Recon: Lundbeck to Buy Parkinson’s Drug Developer; J&J Receives Bid for Diabetes Business

Posted 16 March 2018 | By Ana Mulero 

Recon: Lundbeck to Buy Parkinson’s Drug Developer; J&J Receives Bid for Diabetes Business

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US
  • Pfizer Lifts CEO's Pay 61% to $27.9 Million With Retention Bonus (Bloomberg) (Endpoints) (STAT)
  • J&J says it's received a $2.1 billion bid for LifeScan diabetes business (CNBC) (Reuters) (Fierce)
  • Orthofix to acquire Spinal Kinetics in deal worth up to $105M (Fierce) (MassDevice)
  • Why Google co-founder Sergey Brin was using a robot to put sutures in synthetic tissue (CNBC)
  • Citing risk of 'serious consequences,' Bayer pulls Alka-Seltzer boxes listing incorrect ingredients (Fierce) (Miami Herald)
  • Bill Of The Month: For Toenail Fungus, A $1,500 Prescription (KHN)
  • Theranos and the Problem With Booming Biotech Funding (Bloomberg)
  • Five Reasons for Receiving an FDA Refuse-to-Accept (RTA) Decision on your 510(k) Registration (Emergo Group)
  • Big Pharma's winners and losers last year? AbbVie and AstraZeneca up, GSK down (Fierce)
In Focus: International Pharmaceuticals & Biotechnology
  • Grassley, Leahy: It’s time to empower generic drug makers to bring down prices (STAT)
  • Drug makers jostle over potential Medicare changes in congressional spending deal (STAT-$)
  • Lawmakers want to remove gag clauses that boost drug costs at the pharmacy counter (STAT-$)
  • Practical magic: Google counsels pharma to create 'seamless' digital experiences (Fierce)
  • ICER Weekly View 03-16-18 (ICER)
  • Q Biomed Inc. Announces FDA Filing for Approval of a New Manufacturing Facility for Non-Opioid Strontium Chloride SR89 Injection USP for Relief of Cancer Bone Pain (Press)
  • GlaxoSmithKline chief Emma Walmsley nets $6.8M in pay in her first year at the helm (Fierce)
  • Getting past the bad blood of Theranos through collaboration (STAT)
  • CVS Health Applauds New Legislation to Better Inform Pharmacy Choices (Press)
  • ImmunoPrecise to acquire ModiQuest Research (The Pharma Letter)
  • PTAB Releases Orange Book-Listed Patent Study (Patent Law Weblog)
  • Plan Sponsors Prefer Specialty Pharmacies Over Retail Drugstores (Drug Channels)
  • Theranos Serves as a Cautionary Tale for Biotech Funding (BioSpace)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • FDA OK’s Hizentra for rare autoimmune disease CIPD (Endpoints)
  • Adaptimmune shares boosted by new signs of success with TCR cell therapy (Endpoints)
  • FDA Gives Go-Ahead for Tetra's Phase II Trial (BioSpace) (Press)
  • CVS Pharmacy Now Offering New Shingles Vaccine at Locations Nationwide (Press)
  • Covance forms I&I unit to meet increasing demand for biologics services (Outsourcing-Pharma)
  • Zosano Reaches Enrollment Milestone In M207-Adam Long-Term Safety Study (Reuters)
  • Cellular Biomedicine Announces Positive Clinical Data Of Knee Osteoarthritis China Phase I Trial (Reuters)
  • Adaptimmune’s GSK-partnered T cells trigger responses in solid tumor patients (Fierce)
  • Tumor-derived T-cells show promise against ovarian cancer (Fierce)
  • Boehringer, Vanderbilt U to develop cancer MCL1 inhibitors in third team-up (Fierce)
  • ADDMEDICA Receives FDA-Approval for Orphan Drug Siklos, First and Sole Hydroxyurea-Based Treatment for Paediatric Patients with Sickle Cell Anaemia. (Press)
  • Novartis, UNC study suggests mRNA structures are a common, untapped pool of drug targets (c&en)
  • Imaging tool may optimize CAR T therapy for solid tumors (BioCentury)
  • Kinase inhibitors: the road ahead (Nature)
  • AACR preview: a lung cancer showdown (EP Vantage)
  • Precision Medicine, Genome Sequencing, and Improved Population Health (JAMA)
  • Docs more likely to prescribe opioids after pharma pay, study finds (Healthcare Dive)
Medical Devices
  • Genetic tests ordered by doctors race to market, while ‘direct-to-consumer’ tests hinge on FDA approval (STAT)
  • AVATR Is An AI Smartphone Companion That Looks Out For You By Being You (Forbes)
  • CARB-X backs HelixBind to develop sepsis test (Fierce) (Press)
  • Noninvasive injection detection system iSenz completes validation trials, seeks commercialization (mobihealthnews)
  • Parachute Health raises $5.5M to digitize 'archaic' medical equipment orders (mobihealthnews)
  • Cook Medical touts win in IVC filter bellwether (MassDevice)
  • Study: Wearable AI-powered biosensors show promise for HF detection (MassDevice)
  • FDA tells Opternative to pull eye exam app from the market (Fierce)
  • Bankrupt Laser Co. Hid Assets To Duck Court Judgments: Suit (Law360-$)
  • Abbott Says Ex-Employee Should Pay For Dismissed FCA Suit (Law360-$)
  • Mayo Clinic and Orbita forge partnership to expand health and wellness content reach (Medical Design & Outsourcing)
  • Organogenesis launches new sizing option for PuraPly wound care device (Drug Delivery Business News)
  • Clarify Medical Announces Issuance of Patent for Smartphone-Connected Phototherapy System (Press)
  • OntarioMD Enters into New Partnership with the Ontario Telemedicine Network for Provincial Digital Health Delivery (Press)
  • Houston hospitals used augmented reality to guide sinus surgery (Healthcare Dive)
  • Reducing inappropriate joint replacements could save billions (Healthcare Dive)
US: Assorted & Government
  • Cigna, Express Scripts To Face Tough Antitrust Review (Law360-$)
  • FDA chief becomes point man on drug prices (The Hill)
  • Why MyHealthEData Could Change the Pharmacy Field (PharmacyTimes)
  • Pharmacy benefit managers lobby against rebate rule (Axios)
  • Defense Sec. Mattis won't comment on Theranos fraud allegations (Axios)
  • Here’s what needs to happen for digital health care information-sharing to actually become a successful reality (Recode)
  • How ER Doctors Are Fighting The Opioid Crisis (Forbes)
  • Lawyers: Elizabeth Holmes Could Still Serve Time In Prison (Forbes)
  • Senator Murray Pushes FDA for Strong Rulemaking Process to Lower Nicotine Levels (Press)
  • Alexander: 340B Program May Need Improvement to Fulfill Purpose of Helping Low-Income Patients (Press)
  • US FDA's Cancer Review Staff Should All Move To Oncology Center of Excellence, Advocates Say (Pink Sheet-$)
  • Getting By On Their Own Supply: The Economics Of Hospitals As Generic Prescription Drug Manufacturers (Health Affairs)
  • LISTEN: Theranos’s fate, biotech’s awkward SXSW, and a word on cow loogies (STAT)
  • MITA Requests to participate in selection of participants for the NMQAAC (MITA)
Upcoming Meetings & Events Europe
  • Siemens Healthineers Shares Jump After $5 Billion German IPO (Bloomberg)
  • Ferring announces positive outcome of European Decentralised Procedure (DCP) for Testavan, a treatment for men with hypogonadism (Press)
  • EMA Management Board: highlights of March 2018 meeting (EMA)
Asia
  • Parliament to discuss SingPass disruption, student mental health and maid insurance (Channel NewsAsia)
  • ViewRay wins Japanese approval for MRIdian Linac system (MassDevice)
  • Foundation Medicine Advances Patient Access to Precision Medicine; Pursues Regulatory Approval for FoundationOne CDx in Japan (Press)
  • Report of the PMDA-ATC Pharmacovigilance Seminar 2018 (PMDA)
India
  • Higher Incomes, Rising Medical Costs, Create A Health Insurance Crisis In India (Bloomberg)
  • Jagan DA case: Relief to pharma companies (Times of India)
  • Dr Reddy's gets 4 observations from USFDA for Telangana plant (Economic Times)
  • Over 17 lakh beneficiaries linked with maternity scheme, says Centre (Hindustan Times)
Australia
  • Duro-K lead issue no cause for alarm (AJP)
  • PreveCeutical Announces Incorporation of Australian Subsidiary to Support Ongoing Research Programs (Press)
  • World’s first portable fingerprint drug test now available in Australia and New Zealand (Press)
Canada
  • Costco under investigation by Ontario forensic team over drug company payments (CBC News)
  • Pharmacare and the chaotic world of Canadian drug prices (iPolitics)
  • Ipsen Announces Health Canada Approval of DYSPORT THERAPEUTIC (abobotulinumtoxinA) for the Treatment of Lower Limb Spasticity in Adults (Press)
  • Government of Canada continues to invest in research to address global health threat of antimicrobial resistance (Press)
General Health & Other Interesting Articles
  • Artificial Intelligence Is Infiltrating Medicine -- But Is It Ethical? (Forbes)
  • This revolutionary healthcare firm producing affordable medical devices first started as a college project (YourStory)
  • Digital Health Isn't A Social Science (Forbes)
  • A Quiet Drug Problem Among the Elderly (NYT)
  • The Future of Medicine From a Leader in Biosensors (Medscape)
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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