the Truth (SIRF)
  • Extreme Temperatures May Pose Risks To Some Mail-Order Meds (NPR)
  • Keeping Track: US FDA Receives Submissions Galore As Year Ends (Pink Sheet-$)
  • 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)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • 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)
Medical Devices
  • Sequencing Startup 10x Genomics Hits Unicorn Status With $35 Million Fundraise (Forbes)
    Endologix Voluntarily Recalls Nellix (MDDI)
  • Abiomed jumps on fiscal Q3 prelims, raised outlook (MassDevice)
  • Akonni Biosystems Submits Multiplex Diagnostics System to FDA (GenomeWeb)
  • Novel Intrasaccular Aneurysm Treatment Device Receives FDA PMA Approval (Press)
US: Assorted & Government
  • FDA Accuses Juul and Altria of Backing Off Plan to Stop Youth Vaping (NYTimes)
  • Argument preview: Revisiting impossibility pre-emption (SCOTUS Blog)
  • Poll: 68 percent of Americans support a national health plan (Politico)
  • A Closer Look At New Pharmaceutical Hazardous Waste Regs (Law360-$)
  • 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)
Upcoming Meetings & Events Europe
  • 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)
General Health & Other Interesting Articles
  • Ambulance equipment contaminated with drug-resistant superbug (Reuters)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.
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