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Regulatory Focus™ > News Articles > 2019 > 6 > Recon: Roche Notches First Approval for Personalized Cancer Drug Rozlytrek in Japan

Recon: Roche Notches First Approval for Personalized Cancer Drug Rozlytrek in Japan

Posted 18 June 2019 | By Michael Mezher 

Recon: Roche Notches First Approval for Personalized Cancer Drug Rozlytrek in Japan

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • There’s a fight brewing in Congress over pharma’s patents (STAT)
  • With eyes on Gilead, lawmakers want details on how HHS reviews possible patent infringement (STAT) (House Oversight)
  • No provisions in USMCA to change U.S. pharmaceutical patent laws: Lighthizer (Reuters) (AAM)
  • Why Democrats reopened the debate about germline gene editing (STAT)
  • Merck racks up another FDA approval for Keytruda cancer drug (BioPharmaDive) (Endpoints) (FDA) (Press)
  • Google’s life sciences unit reveals data-driven opioid addiction centre (Financial Times)
  • Israel's Zebra Medical gets FDA ok for brain bleeds product (Reuters)
  • FDA approves Novo Nordisk's Victoza for children with type 2 diabetes (Pharmafile) (FDA) (Press)
  • By the Numbers: Vaccines Are Safe (NYTimes)
  • Vaccine Injury Claims Are Few and Far Between (NYTimes)
  • FDA poliovirus assay is faster and more versatile than current assays used in vaccine development and environmental surveillance (FDA)
  • Mylan Escapes Novartis MS Drug Patent Suit (Law360-$)
In Focus: International
  • Roche wins Japan approval for personalized cancer drug Rozlytrek (Reuters) (Endpoints) (Press)
  • AstraZeneca's Lynparza gets EU nod as first-line ovarian cancer maintenance treatment (Reuters) (Endpoints)
  • China's Fosun Mulls Joint Bid for Bayer Animal Health Arm (Bloomberg) (Financial Times)
  • French drugmaker Sanofi, Google to use data tech for innovations (Reuters) (Endpoints) (PMLive) (Financial Times)
  • Uganda clears three experimental Ebola treatments, watches for spread (Reuters)
  • Right back at you, Pfizer: BeiGene and a Pfizer spinout launch a newco to develop a MEK/BRAF inhibitor that could rival $11.4B combo (Endpoints)
  • NICE To Be Sovereign: U.K. Rejects Trump Suggestion To Include NHS In Possible Trade Deal (Forbes)
  • GSK pharma head flags need for speed in high-pressure drug market (Reuters)
  • EMA to Reinstate Some Activities Halted by Brexit (Focus) (BioCentury)
  • Brazil’s ANVISA adjusts upcoming regulation for custom-made medical devices (Emergo)
  • Korea Steps Up AI Adoption In Drug Discovery, Repositioning And Surveillance (Scrip-$)
  • PMDA to Prohibit Staffers from Trading Pharma Shares (PharmaJapan)
Pharmaceuticals & Biotechnology
  • Fourth Carcinogen Discovered in Heart Pills Used by Millions (Bloomberg)
  • Biotech ETFs are breaking out—here are 3 ways to play the space (CNBC)
  • Zolgensma: A Remarkable New Treatment, An ICER Analysis, And A Poorly Justified Price (Health Affairs)
  • Meet the Top Ten Drugs of 2024 (Maybe) (Drug Channels)
  • Common nerve pain drug linked to suicidal behavior, overdose (Reuters)
  • New Study Questions the Need for 12 Years of Market Exclusivity for Biologics (Focus) (Nature)
  • Study: Just Half of Postmarketing Commitment Trials are Published (Focus)
  • VBI's shares plunge after hep B vaccine fails secondary goal in late-stage trial (Reuters)
  • Real-World Evidence Could Become Effective Tissue-Agnostic Carving Knife (Pink Sheet-$)
  • US FDA Seeks Ways To Prevent Non-Responders From Sinking Tissue-Agnostic Indications (Pink Sheet-$)
  • Tissue-Agnostic Cancer Treatments: Can US FDA-Approved Diagnostics Limit Access? (Pink Sheet-$)
  • US FDA Pressing Industry To Use Standards For Cell and Gene Therapies (Pink Sheet-$)
  • Agency Information Collection Activities; Proposed Collection; Comment Request; Data to Support Social and Behavioral Research as Used by the Food and Drug Administration (FDA)
  • After watching its share price soar on a Bloomberg report and heated rumors, Biohaven stock takes a billion-dollar bath (Endpoints)
  • Roche's Floodlight MS app mines 'hidden' data to advance disease mapping (Fierce)
  • Why some people don’t respond to childhood vaccines—and how our DNA could fix it (PBS)
  • Unity Biotechnology, with big hopes for longevity drugs, shows results highlighting long road ahead (STAT) (Endpoints)
  • Sanofi, Voyager Therapeutics rejig gene therapy partnership (MedCity)
  • AstraZeneca spinout Viela bags $75M as FDA filing nears (Fierce)
  • GSK snares top pharma honors at Lions Health with first Grand Prix in years (Fierce)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • Positive results for AZ’ Lokelma in hyperkalaemia (PharmaTimes)
  • Eiger Announces Breakthrough Therapy Designation Granted by FDA for Avexitide for Treatment of Post-Bariatric Hypoglycemia (PBH) (Press)
  • Rocket Pharmaceuticals Announces Patient Dosing Has Commenced in Phase 1 Clinical Trial of RP-A501, the First Gene Therapy to Treat a Monogenic Heart Failure Syndrome (Press)
  • Hypercholesterolemia Drug Repatha® SC Injection Receives Supplemental Indication Approval As Monotherapy For Treating Hypercholesterolemia Patients Not Suitable For Statin Therapy (Press)
  • Triumvira Immunologics Announces Clearance of IND and CTA by U.S. FDA and Health Canada for Its First TAC T-cell Therapeutic Product Candidate, TAC01-CD19 (Press)
  • Imara Presented Positive, Interim Phase 2a Data on IMR-687 for the Treatment of Sickle Cell Disease at the 24th Congress of the European Hematology Association (Press)
  • Navidea Biopharmaceuticals Announces Day and Time of SNMMI Presentation of Phase 1/2 Study Results and Enrollment Update on its Phase 2B Study (Press)
Medical Devices
  • The FDA’s NEST Initiative and Women’s Health (Harvard Bill of Health)
  • Zoll acquires TherOx (MassDevice)
  • CDRH Discusses Evolution of Q-Submission Program (Focus)
  • Miracle Machine Makes Heroic Rescues — And Leaves Patients In Limbo (KHN)
  • Edwards Lifesciences warns on risk of IntraClude balloon bursting (MassDevice)
  • Merit puts $50m on the table for Brightwater (MassDevice)
  • Gel-e Gets Breakthrough Device Designation for internal-use flowable device (Press)
  • Real-World Data Collection – What Role Could Your Device Play? (MDDI)
  • Gel-e gains breakthrough device nod for internal bleeding control device (MassDevice)
  • Axonics wins FDA nod for MR-safe neurostim device in trial (MassDevice)
  • Murata Vios, Inc. Announces FDA Clearance for Second Generation Wireless Monitoring Platform (Press)
US: Assorted & Government
  • Former FDA chief Scott Gottlieb says some claims about health benefits of CBD are ‘pretty hokey’ (CNBC)
  • The Complex Web of Prescription Drug Prices, Part III: Examining Agency Efforts to Further Competition and Increase Affordability (Senate Aging)
  • Welcome to the Preemption Family (Drug & Device Law)
Upcoming Meetings & Events Europe
  • EMA Begins Review of Handling Errors Linked to Leuprorelin (Focus)
  • EC Cautions on MDR/IVDR Impact on Device Availability (Focus)
  • Ireland Makes a Push to Switch to Biosimilar Adalimumab and Etanercept (CFB)
  • MHRA Register of Written Confirmations For UK Active Substance Manufacturers (MHRA)
  • UK Request Pushes Illumina's Timeline for Completion of PacBio Acquisition to Q4 (GenomeWeb)
  • Shanghai's Zai Lab in-licenses novel oncology candidate (PharmaLetter-$)
  • ADHD drug Intuniv now approved for adults in Japan (PharmaLetter-$)
  • Biocon board approves sale of branded formulations business to subsidiary (Economic Times)
  • Introduction to TGA Business Services (TBS) (TGA)
Other International
  • Xiaflex® (Collagenase Clostridium Histolyticum) Product Discontinuation From New Zealand On 28 June 2019 (Press)
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.
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