Regulatory Focus™ > News Articles > 9 > Recon: Amarin’s Fish Oil Drug Cut Heart Risks by 25% in Ph. III Study

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

Posted 24 September 2018 | By Michael Mezher 

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

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • 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)
 
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In Focus: International
  • 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)
Pharmaceuticals & Biotechnology
  • 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)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • 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)
Medical Devices
  • 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)
US: Assorted & Government
  • 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)
Upcoming Meetings & Events Europe
  • Dutch Insurer Seeks €4m from AZ Over ‘High’ Seroquel Price (Pink Sheet-$)
  • Single-Touch Labeling: The Answer to EU MDR? (MDDI)
  • Imatinib 400mg Capsules (3 x 10) PL 36390/0180 : Company-led recall (MHRA)
  • Various trauma guide wires – risk of infection due to packaging failure (MDA/2018/032) (MHRA)
  • Reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health (EMA)
  • Reflection paper on resistance in ectoparasites (EMA)
  • Guideline on determination of withdrawal periods for edible tissues (EMA)
India
  • USFDA inspection of Biocon's drug substance unit at Bengaluru complete (Economic Times)
  • Roche To Set Right Avastin Post-Marketing Surveillance Delay In India (SCRIP-$)
  • 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)
Australia
  • Outcomes: Options for the implementation of a claimer for efficacy assessed non-prescription medicines (TGA)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.
 
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