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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)
Asia
  • Aging Trend Helps New Billionaire Couple Emerge From China's Medical Industry (Forbes)
India
  • 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)
Australia
  • Medical device application processing times (TGA)
Canada
  • 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.
 
Need to contact the editor of Regulatory Reconnaissance? Email us at news@raps.org.
 
A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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