Recon: Following Pfizer, Novartis Hits Pause on Price Hikes

• Bill Gates jump-starts research for an affordable Alzheimer's test (CNN) (Fortune) (Forbes)
• Novartis shelves US price increase (Financial Times) (CNN) (WSJ) (Bloomberg) (Reuters)
• Pfizer-Lilly pain drug meets late-stage trial goals (Reuters) (BioPharma Dive) (Endpoints) (Fierce)
• Sanofi bags rights to Revolution’s SHP2 cancer drug (Fierce) (Endpoints) (C&EN)
• Questions Raised About “Breakthrough” Therapies’ Clinical Support (The Scientist) (AJMC) (CNN)
• Abbott Labs Rallies to Record Despite Strong Dollar (Bloomberg) (Forbes) (Reuters) (MassDevice)
• J&J joins blockbuster HIV combo race with newly approved 4-in-1 pill (Endpoints) (PharmaTimes)
• How drugmakers sway the state system meant to protect taxpayers and patients (Center for Public Integrity/NPR) (Axios)

• Medical devices woes weigh on British conglomerate Smiths Group (Financial Times) (Reuters)
• Hikma acts to ease critical shortage of pain meds in USA (The Pharma Letter) Reuters)
• AstraZeneca to stockpile drugs for Brexit (BBC News) (The Telegraph) (Reuters)
• China heart drug sold globally may have had impurity since 2012 (Reuters) (Newsweek)
• J&J Unit to Sell Sylvant Rights to U.K. Drugmaker Eusa Pharma (Bloomberg) (The Pharma Letter)
• Takeda Bets on China for Global Growth (Bloomberg)
• Ovid, Takeda add 2 rare epilepsies to rare drug pact (Fierce)
• U.N. says global fight against AIDS is at 'precarious point' (Reuters)
• GE Health, Change Healthcare, Medtronic to Receive Israeli Government Grant (CTech)
• Funding gaps threaten closure of health facilities serving almost one million vulnerable Iraqis (WHO)

• Biotech IPO Boom Comes With Side Effects (WSJ)
• The News on Drug Prices? Nothing Good (NYT)
• McKesson, Cardinal Health Must Face New York Opioid Suits (Bloomberg)
• Senate Eyes Drug Treatment Record Privacy Changes (Bloomberg-$)
• New challenge filed to CRISPR patent licensed by Editas Medicine (STAT-$)
• Boston-area companies bet on antibiotic development, even as big drug makers step back (STAT-$)
• Lilly CEO Breaks From PhRMA, Innovators With Support For CREATES Act (Scrip-$)
• Boom time: Rubius, Crinetics find big support in upsized IPOs totaling $343M raise (Endpoints)
• Startup Neuraly Launches with $36 Million: Targets Neurodegenerative Diseases (BioSpace)
• Boehringer exercises option to license novel TCRm antibodies (The Pharma Letter-$) (Press)
• Where does J&J's new drug fit in the crowded HIV market? (BioPharma Dive)
• Appeals court rejects hospital industry’s challenge on 340B changes (STAT)
• Administrator Verma Statement on Recent 340B Court Decision (CMS)
• Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of Valsartan and Valsartan Hydrochlorothiazide Tablets (FDA)

• FDA Uses New Process to Approve Ribociclib Extensions (Medscape) (FDA)
• Eisai obesity drug Belviq may have an edge with new heart safety data—but to what end? (Fierce)
• Roche's Tecentriq extends its hot streak with liver cancer combo breakthrough (Fierce)
• Type 2 diabetes research: fewer side effects from modified medication (pharmaphorum)
• Broadly acting antibodies found in plasma of Ebola survivors (NIH)
• Issuance of Priority Review Voucher; Rare Pediatric Disease Product to GW Research (FDA)
• Karyopharm Initiates Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Selinexor as a Treatment for Patients with Penta-Refractory Multiple Myeloma (Press)
• FDA Accepts Biologics License Application for Filing and Grants Priority Review for Sacituzumab Govitecan for the Treatment of Metastatic Triple-negative Breast Cancer (Press)
• Catalyst Biosciences Announces Positive Interim Data from a Phase 2/3 Study of Marzeptacog Alfa (Activated) in Individuals with Hemophilia A or B with Inhibitors (Press)
• CTI BioPharma Announces Pacritinib Program Update Following Type B Meeting with U.S. FDA (Press)
• Adaptimmune Announces Favorable Review of Safety from One Billion Cell Dose Cohort in MAGE-A10 SPEAR T-cell Study and Initiation of Third Dosing Cohorts (Press)
• Data to be Presented From Biogen’s Alzheimer’s Disease Clinical Development Portfolio at the 2018 Alzheimer’s Association International Conference (AAIC) (Press)
• Biogen receives FDA orphan drug designation for treatment of spinal muscular atrophy (FDA)
• Puma Biotechnology and Strata Oncology Announce Collaboration to Accelerate Enrollment in Neratinib HER2 Mutation Basket Study (SUMMIT Trial) (Press)
• Poxel Announces Favorable Results for PXL770 Phase 1b Multiple Ascending Dose Trial and Drug-Drug Interaction Study (Press)

• Cook Medical touts launch, first use of Advance CS, Compass CT systems (DDBN)
• Why a Melanoma Blood Test Would Be Such a Big Deal (Fortune)
• Genetic testing is coming of age, but for consumers it's buyer beware (CNBC)
• Polares raises $25M to bring its 'hemi-replacement' mitral valve to the clinic (Fierce)
• Diassess to get up to $21.9M from the feds to develop its at-home flu diagnostic (Fierce)
• FDA Clears First Nanotechnology Peek Devices for Spinal Intervertebral Fusion (Press)
• Zavation Announces 510(k) Clearance of the Normandy VBR System (Cervical and Thoracolumbar Expandable Corpectomy Cage) (Press)
• Acron Medical Announces FDA 510(k) Clearance of its Signature PEEK TLIF Interbody System, the ACRON Interbody. (Press)
• Spectral Announces Successful Manufacturing Audit of Toray by the US FDA (Press)
• Adaptiiv Receives FDA 510(k) Clearance to Market 3D Bolus Software (Press)

• Insurers are helping shape the future of our health care system (STAT)
• Cyberattacks on Health-Care Providers Are Up in Recent Months (Bloomberg)
• NIH and Prostate Cancer Foundation launch large study on aggressive prostate cancer in African-American men (NIH)
• Overcoming health-care challenges by moving from volume to value (The Hill)
• ONC opens innovation contest for Certified Health IT Product List data (Healthcare IT News)
• LabCorp goes down after network breach, putting millions of patient records at risk (Healthcare IT News)
• No exclusive deal, no problem: Quest and LabCorp shares surge on optimism (CNBC)
• Big money rolls in as GOP challenger pressures Democratic Sen. Bob Menendez for his traditionally safe seat in New Jersey (CNBC)
• FDA Updates Patent Listing Disputes (Lachman Consultants)
• CDx Diagnostic, Inc. v. United States Endoscopy Group, Inc. (S.D.N.Y. 2018) (Patent Law Weblog)

• FDA Advisory Committee Calendar

• NICE calls for quicker treatment of kidney stone patients in pain (PharmaTimes)
• Record numbers taking part in life sciences industry research (PharmaTimes)
• OD-OS claims European ophthalmic-laser patent win over Iridex (MassDevice)
• Co-Diagnostics Completes Submission of CE Mark Registration for Tuberculosis Screening Test (Press)

• Pre-revenue vaccine developer CanSino lines up at a buzzing HKEX (Endpoints)
• Home DNA Testing Starts to Gain Ground in Japan’s Aging Society (Bloomberg-$)
• Joint R&D program to test Keytruda combo in breast cancer patients (Korea Biomedical Review)
• Novo Nordisk Korea gets nod for diabetes drug Fiasp (Korea Biomedical Review)
• MHLW to Introduce Guidelines for Sales Reps’ Activities, Calling for the Creation of Supervising Offices (Pharma Japan)

• Amazon to invest in Indian Pharma brand MedPlus (BioSpectrum)
• Govt grants four-month relaxation to Tramadol manufacturers and exporters to clear the existing stock (Pharmabiz)

• Intragastric balloon systems: TGA product safety review (TGA)
• Sodium glucose co-transporter 2 inhibitors: Safety advisory - diabetic ketoacidosis and surgical procedures (TGA)
• A$50 million to provide life-saving support to cancer patients in Australia (The Pharma Letter-$)

• Are opioid deaths reducing our average life expectancy? Canada now investigating (Global News)
• Health Canada is ordered to provide clinical trial data on several medicines to a researcher (STAT-$)
• Panther Medical Canada Inc. Opens in Canada Bringing State of the Art, Clinically Proven, Economically Viable Laparoscopic Surgical Solutions, while Saving Tax Payers Millions in Health Care Costs (Press)

• What Can Odd, Interesting Medical Case Studies Teach Us? (NYT)
• The Startup Selling Generic Viagra and Rogaine to the Instagram Crowd (Bloomberg)
• Hospitals up the ante for medical transcription tools as vendors modernize with automation, voice recognition (Healthcare IT News)
• How to put your medical history on your iPhone in less than 5 minutes (CNBC)