Recon: Merck Leapfrogs Bristol-Myers to Take the Lead on PD-1/L1 market

• Amgen R&D head Harper to leave (Fierce) (Endpoints) (WSJ) (Bloomberg)
• After an epic battle of blockbusters, Merck leapfrogs Bristol-Myers to take the lead on PD-1/L1 market (Endpoints) (Reuters) (Bloomberg) (Financial Times)
• Achaogen Eliminating 80 Jobs, 28% of Staff, in Restructuring (GEN) (Fierce) (Endpoints)
• Sutro raises $85.4 million in Series E round to advance blood cancer, solid tumor drugs (MedCity News) (Endpoints) (Fierce)
• AbbVie tops second-quarter estimates, sets higher earnings target (Reuters)
• No, A Big NIH Trial Did Not Show That Lowering Blood Pressure Will Prevent Dementia (Forbes)

• Medicine production in Bangladesh: GSK shuts factory after six decades (The Daily Star) (Reuters)
• Bluebird’s first gene therapy gets European fast track (PMLiVE) (The Pharma Letter-$)
• Cannabis-based medicines get green light as UK eases rules (The Guardian) (Reuters) (Gov UK)
• China says vaccine maker Changsheng broke manufacturing rules, faked records: Xinhua (Reuters)
• Airborne Ebola: new species of notorious virus is discovered in bats in Sierra Leone (South China Morning Post) (STAT) (Sierra Leone Telegraph)
• Urgent increase in hepatitis testing and treatment needed (WHO)

• Several of the Biggest Pharma Giants Are Freezing Drug Prices. Here's How It Will Affect You (TIME)
• CRISPR Chaos: 3 Shorts And A Buy In Gene Editing (Forbes)
• Right To Try For Some Raises False Hopes For Many (Forbes)
• Apotex acquisition likely to reduce Aurobindo's dependence on US market (Business Standard)
• Judge's order keeps opioid pill numbers under wraps (Charleston Gazette)
• When modest is actually excessive: AstraZeneca spins its price hikes (STAT-$)
• FDA Chief Wants to Break Down Rare Disease Drug Monopolies (Bloomberg-$)
• McKesson Sales Growth at Risk as Drugmakers Curb Price Increases (Bloomberg-$)
• Horizon Pharma Vimovo Suit Won’t Wait for Patent Board (Bloomberg-$)
• Pharma AI Requires a New Approach to Governance (PharmExec)
• GlaxoSmithKline's Shingrix beats expectations again in Q2 despite supply constraint (Fierce)

• Alzheimer's research yields some promising results (Axios)
• Here’s why Biogen lost $7 billion overnight despite ‘positive’ Alzheimer’s data (STAT-$)
• Alzheimer’s Study Lacks `Shock and Awe’ Biogen Investors Sought (Bloomberg-$)
• Tonix crashes on PhIII PTSD failure, sending stock to the gutter (Endpoints)
• Sunovion drug cuts binge eating days at higher dose (BioPharma Dive)
• Tonix Pharmaceuticals Announces Outcome of Interim Analysis for Phase 3 HONOR Study of Tonmya in Military-Related PTSD (Press)

• Bayer's Removal Of Contraceptive Device Essure Praised By Activists (Forbes)
• Warning Claims Axed In Bard Blood Vessel Filter Bellwether (Law360-$)
• Artificial hip maker demands retraction of a paper calling its research ‘grave fraudulence’ (STAT)
• Flexible electronics are the key to a human ‘check engine’ light (STAT)
• MilliporeSigma, InnoCore team up on extended-release platform for large biologics (Fierce)
• Pharmacokinetic study of Proteus' ingestible sensor paves way for clinical trials of HIV prevention drug (MobiHealthNews)
• FDA Regulation of Mobile Medical Apps (JAMA)
• Improving Access To Medical Devices: The Use And Evolution Of Objective Performance Criteria (Health Affairs)
• NuVasive Unveils Spine's First Integrated Surgical Automation Platform (Press)
• Adherium Receives Additional U.S. FDA 510(k) Clearance, Setting in Motion a Full U.S. Consumer Launch of the Hailie Solution (Press)
• Mighty Oak Medical Receives FDA 510K Clearance for S2AI (Press)
• New Study Investigates Impact of General Ward Clinical Monitoring Using Masimo Root, Radius-7, and Patient SafetyNet on Clinical Workflow and Patient Care (Press)
• BD Drives the Future of Immunology Research with Expanded Offerings for Simultaneous RNA and Protein Expression Analysis (Press)

• Switch to electronic health records tied to fewer hospital deaths (Reuters)
• FDA’s Exploration of Innovation vs. Access Continues with Public Hearing on the Biosimilar Marketplace (FDA Law Blog)
• States sue Trump administration over expansion of skimpy group insurance plans (The Hill)
• Why Medicare is going after hospital outpatient rates (Axios)
• Proposed site-neutral payment policy sets the stage for battle royale between CMS, hospitals (Modern Healthcare)
• Doctors Hold the Key to Lower Drug Prices (Bloomberg)
• NIH Nixes Ethics Review of Human Research Grant Proposals (Bloomberg-$)
• Dozens of patient and provider groups ask state insurance officials to probe a cost-shifting tool (STAT-$)
• Ciitizen raises $3M for personal health records, soon to open private beta (MobiHealthNews)
• Mammography Facility Adverse Event and Action Report – July 26, 2018: Palm Beach Broward Medical Imaging Center (FDA)

• FDA Advisory Committee Calendar

• Protecting innovation in pharma is in Ireland’s interests (Irish Times)
• Congenica aims to turn data into information (EP Vantage)
• Nanobiotix signs €40m deal with the EIB (PMLiVE)
• Bristol-Myers Drops After Cancer Drug Combo Rejected in Europe (Bloomberg-$)
• NHS test drones for blood and medical test delivery between London hospitals (Healthcare IT News)
• PharmaMar Reaches an Agreement With Impilo Pharma, a Part of Immedica Group, for the Promotion and Distribution of Yondelis in the Nordic Countries and Eastern Europe (Press)
• Philips and Oxford University Hospitals NHS Foundation Trust team up to deploy innovative digital pathology network (Press)

• In for the China biotech gold rush, BeiGene eyes monster $800M-plus Hong Kong IPO (Endpoints)
• Pfizer gets additional indication for kidney cancer drug Sutent (Korea Biomedical Review)
• China FDA Adds to List of Medical Devices, IVDs Exempt from Clinical Trials (Emergo Group)
• Final Guidance on Saudi Arabia’s Medical Device National Registry (MDNR) Route Published (Emergo Group)
• China's New Medical Device Regulations Bring Big Changes (Lexology-$)
• Solasia wins Chinese approval for transdermal anti-emetic patch (The Pharma Letter-$)
• AstraZeneca CEO champions China’s Internet of Things tech (pharmaphorum)

• KAPL to be sole manufacturer & supplier of Oxytocin injection for domestic use from Sept 1 (Pharmabiz)
• Companies drag J&K and central government to court over rolling back tax sops (Economic Times)
• TPG Capital to buy into Sai Life Sciences (Economic Times)

• Australian regulatory guidelines for biologicals (ARGB) (TGA)
• General dossier requirements (TGA)
• Syphilis: How deadly disease has spread in Australia (BBC News)
• Aussie biotech firm wins 'fast track' US review for rare cancer drug (The Sydney Morning Herald)
• GPs and social service providers demand My Health Record protections (The Guardian)
• Access to My Health records too easy, police say (The Australian)

• Codeine tops list of pharmaceutical drugs reported missing in Manitoba (CBC News)

• The Real Future Of Artificial Intelligence And Cancer (Forbes)
• Effect of a Lay Health Worker Intervention on Goals-of-Care Documentation and on Health Care Use, Costs, and Satisfaction Among Patients With Cancer (JAMA)
• Hospitals know how to protect mothers. They just aren’t doing it.  (USA Today)