Recon: Takeda Weighs $50B Bid for Shire

Posted 28 March 2018 | By Ana Mulero 

Recon: Takeda Weighs $50B Bid for Shire

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

In Focus: US In Focus: International Pharmaceuticals & Biotechnology
  • In a bitter brawl, Arcturus details ex-CEO’s alleged misconducts in lawsuit (Endpoints) (Press)
  • Congress loves shaming CEOs. So why hasn’t pharma been put on the hot seat? (STAT)
  • Biotech saw positive results this quarter; shares still tanked. Here are some explanations (STAT-$)
  • In Battle To Cut Drug Prices, Outcome-Based Pricing Carries Big Risks For Biopharma (Forbes)
  • Top drugs and companies by sales in 2017 (Nature)
  • Vantage point – Vertex and orphan drugs test limits of US payers (EP Vantage)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • Clinical trials take a long time to get started. Here’s how to speed it up (STAT)
  • NIAID chief: Platform tech will bring a 'major switch'—and shorter timelines—to vaccine R&D (Fierce)
  • Urovant starts pursuit of Astellas’ overactive bladder drug Myrbetriq with new Ph3 trial (Fierce) (Press)
  • Bluebird whistles up a co-development/co-promotion pact with Celgene on bb2121 CAR-T (Endpoints) (Press)
  • Edge plans job cuts as phase 3 brain-bleed fail routs stock (Fierce) (Press)
  • Preclinical study shines a light on BET inhibitors’ potential to prevent obesity-related cancer growth (Endpoints)
  • Works in mice? It’s a winner for Homology as IPO reaps $144M haul, with biotech on a roll (Endpoints) (Fierce)
  • Protagonist halts colitis study after missed endpoint (BioPharma Dive)
  • Targeted Combo Active in Advanced Ovarian Cancer (MedPage Today)
  • Cytokines emerge as 2018’s immune-oncology stars (EP Vantage)
  • Pediatric Exclusivity Statistics (FDA)
  • 2018 Center for Biologics Evaluation and Research Science Symposium (FDA)
Medical Devices
  • Inducement ban regarding medical devices (Lexology)
  • Siemens Healthineers wins FDA nod for Mammomat mammography system (MassDevice)
  • Hologic wins expanded approval for 3Dimensions mammography systems (MassDevice)
  • Study shows use of EpiSwitch blood test can aid in treatment decision for rheumatoid arthritis (Fierce)
  • Abionic bags $21M to trial rapid test of sepsis risk (Fierce) (Press)
  • Bigfoot brings Series B total to $55m with new investment from Abbott (Drug Delivery Business News)
  • How medical device industry suppliers can save their clients money (MassDevice)
  • Is the Essure Sterilization Device Safe Enough? (MedPage Today)
  • Webinar - Combination Product Updates for “Acceptance and Filing Reviews for Premarket Approval Applications” and “Refuse to Accept Policy for 510(k)s”- March 20, 2018 (FDA)
  • National Evaluation System for health Technology Coordinating Center: Opportunities for Engagement (NESTcc)
  • Haemonetics Announces Regulatory Clearances of NexSys PCS Enhanced Software with YES Technology (Press)
  • Fast Track Diagnostics releases CE-labelled, real-time PCR kit for the detection of 14 HPV High-Risk subtypes (Press)
  • BioSig Announces Submission of FDA 510(k) Application for PURE EP System (Press)
US: Assorted & Government
  • Walgreens CEO: We Can Change Without Buying A Health Plan (Forbes)
  • Fiscal Year 2018 Generic Drug Regulatory Science Initiatives; Public Workshop; Request for Comments (FDA)
  • Medical Gas Regulation; Public Workshop; Request for Comments (FDA)
  • Rite Aid Says All 1,932 Stores Transferred To Walgreens (Forbes)
  • Cities Vs. States: A Looming Battle For Control Of High-Stakes Opioid Litigation (Forbes)
  • FDA sued for delaying e-cigarette, cigar regulations (Washington Post)
  • In broad healthcare bets, small stocks favored over large (Reuters)
  • Why DOJ must block the Cigna-Express Scripts merger (The Hill)
  • Zostavax (Herpes Zoster Vaccine) Questions and Answers (FDA)
  • As Amazon moves into health care, here's what we know — and what we suspect — about its plans (CNBC)
  • A Path to Sustain Rural Hospitals (JAMA)
  • Electronic Health Record Usability Issues and Potential Contribution to Patient Harm (JAMA)
  • A 21st-century solution to the opioid crisis (The Hill)
Upcoming Meetings & Events Europe
  • Tasermity Cessation of validity of the marketing authorisation in the European Union (EMA)
  • The launch of the new EudraVigilance System Questions and Answers from stakeholders (EMA)
  • Boston Scientific touts win in UK-based patent spat with Edwards Lifesciences (MassDevice) (Press)
  • Reva touts first implant of Fantom Encore bioresorbable scaffold in Switzerland (Drug Delivery Business News)
  • All T34 ambulatory syringe pumps – risk of unintended pump shutdown and delay to treatment (MHRA)
  • Ipsen Announces EMA Validation of Filing of a New Application for Additional Indication for Cabometyx, for Patients with Previously Treated Advanced Hepatocellular Carcinoma (Press)
  • Brexit and the potential impact on patients access to medicines and medical devices (The EFPIA View)
Asia
  • Alteogen to supply Herceptin biosimilar for LinXis’ ADC therapy (The Investor)
  • India, China to resolve agri, pharma trade issues in shadow of trade war (Business Standard) (New Indian Express)
  • India's Alkem Labs gets USFDA report about Amaliya unit (Reuters) (Times of India)
  • Tokyo court rejects Shire claim against Roche hemophilia drug (Reuters)
  • Israel aims for 100,000 people to volunteer for health database (Reuters)
  • Aging Japan: Robots may have role in future of elder care (Reuters)
India
  • CDSCO's new intelligence cell to check illegal activity in India’s pharma sector (Economic Times)
  • Horlicks, the beloved 140-year-old brand, may have a new owner—again (Quartz)
  • 'Disappointed' with draft norms for public procurement of medical devices: MTaI (Business Standard)
Australia
  • Transvaginal mesh inquiry criticises Australia's medical device regulation (The Guardian)
  • Australia investigates implants that left some women with 'rotting pelvises' (CNN)
Canada
  • Health Canada releases report from external review of pan-Canadian health organizations (Health Canada)
  • Fentanyl fuelled increase in accidental opioid deaths, Public Health Agency of Canada says (CBC News)
  • Revamp national cancer, mental health groups, panel tells minister (CBC News)
General Health & Other Interesting Articles
  • 7M Doctor Reviews Show Need For Bedside Manner, Personality And Compassion (Forbes)
  • Children Exposed To Drugs For Epilepsy, Bipolar Disorder Have Lower Academic Scores (Forbes)
  • Oscar Health Raises $165M For Multi-City Obamacare Expansion (Forbes) (CNBC) (Reuters)
  • Trump's travel ban imperils U.S. citizen with cancer (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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A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.
 

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