Recon: J&J Hit With $8B Damages in Risperdal Suit; FDA Approves Clinuvel’s Genetic Skin Disorder Drug

• J&J Hit With $8 Billion Jury Award Over Antipsychotic Drug (WSJ) (Reuters)
• FDA approves Clinuvel's rare genetic disorder treatment, shares at record high (Reuters) (FDA)
• Trump to Sign Order Reining in ‘Rogue Agencies’ Rulemaking (Bloomberg)
• Cracks in Purdue's proposed opioid settlement as Arizona backs out (Reuters) (Law360-$)
• 2020 Democrats embrace aggressive step on drug prices (The Hill)
• Illumina confronts the innovator’s dilemma (STAT)
• The return of Vioxx: Can a drug once deemed deadly be relaunched to treat rare disease? (STAT)

• The new top 20 pharma list: Takeda jumps on, Biogen pushed out — and more big changes are on the way (Endpoints)
• GSK recalls popular heartburn drug Zantac globally after cancer scare (Reuters) (The Guardian)
• Swedish hospital sounds all clear after testing patient for Ebola (Reuters) (NBC)
• Novo taps bluebird bio for gene-editing tech (Fierce)
• Merck seeks partner for disease-modifying osteoarthritis drug (PMLive)
• Scotland’s SMC OKs Drugs For Cancer & Plaque Psoriasis (Pink Sheet-$)
• Bayer forms drug discovery pact with Japan's Riken Innovation (Fierce) (Press)
• Another one of Neil Woodford's portfolio companies escapes as UK biotech execs flee (Endpoints)

• Pharma, Biotech VC Investments Continue Shift to Early Stage Deals (Xconomy)
• Five Years After Y Combinator First Admits Biotechs, They’re Dug In (Xconomy)
• Partner Bayer pushes Ionis' antithrombotic drug into mid-stage development (Endpoints)
• Pregnant Women Should Get Flu and Whooping Cough Shots, CDC Says (NYTimes)
• Sexually Transmitted Disease Cases Rise to Record High, CDC Says (NYTimes)
• BioMarin puts Lon Cardon in charge of portfolio strategy while gene therapy filings get underway (Endpoints)
• Theragnostics, GE Healthcare announce prostate cancer diagnostic partnership (PharmaTimes) (MassDevice)
• Defying FDA: Shanghai Lab Gets Warning Letter But Won’t Relent (Pink Sheet-$)
• GSK partners with Lyell Immunopharma to develop cell therapies for cancer (Pharmafile)
• Novartis' ligelizumab outperforms Roche's Xolair in chronic urticaria clearance (Pharmafile)
• A new player is taking the field in a push for a hemophilia A gene therapy, and it’s a big one (Endpoints)
• FDA Issues Draft Guidance on Expanded Conditional Approval for Animal Drugs (FDA Law Blog)
• Prolific Insilico scores up to $200M deal in China; Researchers retract paper on gene involved in CRISPR baby controversy (Endpoints)
• A small biotech raises the price on its cancer drug by 20% this year, but will anyone notice? (STAT)
• ICER’s concern for patients: Where’s the beef? (STAT)
• Audentes' Gene Therapy Allows Ventilator Independence For Rare Disease (Scrip-$)
• Innovative treatment Cablivi (caplacizumab-yhdp) granted new technology payment (NTAP) for Medicare payment (Press)
• Economic Impacts of the California Institute for Regenerative Medicine (CIRM) (Report)
• ICU Medical Issues a Voluntary Nationwide Recall of Certain Lots of Plum and Sapphire Microbore Infusion Sets with Inline Filters (FDA)

• FDA approves Pfenex's osteoarthritis drug for patients at high risk of fracture (Pharmafile)
• Shionogi celebrates antibiotic win in pneumonia just ahead of its date with FDA regulators (Endpoints) (Press)
• FDA Approves Octapharma’s WILATE® for Hemophilia A in Adult and Adolescent Patients (Press)
• Dermira Announces Initiation of Phase 3 Program Evaluating Lebrikizumab in Patients with Moderate-to-Severe Atopic Dermatitis (Press)
• Galderma Announces Positive Phase 2 Results for its Proprietary Liquid Formulation of an Investigational Botulinum Toxin and Approval of New State-of-the-Art Manufacturing Facility (Press)
• Annexon Biosciences Reports Top-line Phase 1b Results for Novel C1q Inhibitor ANX007 in Glaucoma (Press)
• Stuck with a PhIII gene therapy failure at 96 weeks, GenSight prefers the upbeat assessment (Endpoints)
• VirTrial Awarded FDA-Approved Decentralized Clinical Trial with Hope Biosciences (Press)

• Medtronic Recalls 6 French Sherpa NX Active Guide Catheters Due to Separation and Fragmentation Issue (FDA)
• Dexcom G6 Pro CGM gets FDA nod (Mobihealthnews)
• Qiagen and Illumina in It for the Long Haul with 15-year Collaboration (MDDI)
• Medtronic and Axonics Go Toe-to-Toe in Fast-Growing Sacral Neuromodulation Market (MDDI)
• Corvia Medical's Interatrial Shunt Device (IASD®) Receives Breakthrough Device Designation For Heart Failure (Press)
• BioCardia wins CE Mark renewal for Helix, Morph catheters (MassDevice)
• Mobidiag Gets CE Mark for Intestinal Parasites Test (GenomeWeb)
• Study: Abbott, Edwards may have mislabeled hundreds of patient deaths (MassDevice)

• Medicare Fraudsters Now Tap Telemedicine In Medical Equipment Scams (KHN)
• Questions Swirl Around Opioid MDL Bellwether Trial (Law360-$)
• Amid next-gen vaccine race, Merck says ex-employee bolted to Pfizer with 'thousands' of key documents (Fierce)
• Purdue's Sackler Family Loses Bid To Toss Mass. Opioid Suit (Law360-$)
• Purdue Agrees To Put Off Consideration Of Ch. 11 Bonuses (Law360-$)
• Insys Seeks Extension Of Ch. 11 Plan Exclusivity Period (Law360-$)
• Ex-Biomet worker in Brazilian bribery case loses appeal in defamation suit (MassDevice)
• PixarBio CEO's Greed Drove Stock Fraud, Boston Jury Hears (Law360-$)
• Pharmacists in Maryland Owe No Duty of Informed Consent (Drug & Device Law)
• OSI Pharmaceuticals, LLC v. Apotex Inc. (Fed Cir. 2019) (Patent Docs)

• FDA Advisory Committee Calendar
• Enhancing the Clinical Trial Enterprise for Antibacterial Drug Development in the United States – 18-19 November 2019
• Workshop on the role of registries in the monitoring of cancer therapies based on genetic and molecular features – 29 November 2019
• Advancing the Development of Pediatric Therapeutics: Pediatric Clinical Trial Endpoints for Rare Diseases with a Focus on Pediatric Patient Perspectives; Public Workshop – 12 November 2019
• PMDA-ATC Pharmacovigilance Seminar 2020 – 3-6 February 2020

• MHRA Portal: register to submit forms (MHRA)
• Medical devices: UK notified bodies (MHRA)
• Good manufacturing practice and good distribution practice (MHRA)
• Guidance on pharmacovigilance procedures in the event of a no-deal Brexit (MHRA)
• Guideline on Paediatric Investigation Plans, waivers, deferrals and compliance check (MHRA)
• Completed Paediatric Studies - submission, processing and assessment in a no-deal Brexit (MHRA)
• Converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs) in a no-deal Brexit, 'grandfathering' and managing lifecycle changes (MHRA)
• Rocket and NuSurgix fetal blood sampling (FBS) amnioscopes and FBS kits – stop using ethyl chloride spray during the fetal blood sampling procedure with these devices (MDA/2019/035) (MHRA)
• Intraoperative probe cover with long Surgi-tip – risk of infection due to manufacturing failure (specific lot numbers affected) (MDA/2019/034) (MHRA)

• CDSCO notifies four medical devices testing labs in the country to ensure quality (Pharmabiz)
• Govt assures regulation of all medical devices in a stipulated time frame (Pharmabiz)
• NHSRC re-designated as WHO collaborating centre for priority medical devices and health technology policy (Pharmabiz)

• Guidelines for using the TGA assessed claim on medicine labels (TGA)
• Targeted consultation: Review of chemical scheduling in relation to cosmetic and fragrance ingredients (TGA)
• Importation of e-cigarettes containing nicotine (and nicotine-containing liquids for use in e-cigarettes) (TGA)