Recon: FDA Rejects Lipocine Testosterone Drug for the Third Time; Roche SMA Drug Hits Goal in Pivotal Study

ReconRecon | 11 November 2019 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Democratic presidential hopefuls want to take on pharma. Here’s how they’d do it (STAT)
  • Voters Say Congress Needs to Curb Drug Prices, But Are Lawmakers Listening? (KHN)
  • Celgene's drug for anemia in beta thalassemia priced at $3,441/ 25 mg vial (Reuters) (Endpoints) (FDA)
  • FDA rejects Lipocine's testosterone drug for third time (Reuters) (Endpoints) (Press)
  • Medicare’s outpatient ‘Part B’ premium going up to $144.60 (AP)
  • Even a Modest Co-Payment Can Cause People to Skip Drug Doses (NYTimes)
  • AbbVie Looking to Raise $28 Billion in High-Grade Bond Market (Bloomberg)
  • Bernard J. Tyson passes away: KP's leader was a health care titan (Politico) (Reuters)
In Focus: International
  • Merck Ebola vaccine approved in Europe (STAT) (Press)
  • Cannabis-based medicines: Two drugs approved for NHS (BBC) (The Guardian) (PMLive)
  • Lupin sells off Japanese operation to tidy up its balance sheet (Fierce) (Press)
  • Novartis' Sandoz builds global generics presence with Japan acquisition (BioPharmaDive) (BioProcessInternational) (Press)
  • How Germany Averted An Opioid Crisis (KHN)
  • Roche sets sights on Novartis, Biogen as SMA trial hits target (Reuters) (Endpoints) (Press)
  • Roche tests 'brain shuttle' in humans in Alzheimer's project (Reuters)
  • ICH Survey Shows Wide Adoption of Guidelines Among Regulators, Industry (Focus)
  • WHO Commends Russian Response to Proposed Heritable Human Genome Editing (Focus)
Pharmaceuticals & Biotechnology
  • Orphan Drug Recall Leaves Patients in the Lurch (Focus)
  • FDA to Revoke Orphan Designation for Opioid Addiction Drug Sublocade (Focus)
  • Experts Pitch FDA on Policies to Improve Drug Development (Focus)
  • Special report: Twenty extraordinary women in biopharma R&D who worked their way to the top (Endpoints)
  • Evaluation of epinephrine's expiration date: A US Food and Drug Administration's perspective (ScienceDirect)
  • FDA ‘Best Practices’ Include Weekly Adverse Event Screening For New Drugs (Pink Sheet-$)
  • FDA’s OPQ Chief Tells Generic Drug Makers Its Time To Up Their Quality Game (Pink Sheet-$)
  • Safety data on AstraZeneca anemia drug points to potential use in dialysis (Reuters)
  • Novartis makes case for NASH candidate tropifexor (PMLive)
  • Immunotherapies targeting melanoma post encouraging results, new data show (STAT)
  • Israeli biotech gambles on a failed drug, merging with troubled Menlo ahead of PhIII data (Endpoints)
  • The latest Cinderella story in oncology ends with a sudden rout as updated data display spooks investors (Endpoints)
  • Aslan's latest cancer focus also flops, leaving just two major programs for the troubled biotech (Endpoints)
  • Study vaccine protects monkeys against four types of hemorrhagic fever viruses (NIH)
  • Industry Experience with Autologous Cell Therapies Underscores Need for Upfront Planning on Integrating Facility Design, Operations, and Supply Lines (IPQ)
  • Bolt Bio preps clinical trials of immune-stimulating cancer drug in stubborn solid tumors (Fierce)
  • Aslan's varlitinib hopes fade after latest failure (Fierce)
  • American Health Packaging Issues Voluntary Nationwide Recall of Ranitidine Syrup (Ranitidine Oral Solution USP) 150 mg/10 mL Liquid Unit Dose Cups Due to the Detection of N-nitrosodimethylamine (NDMA) Impurity (FDA)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
  • Breakthrough status and promise of a speedy review arrives for Opdivo/Yervoy combination as Bristol-Myers bites at Bayer (Endpoints) (Press)
  • Roxadustat moves on to the regulators (Evaluate) (Press)
  • Allergan Receives FDA Qualified Infectious Disease Product (QIDP) Designation And Fast Track Designation For ATM-AVI (Aztreonam And Avibactam) For Antibiotic-Resistant Gram-Negative Infections (Press)
  • Roche steers Gazyva into a new PhIII program after combo shows promise in lupus nephritis study (Endpoints) (Press)
  • New Data on Filgotinib in Rheumatoid Arthritis (RA) Demonstrate Durable Efficacy and Safety Profile (Press)
  • TREMFYA®▼ (guselkumab), a First-in-Class IL-23 p19 Subunit Inhibitor, Meets Primary Endpoints of Superior ACR20 Responses versus Placebo at Week 24 in Phase 3 Psoriatic Arthritis Studies (Press)
  • Nektar Therapeutics Presents Data from First-in-Human Phase 1a Study on Novel T Regulatory Cell Stimulator, NKTR-358 at 2019 Annual Meeting of the American College of Rheumatology (Press)
  • New Data From the Phase III DAPA-HF Trial Showed FARXIGA Reduced the Worsening of Heart Failure or Cardiovascular Death in HFrEF Patients With and Without Chronic Kidney Disease (Press)
  • F2G Receives US FDA Breakthrough Therapy Designation for Olorofim (Press)
  • Five Prime Therapeutics Presents Initial Safety Data from the Phase 1 Trial of FPT155 at the Society for Immunotherapy of Cancer Annual Meeting (Press)
  • Alnylam Initiates ILLUMINATE-C Phase 3 Study of Lumasiran for the Treatment of Advanced Primary Hyperoxaluria Type 1 and Presents New Positive Results from Phase 2 Open-Label Extension Study (Press)
  • Akebia Announces Positive 52-week Efficacy and Safety Data for Vadadustat from Two Pivotal Phase 3 Studies in Japanese Patients with Anemia Due to Chronic Kidney Disease (Press)
  • New Analysis from Landmark CREDENCE Study Shows the Efficacy and Safety Profiles of INVOKANA® (canagliflozin) are Consistent Across Various Levels of Kidney Function (Press)
  • Promethera Biosciences Presents Updated Clinical Results at AASLD 2019 for World’s First Stem Cell Therapy Trial using HepaStem™ in Acute-on-Chronic Liver Failure (Press)
  • Akesobio Presents Phase 1 Clinical Data from First-in-class Bispecific Drug Candidate AK104 (PD1/CTLA4) As Oral Presentation, at 2019 SITC Annual Meeting (Press)
  • VBI Vaccines to Present Initial Phase 1/2a Part B Data of VBI-1901 at the 2019 Society for Neuro-Oncology (SNO) Annual Meeting (Press)
Medical Devices
  • Wright Medical growth slowed in run-up to Stryker deal (MedtechDive)
  • Duodenoscope reprocessors' poor work conditions exacerbate infection problem, FDA panel says (MedtechDive)
  • Biocept Receives CE Mark for Blood Collection Tube, Sample Collection Shipping Kit (GenomeWeb)
  • Noteworthy Changes From FDA's Latest Software Guidance (Law360-$)
  • AI Medical Service Inc. announces FDA Breakthrough Device Designation for endoscopic AI system (Press)
  • Value of Human Factors Engineering for ancillary adherence technologies in clinical studies (Emergo)
US: Assorted & Government
  • PhRMA submission to 2020 National Trade Estimate Report: Urgent action required to protect U.S. biopharmaceutical innovation (PhRMA)
  • Berkeley Files Opposition to Broad's Substantive Motion No. 1 in Interference (Patent Docs)
  • Amid Opioid Lawsuits, Walgreens Wants Distance From AmerisourceBergen (Forbes)
  • US CDC reports 'breakthrough' in vaping lung injury probe as cases top 2,000 (Reuters)
  • DC Circ. Asks If HHS Had Leeway For Drug Payment Cuts (Law360-$)
  • Citizen Petitions Are Crucial In Managing A Drug's Life Cycle (Law360-$)
  • White House Wants To Avoid Fight On Rebates, Get Quick Passage Of Senate Rx Pricing Bill (Pink Sheet-$)
  • Why Erie Is an Inherently Conservative Doctrine (Drug & Device Law)
Upcoming Meetings & Events
  • FDA Advisory Committee Calendar
  • ‘Regulatory science to 2025’: live broadcast of post-consultation workshop – 18-19 November 2019
  • Advancing the Development of Pediatric Therapeutics (ADEPT 6): Pediatric Clinical Trial Endpoints for Rare Diseases With a Focus on Pediatric Patient Perspectives – 12 November 2019
  • Immunology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement - 13-14 November 2019
  • EMA Update: What Challenges Are Biosimilars Bringing To The Table? (Biosimilar Development)
  • NHS England Hails Biggest CAR-T Uptake In Europe (Pink Sheet-$)
  • EU Explains How Info Requests Will Be Managed Under Clinical Trials Regulation (Pink Sheet-$)
  • Fair Pricing A Key Feature Of NHS England Drug Funding Proposals (Pink Sheet-$)
  • Class 2 Medicines Recall: Sandoz Limited, Omeprazole 40 mg Powder for Solution for Infusion, PL 04416/0701 (EL(19)A/34) (MHRA)
  • First sexually transmitted dengue case confirmed in Spain (The Telegraph)
  • New policy likely to resolve drug name anomaly (Economic Times)
  • Glenmark recalls over 2 lakh cartons of product in US (Economic Times)
  • DCGI directs manufacturers to furnish undertaking for not marketing drugs having similar brand names (Pharmabiz)
  • Advertising guidance for businesses involved with stem cells and other human cell or tissue (HCT) products (TGA)
  • Microneedling device cancelled in Australia (TGA)
General Health & Other Interesting Articles
  • Deaths of 3 Infants Traced to Contaminated Equipment, Hospital Says (NYTimes)
  • With Medical Bills Skyrocketing, More Hospitals Are Suing for Payment (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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