Recon: Mylan Seeks to Buy Merck KGaA’s Consumer Health Business

• For Cancer Drugs, Will Monday's Data Be As Good As It Gets? (Forbes) (EP Vantage)
• FDA acts to pull concentrated caffeine from market (NBC News) (MedPage Today) (CNBC)
• Rite Aid Sees 'Mid-Sized Market' Future For Its PBM (Forbes) (WSJ) (Reuters)
• New Jersey jury hits BD subsidiary Bard with $33m pelvic mesh verdict (MassDevice) (Law360-$)
• Pfizer puts Bamboo’s muscular dystrophy gene therapy to the test (Fierce) (STAT-$)
• Next-Generation Sequencing: FDA Offers Guidance to Streamline Path to Market (Focus) (Fierce)

• Mylan seeks deal for German Merck's consumer products unit: sources (Reuters) (Fierce)
• Hanmi gives up on lung cancer drug Olita (Korea Biomedical Review) (Endpoints) (Fierce)
• Sanofi to Invest Roughly $430 Million in Canadian Vaccine Facility (BioPharm International) (BioPharma Dive) (Reuters)
• Personalized vaccine could boost survival in late-stage ovarian cancer (Fierce) (Los Angeles Times) (The Scientist) (Endpoints)
• Inventiva raises $44M as it preps for a PhIII NASH program, upcoming IIb readout (Endpoints) (Fierce)
• Respiratory diseases firm’s funding round raises £29 million (The Pharma Letter) (Endpoints) (Fierce)
• Health Canada warns about EpiPen shortage (Vancouver Sun) (CBC News) (CTV News)
• As gene editing explodes, a new report from Goldman says Chinese groups are seizing the lead on CRISPR and CAR-T studies (Endpoints)
• Outcome statement of the IMDRF-13 management committee 20 too 22 March 2018 (IMDRF)
• How surveillance programmes can help prevent a post-antibiotic apocalypse (EFPIA)
• FDA/IMSN Summit with international drug regulators to discuss medication safety issues (FDA)

• Mallinckrodt shares slide on whistleblower lawsuit involving its best-selling drug (CNBC)
• Hepatitis C Drugs Can Cost $84,000. This New One May Be Just As Good—But Cost $300 (Fortune) (DNDi)
• Drugmakers Duped Medicaid Rebate Regulators, 3rd Circ. Told (Law360-$)
• Biosimilar Discounting & Contracting: What Can The US Learn From Europe? (Biosimilar Development)
• Overdose Antidote Is Supposed to Be Easy to Get. It’s Not. (NYT)
• Pfizer, Allergan Win Out With Tax Benefits (Bloomberg)
• Pfizer's Deal Potential Doesn't Stop at Bristol-Myers (Bloomberg)
• Retire? Bill Chin’s tried it three times, and he’d rather be working at Frequency Therapeutics (Endpoints)
• Gilead May Have Forfeited Ownership of Its Blockbuster Hepatitis Drug Patents (Bloomberg)
• New migraine drugs may give insurers a headache (STAT-$)
• In a bid to promote stem cell therapies, health officials open a new door for promising contenders (STAT)
• Asbestos case against Johnson & Johnson, Imerys climbs to $117M in damages (Fierce)
• Gene therapy heavyweights talk next steps for CAR-T (BioPharma Dive)
• Theranos’ Letter To Shareholders Shows The Company Is On Its Deathbed (BuzzFeed News)

• Snippet roundup: Icer gives migraine price advice and Bellicum restarts stem cell trial (EP Vantage)
• Deinove acquires FDA-Fast Track antibiotic compound (European Biotechnology) (The Pharma Letter-$)
• Hereditary Angioedema: Draft Scoping Document (ICER)
• BMS begins Harvard fibrosis stem cell research collaboration (pharmaphorum)
• Rigel falsely claims FDA approval in ‘website error’ (Fierce) (Press)
• AACR preview – an existential crisis for Opdivo (EP Vantage)
• ICER To Open Cost Effectiveness Models To Drug Firms During Review Process (Pink Sheet-$)
• Certara Acquires Analytica Laser, a Leader in Market Access, Health Economics and Outcomes Research (HEOR), and Real-world Evidence Solutions (Press)

• Oxygen device maker Inogen discloses customer data breach (Reuters) (MassDevice)
• Diabetes monitoring startup raises $105 million (Axios)
• Analogic succumbs to a take-under (EP Vantage)
• Qiagen launches liquid biopsy tests for lung, prostate cancer (MassDevice)
• Philips warns on imaging system vulnerabilities (MassDevice)
• Confer Health raises $9.5m for fertility diagnostic (MassDevice)
• NuVasive Urges 9th Circ. To Toss $27M Poaching Verdict (Law360-$)
• Sorin Denies Family’s Claim It Hid Heart Valve Info From FDA (Law360-$)
• J&J Unit Wants Whistleblower Docs In Hip Implant FCA Suit (Law360-$)
• Smart Inhaler is About to Reach OTC Market (PharmacyTimes)
• Fall of Theranos Still Haunts the Digital Health Space (PharmacyTimes)
• MDIC Request for Proposal on Cybersecurity in the Medical Device Sector: Coordinated Vulnerability Reporting (MDIC)
• QIAGEN Launches AdnaTest Liquid Biopsy Kits in Prostate and Lung Cancer (Press)
• Fresenius Kabi Announces New Approval and Immediate Availability of Daptomycin for Injection (Press)
• Pulse Biosciences Announces Positive Results from Its First Study Evaluating a Clinical Target at Major Scientific Meeting (Press)
• CheckedUp’s Impact at the Point of Care, Network Expansion, and Plans for Educational Partnerships (Press)

• Funding opportunity: Characterize skin physiology parameters utilized in dermal physiologically-based pharmacokinetic model development across different skin disease states (U01) (HHS)
• Funding opportunity: Formulation drug product quality attributes in dermal physiologically-based pharmacokinetic models for topical dermatological drug products and transdermal delivery systems (U01) (HHS)
• ManorCare seeks court approval to exit bankruptcy under landlord (Reuters)
• Preempting Preemption: Device Cases After Shuker — Part 2 (Law360-$)
• New Jersey is trying to bring back the individual mandate (Axios)
• Outsourcing Facilities Make the News Again (Lachman Consultants)
• Last Minute Dissolution Testing Requirement Avoids Forfeiture of 180-Day Exclusivity for Generic COREG CR Staggered Strengths (FDA Law Blog)
• The Food Labeling Modernization Act Is Back Again… (FDA Law Blog)
• Hatch, Wyden to Hold Finance Hearing on How to Improve Medicare, Medicaid Response to Opioid Epidemic (US Committee on Finance)
• Premier Pharmacy Labs Issues Voluntary Nationwide Recall of Specific Sterile Injectable Products Lots Due to a Potential Lack of Sterility Assurance (FDA)

• FDA Advisory Committee Calendar

• The European Biosimilars Landscape: What To Expect In The Year Ahead (Biosimilar Development)
• SillaJen reveals clinical results on Pexa-Vec in UK (Korea Biomedical Review)
• UK study to investigate kidney disease progression (PharmaTimes)
• NHS in “never-ending winter” (PharmaTimes)
• Merck's supply of HPV shot Gardasil 9 is running short in the U.K. (Fierce)
• EMA’s PRAC to view methotrexate and HES (The Pharma Letter-$)
• Ten-year study proves: Official batch testing of vaccines remains indispensable (Paul-Ehrlich-Institut)
• HeartStitch wins CE Mark for Trans-Apical Access and Closure device (MassDevice) (Press)
• Olerup QTYPE Receives CE Mark Certification (Press)

• Roche Korea’s Alecensa gets approval as 1st line lung cancer therapy (Korea Biomedical Review)
• Yonsei researchers find novel autophagy enhancer as new diabetes therapy (Korea Biomedical Review)
• Ohara Pharma cuts price of generic drug for leukemia in Japan (The Pharma Letter)
• China moves on to ICH GCP, despite great challenges (The Pharma Letter-$)

• Indian Tycoons Offer to Invest $192 Million in Fortis Health (Bloomberg)
• Hope trundles into remote hamlets on India's hospital train (Reuters)
• Mental Health and the Workplace: Time for Indian companies to take employees' well-being seriously (FirstPost)

• Supercharged sector as the Federal Government backs $200 million Digital Health CRC (Healthcare IT News)
• Turnbull closer to deal with states on health funding (The Weekend Australian)
• AIA Australia spearheads mental health law reforms (Financial Standard)

• Canada To Measure Marijuana Use By Testing Sewage (NPR)
• Canadian pharmacy to be fined millions for illegal imports (Business Standard)
• Insect farms gear up to feed soaring global protein demand (Reuters)
• Vancouver MP calls for criminal investigation, payment for addiction treatment from pharma (The Canadian Press)
• Innovus Pharma Announces Its Direct Launch of Apeaz, a Cream for Arthritis Pain Relief, in Canada (Press)

• Cancer Can Start To Develop Fifty Years Before Diagnosis (Forbes)
• Patients more satisfied when doctors treat fewer people (Reuters)
• Just five alcoholic drinks a week could shorten your life, study says (CNBC)
• CVS Hires Doctor From Health Startup in Sign of Medical Ambition (Bloomberg) (CNBC) (Reuters)
• Scientists discover unlikely link between ‘sweet tooth gene’ and reduced body fat (Fierce)
• Adding a citizenship question to the 2020 census would be disastrous for public health  (STAT)