Recon: Takeda to Buy Shire for $62B

• Valeant, Distancing Itself From Its Past, Will Change Its Name to Bausch Health (NYT) (Fortune) (Reuters) (WSJ) (BioPharma Dive) (Fierce)
• Trump calls on Congress to pull back $15 billion in spending, including on Children’s Health Insurance Program (The Washington Post) (The Hill) (Politico) (Reuters)
• Merck and OncoSec expand Keytruda/IL-12 collaboration into triple-negative breast cancer (Fierce) (Drug Delivery Business News)
• FDA OKs Marketing of Endoscopic Hemospray for Most GI Bleeds (Medscape) (MedPage Today)
• Darzalex combo wins nod for newly diagnosed multiple myeloma (PharmaTimes) (Fierce) (The Pharma Letter-$) (PMLiVE)
• US FDA approves Astellas' sNDA for Myrbetriq for use in combo with solifenacin succinate to treat overactive bladder symptoms (Pharmabiz) (The Pharma Letter)
• Walmart Limits Opioid Prescriptions In Bid To Curb Epidemic (HuffPost) (Reuters) (Fortune) (Fox)
• Surgical device firm demands the retraction of a study paid for by its rival (STAT) (MassDevice)
• Poised to launch its first marketing effort, Alnylam makes a big leap into CNS diseases and Alzheimer’s (Endpoints) (Fierce)
• Autolus seeks $100M IPO to take next-gen CAR-Ts deep into the clinic (Fierce) (Endpoints)

Currently, approximately 70% of IVDs on the market are sold without the involvement of a Notified Body. The IVDR will change that while also making sweeping changes to medical device regulations, all aimed at protecting end users.

Join us on May 16th at 11:00am EDT for our complimentary webinar Overview of the New European IVDR and find out how you can prepare your business for the transition.

• Takeda Wins Battle for Shire With $62 Billion Deal (WSJ) (Reuters) (BBC) (EP Vantage) (Fortune)
• AstraZeneca sells rights for Seroquel to Luye Pharma for $538 million (Reuters) (The Pharma Letter-$) (PBR) (PharmaTimes) (Fierce)
• Centre to push pharma exports to China (Times of India) (Economic Times) (Firstpost)
• Daiichi and Kaketsuken end vaccines agreement (The Pharma Letter) (Pharmabiz)
• Daiichi scores in PhIII study of AML drug, beating chemo and building its case for worldwide approvals (Endpoints)
• Democratic Republic of Congo confirms two Ebola cases, 10 more cases suspected (Reuters)
• Pandemic flu is #1 health security concern: WH official (Axios)
• Faron Pharma flummoxed as Traumakine fails in ARDS (Fierce)
• Boosted by China launch, Merck's Gardasil turns in a big first-quarter performance (Fierce)
• CDSCO increases WHO GMP certificate to three years for ease of doing business (Economic Times)
• Governments fail to curb research waste in publicly funded clinical trials - new study (TranspariMED)
• Conference on “Best practices in implementing the International Health Regulations” (EC)

• First US drug priced at more than $1 million may be on the horizon (CNBC)
• Mallinckrodt shares rebound after '60 Minutes' report on drug prices (CNBC)
• The (new) top 10 pharma companies by 2017 revenue (Endpoints)
• Drug distributor admits contributing to opioid crisis (Axios)
• The fight for new Medicare drug codes (Axios)
• $1,500,000 could be a great deal (Balloon Juice)
• Antitrust, Market Exclusivity, and Transparency in the Pharmaceutical Industry (JAMA)
• Generic Price Competition For Specialty Drugs: Too Little, Too Late? (Health Affairs)
• AbbVie's elagolix could put pressure on budgets, ICER estimates (BioPharma Dive)
• The Amish pool resources for their medical care. A budget-busting gene therapy puts them in a bind (STAT)
• CMS chief criticizes Medicare drug payments for ‘perverse’ incentives (STAT-$)
• Vantage view – could big biotech succumb to the urge to merge? (EP Vantage)
• DEA's Proposed Opioid Limits Meet Industry Resistance (Law360-$)
• PTAB Won't Revisit Patent For Astellas Bladder Drug (Law360-$)
• New Preventeza (Levonorgestrel Tablet, 1.5 mg) Emergency Contraceptive Brought To You by Vagisil Helps Prevent Pregnancy Before It Starts (Press)

• Ionis, Akcea team face some tough questions on safety as FDA insiders ponder risks linked to volanesorsen (Endpoints)
• US FDA approves new label for Veltassa (The Pharma Letter) (Press)
• Gilead to collaborate with Google’s Verily in inflammatory diseases (pharmaphorum)
• MedCo uses a Phase 2 analysis to build its PCSK9 case (Biopharma Dive)
• Controlling CAR-T: How scientists plan to make the engineered T cell therapy safer, and work for more cancers (C&EN)
• Richard Lehman’s journal review—8 May 2018 (The BMJ Opinion)
• Targeting RNA – Lessons Learned from Oligos (Dark Matter Blog)
• Crowd-Funding for Stem Cell Tx Often Based on Misinformation (MedPage Today) (JAMA)
• Better together: Merged microscope offers unprecedented look at biological processes in living cells (NIH)
• Scientists discover roadblocks that stop brain white matter healing (NIH)
• NIH clinical trial to track outcomes of kidney transplantation from HIV-positive donors to HIV-positive recipients (NIH)
• Neon Therapeutics Announces First Patient Treated in Clinical Trial Evaluating Personal Cancer Vaccine NEO-PV-01 in Combination with KEYTRUDA (pembrolizumab) and Chemotherapy (Press)
• US FDA Procures DILIsym Software License Package (Press)
• Agilent Completes Acquisition of Lasergen, Inc. (Press)
• Medidata Offers Breakthrough to De-Risk Clinical Trial Submissions (Press)
• Genentech to Present New Data from its Industry-Leading Oncology Portfolio at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting (Press)
• Proteostasis Announces Formation of Independent Steering Committee of Leading Experts to Advise on the Global Phase 3 Clinical Development Program for PTI-428 in Cystic Fibrosis (Press)
• CymaBay Therapeutics Announces the Initiation of a Phase 2b Study of Seladelpar in Patients with Non-Alcoholic Steatohepatitis (Press)
• Bellerophon Reaches Agreement with FDA on Study Design of Phase 2b Trial of INOpulse for Treatment of Pulmonary Hypertension Associated with Chronic Obstructive Pulmonary Disease (Press)
• Nektar Therapeutics Announces Initiation of a Phase 1b Clinical Study of NKTR-358, a First-in-Class Regulatory T Cell Stimulator, in Patients with Systemic Lupus Erythematosus (Press)

• Multiple Function Device Products – FDA Clarifies Its Approach (FDA Law Blog)
• Fitbit adds female health feature to its app which lets women keep track of their menstrual cycle (USA Today) (MobiHealthNews) (Firstpost) (The Verge)
• Medtronic initiates select recall of Covidien Endo GIA staplers (MassDevice)
• Olympus enters co-development agreement to offer AI for colonoscopy: 4 insights (Becker’s)
• Itamar Medical launches SleePath to track sleep apnea in AFib patients (MobiHealthNews)
• CTA and Xcertia to develop rules of the road for mobile apps (Healthcare IT News)
• Neurovascular Stents Used for Stent-Assisted Coiling of Unruptured Brain Aneurysms: Letter to Health Care Providers (FDA)
• Terumo Recalls Sarns TCM and TCM II Cooling and Heating Systems and HX2 Temperature Management Systems Due to Revised Cleaning Instructions (FDA)
• Cytox in Collaboration with AKESOgen Extends Genetic Test for Assessing Alzheimer's Risk to Include Saliva Samples (Press)
• DarioHealth Releases Next Generation Version 4.0 of its Award-Winning App (Press)
• Arch Therapeutics Provides Update on Study Initiation and 510(k) (Press)

• The 340B Program Reached $19.3 Billion in 2017—As Hospitals’ Charity Care Has Dropped (Drug Channels)
• Ex-Medicare chief Slavitt adds partners to venture firm, which will invest in the 'most vulnerable Americans' (CNBC)
• CVS To Buy Fred's Specialty Pharmacy Business (Forbes)
• 3 Ways To Fix The VA Amid Ongoing Scandals (Forbes)
• Get ready for higher Affordable Care Act premiums nationwide (Axios)
• Trump administration draws a line on Medicaid rollbacks (Axios)
• Nearly 80% of prescriptions delivered electronically, Surescripts says (Healthcare Dive)
• Buoy Health, CVS MinuteClinic partner to send patients from chatbot to care (MobiHealthNews)
• CMS administrator Verma calls on insurers, providers to give patients their data (MassDevice)
• RxStrategies Says CVS, Rival Swiping Its Customers (Law360-$)
• CMS Announces Agency’s First Rural Health Strategy (CMS)
• Using Antitrust Law to Challenge Turing's Daraprim Price Increase (SSRN)
• General Hospital Corp. v. Sienna Biopharmaceuticals, Inc. (Fed. Cir. 2018) (Patent Docs)
• Examining Oversight Reports on the 340B Drug Pricing Program (US HELP Committee)

• FDA Advisory Committee Calendar

• EMA approves Lynparza tablets for treatment of platinum-sensitive ovarian cancer (EPM Magazine) (Press)
• Five therapies endorsed for use on NHS Scotland (PharmaTimes)
• NICE OKs three new therapies for blood cancer (PharmaTimes)
• EMA Takes Flexible Approach In Setting Exposure Limits for Drugs Produced In Shared Facilities (Pink Sheet)
• Swissmedic Journal Latest Edition (Swissmedic)

• Listing in Shanghai, WuXi AppTec raises a $354M IPO for China R&D facilities (Endpoints)
• Ascletis files for Hong Kong IPO as floodgates open to prerevenue biotechs (Fierce)
• Victims of Japan's forced sterilizations demand justice after decades of silence (Reuters)
• Sinovac Forced to Temporarily Suspend Hepatitis A Vaccine Production Line Due to Disruptive Actions taken by Minority Shareholder of Sinovac Beijing (Press)

• Capping profit margin: doctors say wider consultation needed (The Hindu)
• Sanofi India net moves up by 37.5% in Q1, Charles Billard will be new CFO (Pharmabiz)
• ICMR issues new guidelines for type 2 diabetes management as patient numbers touch 72.9 million (Pharmabiz)
• MTaI calls for wider consultation on trade margin capping by Delhi govt (Pharmabiz)
• India’s healthcare: does Modi have the right cure? (Financial Times)
• Private Healthcare in India Part II: Govt caps price of medicine, stents, consumables but industry finds way around it (Firstpost)
• Letter to BS: Investment in public health is abysmally low in India (Business Standard)

• Australia to let in fewer overseas doctors, in one of biggest budget savings (The Guardian)
• Federal budget 2018: $1.3b plan to make Australia a medical technology leader (Australian Financial Review)
• Child-resistant packaging requirements for medicines - Guidance on TGO 95 (TGA)
• Outcomes of the consultation on the draft list of permitted indications (TGA)

• Drinking More Water No Help in CKD (MedPage Today)
• Lynparza (olaparib) tablets receive approval as maintenance therapy treatment for ovarian cancer regardless of BRCA status (Press)

• Giving doctors the ‘capability’ they need to care for patients can fight burnout (STAT)
• The Deadly Viruses Being Used To Combat Incurable Cancers (Forbes)
• When Physicians Turn Into Patients—Becoming Kafka’s Cockroach (JAMA)
• Healthcare Startup Solv Raises $16.8 Million To Build The OpenTable For Urgent Care (Forbes)
• Through the Looking Glass: Cybersecurity is shared global responsibility, be proactive (Healthcare IT News)
• Being called 'fat' in early teens tied to later eating disorders for girls (Reuters)