Recon: Amarin’s Fish Oil Drug Cut Heart Risks by 25% in Ph. III Study

• In Blowout, Amarin's Fish-Oil-Derived Drug Dramatically Cuts Heart Risk In Study (Forbes) (STAT) (Endpoints) (Xconomy) (CNBC) (Press)
• Alexion’s Soliris wows in rare disease PhIII trial, opening up a new franchise worth $500M-$700M (Endpoints) (Press)
• FDA lifts clinical hold on Sarepta’s Duchenne MD gene therapy, clearing the way to a quick launch of a pivotal trial (Endpoints) (Fierce)
• AstraZeneca diabetes drug cuts heart risks in major study (Reuters) (Endpoints) (Press)
• Endo puts Vasostrict case against FDA on hold (Reuters)
• The Rising Tide Of Biotech IPO Valuations (LiveSciVC)
• Tiny Device Is a ‘Huge Advance’ for Treatment of Severe Heart Failure (NYTimes) (MassDevice)
• Boston Scientific's drug-coated stent gets FDA approval (Reuters)
• Drug shortages may add $230 million to annual US drug costs (Reuters)
• With new blood test, Roche dives deeper into personal cancer care (Reuters) (Press)
• Generic drug makers face ‘a silent crisis,’ FDA official says, and raising prices could help (STAT)
• ‘Stuff floating’ in compounded drugs prompts FDA to appeal for more funding (STAT)
• Inclusion Across the Lifespan: NIH Policy for Clinical Research (JAMA)

• As China builds biotech sector, cash floods U.S. startups (Reuters)
• Novartis and Bayer lose a UK court fight over a switch to a cheaper eye drug (STAT) (Reuters) (Pharmafile) (PharmaTimes)
• EU approves new option for metastatic melanoma (PharmaTimes)
• Novartis to file Lucentis for rare sight condition in premature babies (PharmaTimes)
• Fosun Pharma Sees ‘Huge’ Opportunities In India, Southeast Asia, Africa (Forbes)
• Scientists use gene drive to eradicate lab mosquitoes for the first time (STAT)
• Why Delta-Fly Is Only The Third Biotech To List In Japan In Three Years (BioCentury)
• Congo confirms Ebola case at Ugandan border (Reuters)
• EMA to launch new corporate website on 27 September 2018 (EMA)
• Improving how we collect and document consent (MHRA)

• Can building a better research mouse open the black box of Alzheimer’s? (STAT)
• Starring in That Drug Commercial? An Actual Patient (NYTimes)
• CRISPR screen identifies Zika-fighting gene (Fierce)
• FDA approves first spray-on skin treatment for burns (NBC)
• Senolytic Therapies Seem To Stop Alzheimer's Disease 'In Its Tracks' (Forbes)
• What Rx Drugs And Luxe Handbags Have In Common (Forbes)
• To Include Or Not Include Drug Prices In DTC Ads (Forbes)
• Gilead Subsidiary to Launch Authorized Generics of Epclusa® (Sofosbuvir/Velpatasvir) and Harvoni® (Ledipasvir/Sofosbuvir) for the Treatment of Chronic Hepatitis C (Press)
• More Complete Response Letters – Good News or Bad News? (Lachman)
• Advertising Enforcement: US FDA Content To Let Competitors 'Duke It Out,' Woodcock Says (Pink Sheet-$)
• FDA Approving Complex Generics Pre-ANDA Meeting Requests At Higher Rates (Pink Sheet-$)
• US FDA’s Streamlined Drug Approval Packages Shine Less Light On Sponsor Interactions (Pink Sheet-$)
• Biosimilar Action Packages Low On US FDA Priority List For Redaction And Posting (Pink Sheet-$)
• AstraZeneca CEO Pascal Soriot: ‘I’m the lowest-paid CEO in the whole industry’ (Endpoints)
• Common painkiller tied to increased risk of heart problems (Reuters)
• PhaseBio details dollars in AstraZeneca deal as it rolls out a plan for $86M-plus IPO (Endpoints)
• Ex-Cascadian chief Scott Myers lands at BioClin; Kodiak woos Genentech vet Jason Ehrlich for CMO role (Endpoints)
• Former Merck clinical research VP Arthur Santora joins Entera Bio as CMO (Fierce)
• First half of 2018 sees 18.7M pills and $164M lost due to drug diversion (MedCity)
• GTX Shares Crater After Incontinence Readout (BioCentury)
• How Arrowhead’s Toxicity Blowup Gave It A Jump Start On A Better RNAI Platform (BioCentury)
• FDA Announces Availability of Resources for Animal Drug Sponsors (FDA)
• Fee for Using a Tropical Disease Priority Review Voucher in Fiscal Year 2019 (Federal Register)
• Further Testing of Donations that are Reactive on a Licensed Donor Screening Test for Antibodies to Hepatitis C Virus; Draft Guidance for Industry (Federal Register)
• Recommendations for Requalification of Blood Donors Deferred Because of Reactive Test Results for Antibodies to Human T-Lymphotropic Virus Types I and II; Draft Guidance for Industry (Federal Register)
• Pediatric Medical Device Development; Public Meeting; Request for Comments; Reopening of Comment Period (Federal Register)

• Roche’s Tecentriq in combination with pemetrexed and platinum-based chemotherapy reduced the risk of disease worsening or death in a type of previously untreated advanced lung cancer (Press)
• Roche’s investigational medicine entrectinib showed a durable response of more than two years in people with a specific type of lung cancer (Press)
• Janssen Announces Results of Esketamine Nasal Spray Phase 3 Study in Patients with Treatment-Resistant Depression (Press)
• Nightstar posts early-phase data on retinal gene therapy (Fierce)
• FDA gives Epizyme a green light on trial recruitment, but tazemetostat isn’t completely out of the woods yet (Endpoints) (Fierce)
• AnaptysBio’s lead IL-33 antibody clears midstage test in asthma (Fierce)
• T-cell therapy for eradicating HIV reservoirs proves safe in small study (Fierce)

• Report: Medical Technology Industry 'Under-Investing' In R&D (Forbes)
• FDA Panel To Discuss How Patients Can Improve Medical Device Review (BioCentury)
• Avita Medical wins FDA PMA for Recell severe burn treatment device (MassDevice)
• Late-Breaking Clinical Study Results Demonstrate Exceptional Safety and Efficacy Outcomes for Resolute Onyx(TM) DES (Press)
• Medtronic Presents IN.PACT Global Study Three-Year Data and Total IN.PACT(TM) Imaging and Propensity Analyses (Press)

• FDA Is At An Inflection Point, Says Former Chief Counsel Rebecca Wood (BioCentury)
• Special Report: Juul copycats flood e-cig market, despite FDA rule (Reuters)
• Poorer immigrants would face new hurdles under Trump proposal (Politico)
• ACLA lab payment lawsuit dismissed by judge (BioPharmaDive)
• Trump Administration Proposes Weakening Rules Governing Organ Transplant Centers (ProPublica)
• Trump Claims to Protect Pre-Existing Health Conditions. That’s Not What the Government Says. (NYTimes)
• Ruling on Health Care Subsidies Could Prove Costly for Government (NYTimes)
• Positive Thoughts on an Imperiled Four-Bill Minibus (Alliance for a Stronger FDA)
• Heck No, FDCA Violations Can’t Be Inferred Merely From Product Malfunctions (Drug & Device Law)
• Athenex Gets FDA Compounding Policy Wrong, Amicus Says (Law360-$)
• Owner of New York City Pharmacies Charged in Scheme to Defraud Medicare and Medicaid (DoJ)

• FDA Advisory Committee Calendar
• Patient Engagement Advisory Committee; Notice of Meeting – 15 November 2018
• Extraordinary meeting of the Steering Group on Health Promotion, Disease Prevention and Management of Non-Communicable Diseases – 28 September 2018

• Dutch Insurer Seeks €4m from AZ Over ‘High’ Seroquel Price (Pink Sheet-$)
• Single-Touch Labeling: The Answer to EU MDR? (MDDI)
• Imatinib 400mg Capsules (3 x 10) PL 36390/0180 : Company-led recall (MHRA)
• Various trauma guide wires – risk of infection due to packaging failure (MDA/2018/032) (MHRA)
• Reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health (EMA)
• Reflection paper on resistance in ectoparasites (EMA)
• Guideline on determination of withdrawal periods for edible tissues (EMA)

• USFDA inspection of Biocon's drug substance unit at Bengaluru complete (Economic Times)
• Roche To Set Right Avastin Post-Marketing Surveillance Delay In India (SCRIP-$)
• India Medical Device and IVD Regulatory Update: September 2018 (Emergo)
• Govt gets ready to amend rules to hold manufacturers accountable for faulty medical devices (PharmaBiz)

• Outcomes: Options for the implementation of a claimer for efficacy assessed non-prescription medicines (TGA)