Recon: FDA Panel Warns No Adequate Replacement for Ethylene Oxide; Cardinal Health Wins $2.25B DoD Medical Supplies Contract

• Ethylene oxide plant closures put US on 'cusp of a major medical logistical failure' (MedtechDive)
• AdvaMed Statement on EtO Air Testing by EPA (AdvaMed) (EPAv)
• Sarepta Therapeutics CEO playing nice with FDA over rejection of Duchenne drug (STAT) (Fierce)
• House Speaker Nancy Pelosi pushes vote on sweeping drug-pricing bill to December (CNBC)
• Senate fight derails bipartisan drug pricing bills (The Hill)
• Durbin Pushes for Senate Vote on Bill to Include Drug Prices in Ads (Focus)
• AnaptysBio shares collapse after 'worst case scenario' for key drug (BioPharmaDive) (Endpoints)
• Fagron to pay $22.5 million to settle US allegations over inflated drug prices (Reuters) (DOJ)
• Cardinal Health Inc wins $2.25 billion US defense contract: Pentagon (Reuters)
• Pfizer, Merck KGaA's Bavencio flunks study in hard-to-treat gastric cancer (Fierce) (Endpoints) (Press)

• Italy is urged not to replace a public health official who pushed for drug pricing transparency (STAT)
• EC Extends Deadline for Experts to Apply for MDR/IVDR Panels (Focus) (MedtechDive)
• Teva names new CFO and bulks up its opioid liability fund (PMLive)
• Eyeing second Japanese approval, Daiichi and Exelixis announce positive pivotal for kidney drug (Endpoints)
• Tot Biopharm completes HKEX listing, raising $63M in modest debut (Endpoints)
• Roche terminates Duchenne muscular dystrophy candidate due to poor clinical outlook (Pharmafile)
• Takeda opens German vaccine plant as dengue shot shows promise (BioPharmaDive)

• Strides Pharma relaunches Ranitidine tablets in US (Economic Times)
• Pfizer unveils biosimilar launch plans and shares view on US market (BioProcess International)
• Deal Watch: Biosimilars, Biosimilars and More Biosimilars (BigMoleculeWatch)
• A tiny pharmacy is identifying big problems with common drugs, including Zantac (Washington Post)
• Who Owns H.I.V.-Prevention Drugs? The Taxpayers, US Says (NYTimes)
• Personalised medicine can improve treatment, but access still an issue (PMLive)
• Trifecta of incoming migraine meds must be cheaper than triptans to be cost-effective — ICER (Endpoints) (ICER)
• Celgene's last hurrah at ASH a defining moment for Bristol-Myers' buyout (BioPharmaDive)
• Gottlieb: Branded Industry 'Gaming' Tactics Have Shifted From Regulatory To Commercial Space (Pink Sheet-$)
• Biosimilar Switching Studies May Not Be Worth Effort For US Interchangeability, Sponsors Say (Pink Sheet-$)
• Industry Experience with Autologous Cell Therapies Underscores Need for Upfront Planning on Integrating Facility Design, Operations, and Supply Lines (IPQ)
• Rx Pricing, Rebating Should Be Back To Business As Usual In 2020, PBMs Say (Pink Sheet-$)
• My life depends on medicine made from plasma. The plasma shortage worries me (STAT)
• A medicinal chemist sees some red flags on China’s newly approved Alzheimer’s drug (STAT)
• Doctors not talking enough about cancer genetic testing costs (Reuters)
• Monopar Therapeutics puts the brakes on IPO, again (Fierce)
• Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Consumer Level Recall of 38 Lots of Ranitidine Tablets 150mg, Ranitidine Capsules 150mg, Ranitidine Capsules 300mg and Ranitidine Syrup 15mg/mL Due to the Detection of NDMA (Nitrosodimethylamine) Impurity (FDA)

• AstraZeneca's roxadustat boosts haemoglobin levels in two Phase 3 trials  (Pharmafile) (Press)
• AbbVie Submits Supplemental New Drug Application to U.S. FDA For IMBRUVICA® (ibrutinib) in Combination with Rituximab for the Treatment of Previously Untreated, Younger Adults with Chronic Lymphocytic Leukemia (Press)
• NantKwest Announces Presentation of Positive Phase 2 Clinical Data of Natural Killer Cell Therapy in Metastatic Merkel Cell Carcinoma at SITC 2019 (Press)
• Exelixis’ Collaborator Daiichi Sankyo Announces Positive Results From Phase 3 Pivotal Trial of Esaxerenone in Patients With Diabetic Nephropathy (Press)
• Arrowhead and Collaborator Janssen Present Phase 2 Clinical Data for Investigational Hepatitis B Regimens at The Liver Meeting® 2019 (Press)
• Fresenius Kabi Introduces Heparin Sodium Injection, USP Simplist® Prefilled Syringe in 5,000 USP units per 0.5 mL presentation (Press)
• Poxel Announces Positive Update Following FDA Meeting for PXL065 for Treatment of NASH (Press)
• Forbius Completes Phase 1 Oncology Dose-Escalation with AVID200, First-in-Class TGF-beta 1 & 3 Inhibitor: Well Tolerated, Target Inhibition Demonstrated at All Dose Levels, Data Reported at SITC (Press)
• Ligand Presents Positive Results from Phase 1 Clinical Trial of Captisol-enabled Iohexol (Press)
• AR101 Demonstrates Consistent Efficacy and Safety in New Analysis at ACAAI Comparing PALISADE and ARTEMIS Phase 3 Clinical Data (Press)
• New Analyses from the Phase 3 HELP Study™ Open-Label Extension in Hereditary Angioedema Evaluate Efficacy and Safety of TAKHZYRO® (lanadelumab-flyo) Injection During Extended Study Treatment Period (Press)

• Zimmer Biomet's Rosa Brain recall categorized as Class I MedtechDive) (FDA)
• Medtronic reveals high-risk cyber vulnerability in electrosurgical generators (MedtechDive)
• Exact Sciences closes Genomic Health deal, wins breakthrough tag for liver cancer blood test (MedtechDive)
• Endologix rises after posting improved Q3 earnings (MassDevice)
• Class 1 Device Recall Teleflex Babi.Plus 12.5 cm H2O Pressure Relief Manifold (FDA)

• Former Biogen sales rep, who says she was fired for complaining about off-label marketing, is awarded $6 million (STAT)
• Another former Sun Pharma sales rep claims she was fired for complaining about off-label marketing (STAT)
• NY AG's Trial Against Opioid Makers Scheduled For January (Law360-$)
• Achillion Investor Seeks To Halt $930M Pharma Tie-Up (Law360-$)
• With Vape Curbs Pending, White House Questions FDA Tobacco Role (Bloomberg)
• Trump says will issue final decision on vaping product next week (Reuters)
• Ex-Theranos President Must Reveal Portfolio, Net Worth to SEC (Bloomberg)
• What Bloomberg believes on health care (Politico)

• FDA Advisory Committee Calendar

• Danish Medicines Agency Revokes Scanpharm’s Authorization to Manufacture Drugs (Focus)
• French Industry Denies Influence On Prescribing Practices (Pink Sheet-$)
• Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 5-7 November 2019 (EMA)
• Committee for Advanced Therapies (CAT): 06-08 November 2019 (EMA)

• Embracing China 2.0: AZ, Merck KGaA Set Up Funds, J&J Steps Up Digital Push (Scrip-$)

• Submissions received: Regulation of software, including Software as a Medical Device (SaMD) (TGA)

• The world’s first Gattaca baby tests are finally here (MIT Technology Review)