Recon: Lilly Buys Immunotherapy Company for $1.6B

• Eli Lilly Buys Immunotherapy Cancer Treatment Company for $1.6 Billion (WSJ) (Bloomberg) (Endpoints) (STAT-$) (Fierce) (Reuters)
• Proposal to Curb Drug Prices Would Hand More Competition to Insurers (WSJ) (Fierce) (The Hill)
• Setback to Roche hopes for Tecentriq as fails key cancer trial (Reuters) (PMLiVE) (Fierce)
• Eight years after Eli Lilly dumped it, an upstart biotech has nabbed teplizumab and filed a $56M IPO to back a PhIII comeback (Endpoints) (Fierce)
• ‘Not a good day for Novartis’: CEO tries to reassure employees amid fury over payments to Trump’s lawyer (STAT) (Fierce) (Endpoints)
• Semma names former Novartis, Magenta executive as new CEO (Fierce) (Boston Business Journal-$) (Endpoints)

• To Lower Drug Costs at Home, Trump Wants Higher Prices Abroad (NYT) (Politico) (Modern Healthcare) (Washington Examiner)
• Chinese medical devices maker forays into Indian market (Economic Times) (The Hindu) (United News of India)
• NHS England pledges to streamline clinical trial setup (PMLiVE) (pharmaphorum)
• Takeda to cut IT, marketing and sales jobs after Shire merger (pharmaphorum)
• New Ebola outbreak declared in Democratic Republic of the Congo (WHO)
• In Europe, Mylan's rivals try to plug EpiPen shortages (Reuters)
• Merck, J&J vaccines ready for Ebola outbreak (BioCentury)
• NSF International Launches Online Training on Medical Device Regulations for MDSAP Countries (NSF)

• Judge Sees Litigation As Only An `Aid In Settlement Discussions' For Opioid Lawsuits (Forbes)
• Patients sue Gilead, saying drug company intentionally delayed safer HIV medicine (LA Times)
• Novartis paid Trump’s lawyer’s firm far more than any of its actual lobbyists (STAT)
• Sanofi’s shift to robots and ‘digital twins’ at U.S. biologics site costs 95 jobs (Fierce)
• U.S. indicts three veterans healthcare providers over MiMedx payments (Reuters)
• U.S. judge blocks DEA from suspending drug distributor over opioid sales (Reuters)
• Neb. Tribes Sue Pharma Cos. Over 'Havoc' From Opioid Crisis (Law360-$)
• Insurers' answer on drug prices: Hold drug companies accountable (Washington Examiner)
• GSK’s chief financial officer to retire (PharmaTimes)

• Genentech forms $1B discovery collaboration with soil-prospector Lodo Therapeutics (Fierce)
• Scientists Identify Why Some People May Be Resistant To PARP Inhibitor Drugs (Forbes)
• Little vTv once again circles subgroup number, struggling to find something good to say about failed Alzheimer’s drug (Endpoints) (Press)
• Astellas to pay Aquinox $25M upfront for regional rights to phase 3 inflammatory pain drug (Fierce)
• Longer-term results back Rhythm’s ultrarare obesity drug (Fierce)
• Novartis, Durect renegotiate $293M painkiller deal after phase 3 failure (Fierce)
• Roche’s colon cancer failure turns the focus to other combinations (EP Vantage)
• Cosmo’s shares saved by no bell as FDA halts approval (EP Vantage)
• Testosterone replacement drug rejected by FDA (PharmaTimes)
• HRS 2018: Study questions benefit of ablation over drug therapy for atrial fibrillation (Drug Delivery Business News)
• FDA planning guidance on designations for tissue agnostic therapies (BioCentury)
• Study upends conventional view of opioid mechanism of action (NIH)
• Scientists uncover brain circuits behind putting up a fight or freezing in place (NIH)
• Uptake, Results, and Outcomes of Germline Multiple-Gene Sequencing After Diagnosis of Breast Cancer (JAMA)
• A New Method to Weigh Biomolecules (Science Magazine)
• New protein may help to catch lung cancer early (Medical News Today)
• S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies: Focus on Microsampling Questions and Answers Guidance for Industry (FDA)
• Uncomplicated Urinary Tract Infections: Developing Drugs for Treatment: Guidance for Industry (FDA)
• Chugai's Anti-IL-31 Receptor A Humanized Monoclonal Antibody "nemolizumab," Long Term Data from Global Phase II Study Published in Journal of Allergy and Clinical Immunology Online (Press)
• Exelixis Provides Update on IMblaze370 Phase 3 Pivotal Trial of Atezolizumab and Cobimetinib in Patients With Heavily Pretreated Locally Advanced or Metastatic Colorectal Cancer (Press)

• Artificial intelligence could help diagnose a deadly heart condition (CNBC) (Press)
• Ultrasound targeting the brain is poised to revolutionize the treatment for Parkinson’s disease (CNBC)
• FDA Cautions About Risks of Coiling for Brain Aneurysms (MedPage Today)
• How Does Your Regulatory Salary Match Up, And What Are Current Trends? (Medtech Insight)
• Medicare reverts to bigger payments for equipment suppliers (Axios)
• Is BD Running a Monopoly on the Safety Syringe Market? (MD+DI)
• Investors win class certification in lawsuit against Abbott’s Thoratec (MassDevice)
• J&J’s Biosense Webster launches Carto Vizigo guiding sheath (MassDevice) (Press)
• Implantable cardiac device data collector Murj lands $8.5M (MobiHealthNews)
• Kessler Foundation, Virtualware team up to create VR tool for stroke patients (MobiHealthNews)
• Arnold & Porter Sanctioned In Boston Scientific IP Case (Law360-$)
• Dräger Medical Recalls Fabius Anesthesia Machines Due to Production Step Error (FDA)
• Faxitron VisionCT System Granted 510(k) Clearance for True 3D Imaging of Breast Specimens (Press)
• Data Reinforce Reduced Complications with Medtronic Micra Transcatheter Pacing System Over Traditional Pacemakers in Real-World Use (Press)
• Philips advances interventional oncology research together with St Bartholomew’s Hospital in London (Press)
• GE Healthcare and Preventice Solutions Collaborate to Extend the Heart Station Beyond the Hospital (Press)

• Knowing what Medicare actually covers will help avoid these costly mistakes (CNBC)
• He’s a former PBM insider now shaping Trump’s drug policy. Will he reveal industry secrets? (STAT-$)
• 3 things Trump can do now to lower drug prices (CBS News)
• Here is what Trump should do about the drug pricing problem (The Hill)
• Affordable Prescription Drug Task Force Lays Out Priorities for Trump to Lower Prescription Drug Prices (Congressman Peter Welch)
• Making Bundled Payments Work: Leveraging the CMS DRG Experience (NEJM)
• Alliance “Deeply Appreciative” of House’s FY 19 Funding Mark (Alliance for a Stronger FDA)
• Authority of Health Care Providers to Practice Telehealth: Department of Veterans Affairs: Final rule (Department of Veterans Affairs)
• Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment
• Parameters for 2019; Correction (Centers for Medicare & Medicaid Services)
• Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting (FDA)
• Updated Agenda Information: May 10, 2018: Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement (FDA)
• Comment Request; Pilot Project Program Under the Drug Supply Chain Security Act (FDA)
• Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry (FDA)
• Summary Basis for Regulatory Action: Plasma Cryoprecipitate (FDA)

• FDA Advisory Committee Calendar

• EFPIA welcomes HTA proposals from Commission (The Pharma Letter)
• Rules Issued For EU Commission's Main Governance Group For Implementing New Regulations (Medtech Insight)
• Gov’t suspends controversial NHS data sharing deal (PharmaTimes)
• Maintenance OK boosts AstraZeneca’s Lynparza in Europe (PMLiVE)
• Church and religion take back seat as a secular Ireland votes on abortion (Reuters)
• Alexion’s Soliris successor aces two phase 3 trials (pharmaphorum)
• The HPRA wishes to seek comments on the annual review and proposal for medical device fees 2018. (HPRA)
• Invitation to Exhibit at the HPRA PRE- ICDRA conference 3-4 September 2018 (HPRA)
• Guidance: E-cigarettes: regulations for consumer products (MHRA)

• China’s CStone bags $260M Series B for ambitious I/O work, expanding its list of marquee investors (Endpoints)
• China’s Lock on Drugs (US News & World Report)

• Heart transplants picking up in India, 10-fold increase since 2016 (Hindustan Times)
• 'Indian IP and liabilities law barrier to pharma R&D investment' (Economic Times)
• Manufacturers body welcomes Delhi govt steps to cap profit margins of hospitals on medical devices (India Today)
• In India, Health Insurance Doesn't Work in a Desirable or Sustainable Manner (The Wire)
• Controversy over HPV vaccines in India accelerates (The Pharma Letter-$)

• 'This is taking an awfully long time!', says scientist before assisted suicide (Reuters)
• Merger creates leading player in Australian generics market (The Pharma Letter-$)
• Consultation: Options for the implementation of a claimer for efficacy assessed non-prescription medicines (TGA)
• Breast implants and anaplastic large cell lymphoma: Update - additional confirmed cases of anaplastic large cell lymphoma (TGA)
• Inhalation and nasal spray registered medicines: Application pathways and data requirements for registration of new generic medicines and variations to existing medicines (TGA)

• Six Canadians have gotten sick from E. coli in romaine lettuce, public health agency says (Toronto Star)
• Health Canada launches consultations on palliative care framework (Health Canada)

• GP continuity of care is slipping, finds study (PharmaTimes)
• A new health threat: "Thirdhand smoke" (Axios)
• Apple always viewed the Watch as a health device, Jony Ive says (CNBC)
• Is the US Border Patrol Committing Crimes Against Humanity? (Guernica)
• Children of the Opioid Epidemic (NYT Magazine)