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

Posted 13 April 2018 | By Ana Mulero 

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

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

In Focus: US
  • 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)
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In Focus: International Pharmaceuticals & Biotechnology
  • 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 $117M in damages (Fierce)
  • Gene therapy heavyweights talk next steps for CAR-T (BioPharma Dive)
  • Theranos’ Letter To Shareholders Shows The Company Is On Its Deathbed (BuzzFeed News)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • Snippet roundup: Icer gives migraine price advice and Bellicum restarts stem cell trial (EP Vantage)
  • Deinove acquires FDA-Fast Track antibiotic compound (European Biotechnology) (The Pharma Letter-$)
  • 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)
Medical Devices
  • 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)
US: Assorted & Government
  • 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-$)
  • New Jersey is trying to bring back the individual mandate (Axios)
  • Outsourcing Facilities Make the News Again (Lachman Consultants)
  • Last Minute Dissolution Testing Requirement Avoids Forfeiture of 180-Day Exclusivity for Generic COREG CR Staggered Strengths (FDA Law Blog)
  • The Food Labeling Modernization Act Is Back Again… (FDA Law Blog)
  • Hatch, Wyden to Hold Finance Hearing on How to Improve Medicare, Medicaid Response to Opioid Epidemic (US Committee on Finance)
  • Premier Pharmacy Labs Issues Voluntary Nationwide Recall of Specific Sterile Injectable Products Lots Due to a Potential Lack of Sterility Assurance (FDA)
Upcoming Meetings & Events Europe
  • The European Biosimilars Landscape: What To Expect In The Year Ahead (Biosimilar Development)
  • SillaJen reveals clinical results on Pexa-Vec in UK (Korea Biomedical Review)
  • UK study to investigate kidney disease progression (PharmaTimes)
  • NHS in “never-ending winter” (PharmaTimes)
  • Merck's supply of HPV shot Gardasil 9 is running short in the U.K. (Fierce)
  • EMA’s PRAC to view methotrexate and HES (The Pharma Letter-$)
  • 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)
Asia India
  • 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)
Australia Canada
  • 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)
General Health & Other Interesting Articles
  • 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)
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.

Need to contact the editor of Regulatory Reconnaissance? Email us at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.
 

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