Regulatory Focus™ > News Articles > 5 > Recon: EC Approves 4th Infliximab Biosimilar

Recon: EC Approves 4th Infliximab Biosimilar

Posted 24 May 2018 | By Ana Mulero 

Recon: EC Approves 4th Infliximab Biosimilar

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In Focus: International
  • Novartis receives EU approval for biosimilar Zessly (Reuters) (PharmaTimes) (The Center for Biosimilars) (The Pharma Letter-$)
  • Astellas cuts 600 positions in Japan as new CEO makes his mark (Fierce) (Endpoints)
  • Venture Capitalists Put $260 Million Into New Chinese Biotech (Forbes) (Fierce) (Endpoints)
  • India below Sudan on healthcare access (The Telegraph) (FirstPost) (Business Standard)
  • As Nipah virus spread is suspected, government to compensate victims (CNN) (Reuters)
  • U.S. biotechs to speed work on Nipah vaccine as virus hits India (Reuters)
  • WHO: DRC Ebola outbreak on a 'knife's edge' as urban cases rise (Al Jazeera) (The Telegraph)
  • Congo says Ebola cases have reached 30, warns against rumors (AP News) (Reuters)
  • World Health Assembly delegates agree new five-year strategic plan (WHO)
  • Seventy-First World Health Assembly update, 23 May (WHO)
  • Development of antibiotics for children - towards a global approach (EMA)
  • NIH begins testing Ebola treatment in early-stage trial (NIH)
  • 50 Years Of Global Health Progress – Interview With IFPMA Head Thomas Cueni (Health Policy Watch)
  • USTR calls on Mexico to improve pharmaceutical and medical device innovation and market access (Lexology-$)
Pharmaceuticals & Biotechnology
  • We're getting new treatments for 'a disease that once was definitely a death sentence' — but it comes with a big price tag (Business Insider) (BioPharma Dive) (Fierce)
  • Biotech IPOs Roll On as Kiniksa, Scholar Rock Get $227M Combined (Xconomy)
  • DEA gives some of Pfizer's injected narcotics allotment to competitors as production issues intensify shortages (Fierce)
  • Novo Nordisk licenses kidney disease drug from Epigen (Fierce)
  • Look out, J&J. Sun Pharma's Yonsa nod in prostate cancer puts Zytiga on notice (Fierce)
  • FDA head worries drug companies will abandon making cheaper drugs (Washington Examiner)
  • A career in biotech brought success. Then the birds came calling (STAT)
  • Why was Theranos so believable? Medicine needs to look in the mirror (STAT)
  • Are small companies carrying the complete response letter can? (EP Vantage)
  • Vantage view – Why competitive bidding will be a hard task in Medicare (EP Vantage)
  • Supreme Court Denies Cert. Petition Accusing Fifth Circuit of “Sabotage of Off-Label Enforcement” (FDA Law Blog)
  • Kickback Convictions Don’t Mean Valeant Is Off The Hook (Law360-$)
  • Doughnuts and Discounts — Changes to Medicare Part D under the Bipartisan Budget Act of 2018 (NEJM)
  • Consequences of the 340B Drug Pricing Program (NEJM)
  • Drugmakers Blamed For Blocking Generics Have Jacked Up Prices And Cost U.S. Billions (KHN)
  • Celgene Corporation Announces Additional $3 Billion Share Repurchase Authorization and Plans to Execute a $2 Billion Accelerated Share Repurchase Program (Press)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • AstraZeneca expands development deal with Bicycle (BioPharma Dive)
  • Bloom bags cash, UCLA tech to treat epilepsy via the microbiome (Fierce)
  • Neoadjuvant PD-1 Blockade in Resectable Lung Cancer (NEJM)
  • Clementia adds phase II failure to its patent woes (EP Vantage)
  • Calgary Researchers Discover a Novel Approach to Treatment of Inflammatory Bowel Diseases (IBD) Using Hydrogen Sulfide Technology (Press)
Medical Devices
  • Merck, Pfizer power tumor profiling firm Strata to $26M round (Fierce)
  • Teleflex to acquire QT Vascular assets, takes option on Chocolate Heart DCB (Drug Delivery Business News) (Press)
  • DOD Bars Mobile Devices From Secure Areas At Pentagon (Law360-$)
  • Avinger wins FDA nod for next-gen Pantheris (MassDevice) (Press)
  • FDA Approves Newest Generation of XIENCE Stent for Blockage in CAD (MD Magazine)
  • Abbott's Tendyne device for mitral valve replacement demonstrates positive outcomes at 30 days in global study (Pharmabiz)
  • Christine Aylward launches new firm called Magnetic Ventures (Axios)
  • Renal denervation goes from Symplicity to complexity (EP Vantage)
  • LuViva scanner could provide alternative to smear test (pharmaphorum)
  • Company Ignores FDA’s Request to Cease Commercial Distribution (MedTech Intelligence)
  • Determining Significant Vs. Nonsignificant Risk In Medical Devices (Med Device Online)
  • Congress Continues Push on Medical Device Cybersecurity Mandates (Lexology-$)
  • New tech could make prosthetic hands easier to use (Verdict Medical Devices)
  • On the Marketing and Use of Pharmacogenetic Tests for Psychiatric Treatment (JAMA)
  • This digital pill wants to make following your prescription easier (PBS NewsHour)
  • It takes an ecosystem for a vibrant personal genomics industry to grow (MedCity News)
  • Inside Geisinger Health System’s plan to offer DNA sequencing to patients (KHN)
  • UPS Launches New Technology To Optimize Field Inventory For Critical Medical Devices (Press)
  • Independent Stent Imaging Study Shows Excellent Healing Profile with Resolute Onyx DES in Complex Patients with Coronary Artery Disease (Press)
  • New Medtronic Data Show Significant Blood Pressure Lowering Effect of Renal Denervation in Patients Taking Anti-Hypertensive Medication (Press)
  • Synedgen Receives FDA 510(k) Clearance for Catasyn Advanced Technology Wound Hydrogel (Press)
  • Zimmer Biomet Announces 510(k) Clearance for Zyston Strut Open Titanium Interbody Spacer System (Press)
US: Assorted & Government
  • US FDA: No Additional Regulations for Medical Device OEMs and Third-party Service Providers (Emergo Group)
  • Senate sends major VA reform bill to Trump's desk (The Hill) (Modern Healthcare) (AP News)
  • The head of the National Cancer Institute on hopes for AI, the future of precision medicine, and big data (STAT-$)
  • The Title X cuts are here (Axios)
  • Democrats running for Maryland governor pledging to support a state individual mandate for health care (The Baltimore Sun)
  • Subscribing to Your Patients — Reimagining the Future of Electronic Health Records (NEJM)
  • Higher Lung Cancer Incidence in Young Women Than Young Men in the United States (NEJM)
  • The Comprehensive Primary Care Initiative: Effects On Spending, Quality, Patients, And Physicians (Health Affairs)
  • Good News For Patients: Trump Won't Dramatically Lower Drug Prices (Forbes)
  • All of Us Research Program Issues Funding Announcement for Genome Centers (NIH)
  • Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting (FDA)
  • The Cost of Prescription Drugs: Examining the President’s Blueprint ‘American Patients First’ to Lower Drug Prices (US HELP Committee)
Upcoming Meetings & Events Europe
  • NICE rejects Chiesi’s Lamzede (PharmaTimes)
  • Tax rises needed to boost health and social care funding (PharmaTimes)
  • Helsinn invests to safeguard the quality and authenticity of its products (The Pharma Letter)
  • France Simplifies Local Medical Device Regulations and Sets Precedent for Other Member States (Lexology-$)
  • Ireland Is Holding a Once-In-a-Generation Abortion Referendum Tomorrow. Here's What's at Stake (Fortune)
  • BioGX Launches Six CE-Mark Tests for Meningitis and Antibiotic Resistance (Press)
  • The First AHWP Technical Committee Meeting in 2018 held in Beijing (CFDA)
  • Jiao Hong,CNDA Commissioner,meets Rafael Perez Christian,the Director General of the Center for State Monitoring of Medicines,Medical Equipment and Devices of Cuba(CECMED) (CFDA)
  • Jiao Hong,CNDA Commissioner,meets Mr.Alain Merieux,President of Foundation Merieux and Institute Merieux,France (CFDA)
  • China says finds no clues to explain U.S. sonic incident (Reuters) (NYT) (WSJ)
  • Initiative for the Compilation of Database-stored Data and Provision of Information concerning Pediatric Drugs (PMDA)
  • Soon a text message will be enough to spot fake medicines (Economic Times)
  • Whether It's Health or Crops, India Isn't Doing Social Insurance Right (The Wire)
  • Delhi govt to set up licensing authority to monitor & streamline functioning of de-addiction centres (Pharmabiz)
  • Meeting of DTAB Sub Committee for examining the 344 FDCs + 05 FDCs and to provide hearing to the petitioners/appellants including AIDAN-regarding (CDSCO)
  • Special operations to prevent and detect illegal manufacturing of (API, formulations) and import of Oxycotin in India - regarding. (CDSCO)
  • Pfizer Inc recalls 1.8 million vials of antibiotics (Economic Times) (Hindustan Times)
  • Public patients waiting twice as long for elective surgery, hospitals data reveals (The Guardian)
  • Submissions received: Proposed regulatory changes related to personalised and 3D printed medical devices (TGA)
  • Black Triangle Scheme: Information for sponsors (TGA)
  • Consultation: miconazole and fluconazole: proposed advisory statements for medicines (TGA)
  • Consultation: Sedating antihistamines: proposed additional advisory statements for medicines (TGA)
  • TGA presentation: Update on the therapeutic goods advertising reforms (TGA)
  • Inaugural Industry Forum on Good Manufacturing Practice (GMP) (TGA)
  • Submissions received: Prescription strong (Schedule 8) opioid use and misuse in Australia – options for a regulatory response (TGA)
  • Federal panel urging Canada to ramp up efforts to collect blood plasma (The Canadian Press)
  • Statement from Health Canada - Final Report of the Expert Panel on Immune Globulin Product Supply and Related Impacts in Canada (Health Canada)
  • Lynparza - Notice of Compliance with Conditions - Qualifying Notice (Health Canada)
  • OIE declares Brazil free of foot-and-mouth with vaccination (Reuters)
  • Anvisa presents system to monitor prosthetics (ANVISA)
General Health & Other Interesting Articles
  • A Pioneering Heart Surgeon’s Secret History of Research Violations, Conflicts of Interest and Poor Outcomes (ProPublica-Houston Chronicle)
  • New Cancer Treatments Lie Hidden Under Mountains of Paperwork (NYT)
  • Why the U.S. never got universal health care (Axios)
  • Sleep-tracking wearables and apps no substitute for sleep tests (Reuters)
  • A focus on cost instead of value threatens the future of personalized medicine (STAT)
  • He went to an in-network emergency room. He still ended up with a $7,924 bill. (Vox)
  • Can VR training churn out better surgeons? (MedCity News)
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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