Recon: AZ's Lupus Drug Fails in Phase III; FDA Approves Two Merck HIV Drugs

• FDA approves two new HIV drugs from Merck (Reuters) (Press)
• FDA widening probe into heart drugs linked to cancer risk (STAT) (CNN) (FDA)
• Big Data Is Remaking Big Pharma (Forbes)
• Pew Urges FDA to Ensure Appropriate Use of Antibiotics Approved Through Limited Population Pathway (Pew)
• Trump administration resists WHO efforts to tackle antimicrobial resistance (Pharmafile)
• Stryker to acquire K2M for $1.4B (MassDevice) (MedCity)
• Biogen, Teva benefit as payers ease up on multiple sclerosis meddling: analyst (Fierce)
• Did HHS chief Alex Azar work with ex-employer Lilly on drug rebate plans? A watchdog wants to know (Fierce)
• DOJ Says It Can Prove Novartis Dinners Were Kickbacks (Law360-$)
• The Senate could soon pass an opioids package. But a new law is still a long way away (STAT)
• CVS exec: Our new reliance on cost effectiveness should make drug makers ‘think about launch prices’ (STAT)
• At $1,650 per month, the first digital pill will soon roll out to certain Medicaid patients with mental illness (STAT)

• AstraZeneca lupus drug fails to meet main goal in study (Reuters) (Bloomberg) (Press)
• China is sprucing up its pharma sector (The Economist)
• EMA Relocation Progress Tracker (EMA)
• Merck’s Experimental Ebola Vaccine Seeing Wide Use in Outbreak (Bloomberg)
• UK pharma Code of Practice to change with digital times (PMLive) (Pink Sheet-$)
• GSK’s Nucala approved for younger asthma patients (PhamraTimes)
• Shire completes sale of oncology franchise to Servier (PharmaTimes)
• WHO: DRC May See Continued Ebola Cases for 'Another Few Weeks' (MedPage)
• IP Absent From Latest List Of China Healthcare Reforms (BioCentury)
• Vertex Back For Second Deal With Genomics, Leads Series B (BioCentury) (Fierce)
• Report: Boston Scientific to expand Clonmel, Ireland-based facilities (MassDevice)
• NZ Funding Body To Ditch Janssen’s Eprex In Favor Of Novartis Biosimilar (Pink Sheet-$)
• Calif. Gets PhRMA's Challenge To Drug Pricing Law Axed (Law360-$)
• Sixty-eighth session of the WHO Regional Committee for Africa (WHO)

• Next-generation sequencing market to nearly triple in size by 2024, report says (MedCity)
• Exonics Shows CRISPR Treats DMD In Dogs (BioCentury) (Fierce) (Endpoints)
• Closely allied with (both) Mercks and Celgene, Sutro CEO Bill Newell is laying out all his cards in a new IPO (Endpoints)
• 3D-Printed Pharmaceuticals? Don't Try This At Home (Law360-$)
• Guidance By Guidance, US FDA Is Reshaping The Look Of Cancer Drug Trials (Pink Sheet-$)
• Expecting mothers' opioid use may stunt kids' learning (NBC)
• Liquid Biopsy 'Weather Forecast' Can Predict When Tumors Will Return (Forbes)
• Sutro Biopharma, Arvinas Are Latest to Tee Up Biotech IPOs (Xconomy) (BioCentury) (Endpoints)
• Why patient counseling is an essential component of genetic testing (Outsourcing Pharma)
• Allergan architect Bisaro bids farewell as its board revamp continues (Fierce)
• US FDA’s Non-Guidance On Osteoarthritis Drugs: Starting Over On Structural Claims (Pink Sheet-$)
• Puretech Founder Steinberg Departs For Longwood Fund (BioCentury)
• RegenXBio adds another CNS program to gene therapy plans (Fierce)
• Novartis, Healint study uses self tracking app to examine migraine, mental health connection (mobihealthnews)
• Otsuka, Magellan Health announce plans for US rollout of Abilify MyCite (mobihealthnews)
• Diverging Regional Excipient Regulations Are Creating Problems For Excipient Manufacture, Distribution and Use Globally (IPQ)
• Novel Excipients, DMFs, and Atypical Actives Among Pressing Issues on IPEC-Americas’ Front Burner (IPQ)
• RootPath Raises $7M to Bring Cancer Cell Therapy to Solid Tumors (Xconomy)

• U.S. Food and Drug Administration Accepts Bristol-Myers Squibb’s Application for Sprycel (dasatinib) in Pediatric Patients with Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Press)
• PolyActiva Commences Its First Phase I Clinical Trial with Potential to Improve Daily Lives of Millions of Glaucoma Patients (Press)

• US FDA's Digital Health Plan Could Brighten OTC Device Outlook (Pink Sheet-$)
• Avinger asks for FDA approval of small-vessel PAD device (Medical Design & Outsourcing)
• Bovie Medical closes $97m sale of core electro-cautery biz to Symmetry Surgical (MassDevice)
• Class 1 Device Recall Coherex WaveCrest Left Atrial Appendage Occlusion System (FDA)

• The White House Allegedly Has A Marijuana Smear Squad. Cannabis Experts Say Bring It On. (Forbes)
• Texas AG Finds County Violated State Law In Request For Opioid Lawyers' Billing Records (Forbes)
• Amgen Inc. v. Hospira, Inc. (D. Del. 2018) (Patent Docs)
• Bayer, Janssen Win Another Xarelto Injury Trial In Philly (Law360-$)
• Purdue Ends OxyContin Patent Suit With $62M Payout (Law360-$)
• Medtronic Can't Nix Shareholder Suit Over Merger In Ireland (Law360-$)
• Justice Department Announces Release of New Fentanyl Safety Video for First Responders (DoJ)
• District Court orders permanent injunction against companies selling sexual enhancement products containing undisclosed drugs (FDA)
• Adocia Arbitration Claim Against Eli Lilly Climbs To $1.8B (Law360-$)
• Coffee Does Not Merit Cancer Warning Label Ordered In California, FDA Says (NPR)

• FDA Advisory Committee Calendar

• RPS Scotland to move into new headquarters in Edinburgh (Pharmaceutical Journal)
• Medicines and Healthcare products Regulatory Agency spending over £25,000: 2018 to 2019 (MHRA)
• Facebook Messenger, WhatsApp, iMessage use at UK NHS adds new security concerns (mobihealthnews)

• IPEC Digesting Implications of CFDA’s Ending of Separate Excipient Approval Process (IPQ)

• India's oxytocin ban delayed by a month as Delhi HC hears cases against it (Economic Times)

• ACV meeting statement, Meeting 9, 1 August 2018 (TGA)
• Consultation: Referral of proposed amendments to the current Poisons Standard to the ACMS, Joint ACCS-ACMS or ACCS meeting, November 2018 (TGA)