Recon: Novartis Drops 20% of Drug Research Programs; Pfizer Reports Mixed Q3 Results

• Pharma’s ‘come-to-Jesus moment’: The industry braces for a Pelosi speakership and Democrats’ drug pricing agenda (STAT)
• Pfizer cuts revenue forecast as supply snags, dollar strength weigh (Reuters) (CNBC) (Financial Times) (Press)
• He Promised to Restore Damaged Hearts. Harvard Says His Lab Fabricated Research. (NYTimes)
• Heart failure study paused over concerns about disputed cell therapy papers (STAT) (NIH)
• Financial conflicts of interest in clinical practice guidelines remain an ‘intractable problem’ (STAT)
• J&J loses patent fight over key prostate cancer drug, teeing up generic competition (STAT)
• FDA Blasts Data, Trial Design For Alkermes Depression Drug (Xconomy) (Endpoints)
• Lucrative Drug Trials Prompt Regional Hospitals to Join Forces (Bloomberg)
• Ex-Genentech Workers Charged With Stealing Secrets to Taiwan (Bloomberg) (Fierce)
• Doctors Test Bacterial Smear After Cesarean Sections To Bolster Babies' Microbiomes (NPR)
• Pre-Existing Immunity to CRISPR Found in 96% of People in Study (Xconomy)
• Glenmark opens $100M plant in North Carolina, its first in US (Fierce)
• Pfizer manufacturing ills mean ongoing shortages for hospitals (Fierce)
• Supreme Court Won't Look At HIV Drug Patent Challenge (Law360-$)
• J&J Zytiga patent struck down by US court, opening door for generics (BioPharmaDive) (Fierce)

• Novartis Cuts 20% of Drug-Research Projects After Review (Bloomberg) (Endpoints)
• AstraZeneca hands over some rights to Nexium, Vimovo to Grünenthal as it plots turnaround (Endpoints)
• Johnson & Johnson to open JLabs virtual networking pod in Philadelphia (Fierce)
• NHS to receive additional £20.5 billion each year from 2018 Budget (Pharmafile) (PMLive)
• GSK’s says depot HIV injection works over three years (PMLive) (PharmaTimes)
• Aspen Pharmacare to build $235M production facility in South Africa, add hundreds of jobs (Fierce) (Press)
• India Pharma Firms Eye China, Dr Reddy’s Sees ‘Great Opportunity’ There (SCRIP-$)
• Roche, Novartis are revving up next-generation eye drugs, but are they true contenders? (Fierce)
• Half of all kidney cancer patients initially misdiagnosed (PharmaTimes)
• WHO says air pollution kills 600,000 children every year (Reuters)
• Brazil’s ANVISA Reports Increase in Medical Device Modification Submissions (Emergo)
• Draft agenda - HMA/EMA workshop on availability of authorised medicines (EMA/HMA)

• US FDA May Create Rare Disease Expert Pool For Advisory Committee Reviews (Pink Sheet-$)
• The hunt for an Ebola drug (Medical XPress)
• Arch Venture sets its sights on raising $600M for Fund X (Endpoints)
• Extended Use Dates Provided by Impax Generics to Assist with Epinephrine Auto-Injector Intermittent Supply Interruptions (FDA)
• Patient-Focused Drug Development: US FDA 'Needs To Be Brave,' Tell Sponsors What Works Best (Pink Sheet-$)
• Real-World Evidence Could Speed Development Of Drugs Offering Incremental Improvements (Pink Sheet-$)
• Novo Nordisk leads pharma pack breaking into Reputation Institute’s corporate responsibility ranking (Fierce)
• Terns scores $80M in Series B financing led by Vivo, OrbiMed (Endpoints)
• WuXi dives into computational drug discovery, launches New York-based JV with Schrödinger (Endpoints)
• DrugCentral 2018: an update. (Oxford Academic)
• Opioid Antidote Can Save Lives, But Deciding When To Use It Can Be Challenging (NPR)
• 'Unprecedented' demand for Merck's Gardasil drives monster Q3 (Fierce)
• Re-assessing the rule of 5, two decades on (Nature)
• FDA new drug approvals in Q3 2018 (Nature)
• Curing infection with antibacterial drones (Nature)
• Eliminating mutant mitochondrial DNA (Nature)
• Nicox pauses Nasdaq IPO plan amid market volatility (Fierce)
• Bach, Trusheim, Sen. Cassidy Outline Scheme For Subscription-Based Purchasing (BioCentury)
• States With Age Restriction On OTC DXM Sales Number 17 – And Counting (Pink Sheet-$)
• Aurobindo Pharma Limited Issues Voluntary Recall of Irbesartan Drug Substance due to the Detection of Trace Amounts of NDEA (NNitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API) (FDA)

• Gilead Announces 96-Week Results From Phase 3 Study of Biktarvy® (Bictegravir, Emtricitabine, Tenofovir Alafenamide) for the Treatment of HIV-1 in Adults New to HIV Therapy (Press)
• Alkermes Announces Publication of Phase 3 Data for ALKS 5461 for Adjunctive Treatment of Major Depressive Disorder in Molecular Psychiatry (Press)
• Horizon Pharma plc Announces Presentation of Results of 48 Week Off-Therapy Follow-Up to the Phase 2 Trial of Teprotumumab at 2018 American Academy of Ophthalmology (AAO) Annual Meeting (Press)
• Variant Pharmaceuticals Submits Application for U.S. Orphan Drug Designation for VAR 200 (2-Hydroxypropyl-β-Cyclodextrin) To Treat Focal Segmental Glomerulosclerosis (FSGS) (Press)
• Aura Biosciences Presents Updated Phase 1b/2 Clinical Data for AU-011 at the American Academy of Ophthalmology 2018 Annual Meeting (Press)
• FDA Grants Breakthrough Therapy Designation (BTD) for UroGen Pharma’s UGN-101 for the Treatment of Patients with Low-Grade Upper Tract Urothelial Cancer (LG UTUC) (Press)
• L.E.A.F. Pharmaceuticals Receives Positive US FDA Feedback and Comprehensive Roadmap for Clinical Development as well as Registration of its Four Lead Novel Anticancer Drugs (Press)
• Cellix Biosciences Completes Pre-IND Meeting with FDA on CLX-103 for Ulcerative Colitis (Press)
• Achieve Life Sciences Announces Initiation of Phase 2b ORCA-1 Trial Evaluating Cytisinicline (cytisine) for Smoking Cessation (Press)
• CStone announces first patient dosed in Phase I study in China for MEK inhibitor CS3006 (Press)
• Syros to Present Clinical and Preclinical Data on SY-1365 and Earlier-Stage Pipeline at EORTC-NCI-AACR Meeting (Press)

• FDA Issues Two New Guidance Documents on Voluntary Consensus Standards, Consolidating and Replacing Earlier Guidance (FDA Law Blog)
• Amazon launches medical device brand focused on diabetes and cardiovascular disease (MedCity)
• Novarad lands FDA clearance for its HoloLens-augmented preoperative system (mobihealthnews)
• Connected armband detects 85 percent of nighttime epileptic seizures in new trial (mobihealthnews)
• Baxter wins CE Mark for PrisMax continuous renal replacement system, TherMax blood warmer (MassDevice)
• Sanofi leads $50m round for Enable Injections’ on-body drug-delivery platform (Drug Delivery)
• Impulse Dynamics wins FDA panel date for Optimizer PMA (MassDevice)
• Prevent Biometrics acquires X2 Biosystems head impact monitoring assets (MassDevice)
• Aptatek BioSciences, Inc. Receives FDA Breakthrough Device Designation for a Home-Based Test System that Enables Patients to Monitor Blood levels of Phenylalanine in Real Time (Press)

• Kentucky AG Sues Teva for Promoting Off-Label Uses of Fentanyl Products (FDANews-$)
• How SUPPORT Will Affect Pharma Interactions With DEA (Law360-$)
• Judge Lets FTC Slip Allergan’s Suit, But Rips Venue Conduct (Law360-$)
• Endo Shareholders Fight Bid To Nix Generic Price-Fixing Suit (Law360-$)
• Solicitor General Asked To Weigh In On Roche Patent Appeal (Law360-$)
• In Shadow Of Opioid Crisis, Methamphetamine Use Rising In US (Forbes)
• Aetna Reports $1B Profit As Sale To CVS Health Nears Closing (Forbes)
• Red state governor races could bring Medicaid expansion to millions (Politico)
• Third Circuit Rejects Failure to Report Claims (Drug & Device Law)

• FDA Advisory Committee Calendar
• Science Advisory Board to the National Center for Toxicological Research Advisory Committee; Notice of Meeting – 4-5 December 2018

• EC opens up Xtandi use to non-metastatic group (PharmaLetter-$)
• Johnson & Johnson boost vaccine production at Dutch facility (BioPharmaReporter)
• Medicines: reclassify your product (MHRA)

• Finance ministry clarifies on procedure for return of expired drugs under GST (PharmaBiz)

• Baby 'sleep sacks' might be safer than blankets (Reuters)