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

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• Scientists devise new, more accurate peanut allergy test (Reuters)