Recon: Novartis to Cut 2,550 Jobs in Switzerland, UK

• Amarin Sees Off-Label Claims Boosted By Study Results (Law360-$)
• J&J pledges to end global TB pandemic (Pharmafile)
• Drug Industry Tries to Slip $4 Billion Windfall Into Opioid Bill (NYTimes)
• Roche's Tecentriq adds two months to lung cancer patients' lives: study (Reuters) (Endpoints) (Press)
• Gilead to launch generic versions of its hepatitis drugs (Reuters)
• AP investigation: Drug prices going up despite Trump promise (AP)
• Trial by Fire: Critics Demand That a Huge Sepsis Study Be Stopped (NYTimes)
• Paralyzed Patients Go From Wheelchairs To Walkers With Experimental Treatment (Forbes) (Reuters) (NEJM) (Nature)
• Pfizer hiring 350 at Kansas sterile injectables plant (Fierce)
• Insulin prices could be much lower and drug makers would still make healthy profits (STAT)
• High Hopes for a Gene Therapy Come With Fears Over Cost (WSJ)
• AdvaMed lobbying CMS for speedy Medicare coverage of breakthrough devices (MedTechDive)
• Cerecor to Acquire Ichorion Therapeutics (Press)
• The FDA Amendments Act of 2007 — Assessing Its Effects a Decade Later (NEJM)

• Novartis to cut 2,550 jobs in Switzerland, UK in profit push (Reuters) (Pharmafile) (Endpoints) (Financial Times)
• Pharmaceutical industry donates millions to both Australian political parties (The Guardian)
• Brazil court strips Gilead of hepatitis C drug patent (Reuters)
• EU approves AstraZeneca immunotherapy drug for lung cancer (Reuters) (Financial Times)
• AstraZeneca immunotherapy drug cuts lung cancer deaths by almost a third (Reuters) (Endpoints)
• WHO extremely concerned about Ebola 'perfect storm' in Congo (Reuters)
• Some 129 countries sign up to Trump's pledge at UN to fight drugs (Reuters)
• As Trump's Trade War Grows, China Hits Medical Device Makers (Forbes)
• Japan's MHLW approves vibegron for overactive bladder (PharmaLetter-$)
• Biosimilars market to increase to $61.47 billion (EPR)
• Brazil Takes Steps Towards Harmonization On Pharmacovigilance (Pink Sheet-$)
• UK launch for Ferring’s new testosterone replacement therapy (PharmaTimes)
• Updated bioequivalence and biowaiver application documents (WHO)
• Additional bioequivalence information now required in Module 2.7 (WHO)
• New appendix added to Bioequivalence Trial Information (BTIF) (WHO)

• Researchers consider ethics of addressing race in biomedical studies (Reuters)
• Production costs and potential prices for biosimilars of human insulin and insulin analogues (BMJ)
• Me KASA es Su KASA – Long Overdue but Very Welcome (Lachman)
• A Beginning to Principles of Ethical and Regulatory Oversight of Patient-Centered Research (Annals of Internal Medicine)
• Unwanted by AbbVie and Infinity, battered Verastem gets an OK for duvelisib and a second shot at success (Endpoints) (Press)
• Cleveland Clinic “Outsourcing”? 503B Status Would Be Milestone For US FDA’s Compounding Model (Pink Sheet-$)
• Cantrell Drug Company Resumes Operations with FDA Approval (Press)
• FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases (FDA)
• FDA's Woodcock on drug companies' sluggish march toward manufacturing's future (BioPharmaDive)
• Another Precision Step for Roche as Ignyta Drug Heads to Regulators (Xconomy)
• To Lower Drug Prices, Look At Generic Industry Health Rather Than FDA, Woodcock Says (Pink Sheet-$)
• Praveen Tipirneni’s team at Morphic reels in an $80M round as they turn into the last stretch to the clinic — and a deal (Endpoints)
• The Quality Lowdown: The More Things Change … (Pink Sheet-$)
• Drugmakers Seek Clarification on Use of Liquids, Foods as Drug Delivery Vehicles (FDANews-$)
• Increased use of anti-clotting drugs tied to fewer strokes in patients with atrial fibrillation (Reuters)
• Communication Is Key To Quick ANDA Approvals, FDA Says (Law360-$)
• Arena 3 for 3 as Crohn’s drug meets proof-of-concept test (Fierce)
• FDA Announces FY 2019 Animal Drug User Fee Rates for ADUFA and AGDUFA (FDA)
• Aurolife Pharma, LLC, et al.; Withdrawal of Approval of Seven Abbreviated New Drug Applications (Federal Register)
• Fee for Using a Material Threat Medical Countermeasure Priority Review Voucher in Fiscal Year 2019 (Federal Register)

• FDA Grants QIDP and Fast Track Designations to Cidara Therapeutics’ Rezafungin Prophylaxis Development Program (Press)
• Spectrum Pharmaceuticals Announces Release of Updated Poziotinib Data From MD Anderson Phase 2 Study in Non-Small Cell Lung Cancer Patients (Press)
• Atox Bio Announces Independent Safety Monitoring Committee Recommendation to Continue Phase 3 Study of Reltecimod in Necrotizing Soft Tissue Infections (Press)
• Cerevance Announces First-in-Human Dosing of CVN424 for the Treatment of Parkinson’s Disease (Press)
• Horizon Pharma plc to Present 48-Week Follow-Up Analysis of the Teprotumumab Phase 2 Trial at the Annual Meeting of the American Thyroid Association (Press)
• Catabasis Pharmaceuticals Initiates Phase 3 PolarisDMD Clinical Trial for Edasalonexent in Duchenne Muscular Dystrophy (Press)
• Reata’s bardoxolone hits goals in phase 2 kidney disease trial  (Fierce)
• TP Therapeutics Announces Updated Interim Phase 1/2 Clinical Trial Data of Repotrectinib (TPX-0005) in ROS1 Fusion-Positive Non-Small-Cell Lung Cancer Patients at 19th World Conference on Lung Cancer (Press)

• Medtronic Launches the Infinity(TM) OCT Spinal System (Press)
• Medtronic Builds on TAVR Clinical Evidence Portfolio with Five-Year CoreValve Durability Data and Complete Two-Year Outcomes in Intermediate Risk Aortic Stenosis Patients (Press)
• At AdvaMed’s annual conference, CMS official to industry: Tell us the truth (MedCity)
• Can a Device Be Safe and Effective When FDA Recommends to Not Use It? (MDDI)
• Cook Medical Receives FDA Approval for First 5 mm Diameter SFA Drug-Eluting Stent (Press)
• Exceed Microneedling device first to receive FDA clearance for the treatment of wrinkles (Press)
• Synergy Biomedical Announces FDA Clearance of BIOSPHERE® FLEX (Press)
• Accuray touts high survival rate, low toxicity in Cyberknife studies (MassDevice)

• HHS Cuts Fetal Tissue Contract with Advanced Bioscience Resources (HHS)
• FDA is considering banning online sales of e-cigarettes: Gottlieb (Reuters)
• CIA Director Gina Haspel pledges to target opioids entering the US (NBC)
• Allergan and St. Regis Mohawk Tribe Sue Amneal Over Generic Restasis ANDA (FDANews-$)
• Better Late Than Never – Risperdal Plaintiff Verdict Tossed Out (Drug & Device Law)
• FDA Issues Final Rule on Voluntary Malfunction Summary Reporting Program for Device Manufacturers (FDA Law Blog)
• Opioids Could Become Bioterror Weapons, US Fears; BARDA Funds Countermeasures (Pink Sheet-$)

• FDA Advisory Committee Calendar
• Allergenic Products Advisory Committee; Notice of Meeting – 7 November 2018

• Letters and drug alerts sent to healthcare professionals in August 2018 (MHRA)

• Biosimilar Firms Main Beneficiaries Of Korea R&D Cost Accounting Changes? (SCRIP-$)

• In a first, syringe and needle manufacturers seek price cap (Economic Times)

• Mandatory reporting of shortages from 1 January 2019 (TGA)

• The Ethics Of Transhumanism And The Cult Of Futurist Biotech (Forbes)