Regulatory Recon: J&J's Sales Outlook Falls Amid Remicade Competition; NYC Puts Up $100M to Launch Biotech Hub (23 January 2018)

Posted 23 January 2018 | By Michael Mezher 

Regulatory Recon: J&J's Sales Outlook Falls Amid Remicade Competition; NYC Puts Up $100M to Launch Biotech Hub (23 January 2018)

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

In Focus: US

  • J&J's Remicade sales skid amid cheaper competition (Financial Times) (CNBC)
  • About Those Soaring Pharma Profits (Forbes)
  • New York City Puts Up $100 Million To Create A Biotech Hub (Forbes)
  • Top 10 pipeline blowups, setbacks and snafus in H2 2017 (Endpoints)
  • Carl June's Cancer Startup Raises $100 Million From Gilead, Sean Parker (Forbes) (Endpoints)
  • Two CARTs, Two Charts: Dissecting Returns From T-Cell Therapy M&A (LifeSciVC)
  • Biotech M&A In 2018: A Tsunami Or A Ripple? (Forbes)
  • Biotech M&A takes off as Sanofi and Celgene spend $20 billion (Reuters)
  • Why Celgene's Acquisition Of Juno Matters For Biotech And Investors (Forbes)
  • FDA slaps down Braeburn on opioid addiction drug, putting Indivior and Alkermes in strong position (Endpoints)
  • Opioid commission member: Our work is a 'sham' (CNN)
  • West Virginia dispensed 31 million fewer pills — but opioid OD deaths still rose (CNBC)
  • Lining up against rivals, Amgen and Novartis build a blockbuster case for their CGRP migraine drug (Endpoints) (Press)
  • J&J's move to cut Remicade price cost some big bucks, but guarded against Pfizer's copycat (Endpoints)
  • CDC director urges flu vaccinations as pediatric deaths mount (Reuters) (WSJ)

In Focus: International

  • Human medicines: highlights of 2017 (EMA)
  • Drug companies told to do more to tackle 'superbug' crisis (Reuters)
  • Number of new antibiotics has fallen sharply since 2000 (The Guardian)
  • Canada Wants Views On Three Options For Naming Of Biologic Drugs (Pink Sheet-$)
  • Rexgenero wins £1.4m grant from Innovate UK (PharmaTimes)
  • Novartis, feeling the heat from head-to-head rivals, pulls Arzerra outside the US (Fierce)
  • NICE backs Bayer's Eylea, Novartis' Lucentis for sight condition (PharmaTimes)
  • Takeda bags EU approval for Adcetris in lymphoma (PMLive)
  • New drugs access 'faster than ever' - Welsh Government (BBC)
  • Brazil's death toll from yellow fever triples: WHO (Reuters)
  • Europe's safety watchdog says laxatives may increase cancer risk (Reuters)
  • Johnson & Johnson withdraws pelvic mesh device from Australian market (The Guardian)
  • GSK wins Australian case against Reckitt Benckiser over misleading ad campaign (Pharmafile)
  • Regulator Warns Of Tougher Pricing Regime In India Amid 'Market Failure' (Pink Sheet-$)
  • Iran's CinnaGen milestone paves way for development of its biosimilars in EU and beyond (PharmaLetter-$)
  • Dr Carissa Etienne elected for a second term as WHO Regional Director for the Americas (WHO)

Pharmaceuticals & Biotechnology

  • Vantage point – Biotech gets creative about the pay cheque (EP Vantage)
  • GSK, Pfizer lead in new global Twitter pharma influencer ranking (Fierce)
  • Juno Therapeutics CEO Bishop set for $200M+ payday with Celgene buyout (Fierce)
  • Right after Takeda deal, Denali medical director heads to rival Alkahest (Fierce)
  • Stop lollygagging and step up the search for a 'universal' flu vaccine (Chicago Tribune)
  • Flu shots aren't perfect, but scientists are trying to make them better (CNBC)
  • Hospitals cut back on opioids to battle addiction epidemic (Chicago Tribune)
  • FDA Proposes To Delay Revision to Intended Use Regulation (FDA Law Blog)
  • CNS Treatments Highlight US FDA's Busy Pipeline Of Novel Agents For 2018 (Pink Sheet-$)
  • What They Said – FDA Press Releases 2017 (Eye On FDA)
  • UCLA charts progress in the search for a more effective flu vaccine (Fierce)
  • In conversation with: WuXi NextCODE CEO Hannes Smárason (Fierce)
  • Industry/Regulator Communication is Linchpin in Addressing Cell/Gene Therapy CMC Challenges, Experts on Both Sides Are Affirming (IPQ)
  • BioCryst, Idera Merging (BioCentury)
  • Hyperpersonalization, or super-targeted marketing, is a growing pharma opportunity, agency says (Fierce)
  • Multiple Drug Products by Flawless Beauty: Recall - Misbranded or Unapproved (FDA)
  • Basic Drugs Brand of Senna Laxative by Magno-Humphries Laboratories: Recall – Mislabeling (FDA)
  • Watson Laboratories, Inc.; Withdrawal of Approval of Abbreviated New Drug Applications for Prescription Pain Medications Containing More Than 325 Milligrams of Acetaminophen (FDA)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • Pancreatic cancer combo sees high survival rates in ChemoCentryx PhIb data (Endpoints)
  • Astellas bags orphan drug status for AML drug (PharmaTimes) (Press)
  • Evofem Biosciences Announces First Patient Enrolled in Phase 2b/3 STI Trial of Amphora and Expects Phase 3 Contraceptive Clinical Trial Data First Quarter 2019 (Press)
  • FDA Accepts Investigational New Drug Application and Grants Fast Track Status for SOBI003 for the Treatment of MPS IIIA (Press)

Medical Devices

  • FDA Extends Comment Period on Least Burdensome Principles Draft Guidance Consultation (FDA)
  • Should Risk Assessments Be Made Public? (MDDI)
  • Intersect ENT Announces Publication of Randomized Pivotal Study of the SINUVA Sinus Implant, a New In-Office Treatment Option for Recurrent Nasal Polyps (Press)
  • Bio-Rad Gains Additional FDA Clearances for Blood Typing Products, Expanding its Offering for the Blood Testing Market (Press)
  • Adhesys Medical wins CE Mark for Flix surgical adhesive (MassDevice)
  • Topcon's ocular diagnostic instrument lands 510(k) clearance (Press)

US: Assorted & Government

  • American pharma industry spends record amount lobbying Washington (PharmaLetter-$)
  • Opinion: Right-to-try laws are hazardous to your health--and now they're backed by the Koch brothers (LA Times)
  • Pennsylvania Risperdal Decision Doesn't Go As Far As Plaintiffs Suggest (Drug & Device Law)
  • FDA Faces $50M Suit After Discrediting Drug Research Co. (Law360-$)
  • Cherokee Nation Takes Opioid Claims To Okla. State Court (Law360-$)
  • Express Scripts Beats Pharmacy's Antitrust Suit (Law360-$)
  • Walsh exploring litigation against pharmaceutical companies for opioid crisis (Boston Globe)
  • Kentucky accuses McKesson of helping fuel opioid epidemic (Reuters)
  • Body broker who sold diseased remains is convicted of fraud (Reuters)
  • Vermont becomes ninth US state to legalize marijuana (Reuters)

Upcoming Meetings & Events


  • Why EMA matters to European citizens (EMA)
  • EudraVigilance User Manual: Marketing Authorisation Holders - EudraVigilance access via the EudraVigilance Data Analysis SystemVer 1.1 (EMA)
  • EudraVigilance User Manual Individual Case Safety Report form (EMA)
  • Pulmatrix wins EU nod for inhaled dry-powder anti-fungal trial (Drug Delivery)
  • Emerging and enabling & health and life sciences: apply for funds (GOV.UK)


  • AmoyDx Wins Chinese Approval for Lung Cancer Liquid Biopsy CDx (GenomeWeb)
  • Taiwan Liposome Forms Marketing JV With Jixi (BioCentury)
  • CRO Biorasi on East-Asian expansion: Why Japan, and where to next? (Outsourcing Pharma)


  • Submissions received: Nomenclature of biological medicines (TGA)

General Health

  • 'Misperceptions' keep some from agreeing to donate organs after death (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.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @Michael_Mezher or send him an email at

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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