Regulatory Focus™ > News Articles > 5 > Recon: Takeda to Buy Shire for $62B

Recon: Takeda to Buy Shire for $62B

Posted 08 May 2018 | By Ana Mulero 

Recon: Takeda to Buy Shire for $62B

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In Focus: International
  • 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)
Pharmaceuticals & Biotechnology
  • 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)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • 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)
Medical Devices
  • 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)
US: Assorted & Government
  • 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)
Upcoming Meetings & Events Europe
  • 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)
General Health & Other Interesting Articles
  • 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)
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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