Regulatory Focus™ > News Articles > 2019 > 7 > Recon: Roche Among Companies Hit by Winnti Cyber Attack; FDA Cancels Advisory Panel for Intra-Cellul

Recon: Roche Among Companies Hit by Winnti Cyber Attack; FDA Cancels Advisory Panel for Intra-Cellular’s Schizophrenia Drug

Posted 24 July 2019 | By Michael Mezher 

Recon: Roche Among Companies Hit by Winnti Cyber Attack; FDA Cancels Advisory Panel for Intra-Cellular’s Schizophrenia Drug

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • FDA cancels panel review of Intra-Cellular’s schizophrenia drug, causing shares to tumble (STAT) (Endpoints) (BioPharmaDive)
  • 6 burning questions about the Senate Finance Committee’s ambitious new drug pricing plan (STAT)
  • Sun Pharma sales reps claims he was fired for complaining about off-label marketing (STAT)
  • Patients, backed by ‘dark money’ group, get ready to debate Duchenne drug prices. It will not be boring (STAT)
  • Sage Therapeutics to pursue high-risk, high-reward plan for experimental depression pill (STAT)
  • California cites AmerisourceBergen for failing to flag huge sales of opioids to pharmacies (STAT)
  • Celgene drops $2.6B Jounce pact, bags rights to macrophage drug (Fierce) (Endpoints)
  • Capitalism gone wrong: how big pharma created America's opioid carnage (The Guardian)
  • Drugmakers shell out record amount lobbying Congress (Financial Times)
  • Big Pharma Pounces On Bipartisan Drug Pricing Bill (Law360-$)
  • Senate drug bill sets up Trump’s newest health care test (Politico)
  • Senate will not vote on bipartisan health costs bill before leaving for August (The Hill)
Sponsored Content: Hear from the first Notified Body designated to the new EU-MDR In Focus: International
  • GSK: betting the pharm (Financial Times)
  • BASF, Siemens, Henkel, Roche target of cyber attacks (Reuters) (Fierce)
  • EU Valletta Alliance Ups The Ante On Drug Pricing Transparency (Pink Sheet-$)
  • As Takeda absorbs Shire’s R&D ops, the focus is on replacing a centralized command model with a ‘light touch’ in a restructured global organization (Endpoints)
  • Brexit policy remains at odds with industry as Johnson becomes PM (BioCentury) (Fierce)
  • NICE review could lead to increased use of real-world evidence (BioCentury)
  • How NICE is retooling the way antibiotics are valued (BioCentury)
  • World Bank readies $300 million to cover half of new Ebola response (Reuters)
  • ABPI Chief Executive Mike Thompson to retire by the end of 2019 (Pharmafile)
  • ICH Public Meeting To Get Input From Non-Members On E8 Revision (Pink Sheet-$)
Pharmaceuticals & Biotechnology
  • FDA Approves Two More Biosimilars (Focus)
  • Sharpless Outlines FDA’s Key Priorities for Advancing Public Health (Focus)
  • FDA Warns CBD Seller, HCT/P Maker and Indian Drugmaker (Focus)
  • Multiple sclerosis drug helps Biogen beat Wall St. profit expectations (Reuters) (BioCentury)
  • Do Biopharma Companies Really Spend More on Marketing Than R&D? (Focus)
  • WHO Revises Guidance on QMS Requirements for National Inspectorates (Focus)
  • Expanding the RNA-editing toolbox (Nature)
  • Tips for Industry-Academia Collaboration (LifeSciVC)
  • Pregabalin Approvals Hit the Approval Trail, But Why So Late? (Lachman Consultants)
  • FDA Should Build Greater Public Consensus on Appropriate Use of EFIC, Study Finds (Focus)
  • Novartis, AstraZeneca vet Jonathan Symonds steers back to a top post in Big Pharma, this time at GSK (Endpoints)
  • Boehringer's Ofev Faces Efficacy Hurdle For SSc-ILD Indication At US FDA Advisory Cmte. (Pink Sheet-$)
  • Novartis backs Harvard spinout's quest to build TCR repository in $48M round (Endpoints)
  • Laser-focused on colorectal cancer test, Freenome wins $160M from marquee VC pack led by RA, Polaris (Endpoints)
  • GSK culls more respiratory drugs out of PhII as focus shifts to cancer (Endpoints) (Fierce)
  • Short-term opioids for pain still come with side effects (Reuters)
  • Heart attacks, strokes increase when patients can't afford newer cholesterol drugs (Reuters)
  • Most women use vaginal ring for HIV prevention in open-label study (NIH)
  • NIH awards contract for acute flaccid myelitis natural history study (NIH)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • Merck Announces Presentation of Phase 2b Results for Investigational HIV-1 Therapy Islatravir (MK-8591) at IAS 2019 (Press)
  • ViiV Healthcare announces positive Week 48 results in first study to evaluate treatment switch from TAF-containing regimen with three or more drugs to 2-drug regimen of dolutegravir/lamivudine for HIV-1 infection (Press)
  • ViiV Healthcare presents GEMINI 1 & 2 studies through Week 96 showing 2-drug regimen of dolutegravir plus lamivudine continues to demonstrate high efficacy rates and no cases of treatment emergent resistance (Press)
  • Oyster Point Pharma Announces Enrollment of First Subject in Phase 3 Clinical Trial of Nasal Spray for Dry Eye Disease (Press)
  • Allegro Ophthalmics to Present for the First Time the Results of Its Phase 2 Risuteganib Intermediate Dry Age-Related Macular Degeneration Study at the ASRS Annual Meeting 2019 (Press)
  • Astellas Announces Acceptance by the European Medicines Agency of a Variation Application for Regulatory Review for Use of XTANDITM (enzalutamide) in metastatic Hormone-Sensitive Prostate Cancer (Press)
Medical Devices
  • FDA Recognizes Standards for Medical Device Interoperability, Safety Assurance Cases (Focus)
  • France Drafts Medical Device Cybersecurity Recommendations (Focus)
  • Medical Devices for Weight Loss and Weight Management: What to Know (FDA)
  • Dassault Systèmes and the FDA Extend Collaboration to Inform Cardiovascular Device Review Process and Accelerate Access to New Treatments (Press)
US: Assorted & Government
  • FDA Must Reconsider Denial Of Braeburn Anti-Opioid Drug (Law360-$)
  • Warren Seeks Answers from Pharmaceutical Giant Pfizer on Appointment of Former FDA Commissioner Gottlieb to Board of Directors (Warren)
  • Massachusetts lawmakers approve compromise bill to lower Medicaid drug spending (STAT)
  • US FDA Must Explain How It Defines ‘Innovation’ In Awarding Hatch/Waxman Exclusivity, Court Says (Pink Sheet-$)
  • Senate cannabis hearing shows challenges to rewriting pot laws despite growing support in Congress (CNBC)
  • Corcept Wants Sun's Cushing's Syndrome Drug Blocked (Law360-$)
  • Federal Court Denies Request to Block Amgen, Allergan From Marketing Two Oncology Biosimilars (FDANews-$)
  • Mayne Pharma Int'l v. Merck Sharp & Dohme Corp. (Fed. Cir. 2019) (Patent Docs)
  • Connecticut Trial Court Tosses Vaginal Mesh Case against Hospital (Drug & Device Law)
Upcoming Meetings & Events Europe
  • Paediatric Committee elects Koenraad Norga as its new chair (EMA)
  • GW Pharma's Cannabinoid Medicine Epidyolex Among CHMP Hopefuls (Pink Sheet-$)
  • Professional use capillary blood specimen collection: BD Microtainer® tubes – risk of blood leakage and/or incorrect test results due to defective tubes (MHRA)
  • Notify MHRA about a clinical investigation for a medical device - Updated (MHRA)
  • Class 2 Medicines Recall: Bisacodyl 5mg Gastro-Resistant tablets batch 25074A (MDR 34-04/19) (MHRA)
  • New European MDR guidance on medical device implant cards (Emergo)
India
  • NPPA issues notices against 15 companies for introducing 22 drugs without prior approval (PharmaBiz)
  • Zydus Cadila launches insomnia drug in US market (Economic Times)
Australia
  • TGA Presentation: Consultation on reforms to the generic medicine market authorisation process (TGA)
  • Australian TGA finalizes medical device and IVD cybersecurity guidance (Emergo)
Other International
  • Brazil’s ANVISA now requires electronic submissions of medical device FSCAs (Emergo)
General Health & Other Interesting Articles
  • Your Data Were ‘Anonymized’? These Scientists Can Still Identify You (NYTimes)
  • Genetics play bigger role in autism risk than environmental factors (Reuters)
  • Daniel Callahan, 88, Dies; Bioethics Pioneer Weighed ‘Human Finitude’ (NYTimes)
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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