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

• 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)

• At BSI's full-day EU Medical Device Roadshow, learn the challenges in meeting European CE-marking regulatory and compliance expectations for the new MDR/IVDR requirements. BSI will be sharing our current experiences, best practice and expectations from the perspective of the first notified body designated under the MDR (EU 2017/745).

• 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 $300 million to cover half of new Ebola response (Reuters)
• ABPI Chief Executive Mike Thompson to retire by the end of 2019 (Pharmafile)
• ICH Public Meeting To Get Input From Non-Members On E8 Revision (Pink Sheet-$)

• 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)

• 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)

• 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)

• 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)

• FDA Advisory Committee Calendar

• 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)

• NPPA issues notices against 15 companies for introducing 22 drugs without prior approval (PharmaBiz)
• Zydus Cadila launches insomnia drug in US market (Economic Times)

• TGA Presentation: Consultation on reforms to the generic medicine market authorisation process (TGA)
• Australian TGA finalizes medical device and IVD cybersecurity guidance (Emergo)

• Brazil’s ANVISA now requires electronic submissions of medical device FSCAs (Emergo)

• 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)