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Posted 21 May 2019 | By Michael Mezher 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Merck agrees $1bn deal to buy biopharmaceutical company Peloton (Financial Times) (WSJ) (Reuters) (Endpoints) (Law360-$) (Press)
  • Merck’s Keytruda fails as monotherapy in breast cancer study (Reuters) (Endpoints) (PMLive) (Press)
  • Generic drug price-fixing suit is akin to earlier case, but ‘on steroids,’ Conn. prosecutor says (STAT) (PBS)
  • MIT-owned lab buildings in Kendall Square change hands for reported $1.1 billion (STAT)
  • Google sister-company Verily is teaming with big pharma on clinical trials (CNBC) (Endpoints)
  • Array BioPharma’s colorectal cancer combo treatment meets main goals (Reuters) (Bloomberg)
  • Mallinckrodt sues U.S. health agencies, sees 10% hit to MS treatment sales (Reuters) (Fierce)
  • Measles Outbreak Now at 880 Cases, With Fastest Growth Still in New York (NYTimes)
  • SCOTUS Says Judge, Not Jury, Should Decide Merck Drug Labeling Case (Focus)
  • FDA Officials Explain When Litigation Can Impact Drug Safety Signals (Focus)

In Focus: International

  • Germany’s Evotec expands into biologics with up to $90M deal for Seattle’s Just Biotherapeutics (Endpoints) (Fierce)
  • As Europe goes to polls, pharma seeks to keep healthcare, R&D a priority (PMLive)
  • No deal or revoke looming as fourth vote on Brexit nears (PMLive)
  • China set to introduce gene-editing regulation following CRISPR-baby furor (Nature)
  • WuXi to build dedicated vaccine facility, but who’s the client? (Fierce)
  • No Room For Error: China Proposes Hefty Fines On Quality Violations In Drug Law Overhaul (Pink Sheet-$)
  • Dengue fever numbers soar on La Reunion: WHO (Reuters)
  • UK Clinical Trial Pilot Helps Companies Prep for New EU Regulation (Focus)

Pharmaceuticals & Biotechnology

  • Catalent’s new prize, Paragon, adding capacity to make Sarepta gene therapies (Fierce)
  • Artificial Intelligence in Health Care: Will the Value Match the Hype? (JAMA)
  • Academia and industry: allocating credit for discovery and development of new therapies (JCI)
  • Groups Seek More FDA Flexibility in Early Cell Therapy Development (Focus)
  • Beleaguered Biogen faces the music as a rising chorus of critics push for a transformative approach to M&A (Endpoints)
  • Top AstraZeneca I/O exec jumps to Seattle Genetics as first CCO; Woodford fund downgraded as woes mount (Endpoints)
  • Sen. Cruz Leads Letter To FDA: ‘Expand The Parallel Track To Target Devastating Diseases’ (Heartland Institute)
  • IBD Rx Tied to Pharma Payments to Docs (Medpage)
  • CDK16: the pick of the understudied PCTAIRE kinases (Nature)
  • An Independent US FDA: Gottlieb Supports Position, But Is Pessimistic About Prospects (Pink Sheet-$)
  • Inspired by breath strips, scientists break away from needing a ‘cold chain’ to deliver vaccines (STAT)
  • Hercules vet launches a new life sciences lender with $400M to put into play (Endpoints)
  • Mount Sinai researchers isolate placental cells that regenerate damaged hearts in mice (Fierce)
  • No other interest can take precedence — a patient’s perspective on oncology drug development (Nature)
  • Biosimilar drugmakers partnering to ensure early entry to global markets, says analyst (PharmaLetter-$)
  • Karen Midthun, M.D., Joins Greenleaf Health (Press)
  • Apotex Corp. Issues Voluntary Nationwide Recall of Drospirenone and Ethinyl Estradiol Tablets, USP, 28×3 Blister Pack/Carton Due to Possibility of Missing/Incorrect Tablet Arrangement (FDA)
  • AurobindoPharma USA, Inc. Initiates a Voluntary Nationwide Consumer Level Recall Expansion of 38 Lots of Amlodipine Valsartan Tablets USP and Valsartan Tablets, USP due to the detection of NDEA (N-Nitrosodiethylamine) Impurity. (FDA)
  • Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP (FDA)
  • International Laboratories, LLC Issues Voluntary Nationwide Recall of one (1) Lot of Clopidogrel Tablets USP, 75 mg packaged in bottles of 30 tablets Due to Mislabeling NDC # 54458-888-16; Lot # 117099A (FDA)
  • Prinston Pharmaceutical Inc. issues Voluntary Nationwide Recall of Irbesartan and Irbesartan HCTZ Tablets Due to detection of a Trace Amount of Unexpected Impurity, N- nitrosodiethylamine (NDEA) in the Products (FDA)
  • Macleods Pharmaceuticals Limited Issues Voluntary Nationwide Consumer Level Recall of One Lot (BLM 715A) of Losartan Potassium/Hydrochlorothiazide Combination Tablets 100mg/25mg Due to detection of NDEA (N-Nitrosodiethylamine) Impurity (FDA)

Pharmaceuticals & Biotechnology: Study Results, Filings & Designations

  • BioCryst shares are blasted as a PhIII HAE ‘success’ underwhelms analysts (Endpoints)
  • PhIII setback mars Ocular’s glaucoma drug/device, though company remains ‘encouraged’ by data breakdown (Endpoints)
  • PolyPid Receives a Second QIDP Designation for D-PLEX100 in Abdominal Surgery (Press)
  • Ocular’s sustained-release insert misses bull’s-eye in phase 3 glaucoma trial (Fierce) (Press)
  • Phase III study showed nintedanib slows the loss of pulmonary function in people living with systemic sclerosis associated ILD1 (Press)
  • BELLUS Health Presents Phase 1 Data for BLU-5937, its Lead Product Candidate for the Treatment of Refractory Chronic Cough, at the American Thoracic Society International Conference (Press)
  • Clovis Oncology Presents Patient-Centered Outcomes Data from Phase 3 ARIEL3 Study for Rubraca® in Advanced Ovarian Cancer (Press)
  • Theravance Biopharma Reports Data from Phase 1b Study of TD-1473 in Oral Presentation at Digestive Disease Week (DDW) 2019 (Press)
  • First Sublingual Ketamine Drug for Treatment of Acute Pain to be Evaluated in End-of-Phase 2 Meeting with FDA (Press)

Medical Devices

  • FDA: Survival rates still low for Impella RP patients outside narrow patient selection criteria (MassDevice)
  • Hidden Reports Masked The Scope Of Widespread Harm From Faulty Heart Device (KHN)
  • Class 1 Device Recall MoniTorr (FDA)
  • Class 1 Device Recall LimiTorr (FDA)

US: Assorted & Government

  • Scott Gottlieb is skeptical of the science behind CBD supplements (STAT)
  • High Court Won’t Hear Orexigen Securities Fraud Suit (Law360-$)
  • Drugmaker, Retailers Strike Deal In Loestrin Antitrust MDL (Law360-$)
  • Holidays and Red Herrings: FDA’s “Nonenforcement Discretion” Successfully Challenged (FDA Law Blog)
  • Voluntary Medicare Drug Management Programs to Control Misuse (GAO)

Upcoming Meetings & Events

  • No Shocks Expected In EU Quality Guidance For Drug-Device Combinations (Pink Sheet-$)
  • Are You Prepared For Russia’s New Track And Trace System? (Pink Sheet-$)


  • Asia Regulatory Roundup: TGA Releases Advertising Breach ‘Stop Clock’ Policies as Legal Case Advances (Focus)
  • Ark Bio Of China Bets On Untapped Pediatric Antiviral Market Where Few Have Succeeded (Scrip-$)


  • US targeting to malign the image of Indian pharma industry: Pharmexcil DG (Pharmabiz)
  • Alembic Pharma gets USFDA nod for overactive bladder treatment drug (Economic Times)


  • Canada Moves To Reduce Industry Adverse Action Re-Reporting (Pink Sheet-$)

General Health & Other Interesting Articles

  • ‘Center of Excellence’ may not mean fewer deaths or readmissions (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.
Need to contact the editor of Regulatory Reconnaissance? Email us at [email protected].
A story’s inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

Source: https://www.raps.org/news-and-articles/news-articles/2019/5/recon-merck-to-buy-peloton-for-11b-to-boost-can

The post Recon: Merck to Buy Peloton for $1.1B to Boost Cancer Pipeline – Regulatory Focus appeared first on CBD Oil Headlines.


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