Recon: Lilly's Humalog Successor Hits Marks in Two Ph. III Studies

• J&J shrugs off deals with Aduro that were worth up to $1.2B. Setback forces shift to Novartis alliance now (Endpoints)
• Giving it a GO: Giant Roche selects a tiny player at LabCentral for its next cancer R&D partner (Endpoints)
• Eli Lilly's diabetes treatment meets main goal in two late-stage studies (Reuters) (Endpoints)
• Caregivers or marketers? Nurses paid by drug companies facing scrutiny as whistleblower lawsuits mount (STAT)
• Bucking the trend, Antares gains FDA OK for testosterone injection on second try (Endpoints)
• Momenta calls time on biosimilar R&D, cuts half its staff (Fierce) (BioCentury)
• These Cholesterol-Reducers May Save Lives. So Why Aren’t Heart Patients Getting Them? (NYTimes)
• AmerisourceBergen to pay $625 million in U.S. civil fraud settlement (Reuters) (DoJ)
• Johnson & Johnson closes $2B LifeScan sale (Drug Delivery) (Press)
• Justice Department is Awarding Almost $320 Million to Combat Opioid Crisis (DoJ)
• Biopharma Attacked For Excessive Profits On Drugs For Children (Forbes)

• GSK resumes some doctor payments, backtracking on blanket ban (Reuters)
• WHO plays down risk to Indian children from tainted polio vaccine (Reuters)
• Dong-A and SKK seek approval for Aranesp biosimilar in Japan (Biosimilar News)
• Janssen’s single tablet Symtuza gains NHS England funding (PMLive)
• Canada Agrees To 10 Years Exclusivity For Biologics (BioCentury)
• Japan's Kansai to help Zambia paint out malaria (Reuters)
• Brexit: New Deadlines Kick In For Industry And ‘Reassigned’ Rapporteurs (Pink Sheet-$)
• UK Health Committee Probes Impact Of No-Deal Brexit On Medicines Supply (Pink Sheet-$)
• Korean Pharma Finds Own Way To Collaborative And Open Innovation (SCRIP-$)
• AstraZeneca invests in Taiwan to push clinical studies (PharmaLetter-$)
• GW Pharma in $300 million share sell-off (PharmaLetter)
• Dr. Reddy's unloads antibiotics plant to Abu Dhabi-based Neopharma (Fierce)
• Information Session on the UN Inter Agency Coordination Group on Antimicrobial Resistance (WHO)

• F-Prime’s Ben Auspitz co-leads $30M Series A with OrbiMed for his latest rare disease venture (Endpoints)
• Preventing tumor spread may not improve quality of life (Reuters)
• Value-Based Drug Reviews? US FDA Guidance Emphasizes “Accountability, Communication & Consistency” (Pink Sheet-$)
• EpiPen dearth shows company and regulator failure (Financial Times)
• African-American enrollment disproportionately high in no-consent trials (Pharmafile)
• Biosimilars To Be Subject To Same Pay-For-Delay Deal Reporting As Generics (Pink Sheet-$)
• Priority Reviews At US FDA: From Third Quarter Spikes To A Third Quarter Trough (Pink Sheet-$)
• The snub club: Crucial contributors to cancer immunotherapy were excluded from the medicine Nobel (STAT)
• Ono Pharma shares soar; Nobel awarded for cancer-fighting method used in its drug (Reuters)
• Office of Generic Drugs (OGD/FDA) Awards $1M FDA Contract to CUBRC and EpiVax for Demonstration and Validation of Immunogenicity Risk Assessment Methods for Generic Peptide Drugs and Their Impurities (Press)
• BARDA, Genentech Partner Against Influenza, Health Security Threats (BioCentury)
• Wider Use Of Osteoporosis Drug Could Prevent Bone Fractures In More Elderly Women (NPR)
• Avrobio shares blasted after trial update sours outlook on gene therapy for Fabry disease (Endpoints)
• Novo Nordisk sets up stem cell manufacturing in California, US (BioPharmaReporter)
• Researchers boost understanding of T-cell therapy in blood cancer (Novartis)
• Stokes Pharmacy Earns FDA 503B Registration As An Outsourcing Facility (Press)

• Roche to present five-year OCREVUS (ocrelizumab) efficacy and safety data in relapsing and primary progressive multiple sclerosis (MS) at ECTRIMS (Press)
• Clovis Oncology Receives Breakthrough Therapy Designation for Rubraca® (rucaparib) for Treatment of BRCA1/2-Mutated Metastatic Castration Resistant Prostate Cancer (mCRPC) (Press)
• PharmAbcine Announces FDA Accepts IND Application of TTAC-0001 for the Treatment of Recurrent Glioblastoma (Press)
• Sucraid® (Sacrosidase) Oral Solution, The Only FDA-Approved Therapy To Treat Congenital Sucrase-Isomaltase Deficiency (CSID), Is Now Available (Press)

• Analyst says Flannery's removal at GE could jeopardize spinoff of health-care unit (CNBC)
• Is Stryker on a Buying Spree That Could Rival Boston Scientific’s? (MDDI)
• How Apple could turn the Apple Watch into a blood pressure monitor (CNBC)
• Abbott gets CE Mark for Freestyle Libre 2, adds Bluetooth for realtime alerts (mobihealthnews)
• Merit Medical to acquire Cianna Medical for up to $200m (MassDevice)
• Draft Guidance Explains how Uncertainty should be Handled in Device Premarket Submissions (FDA Law Blog)
• Owlstone Medical raises $50m (MassDevice)
• Acessa Health Receives FDA Clearance for the Acessa ProVu System® - The Next Generation Advancement in Uterine Fibroid Treatment (Press)
• Hologic closes $125m Focal Therapeutics buyout (MassDevice)
• Ra Medical reaps $86m with IPO (MassDevice)
• Baxter, Mayo Clinic ink collab deal to develop US-based renal care center (MassDevice)

• DaVita unit to pay $270 million to resolve Medicare payments probe (Reuters) (DoJ)
• FDA Conducted Surprise Inspection of Juul’s Headquarters (WSJ) (CNBC) (Press)
• Xtampza Not Infringing 2 OxyContin Patents, Judge Says (Law360-$)
• Justices Won't Review Janssen's Liability For Risperdal Death (Law360-$)
• Western District of Wisconsin Rejects Stream of Commerce Jurisdiction (Drug & Device Law)
• Appeals court overturns patent board in Bard spat with AngioDynamics (MassDevice)

• FDA Advisory Committee Calendar

• Drug reaction reporting scheme now more accessible to healthcare professionals (MHRA)
• Protect The Patient Voice In EU HTA Cooperation, Says Eurordis (Pink Sheet-$)
• Procept BioRobotics wins UK NICE nod, CMS NTAP approval (MassDevice)

• Larry Zhang leaves Novartis to lead CASI’s commercialization efforts in China (PharmaLetter-$)
• CANbridge Pharmaceutical Submits New Drug Application for NERLYNX® (neratinib) in China (Press)

• Sun Pharma expects normalisation of India business in FY'19 (Economic Times)

• Notice to Stakeholders – Opioid warning sticker and patient information handout requirements come into force on October 20, 2018 (Health Canada)
• Notice of Amendment: List of Opioids (Part A): Buprenorphine and Methadone (Health Canada)

• TGO 98 Microbiological Standards for Medicines (2018) (TGA)
• Inhaled or injected general anaesthetic agents and sedative medicines (TGA)

• The DNA data storage machine that’s the size of a school bus (MIT Technology Review)