Regulatory Focus™ > News Articles > 5 > Recon: Lilly Buys Immunotherapy Company for $1.6B

Recon: Lilly Buys Immunotherapy Company for $1.6B

Posted 10 May 2018 | By Ana Mulero 

Recon: Lilly Buys Immunotherapy Company for $1.6B

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In Focus: International Pharmaceuticals & Biotechnology
  • 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)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • 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)
Medical Devices
  • 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)
US: Assorted & Government
  • 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)
Upcoming Meetings & Events Europe
  • 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)
Asia
  • China’s CStone bags $260M Series B for ambitious I/O work, expanding its list of marquee investors (Endpoints)
  • China’s Lock on Drugs (US News & World Report)
India
  • Heart transplants picking up in India, 10-fold increase since 2016 (Hindustan Times)
  • 'Indian IP and liabilities law barrier to pharma R&D investment' (Economic Times)
  • Manufacturers body welcomes Delhi govt steps to cap profit margins of hospitals on medical devices (India Today)
  • In India, Health Insurance Doesn't Work in a Desirable or Sustainable Manner (The Wire)
  • Controversy over HPV vaccines in India accelerates (The Pharma Letter-$)
Australia
  • '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)
Canada
  • 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)
General Health & Other Interesting Articles
  • 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)
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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