Recon: Takeda Weighs $50B Bid for Shire

• Gottlieb says FDA will take new action to speed approval of biosimilars (STAT) (CNBC) (Reuters)
• Cigna Says It Reduced Opioid Use By 25% (Forbes) (The Hill) (Business Insider)
• Tempest emerges with $70M to take IDO inhibitor into the clinic (Fierce) (Endpoints)
• FDA OKs First Interoperable CGM System (MedPage Today) (Fierce) (FDA)
• FDA Panel Backs Approval of Lofexidine for Opioid Withdrawal (Medscape) (MedPage Today)
• Infectious disease deaths decline, but U.S. sees wide disparity in outcomes (Modern Healthcare) (MedPage Today) (Medical Xpress)

• Takeda Weighs Bid for Shire, Which Says It Hasn't Received Offer (Bloomberg) (Reuters) (CNBC) (BBC News)
• Roche shares drop after deaths of patients taking Hemlibra (Reuters) (Endpoints) (STAT-$)
• Hikma rebrands to create modern visual identity and common corporate culture (Fierce)
• Celgene drops option to buy Abide, bags preclinical drug (Fierce)
• WuXi AppTec gets fast-track approval for $900M-plus Shanghai IPO (Fierce)
• World's first Lassa vaccine, developed by Themis, nears human testing: CEO (Fierce)
• Ranjan Pai: India's new health care czar (Forbes) (Business Standard) (Times of India) (QZ)
• Biocon and Mylan win EU and Australian approval for biosimilar insulin glargine (The Pharma Letter) (Times of India) (Business Standard)

• 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)

• 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)

• 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)

• 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)

• FDA Advisory Committee Calendar

• 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)

• 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)

• 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)

• Transvaginal mesh inquiry criticises Australia's medical device regulation (The Guardian)
• Australia investigates implants that left some women with 'rotting pelvises' (CNN)

• 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)

• 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)