Recon: Regeneron and Bluebird Team Up; Pain Therapeutics Receives Another CRL

• Regeneron And Bluebird Team To Invent New Cell Therapies For Cancer (Forbes) (Endpoints) (STAT-$) (GEN) (PMLiVE) (Fierce)
• The full Senate position on FDA appropriations (Alliance for a Stronger FDA)
• Ovid’s snapshot of broad efficacy data for their PhII Angelman syndrome trial can’t stop a rout — shares crushed (Endpoints) (Forbes) (Fierce)
• Pain Therapeutics CEO Lashes Out as FDA Rejects Company’s Remoxy (BioSpace) (Reuters)
• Samumed, a $12 billion startup that wants to cure baldness and smooth out your wrinkles, just raised even more funding as it plots an IPO (Business Insider) (Endpoints)
• Pfizer contracts with Antares to build a rescue auto-injector for an unnamed drug (Fierce)
• Drug distributor Cardinal's profit beats on pharma unit strength (Reuters) (MassDevice)

• How China Is Evolving From a Maker of Copycat Medicines Into a Producer of Complex Drugs (WSJ)
• China drug scandals highlight risks to global supply chain (Financial Times)
• Boehringer organizes a coalition in search of first CF gene therapy, working with research, manufacturing partners (Endpoints) (Fierce) (pharmaphorum) (PharmaTimes)
• China to add more cancer drugs to reimbursement list, talks end in Sept: Xinhua (Reuters)
• Novartis restrains local pharma Cos from making patent diabetes drug (Times of India)
• Korean drugmakers rush to establish US subsidiaries (Korea Biomedical Review)
• US proposal on drug pricing may shake up Indian pharma (The Hindu Business Line)
• Ebola vaccinations in eastern Congo due to begin on Wednesday (Reuters)

• Biological Markers to Measure Pain Could Lead to Better Meds (Bloomberg)
• Valeant Faces Wall Street in New Incarnation as Bausch (Bloomberg)
• Anti-Vaccine Activists Have Taken Vaccine Science Hostage (NYT)
• ICER Weekly View 08-03-18 (ICER)
• Administering Health Innovation (Cardozo Law Review)
• ​​​​​​​FTC Can't Block Theoretical Drugmaker Moves, Shire Says (Law360-$)
• Digital technologies hold the key to streamlining and improving clinical trials (STAT-$)
• Blumenthal to announce measures to fight skyrocketing drug prices (WTNH News)
• Tinkering at the edges of drug prices won’t help (American Enterprise Institute)
• Can FDA’s Drug Shortage Task Force Devise New Solutions to an Old Problem? (FDA Law Blog)
• Taking Prime position? A look at Amazon’s potential impact on pharma (EPM Magazine)
• 23andMe’s pharma deals have been the plan all along (Wired)
• Blockbuster dreams quashed, Ironwood drops AstraZeneca’s $1.3B gout drug disaster (Endpoints)
• Who are the most productive drug developers in biopharma? Our top-20 list has lots of surprises (Endpoints)

• Paratek antibiotic not inferior to current treatments: FDA staff (Reuters)
• High replication rate of induced pluripotent stems cells appears to contribute to breaks in DNA (FDA)
• Teva Announces Updated Indication and Vial Presentation for GRANIX (tbo-filgrastim) Injection in United States (Press)
• Alzheon Scientists Discover Endogenous Substance in Human Brain That Inhibits Formation of Toxic Beta Amyloid Oligomers, Key Driver of Alzheimer’s Disease (Press)

• Ind. Court Tosses Surgery-Privacy Suit Against Stryker (Law360-$)
• Questions Remain On FDA Opioid Device Innovation Challenge (Inside Health Policy-$)
• 4 Risks consumers need to know about DNA testing kit results and buying life insurance (CNBC)
• Severe Preeclampsia Heart Imaging Study Reveals Roots of Cardiac Damage in Pregnant Women (Johns Hopkins Medicine)
• Castle study shows DecisionDx gene test predicts melanoma risks better than staging alone (Fierce)
• Bionano files $30M IPO to fund its long base pair DNA sequencers (Fierce)
• Fuse Medical snaps up second company in a year (Medical Design & Outsourcing)
• GUDID Analytics August 2018 (FDA)
• STRATA Skin Sciences Announces FDA Granted 510(k) Clearance for the Multi Micro Dose Tip for its XTRAC 308nm Excimer Laser (Press)

• How Bill Gates Could Transform Alzheimer's Disease (Forbes)
• Obamacare Helped Make This Doctor a Billionaire (Bloomberg)
• Republicans eye another ACA repeal vote if midterms go their way (Axios)
• Less documentation, E/M pay changes proposed in 2019 fee schedule (AMA)
• Gawande says health venture is not seeking profits. But whose bottom line will it benefit? (STAT)
• Crowdfunding for unproven stem cell procedures wastes money and spreads misinformation (STAT)
• Science and Regulation of Live Microbiome-Based Products Used to Prevent, Treat, or Cure Diseases in Humans (FDA)

• FDA Advisory Committee Calendar

• Ireland’s IP image may be hit by drug patent waiver, pharma body warns (Irish Times)
• A Broken Arm in Italy: Waiting for Surgery (Forbes)
• Britain plans for opt-out organ donation scheme to save lives (Reuters)
• NHS faces legal action over fertility treatment for gender transitioning patients (pharmaphorum)
• Updated: Medical devices: UK notified bodies (MHRA)
• Veterinary medicines - information about market access during the implementation period following EU exit (MHRA)
• jHub looks for medical ideas and innovations (Gov UK)

• Janssen, Bayer to close plants in Korea (The Korea Times)
• Prudential and Babylon join forces in Asia (pharmaphorum)
• MFDS to inspect cholera vaccine for WHO (Korea Biomedical Review)
• Chong Kun Dang gets license for generic immunosuppressant (Korea Biomedical Review)
• Gangnam Severance gets patent for customized 3D bolus for breast cancer treatment (Korea Biomedical Review)
• China National Drug Administration Approves Gilead's Genvoya (Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide), a Single Tablet Regimen for the Treatment of HIV-1 Infection (Press)
• Can-Fite Signs Multi-Million Dollar Development and Distribution Agreement for Piclidenoson and Namodenoson in China with CMS Medical (Press)

• Novo Nordisk and Signet collaborate to deliver quats to India (in-PharmaTechnologist)
• CDSCO authorises SLAs to issue NOC for drug exports effective from August 20, 2018 (Pharmabiz)
• DTAB asks health ministry to revoke ban on sale of oxytocin through retail chemists to ensure availability (Pharmabiz)

• EpiPen 300 mcg adrenaline auto-injector (TGA)
• A reminder about the safe and correct use of condoms (TGA)
• Data privacy debacle down under: Is Australia’s My Health Record doomed? (American Enterprise Institute)
• Security fears are still too high, so I'm opting out of My Health Record (Australian Financial Review)
• Eye on Pharma: Australia Approves Its First Trastuzumab Biosimilar (The Center for Biosimilars)

• Janssen and Immune Bioscience team up for oncology antibodies (PharmaTimes)
• Sexual enhancement, workout supplements seized from Windsor store by Health Canada (CBC News)

• How This Bacteria May Becoming More Resistant To Hand Sanitizer (Forbes)
• The Illness Is Bad Enough. The Hospital May Be Even Worse. (NYT)
• Special report: America’s greatest threat is a hurricane-force cyberattack (Axios)
• An Appalachian odyssey: Hunting for ALS genes along a sprawling family tree (STAT)
• Diet Hit A Snag? Your Gut Bacteria May Be Partly To Blame (NPR)