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

Posted 08 November 2019 | By Michael Mezher 

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

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • 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)
In Focus: International
  • 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 $63M in modest debut (Endpoints)
  • Roche terminates Duchenne muscular dystrophy candidate due to poor clinical outlook (Pharmafile)
  • Takeda opens German vaccine plant as dengue shot shows promise (BioPharmaDive)
Pharmaceuticals & Biotechnology
  • Strides Pharma relaunches Ranitidine tablets in US (Economic Times)
  • Pfizer unveils biosimilar launch plans and shares view on US market (BioProcess International)
  • Deal Watch: Biosimilars, Biosimilars and More Biosimilars (BigMoleculeWatch)
  • A tiny pharmacy is identifying big problems with common drugs, including Zantac (Washington Post)
  • Who Owns H.I.V.-Prevention Drugs? The Taxpayers, US Says (NYTimes)
  • Personalised medicine can improve treatment, but access still an issue (PMLive)
  • Trifecta of incoming migraine meds must be cheaper than triptans to be cost-effective — ICER (Endpoints) (ICER)
  • Celgene's last hurrah at ASH a defining moment for Bristol-Myers' buyout (BioPharmaDive)
  • Gottlieb: Branded Industry 'Gaming' Tactics Have Shifted From Regulatory To Commercial Space (Pink Sheet-$)
  • 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)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
  • 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)
Medical Devices
  • 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)
US: Assorted & Government
  • 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)
Upcoming Meetings & Events Europe
  • Danish Medicines Agency Revokes Scanpharm’s Authorization to Manufacture Drugs (Focus)
  • French Industry Denies Influence On Prescribing Practices (Pink Sheet-$)
  • Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 5-7 November 2019 (EMA)
  • Committee for Advanced Therapies (CAT): 06-08 November 2019 (EMA)
Asia
  • Embracing China 2.0: AZ, Merck KGaA Set Up Funds, J&J Steps Up Digital Push (Scrip-$)
Australia
  • Submissions received: Regulation of software, including Software as a Medical Device (SaMD) (TGA)
General Health & Other Interesting Articles 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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