Regulatory Recon: Merck's Keytruda Combo Extends Survival in Lung Cancer Trial; Sandoz Files Humira Biosimilar for US Approval (16 January 2018)

Posted 16 January 2018 By Michael Mezher

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

In Focus: US

  • Room for another: Sandoz files Humira biosimilar in US (BioPharmaReporter) (PMLive) (Press)
  • Eiger to abandon blood pressure drug after trial failure (Reuters) (Endpoints) (Press)
  • Big Pharma efforts on Alzheimer's tested by Pfizer exit (Financial Times)
  • Transparency: FDA to Release Portions of Redacted Clinical Study Reports (Focus) (STAT)
  • Op Ed: We can't wait for deadly disease to spread among us like the plague (Miami Herald)
  • Developers are laying the foundation for a new biotech complex in California (Endpoints)
  • Merck's Keytruda extends lung cancer survival in combination trial (Reuters) (Financial Times) (Endpoints) (Press)
  • Op Ed: Right-to-try legislation offers false hope and would endanger patients (STAT)
  • More fed oversight needed to ensure accurate genetic testing: Jill Levy-Fisch (Cleveland)
  • Next User Fee Cycle Should Focus On Policy Improvements, Gottlieb Says (Pink Sheet-$)
  • US expands scope of BI's lung cancer drug Gilotrif (PharmaTimes) (Pharmafile)
  • FDA expands indication of Teva's Trisenox for acute promyelocytic leukaemia (Pharmafile)

In Focus: International

  • Roche prepares to feel chill of patent expiries (Financial Times)
  • German watchdog calls for direct comparison of cancer immunotherapies (Reuters)
  • Brussels gets into drug business (Politico)
  • China biotech unicorn Innovent in talks on $200M IPO and new funding (Endpoints)
  • 2018 to be a 'transformative' year for Japanese pharma (PharmaLetter-$)
  • EMA Warns of Defect with Buccolam Oral Syringes (EMA)
  • Novartis' Cosentyx beats J&J's Stelara in psoriasis trial (PharmaTimes)
  • Drugmaker Dermapharm gears up for likely first German IPO of 2018 (Reuters)
  • CDSCO weighs inspection of drug-making facilities in US (Economic Times)
  • SMC bars four medicines from NHS (PharmaTimes)
  • Avacta, Glythera link to develop drug conjugates (PharmaTimes)
  • Sweden's Xbrane eyes partnership to bring Lucentis biosimilar to China (BioPharmaReporter)
  • WuXi Biologics To Be 'World's No.1' Biologics Maker (SCRIP-$)
  • BIA cleared to intervene in Supreme Court patent 'plausibility' case (PharmaLetter-$) (BIA)

Pharmaceuticals & Biotechnology

  • Hallucinations After Taking Tamiflu: How Much Is Real Versus Not Real? (Forbes)
  • After a Debacle, How California Became a Role Model on Measles (NYTimes)
  • Cancer.com Site Sat Dormant for 10 Years. Now It's Live Again. (Medpage)
  • 2017 Complete Response Letters: Fewer Than 2016, Still More Than Years Past (Pink Sheet-$)
  • FDA Approved 78 ANDAs, Six First-Time Generics in December (FDANews-$)
  • Manufacturing Compliance In Brief: Seven US FDA Warning Letters, Two EU GMP Non-Compliance Notices (Pink Sheet-$)
  • Creating a Successful Maintenance Strategy for Pharma Plants (Pharmaceutical Manufacturing)
  • The gold standard of scientific evidence (Healthcare Economist)
  • New trial design guidelines address 'inappropriate' patient exclusion (Outsourcing Pharma)
  • Pherecydes raises cash to trial anti-infective phage therapies (Fierce)
  • AveXis steps up gene therapy pursuit of Biogen's SMA pathfinder (Fierce)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • Centrexion Therapeutics Announces Fast Track Designation Granted by FDA to CNTX-4975 for Treatment of Knee Osteoarthritis Pain (Press)
  • Ophthotech Announces First Patient Enrolled in the Phase 2b Clinical Trial of Zimura®, Complement C5 Inhibitor, for the Treatment of Autosomal Recessive Stargardt Disease (STGD1) (Press)
  • Constellation Pharmaceuticals Announces Initiation of Phase 1b/2 Study of CPI-1205 in Combination with Checkpoint Inhibitors (Press)
  • Gamida Cell Announces Initiation of a Phase I Study of NAM-NK Cells Immunotherapy Program for Non-Hodgkin Lymphoma and Multiple Myeloma (Press)
  • Context Therapeutics Announces the Acquisition of Apristor™ (Onapristone XR), an Investigational Phase 2 Drug for Metastatic Breast Cancer (Press)

Medical Devices

  • Tidepool head details pre-cert discussions with FDA, encourages industry participation (MobiHealthNews)
  • FDA approves algorithm that predicts sudden patient deaths to help prevent them (Digital Trends)
  • Next-Day Discharge Seems OK for Select TAVR Patients (Medpage)
  • When You Need A Breast Screening, Should You Get A 3-D Mammogram? (KHN)
  • FDA Formalizes UDI Compliance Deadline Extension for Low-risk Devices (Emergo)
  • CDRH Issues Revised Draft Accessory Guidance (FDA Law Blog)
  • Medgadget's Best of CES 2018 (Medgadget)
  • 5 Predictions For The Medical Device Industry In 2018 (And How You Can Prepare) (Greenlight Guru)
  • OrthoXel Announce FDA 510k and CE Mark Approval for their Orthopaedic Trauma Product the Apex Tibial Nail System (Press)

US: Assorted & Government

  • PTAB Life Sciences Report (Patent Docs)
  • Mixing Medicine & Politics: Why I Ran for Congress (Medpage)
  • Bipartisan REFER Act Targets Sessions' War On Cannabis In High Style (Forbes)
  • Hospitals, Doctors Brace For Loss Of Children's Health Funds (Forbes)
  • Trump's Tax Cuts Will Boost UnitedHealth's 2018 Profits By $1.7 Billion (Forbes) (Reuters)
  • Predictions: Insurers, Hospitals To Merge, Be Led By Movie Studio Execs (Forbes)
  • Michigan clinic office manager pleads guilty in $131M drug fraud conspiracy (Fierce)

Upcoming Meetings & Events

Europe

  • Chair of EMA's committee for orphan medicines receives award for outstanding patient engagement (EMA)

Asia

  • GSK Consumer Healthcare appoints Filippo Lanzi as APAC head (Economic Times)
  • China's Medical Representative Registration System: Action Items for Pharmaceutical Companies (National Law Review)
  • Mundipharma to distribute Grünenthal's pain-relief drug in China (Outsourcing Pharma)

Australia

  • Presentation: Delivering pain management in a rural setting (TGA)
  • Video: Codeine up-scheduling workshop, Panel question and answer session (TGA)

Canada

  • Canada Allows Exemptions To Mandatory eCTD Format In Justified Cases (Pink Sheet-$)

General Health

  • Flu virus now considered an epidemic, CDC says (CBS)
  • New study offers insights on genetic indicators of COPD risk (NIH)

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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