Recon: Solid Biosciences Gene Therapy Study Put on Hold Again; Lonza CEO to Depart After Less Than a Year

• Google’s ‘Project Nightingale’ Gathers Personal Health Data on Millions of Americans (WSJ) (Reuters) (NYTimes) (CNBC)
• Shares of Amarin jump after FDA staff review on fish-oil drug (Reuters) (STAT) (Endpoints)
• Solid Biosciences gene therapy trial put on hold for second time, shares slump (Reuters) (STAT)
• It’s tiny biotechs — not big drug makers — that fear ‘nuclear winter’ from Pelosi’s drug pricing bill (STAT)
• House vote on Pelosi drug pricing plan slips to December (The Hill)
• Divided response to CMS on Part B prices (Politico)
• Biden and Bloomberg are bigger threats to Big Pharma than Warren, analyst says (CNBC)

• China’s Drug Market Is Opening Up (WSJ)
• Deadly Pig Disease Sparks Fear of a Heart Drug Shortage (Bloomberg)
• AstraZeneca succeeds in treating lupus in late-stage study (Reuters)
• How much? Pharma copay cards are increasing costs for private Canadian insurers (STAT)
• Eudamed 2-year delay doesn't mean free pass for manufacturers (MedtechDive)
• Lonza CEO to leave chemicals maker after less than a year (Reuters) (Pharmafile)
• UK biotech Evgen craters on failed stroke trial (PMLive)
• Novartis' Kisqali approved for NHS Scotland in most common advanced breast cancer (Pharmafile)
• Scottish Medicines Consortium recommends Eisai's Kisplyx for advanced kidney cancer (Pharmafile)
• Hong Kong’s CK Life Sciences bets on skin cancer drug as its stock soars more than 200% (CNBC)

• Should employers take a chance on little-known Embarc to pay for gene therapy? (STAT)
• How much is a Miami doctor’s endorsement worth? A lot, if you’re a pharma company (Miami Herald)
• Regenxbio Sues FDA Over Unexplained Clinical Trial Hold (Focus)
• FDA Warns Mylan’s Indian API Facility Over Contamination Concerns (Focus)
• Otsuka presses on with Alzheimer’s agitation drug (PMLive)
• Orphan Drug Access: One-Third Of US Coverage Decisions Involve Restrictions, Study Finds (Scrip-$)
• Amgen to cut 149 staff in retreat from neuroscience R&D (Fierce)
• Editas and Celgene sub Juno are tackling hottest immunotherapy cells (Endpoints)
• Many black, elderly U.S. lung cancer patients don't get recommended care (Reuters)
• Omega-3s Show Little or No Benefit for Depression or Anxiety (NYTimes)
• What has Zantac recall cost drugmakers? Dr. Reddy's gives a hint (Fierce)
• Celgene execs shell out $92M cash for a pair of R&D deals that will fit perfectly in their new home at Bristol-Myers (Endpoints)
• Flagship woos Novartis top dealmaker Prakash Raman in move to get the BD ball rolling early (Endpoints)
• Safety qualms in MyoKardia mid-stage study cause investors to pause (Endpoints)
• Kadmon waxes rhapsodic on cGVHD results as race with Jakafi heats up (Endpoints)
• Reata's bardoxolone offers promise in patients with rare kidney disorder (Endpoints)
• BRCA2 Gene Mutations Associated with Risk of Childhood Lymphoma (Patent Docs)

• ARCH-backed Chinese biotech scores PhIII win for glucokinase-modulating diabetes drug (Endpoints)
• X4 Pharmaceuticals Receives Breakthrough Therapy Designation from the FDA for Mavorixafor for the Treatment of WHIM Syndrome (Press)
• Mallinckrodt Presents Positive Phase 3 Results from its CONFIRM Study of Terlipressin in Patients with Hepatorenal Syndrome Type 1 (HRS-1) at The Liver Meeting® 2019 (Press)
• Pfizer Announces Results of Phase 3 Study for XELJANZ® (tofacitinib) in Juvenile Idiopathic Arthritis Ahead of Presentation at 2019 American College of Rheumatology/Association of Rheumatology Professionals Annual Meeting (Press)
• Gossamer Bio Announces Clinical Trial Collaboration Agreement With Merck to Evaluate GB1275 in Combination With KEYTRUDA® (Pembrolizumab) in Selected Advanced Solid Tumors (Press)
• Mycovia Pharmaceuticals Announces Early Completion of Enrollment for Global Phase 3 Clinical Trials for VT-1161 (VIOLET) for the Treatment of Recurrent Vulvovaginal Candidiasis (Press)
• Boehringer Ingelheim and Lilly initiate first ever study to assess empagliflozin in people hospitalised for acute heart failure who have been stabilized (Press)
• Lilly Presents Positive New Data from COAST-X, a Phase 3 Study of Taltz® (ixekizumab) in Patients with Non-Radiographic Axial Spondyloarthritis (Press)
• IVERIC bio Initiating Second Pivotal Clinical Trial of Zimura® in GA with 1Q 2020 Targeted for First Patient Enrolled (Press)
• Poxel Announces Presentation of PXL065 Phase 1a Results at the Liver Meeting® 2019 (Press)

• IMDRF Offers Three Final Clinical Guidelines (Focus)
• FDA panel wants info on metal implant reactions (MassDevice)
• Connected injection devices: Human Factors Challenges (Emergo)
• Indian device for cancer fight gets USFDA’s ‘breakthrough’ tag (Times of India)
• FDA grants breakthrough status to AI-based gastric cancer diagnostic (MedtechDive)
• Medtronic's Micra AV pacemaker meets study goals, submitted for FDA review (MedtechDive)
• Philips issues urgent field safety notice for V60 ventilators (MassDevice)
• DHS warns on Medtronic Valleylab cybersecurity vulnerabilities (MassDevice)
• Establishment Labs sees 40% rise in breast implant sales, on track for $100M benchmark in 2020 (MedtechDive)
• Hologic Announces FDA Approval of 3DQuorum™ Imaging Technology, Powered by Genius AI™ (Press)
• NantHealth Announces FDA Marketing Authorization of Omics Core℠: The Nation’s First Tumor-Normal Mutation Profiling of Overall Tumor Mutational Burden from Whole Exome Sequencing in Solid Tumors (Press)

• How CMS steered funds toward Trump allies (Politico)
• Hospital sticker prices can rise faster than inflation (Reuters)
• Gene Therapy Payment Models Could Be One Focus For 'Cures II' (Pink Sheet-$)
• Allina Comes to Our Neck of the Woods (Drug & Device Law)
• Juul to cut 650 jobs, or 16% of its workforce, slash $1 billion in costs (CNBC)
• Most Americans Wrongly Think CBD Is Regulated By FDA, Survey Finds (Forbes)

• FDA Advisory Committee Calendar

• UK BIA Targets Next Government With ‘Biotech Manifesto’ (Pink Sheet-$)
• France to Maintain Fast Track Schemes for Clinical Trials (Focus)

• Asia Regulatory Roundup: Industry Questions TGA’s Ability to Enforce Proposed Software Rules (Focus)
• China’s regulator accepts surufatinib NDA in non-pancreatic neuroendocrine tumors (PharmaLetter-$)
• Biocon Biologics debuts in Asia IP Elite list (Economic Times)

• Indian Pharma Market growth slips to 5.1% in October 2019 (Pharmabiz)
• Make cancer treatment affordable, upgrade infrastructure: Parliamentary panel (Economic Times)
• NPPA defers decision on Meril’s stent pricing plea (Economic Times)
• India woos Japanese medical device companies (Economic Times)