Regulatory Recon: FDA Rejects J&J's Arthritis Drug Sirukumab, Intelli's Opioid; Pfizer Spins Off New Orphan Drug Focused Startup (25 September 2017)

Posted 25 September 2017 By Michael Mezher

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

In Focus: US

  • FDA declines to approve J&J arthritis drug sirukumab (Reuters) (Fierce) (BioCentury)
  • Pfizer Spins Off New Firm for Some Rare Disease Drugs (Bloomberg) (Endpoints) (STAT) (Financial Times) (Forbes)
  • Native American tribe moves to dismiss Allergan patent case (Reuters)
  • FDA declines to approve Intellipharma's opioid painkiller (Reuters) (Press)
  • Everyone Says We Must Control Exorbitant Drug Prices. So, Why Don't We? (KHN)
  • J&J lines up its 4-in-1 HIV pill for FDA behind rivals from Gilead, GSK (Endpoints)
  • Puretech's Gelesis flunks the FDA's key measure of success for weight loss treatments (Endpoints) (Reuters)
  • FDA Disputes Article Highlighting Lackluster Oversight of Postmarketing Studies (Focus)
  • Generics Industry Calls FDA Draft Guidance on Priority Reviews 'Basically Inoperable' (Focus)
  • Congress Sets Sights on Pharma Cybersecurity After Attack (Focus)
  • FDA conducts major global operation to protect consumers from potentially dangerous prescription drugs sold online (FDA)
  • Allergan unveils new $2bn share buyback (Financial Times)
  • Novelion's Aegerion resolves US drug probes for $40 million (Reuters) (PharmaTimes) (FDA)
  • Whatever happened to the Zika epidemic? (Tampa Bay Times)
  • Republican bill to repeal Obamacare teeters on edge of collapse (Reuters) (NYTimes)
  • Is Health Care a Right? (The New Yorker)

In Focus: International

  • BIA Supporting New UK Investment Fund (BioCentury)
  • China FDA Approves Sovaldi for HCV (Press)
  • Roche receives European approval for Actemra /RoActemra in giant cell arteritis (Press)
  • World Health Officials Describe Progress Against Tetanus, H.I.V. and Malaria (NYTimes)
  • Why Did India Have Ten Million Fewer Childhood Deaths Than Predicted? (NPR)
  • Roche cancer immunotherapy Tecentriq wins EU approval (Reuters) (PharmaTimes) (Press)
  • Sanofi's arthritis treatment Kevzara secures NICE recommendation (Pharmafile) (SCRIP-$)
  • New HTA Methodology Could Solve Value Conundrum (Pink Sheet-$)
  • Refining the system: Improving patients' access to medicine (Pharmafile)
  • Indivior reaches settlement with Mylan over patent dispute (Pharmafile)

Pharmaceuticals & Biotechnology

  • When a Drug Coupon Helps You but Hurts Fellow Citizens (NYTimes)
  • What's on pharma's wish list? Tell us what you think (STAT)
  • Pregnant Women Should Still Get The Flu Vaccine, Doctors Advise (NPR)
  • How Interested Is The FDA In Real-World Evidence? (Clinical Leader)
  • Groupon Cofounder's New Healthcare Startup Raises $70 Million In Latest Funding Round (Forbes)
  • Allergan's Two-Year NASH Data Fail To Show Fibrosis Benefit (SCRIP-$)
  • The top 5 trends in biotech – #3: High valuations for attractive biotechs are a durable symptom of a thriving financing arena (Endpoints)
  • Visualize: What would these 7 biotech companies look like without immigrants? (Endpoints)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • FDA Approves Merck's KEYTRUDA® (pembrolizumab) for Previously Treated Patients with Recurrent Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer Whose Tumors Express PD-L1 (CPS Greater Than or Equal to 1) (Press)
  • Boost for Exelixis as partner Daiichi Sankyo cues up hypertension drug filing (Press) (Fierce)
  • Agilent Technologies Receives Expanded FDA Approval for the Use of Dako PD-L1 IHC 22C3 pharmDx Companion Diagnostic in Gastric or Gastroesophageal Junction (GEJ) Cancer (Press)
  • Bristol-Myers Squibb's Opdivo® (nivolumab) Receives FDA Approval for the Treatment of Hepatocellular Carcinoma Patients Previously Treated with Sorafenib (Press)
  • Geisinger and Boehringer Ingelheim collaborate to create a predictive model to help improve health outcomes for people with type 2 diabetes at greatest risk of serious long-term complications, including cardiovascular death (Press)
  • Ocugen Announces FDA Acceptance of Investigational New Drug Application for OCU310 (brimonidine/steroid combination therapy) and Initiates Proof of Concept Study for Treatment of Dry Eye Disease (Press)
  • Prometic receives FDA clearance of its IND to initiate pivotal PBI-4050 Phase 2/3 trial in patients with idiopathic pulmonary fibrosis (Press)
  • Aradigm Announces FDA Acceptance of NDA for Linhaliq with Priority Review Status (Press)

Medical Devices

  • Class 1 Device Recall Bridge Balloon Catheter (FDA)
  • New handbook helps medical devices sector improve its quality management system (ISO)
  • Democratized Diagnostics: Why Medical Artificial Intelligence Needs Vetting (Harvard Bill of Health)
  • CDRH Issues Final Guidance Regarding Interoperable Medical Devices (FDA Law Blog)
  • Shandong Weigao to pay $850m for Argon Medical Devices (MassDevice)
  • Abbott Catches Up to Peers With MRI-Compatible ICD (MDDI)
  • Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications (FDA)
  • Boston Scientific launches MRI-safe Resonate devices with HeartLogic diagnostic in US (MassDevice)

US: Assorted & Government

  • Sunday Hours: Obamacare Website To Be Shut Down For Portion of Most Weekends (KHN)
  • The Graham-Cassidy Plan: Sweeping Changes In A Compressed Time Frame (Health Affairs Blog)
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA's immediate steps to respond to Hurricane Maria and ongoing recovery efforts related to Hurricanes Harvey and Irma (FDA)
  • Merck's Idenix Denied Enhanced Damages On $2.5B Verdict (Law360-$)
  • Views on Venue -- Take Two: Did the District of Delaware Get It Right? (Patent Docs)
  • Sham Affidavits (Drug & Device Law)

Upcoming Meetings & Events

  • FDA Advisory Committee Calendar
  • FDA Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice; Public Workshop – 15-16 November 2017
  • First EMA workshop on non-animal approaches in support of medicinal product development – challenges and opportunities for use of micro-physiological systems – 5 October 2017
  • SME info day "Supporting innovative medicines' development and early access" – 17 November 2017
  • European Medicines Agency (EMA) / Drug Information Association (DIA) signal management information day – 27 October 2017

Europe

  • Statement ahead of the EMA's Public Hearing on valproate-containing medicines (ABPI)
  • Response to Prime Minister Theresa May's speech in Florence (ABPI)
  • Advertising investigations: August 2017 (MHRA)
  • Updated Guidance - Send and receive information on adverse drug reactions (ADRs) (MHRA)
  • EudraVigilance Technical Support Plan for national Competent Authorities in the EEA (EMA)

Asia

  • Buoyant biotech hub draws Merck KGaA to Shanghai (PharmaLetter-$)
  • FiercePharmaAsia—Big Pharma's performance, Fosun's revised Gland buy, Arcus-Taiho cancer deal (Fierce)

India

  • India's unpredictable drug pricing regime will have severe impact on doing business in India: Bhavik Narsana (PharmaBiz)
  • CDSCO forms high level panel to create exclusive category of OTC drugs to tackle substance abuse, anti-microbial resistance (PharmaBiz)
  • IPA urges govt to involve stakeholders in the process of ensuring quality drugs at affordable price through JAS (PharmaBiz)

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 news@raps.org.

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

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