Regulatory Focus™ > News Articles > 2019 > 9 > Recon: Biogen, Eisai Abandon Two Phase 3 Alzheimer’s Studies Over Safety Concerns

Recon: Biogen, Eisai Abandon Two Phase 3 Alzheimer’s Studies Over Safety Concerns

Posted 13 September 2019 | By Michael Mezher 

Recon: Biogen, Eisai Abandon Two Phase 3 Alzheimer’s Studies Over Safety Concerns

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Biogen scraps two late-stage Alzheimer's trials (Reuters) (Fierce) (Endpoints) (Press)
  • Inside the drug industry’s plan to disarm the DEA (Washington Post)
  • While battling opioid crisis, US government weighed using fentanyl for executions (Reuters)
  • Purdue Pharma Made, Then Ditched, Plans for Opioid-Treatment Nonprofit (WSJ)
  • Chaotic talks show challenge of reaching opioid settlement (AP)
  • An FDA advisory panel is reviewing Aimmune’s peanut allergy therapy. Here’s what’s happening (STAT) (Press)
  • AbbVie/Allergan's merger faces public opposition (PMLive) (STAT)
  • Reuters asks judge to release secret Propecia documents (Reuters)
  • Amgen shares hit after analysts expose buried FDA trial halt (Fierce) (Endpoints)
  • US officials worried about Chinese control of American drug supply (NBC)
  • Pelosi plan could drop next week with no major tweaks (Politico)
In Focus: International
  • Private equity firm to buy Sanofi's oldest plant in India (BioPharmaDive)
  • Exclusive: One Of The Largest Pharma Companies In The World Just Got Into Cannabis (Forbes) (Fierce) (Endpoints)
  • Novartis MS drug cuts relapse rate by half compared to Sanofi medicine (Reuters)
  • Astellas, Iota Biosciences Partner on Ultra-Small Implantable Biosensors (Press)
  • Kenya becomes third African nation to introduce malaria vaccine (Reuters)
  • Indian pharma exports to touch $22 billion this fiscal, Q1 exports stand at $5 billion (Economic Times)
Pharmaceuticals & Biotechnology
  • Avoiding target misidentification (Nature)
  • Breath test to reduce overprescribing of antibiotics (Financial Times)
  • FDA warns about rare but severe lung inflammation with Ibrance, Kisqali, and Verzenio for breast cancer (FDA)
  • FDA OKs expanded use of Glaxo's asthma med Nucala (Seeking Alpha) (Press)
  • Right to try ‘remains a bust,’ as many drug makers prefer FDA reviews (STAT)
  • Chalk up a big win for Bain as SpringWorks IPO tops out at $162M (Endpoints)
  • Ardelyx bags its first FDA OK for IBS, setting up a showdown with Allergan, Ironwood (Endpoints) (Press)
  • IQVIA and partners set up cancer ‘data hub’ to speed up research (PMLive)
  • Early snapshot of Adverum's eye gene therapy sparks concern about vision loss (Endpoints)
  • From partner to knight in shining armor: Castle Creek to buy Fibrocell (Endpoints)
  • Star founders, investigators huddle around new Boston accelerator spotlighting young entrepreneurs (Endpoints)
  • Cancer patients use crowdfunding for medical bills, expenses (Reuters)
  • Everything's Special At US FDA: Priority NDA/BLA Filings Surge (Pink Sheet-$)
  • The New Payer Dogma: US FDA Approved Drugs Have 'Less Evidence' (Pink Sheet-$)
  • Few people with peanut allergy tolerate peanut after stopping oral immunotherapy (NIH)
  • CTD Holdings Announces FDA Approval of US Expanded Access Treatment Program in Niemann-Pick Disease Type C (Press)
  • KRS Global Biotechnology, Inc. Issues Voluntary Nationwide Recall of All Human and Animal Sterile Drug Products Due to Lack of Assurance of Sterility (FDA)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
  • Celgene's phase 3 AML test chalks up a win (Fierce) (Press)
  • Ritter's microbiome modulator fails lactose intolerance phase 3  (Fierce) (Press)
  • Amgen Announces Phase 3 CANDOR Study Combining KYPROLIS® (carfilzomib) And DARZALEX® (daratumumab) Meets Primary Endpoint Of Progression-Free Survival (Press)
  • Positive Results Announced From Phase 3 Trial Evaluating Fixed-Dose Subcutaneous Combination Of Perjeta® And Herceptin® Using Halozyme's Enhanze® Drug Delivery Technology (Press)
  • Roche presents new 6-year OCREVUS (ocrelizumab) data which showed that earlier initiation and continuation of treatment reduced disability progression in multiple sclerosis (Press)              
  • Roche’s fixed-dose subcutaneous combination of Perjeta and Herceptin showed non-inferiority when compared to intravenous formulations for people with HER2-positive breast cancer (Press)
  • Crestone, Inc. (Boulder) Secures NIH Funding for Phase 2 Clinical Trial of Novel Antibiotic Candidate (Press)
Medical Devices
  • CDRH Issues Final Guidance on De Novo Submission Acceptance Review (FDA Law Blog)
  • V-Wave’s interatrial shunt lands another breakthrough nod from FDA (MassDevice)
  • Medtronic recalls certain balloon catheters (MassDevice)
  • FDA clears HeartFlow Planner (MassDevice)
  • Qfix® Announces FDA 510(k) Clearance of Encompass™ 15 Channel Head Coil for Siemens 3T MRI Systems (Press)
US: Assorted & Government
  • Consumer Protection And Commerce Subcommittee Announces Hearing On Protecting Consumers From Pharmaceutical Market Gaming Tactics (House E&C)
  • When will Democratic debates move past 'Medicare for All' fight? (Politico)
  • The Unknown Unknowns – Differential Etiology and Idiosyncrasy (Drug & Device Law)
  • MEDICAID: Efforts to Identify, Predict, or Manage High-Expenditure Beneficiaries (GAO)
  • USPTO Increases Limit on Accepted Requests for Track I Examination (Patent Docs)
  • Vanda Pharma Investor Accuses Brass Of Off-Label Marketing (Law360-$)
  • 3rd Circ. Revives State-Law Fraud Claims By Merck Opt-Outs (Law360-$)
Upcoming Meetings & Events Europe
  • Investigation against Cryo-Save: FOPH has filed charges (Swissmedic)
  • New European Pharmacopoeia Reflects Regulatory And Scientific Progress (Pink Sheet-$)
  • Herbal medicines granted a traditional herbal registration (THR) (MHRA)
Asia
  • First Filing, In Japan, For Daiichi’s Lead ADC As Others Progress (Scrip-$)
India
  • UK regulator reinstates full GMP status of Indoco Remedies Goa facility (Economic Times)
Australia
  • Public submissions on scheduling matters referred to the ACMS #27, ACCS #25 and Joint ACMS-ACCS #22 meetings held in June 2019 (TGA)
  • Webinar: The cybersecurity of medical devices (TGA)
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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