Recon: Merck Beats Q2 Earnings Estimate, Boosted by US MMR Vaccine Sales

• Merck smashes Wall Street earnings and revenue estimates (CNBC) (Financial Times) (Bloomberg)
• Nasty US measles outbreak helps boost Merck’s vaccine sales in second quarter (CNBC)
• Gilead, Novartis cancer therapies losing patients to experimental treatments (Reuters)
• Eli Lilly CEO to 2020 candidates: Capping drug prices would not lead to lower health-care costs (CNBC)
• Aetna will now pay for more kids with a devastating rare disease to get a $2.1 million drug, reversing earlier denials (Business Insider)
• Eli Lilly tops profit estimates on boost from diabetes drugs (Reuters)
• FTC probing J&J on Remicade, as biosimilar market remains muted (BioPharmaDive) (Endpoints)
• Trump administration is drafting plan to allow US consumers to import drugs from Canada (CNBC)
• Hospitals May Be Forced to Disclose Discount Rates Negotiated With Insurers (WSJ) (NYTimes)
• Pharma Companies to Pay California Almost $70M to Settle ‘Pay-for-Delay’ Deals (Focus) (LA Times)
• New York attorney general probes big three insulin makers over their pricing (STAT)
• Congress seeks briefing on potential threat to US heparin supply (Reuters)
• AZ and Novartis ‘most exposed’ to Senate pricing proposals (PMLive)

• Bayer says 2019 profit goal becoming a stretch (Reuters)
• Strides inks JV pact with China's Sihuan Pharma (Economic Times)
• Nesp Biosame to Hit Japan Shelves on August 5 (PharmaJapan)
• Dupixent drives Sanofi again, but other new drugs are lagging (PMLive)
• Chinese biotechs look to raise billions in Hong Kong (Financial Times)
• Suspension of Woodford fund set to continue until December (Fierce)
• Chi-Med cues up two more regulatory filings in cancer (PMLive)
• Novartis’ Zolgensma joins growing list of medicines to lose accelerated assessment status in EU (Focus)

• Pfizer/Mylan: hard reality (Financial Times)
• What is Pfizer going to buy next? Albert Bourla outlines his M&A strategy in the post-Upjohn era (Endpoints)
• Big pharma deals show industry's weak spots (BioPharmaDive)
• Lilly drops PD-L1/TIM-3 bispecific from clinical pipeline (Fierce)
• Column: Where do generic drug names come from? Two women in Chicago, that’s where. (Chicago Tribune)
• The Price to Consumers of Generic Pharmaceuticals: Beyond the Headlines (NBER)
• Industry Groups Support FDA’s Latest Biosimilar Analytic Assessment Guidance (Focus)
• Pharma leaders: support the social contract on drug prices (STAT)
• Pfizer Completes Acquisition of Array Biopharma (Press)
• Gates backs development work on a long-acting contraceptive pill (Endpoints)
• Rare Pediatric Disease PRVs: FDA Updates Guidance (Focus)
• FDA Withdraws Guidance on Electronically Submitting Manufacturing Establishment Info (Focus)
• Do you want to see what winning big in the R&D race looks like in the Big Pharma league? (Endpoints)
• Approval in sight, Perceptive, OrbiMed double down on Foamix's antibiotic foam to the tune of $64M (Endpoints)
• The patent play: Biogen gets a PhIII boost for its bit-better take on the blockbuster MS franchise drug Tecfidera (Endpoints)
• Verastem taps board director and Eli Lilly vet Brian Stuglik to right the commercial boat (Endpoints)
• US FDA Drops Plan To Simplify Pharmaceutical Plant Reporting (Pink Sheet-$)
• US FDA Searches For Consistency On Assessment Of Real-World Evidence (Pink Sheet-$)
• Plagued by production issues, Pfizer aims to shift EpiPen work to Mylan-Upjohn merger (Fierce)
• U.S. doctors giving fewer kids cough and cold medicines (Reuters)
• Nearly 50% Of New Mothers In U.S. Prescribed Opioids During Last Decade, Study Finds (Forbes)

• Astellas Submits Supplemental New Drug Application for Approval of Additional Indication of XTANDI® for the Treatment of Men with Metastatic Hormone-Sensitive Prostate Cancer in Japan (Press)
• European Commission Grants Orphan Drug Designation for SpringWorks Therapeutics’ MEK Inhibitor, Mirdametinib, for the Treatment of Neurofibromatosis Type 1 (Press)
• X4 Pharmaceuticals Receives Orphan Drug Designation from European Commission for Mavorixafor for Treatment of WHIM Syndrome (Press)
• BELLUS Health Announces First Patient Enrolled in Phase 2 Study of BLU-5937 for the Treatment of Refractory Chronic Cough & Pursuit of Second Indication in Chronic Pruritus (Press)
  Sunovion Announces Acceptance by the U.S. FDA of the New Drug Application for Dasotraline for the Treatment of Adults with Moderate-to-Severe Binge Eating Disorder (Press)

• FDA clears new indications for existing Lyme disease tests that may help streamline diagnoses (FDA)
• Boston Scientific launches Tactra penile implant (MassDevice)
• Internet of Bodies: What's getting into you (Emergo)

• Grassley: For Medicaid, greater transparency will open the door to better value and outcomes (STAT)
• How a Medicare Buy-In or Public Option Could Threaten Obamacare (NYTimes)
• Big question in opioid suits: How to divide any settlement (AP)
• Lawmakers Push Bill To Simplify Biosimilar Patent Fights (Law360-$)
• Fate Of CVS-Aetna Deal In The Hands Of Judge (Law360-$)
• Deja vu? Pharma ad tax deduction faces threats—again—in Congress, on the trail (Fierce)
• Bayer faces 5,000 new lawsuits over pesticide cancer claims (Financial Times)
• What’s Next For The International Pricing Index? Parsing A Strange US Senate Vote (Pink Sheet-$)
• Feds sue Medtronic for disability discrimination (MassDevice)
• NY Pharmacist Cops To Role In 'Brazen' $5M Opioid Ring (Law360-$)
• Trump administration tightens opioid prescriptions for feds (AP)
• Surescripts ups its battle with Amazon PillPack: ‘We are turning the matter over to the FBI’ (CNBC)
• What to watch in tonight's Democratic debate (Politico)
• Medicaid: States' Use and Distribution of Supplemental Payments to Hospitals (GAO)
• Fraudulent Joinder and Misjoinder Arguments Prevail in Missouri (Drug & Device Law)

• FDA Advisory Committee Calendar

• Class 2 Medicines Recall: Aripiprazole 1mg/ml oral solution (EL (19)A/20) (MHRA)

• Asia Regulatory Roundup: India Forms Medical Device Technical Advisory Group to Help CDSCO (Focus)

• Warning letter woes: Dr Reddy's expects FDA inspection of AP plant by year-end (Economic Times)
• Pharmexcil to organise International Regulators Meet in Hyderabad on September 19-20 (Pharmabiz)

• Submissions received and TGA response: Proposed criteria for Appendix M of the Poisons Standard to support rescheduling of substances from Schedule 4 (Prescription only) to Schedule 3 (Pharmacist only) (TGA)

• Would You Want a Computer to Judge Your Risk of H.I.V. Infection? (NYTimes)
• Seizures Of Methamphetamine Are Surging In The U.S. (NPR)