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Regulatory Focus™ > News Articles > 2020 > 2 > Recon: Roche Nabs Priority Review for Tecentriq in NSCLC; FDA Rejects 6-Week Dosing Schedule for Key

Recon: Roche Nabs Priority Review for Tecentriq in NSCLC; FDA Rejects 6-Week Dosing Schedule for Keytruda

Posted 19 February 2020 | By Michael Mezher 

Recon: Roche Nabs Priority Review for Tecentriq in NSCLC; FDA Rejects 6-Week Dosing Schedule for Keytruda

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Trump's next health care move: Giving Silicon Valley your medical data (Politico)
  • How the Drug Lobby Lost Its Mojo in Washington (WSJ)
  • FDA sets June decision date for Tecentriq monotherapy in NSCLC (PMLive) (Press)
  • FDA rejects Merck’s applications for 6-week Keytruda dosing schedule (Reuters) (Press)
  • BMS’ Opdivo combo misses the mark in pancreatic cancer (PMLive) (Fierce) (Endpoints) (Press)
  • Incyte hits endpoint in 2nd pivotal atopic dermatitis trial (Fierce) (Press)
  • ITC Bans Bio-Rad DNA Product Imports In Patent Case (Law360-$)
  • 'Oblivious' PixarBio CEO Gets 7 Years For $7.5M Stock Fraud (Law360-$) (STAT) (Pharmafile)
  • Consumer groups and unions try again to block the AbbVie and Allergan merger (STAT)
  • As bluebird makes commercial progress in Europe, US application for Zynteglo suffers delay (Endpoints) (BioPharmaDive) (Press)
In Focus: International
  • China HIV patients risk running out of AIDS drugs in days: UNAIDS (Reuters)
  • In Fighting Outbreaks, Big Pharma Struggles to Get Out Front (Bloomberg)
  • Coronavirus death toll rises above 2,000 worldwide (CNN)
  • India's commerce minister: price cuts on medical devices, drugs here to stay (Economic Times)
  • Israeli biotech NeoTX lands $45M series C for combo I-O cancer trials (Fierce) (Endpoints)
  • UK’s NICE recommends Axonics’ device for overactive bladder treatment (MassDevice)
  • Novacyt Gets CE Mark for Coronavirus Test (GenomeWeb)
  • European Union proposes independent audits for high-risk AI systems (STAT)
Pharmaceuticals & Biotechnology
  • Priority Review Voucher Programs Poised For US Legislative Attention In 2020 (Pink Sheet-$)
  • Pharma execs criticize a drug maker over pricing and claim orphan drug law is being misused (STAT)
  • FDA Continues to Approve Biosimilars (Patent Docs)
  • Audentes to build new gene therapy plant in North Carolina (BioPharmaDive) (Fierce)
  • Imara Reveals IPO Plan as Sickle Cell Drug Advances in the Clinic (Xconomy)
  • Astellas follows up $3B gene therapy buyout with $109M plan to accelerate a manufacturing boom (Endpoints)
  • Could ICER Outreach To US FDA Lead To Better Cost Effectiveness Analyses? (Pink Sheet-$)
  • GSK to shut down Pennsylvania plant, move production to Puerto Rico (PharmaManufacturing)
  • For two decades, a new vaccine technology has been slowly approaching prime time. Now, can it stop a pandemic? (Endpoints)
  • Cellectis boosts its coffers in revised off-the-shelf CAR-T deal with Servier (Endpoints)
  • Specialty Pharmacy M&A in 2019: CVS, OptumRx, and Private Equity Highlight a Slowing Market (Drug Channels)
  • DuPont makes another foray into drug R&D, throwing its name into the microbiome hat (Endpoints)
  • 'Significant problems' at outsourcing sites prompt Trump to plan FDA budget boost (Outsourcing Pharma)
  • Compounding Animal Drugs from Bulk Drug Substances; Draft Guidance (FDA)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
  • Seattle Genetics and Astellas Receive FDA Breakthrough Therapy Designation for PADCEV™ (enfortumab vedotin-ejfv) in Combination with Pembrolizumab in First-Line Advanced Bladder Cancer (Press)
  • Terns Pharmaceuticals Announces Safety and Pharmacodynamic Results of a Phase 1 Clinical Trial of TERN-101, a Liver-Selective FXR Agonist in Development for the Treatment of NASH (Press)
  • Palatin Technologies, Inc. Announces First Patient Enrolled in Dry Eye Disease Phase 2 Clinical Trial with PL9643 (Press)
  • RIBOMIC Announces First Injection in the Phase 2 Clinical Trial of RBM-007 (TOFU Study) in Subjects with Wet Age-Related Macular Degeneration (Press)
  • OrphoMed to Present Phase 1 Results of ORP-101 at Digestive Disease Week 2020 (Press)
Medical Devices
  • Why fixing security vulnerabilities in medical devices, IoT is so hard (Ars Technica)
  • Baxter closes $350M acquisition of Sanofi's Seprafilm adhesion barrier (MedtechDive)
  • Medtronic misses revenue estimates as TAVR position falters (MedtechDive)
  • As CMS coverage decision nears, Abbott gears for MitraClip expansion (MedtechDive)
  • Abbott And Insulet Partner To Integrate Next-Generation Glucose Sensing And Automated Insulin Delivery Technologies For Seamless Diabetes Care (Press)
  • Abbott wins CE Mark for ICD device (MassDevice)
  • Canon Medical Receives FDA Clearance for Aquilion ONE / PRISM Edition, Enabling Deep Learning Spectral Capabilities for Routine Use (Press)
  • EndoClot Plus, Inc. Announces FDA Clearance of GI Submucosal Lifting Product (Press)
US: Assorted & Government
  • What to watch in tonight's debate (Politico)
  • States Rip Opioid Judge For Creating Class Action By 'Decree' (Law360-$)
  • Amgen, Amneal Tell Fed. Circ. To Redo Sensipar IP Ruling (Law360-$)
  • Ill. Consumers Say Walgreens Sold Toxic Blood Pressure Drug (Law360-$)
  • Taxotere Court Finds that Distributor was Fraudulently Joined; Denies Remand (Drug & Device Law)
  • FDA Releases Final Installment of FSMA Intentional Adulteration Guidance; Inspections Start (Gulp) Next Month (FDA Law Blog)
  • New penalty, extended deadline drive increase in California health insurance sign-ups (Sacramento Bee)
Upcoming Meetings & Events Europe
  • Innovation: MHRA’s speedy approval of high dose flu vaccine demonstrates flexibilities in national applications (MHRA)
  • Aging Trend Helps New Billionaire Couple Emerge From China's Medical Industry (Forbes)
  • Jawed Zia quits Abbott India (Economic Times)
  • Coronavirus: Government panel recommends ban on export of 12 drug formulations, ingredients (Economic Times)
  • Pharma cos don't see supply shortage, oppose exports ban (Economic Times)
  • Medical device application processing times (TGA)
  • Notice: Implementation of eCTD for clinical trial regulatory activities (Health Canada)
Coronavirus Outbreak
  • China won't send officials to G20 meeting amid virus outbreak: sources (Reuters)
  • Swiss postpone global patient safety summit amid coronavirus outbreak (Reuters)
  • WHO reports 92 cases of human-to-human coronavirus cases outside China (Reuters)
  • Passengers depart coronavirus cruise ship at last; Japan's effort under fire (Reuters)
  • Coronavirus cases climb to 621 on Japan cruise liner as some passengers leave (Reuters)
  • U.S. CDC places 14-day travel restriction on passengers from quarantined cruise ship (Reuters)
  • South Korea reports 20 new coronavirus cases, church services at center of outbreak (Reuters)
  • Second Hong Kong coronavirus death as it awaits stranded cruise passengers (Reuters)
  • North Korea quarantines in place for coronavirus: envoy (Reuters)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
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