Recon: Roche Gets Fast Approval for Alecensa in China

• Nine things to know about Sangamo Therapeutics and its first-in-human genome editing study (STAT)
• Immense Promise, Hard-Won Progress (SF Chronicle)
• Newest form of CRISPR corrects genetic disease in viable human embryos, with few errors (STAT)
• EpiPen shortage has some relying on expired devices (CBS) (CNBC)
• Security researchers say they can hack Medtronic pacemakers (CNBC)
• States Rush to Rein In Prescription Costs, and Drug Companies Fight Back (NYTimes)
• Biosimilars At US FDA: Personnel Spending Losing Influence Over Program (Pink Sheet-$)
• What's next for the Trump administration on Medicaid (Politico)
• In Pharma Patent Disputes, Data Rules Over Intuition And (Gasp!) Legal Judgment (Forbes)
• The Role Of Lawsuits In Addressing The Opioid Crisis (NPR)
• In San Francisco, Opioid Addiction Treatment Offered on the Streets (NYTimes)
• Bayer rejects WirtschaftsWoche report on Dicamba lawsuits (Bayer)
• This Drug Is Safe and Effective. Wait. Compared With What? (NYTimes)

• Roche's Alecensa latest beneficiary of faster China drug approvals (Reuters) (Endpoints) (Press)
• China Unveils Cancer Drugs for Medical Insurance Access Negotiation (BioCentury)
• China sacks six senior officials at food and drug regulator over vaccine scandal (Reuters)
• WHO announces landmark changes in MDR-TB treatment regimens (WHO) (Economic Times)
• Measles cases hit record high in the European Region (WHO
• WHO Director-General
• Life in Turkey Now: Tough Talk, but Fears of Drug Shortages (NYTimes) (SCRIP-$)
• TimesWellcome sanctions top cancer scientist over bullying allegations (Financial Times)
• Europe’s first allogeneic stem cell therapy rejected by NICE (PharmaTimes)
• Takeda to invest up to $10 million in new Russian production facility for Ninlaro (PharmaLetter-$)
• Korea Toughens Corporate Disclosure Rules To Improve R&D Transparency (SCRIP-$)
• Militia threat hampers Ebola fight in Congo as disease kills 47 (Reuters)

• PPD Biotech panel: Five leaders in the Boston hub evaluate the top trends — and where we’re all headed in the next 5 years (Endpoints)
• Poised for phase 3, Galera's GC4419 wards off radiation side effects (Fierce)
• Blockchain Holds Promise for Thwarting Drug Counterfeiters (Medpage)
• Many people take drugs that interfere with their blood pressure pills (Reuters)
• Why Companies Should Invest In Data, Alliances To Support Pediatric Extrapolation (BioCentury)
• Sirnaomics cleared to start first trial of RNAi lead in cancer (Fierce)
• MD Anderson's Blooms (BioCentury)
• Subject CAR-Ts to price competition or randomized trials to ensure even coverage, expert says (MedCity)
• The Role of Standards in Personalized Medicine (USP)
• US FDA Continues Reviewing Marketing Reports, Will It Punish Scofflaws? (Pink Sheet-$)
• Eisai, Merck take on Bayer's Nexavar with new liver cancer nod for Lenvima (Fierce)
• Biotech Reading List (Biotech Due Diligence)
• Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan / Amlodipine / HCTZ Tablets (FDA)
• Biomimetic nanoflowers by self-assembly of nanozymes to induce intracellular oxidative damage against hypoxic tumors (Nature)

• FDA Accepts Priority Review of ALXN1210 as a Treatment for Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) in the US (Press)
• ASLAN Pharmaceuticals Granted Orphan Drug Designation by the FDA for ASLAN003 for the Treatment of Acute Myeloid Leukaemia (Press)
• Tolero Pharma and AbbVie collaboration on acute myeloid leukemia trial (PharmaLetter-$)

• Brainsway wins FDA nod for OCD-treating TMS system (MassDevice) (FDA)
• Temporary Total Artificial Heart Companion 2 Driver System by SynCardia Systems: Letter to Health Care Providers - Risk of Mortality and Stroke (FDA)
• Class 1 Device Recall VITEK 2 Gram Positive Cefoxitin Screen, VITEK 2 Gram Positive AST for Oxacillin (FDA)
• Building a Better Insulin Infusion System (MDDI)
• Voluntis launches upgraded digital insulin dosing therapeutic (Drug Delivery)
• KFx inks Zimmer licensing deal, sues Stryker over patent infringement (MassDevice)
• Magnolia Medical, Kurin trade lawsuits (MassDevice)
• BoneSupport wins Canadian approval for Cerament G bone graft substitute (MassDevice)

• House and Senate Bills Would Require Reporting of Biosimilar Agreements to the DoJ and FTC (FDA Law Blog)
• Endo Pharmaceuticals Solutions, Inc. v. Custopharm Inc. (Fed. Cir. 2018) (Patent Docs)
• Eighth Circuit Casts Doubt on Medtronic’s Transfer Pricing Method (DoJ)
• Changes to the Pandemic and All Hazards Preparedness Act are essential to saving lives in disasters (BIO)

• FDA Advisory Committee Calendar
• FDA Grand Rounds – 13 September 2018

• Pfizer-BioNTech, U.K. biotechs raise $247M and Vernalis accepts buyout bid (Fierce)
• Pharma Cases Show How Brexit Could Hit Alignment Of UK & EU Competition Law (Pink Sheet-$)
• Neonates, Prolonged Seizures Feature In Latest EU Guidance On Epilepsy Drugs (Pink Sheet-$)
• Largest oral HPV study in England shows lower rates of infection (EPR)
• Kleresca wins CE Mark for biophotonic dermatological system (MassDevice)

• Singapore's first clinical trial approval for T cell engineered (TCR) immunotherapy for treatment of Liver cancer (Press)
• Why Chinese Investor Xuechao Wang Made The Move From Real Estate To Biotech (BioCentury)

• Parliamentary panel bats for taking aggressive measures to end over-dependance on China for import of bulk drugs (PharmaBiz)
• NPPA extends ceiling prices of knee implants for a period of another one year till August 15, 2019 (PharmaBiz)
• Pharma industry demands tax-free zones (The Nation)

• Prominent health policy researcher plagiarized colleagues’ work, Dartmouth investigation finds (STAT)
• Amazon's Clinics Join U.S. Employer Push Into Worksite Healthcare (Forbes)