Recon: Merck to Buy Peloton for $1.1B to Boost Cancer Pipeline

• 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)

• 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)

• 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, 28x3 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)

• 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)

• 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)

• 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)

• FDA Advisory Committee Calendar

• 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-$)

• 'Center of Excellence' may not mean fewer deaths or readmissions (Reuters)