Regulatory Focus™ > News Articles > 5 > Recon: Sandoz Receives CRL in US for Rituximab Biosimilar as Another Trastuzumab Biosimilar Launches

Recon: Sandoz Receives CRL in US for Rituximab Biosimilar as Another Trastuzumab Biosimilar Launches in EU

Posted 03 May 2018 | By Zachary Brennan 

Recon: Sandoz Receives CRL in US for Rituximab Biosimilar as Another Trastuzumab Biosimilar Launches in EU

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US
  • Gottlieb previews drug price policy (BioCentury-$) (Stat) (Speech text)
  • Achaogen slides after ‘yes and no’ adcomm verdict on plazomicin (Fierce) (MedPage Today)
  • Opioid Makers Sued for Premium Hikes in First-of-Kind Cases (Bloomberg) (WSJ-$)
  • Mylan Settles With Most Insurers In $67M Antitrust Appeal (Law360-$)
  • Sandoz receives complete response letter from the US FDA for proposed biosimilar rituximab (Press) (Reuters) (Endpoints) (PharmaLetter-$)
  • CDRH 'Super Office' to Transform Product Evaluations, Surveillance, Inspections (Focus)
In Focus: International
  • Herzuma (trastuzumab), a biosimilar for the treatment of breast cancer, now available in EU (Press) (PharmaLetter-$)
  • Amgen’s Mvasi approved in Canada (Health Canada)
  • P&T Committee Drug Prioritization Criteria: A Tool Developed by a Saudi Health Care System (PubMed)
  • New regulations to provide better information for patients on the safe use of opioid medications (Health Canada)
  • How to use the defective product report to notify a quality defect to European Medicines Agency (EMA)
Pharmaceuticals & Biotechnology
  • Pharmacokinetic advice from Genentech (In the Pipeline)
  • Litigation in Israel and U.S. Mires RNA Drug Developer Arcturus (Xconomy)
  • Novo Nordisk fends off Lilly’s GLP-1 challenge in Q1 (PMLive)
  • Coherus refiles pegfilgrastim biosimilar BLA (Goodwin)
  • Bayer blames currency for drop in earnings and lowers guidance (PharmaLetter-$)
  • Martin Shkreli was hardly an outlier when it came to jacking up prices on older drugs (Stat-$)
  • Out with the Old, In with the New Tech as J&J Eyes CAR-T Investment (BioProcess International)
  • Amgen Response to ICER’s Draft Evidence Report and Voting Questions on CGRP Inhibitors as Preventive Treatments for Patients with Episodic or Chronic Migraine (Amgen)
  • Third Rock Ventures Launches Casma Therapeutics with $58.5 Million Investment to Harness the Cellular Process of Autophagy to Develop Breakthrough Therapies (Press)
  • Caribou Biosciences Appoints Timothy F. Herpin, Ph.D. as Chief Business Officer (Press)
  • Ferring Signs Global Agreement to Commercialise Novel Gene Therapy for Bladder Cancer Patients (Press)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • Regeneron halts high doses of phase 3 osteoarthritis drug fasinumab amid risk-benefit concerns (Fierce)
  • Merck’s snapshot of positive data for frontline lung cancer niche triggers a new scramble for quick Keytruda OK (Endpoints) (Press)
  • More Esperion data give partners more reasons to wait (Evaluate)
  • Alnylam Achieves Alignment with FDA on Accelerated Development Path for Lumasiran, an Investigational RNAi Therapeutic for the Treatment of Primary Hyperoxaluria Type 1 (PH1) (Press)
  • Bacteria therapy for eczema shows promise in NIH study (NIH)
  • Cellectis Files IND for UCART22 in Acute Lymphoblastic Leukemia (B-ALL) (Press)
  • Sage Therapeutics Announces First Quarter 2018 Financial Results (Press)
Medical Devices
  • Cancer sequencing hype and reality (In the Pipeline)
  • For this Abbott executive, solving problems isn’t enough: “We need to add value” (Mass Device)
  • Teleflex blows past Q1 estimates (Mass Device)
  • Globus Medical tops estimates with Q1 sales, earnings (Mass Device)
  • VC-Backed Medical Device Co. Prices Upsized $108M IPO (Law360-$)
  • Layoffs begin for Philips Healthcare at Cleveland plant (Mass Device)
  • Paradigm Spine Announces NASS Coverage Policy Recommendation For coflex Interlaminar Stabilization (Press)
  • PeraHealth Receives U.S. FDA 510(k) Clearance for Industry-Leading Clinical Surveillance Technology (Press)
US: Assorted & Government
  • NIH’s Francis Collins on gene editing, a missed calling, and what he’d change about science (Stat)
  • NIH’s neuroscience institute will limit grants to well-funded labs (Science)
  • Don’t Say They Didn’t Warn You: FDA and FTC Issue 13 Warning Letters to Companies Selling E-Liquid Resembling Kid-Friendly Foods (FDA Law Blog)
  • New Report Shows Synthetic Opioids Now Overtake Prescription Opioids in Amount of Fatal Overdoses (E&C)
  • CBER-Regulated Products: Current Shortages (FDA)
  • Food Information That’s Pro Market and Pro Consumer (FDA)
  • SubOversight Announces Details for Drug Distributors Hearing Regarding their Efforts in West Virginia and Across the Country (House E&C)
  • Ferndale Laboratories, Inc., et al.; Withdrawal of Approval of Nine Abbreviated New Drug Applications (Federal Register)
  • Sun Pharmaceutical Industries, Ltd.; Withdrawal of Approval of Three Abbreviated New Drug Applications (Federal Register)
  • Phillips, Slaughter, and Chopra Sworn in as FTC Commissioners (FTC)
Upcoming Meetings & Events
  • FDA Advisory Committee Calendar
  • RAPS Convergence 2018 Schedule (RAPS)
  • Face-to-Face Training - MedDRA: Safety Data Analysis and SMQs (MedDRA)
  • FY 2018 Generic Drug Regulatory Science Initiatives Public Workshop (FDA)
  • Improving the Coordination and Quality of Substance Use Disorder Treatment (House E&C)
  • Haemophilia registries workshop (EMA)
  • Thirteenth industry stakeholder platform - operation of EU pharmacovigilance (EMA)
  • Procedure for calls for scientific data for use in HMPC assessment works (EMA)
  • Early Career Research Prize in Vaccinology R&D – 2nd edition (EFPIA)
  • European Medicines Agency Validates Bristol-Myers Squibb’s Type II Variation Application for Opdivo Plus Yervoy Combination for Treatment of First-Line Metastatic Non-Small Cell Lung Cancer (NSCLC) (Press)
General Health & Other Interesting Articles
  • Scientists devise new, more accurate peanut allergy test (Reuters)
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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