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Regulatory Focus™ > News Articles > 2019 > 7 > Recon: Amgen, Novartis Halt Alzheimer’s Studies After Patients Worsened

Recon: Amgen, Novartis Halt Alzheimer’s Studies After Patients Worsened

Posted 12 July 2019 | By Michael Mezher 

Recon: Amgen, Novartis Halt Alzheimer’s Studies After Patients Worsened

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Amgen, Novartis abandon two Alzheimer’s drug studies (Financial Times) (Endpoints) (Pharmafile) (Press)
  • Nexus to build $250M manufacturing facility in Wisconsin (BioPharmaDive)
  • Indivior says Reckitt settlement in U.S. unrelated to its cases (Reuters)
  • ‘There’s a lot of screaming into the void’: Toddler’s parents battle for coverage of $2.1 million gene therapy (Washington Post)
  • White House scraps key plan to lower drug prices; may target drugmakers (Reuters) (NPR) (CNBC)
  • Alex Azar's no-good, very tough week (Politico)
  • Six Reasons Why the Rebate Rule Failed—And What’s Next (Drug Channels)
  • Grassley: Deal to lower drug prices moving forward 'very soon' (The Hill)
  • Lawmakers seek scientific review of plan to tightly regulate all fentanyl copycats (Reuters)
  • 23andMe is moving into Apple’s territory with a pilot to pull in medical data, not just DNA (CNBC)
  • Illumina plunges after slashing revenue expectations (CNBC)
  • For Big Pharma, the revolving door keeps spinning (The Hill)
In Focus: International
  • Johnson & Johnson to test experimental HIV vaccine in U.S., Europe (Reuters)
  • Congo rules out using additional trial vaccines to combat Ebola (Reuters)
  • Croatia's drugs wholesalers limit hospital deliveries as debts rise (Reuters)
  • US and EU Fully Implement Mutual Agreement on GMP Inspections (Focus)
  • German court blocks sale of Sanofi, Regeneron cholesterol drug (BioPharmaDive) (Fierce)
  • AstraZeneca takes lessons from fast food to serve China (Financial Times)
  • Ambitious WHO Plan To Help 50 Nations Improve Regulatory Capacity (Pink Sheet-$)
  • How An Island In The Antipodes Became The World's Leading Supplier Of Licit Opioids (Pacific Standard)
Pharmaceuticals & Biotechnology
  • Revenues From New Drugs – And Thoughts on Chance (In the Pipeline)
  • Drug pricing concerns return for pharma (Vantage)
  • Lilly's Shaw to head Gilead's cancer push as new CEO of Kite (BioPharmaDive)
  • Broad star Feng Zhang unveils a new CRISPR platform, editing RNA and eliminating Alzheimer's threat — in cells (Endpoints)
  • ICER update on Duchenne drugs pushes up price estimates for Exondys 51, Emflaza ahead of July panel review (Endpoints)
  • Supercharging CAR-T with cancer vaccine, MIT team spotlights some new tech underpinning Darrell Irvine's startup (Endpoints)
  • Sanofi, Regeneron turn to photos, data plots to set Libtayo apart from I-O rivals (Fierce)
  • Pairing targeted drugs could overcome breast, lung cancer treatment resistance (PharmaTimes)
  • Hormonal Contraception: FDA Drafts Guidance on Clinical Trial Recommendations (Focus)
  • FDA Revises 1999 Draft Guidance on Population Pharmacokinetics (Focus)
  • Minority Males Less Aware Than Whites of HIV-Protection Drugs (US News)
  • Ex-DARPA director pursues all-in-one cancer pill as NED CEO; Karyopharm loses commercial chief ahead of drug rollout (Endpoints)
  • Sofinnova lends AbiVax a hand for PhII anti-inflammatory trials, picking up €12M worth of stock (Endpoints) (Fierce)
  • Drug Trials Snapshots: VYLEESI (FDA)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • AstraZeneca's Imfinzi gets orphan drug designation from FDA (Pharmafile)
  • Janssen Submits Application to U.S. FDA Seeking Approval of New DARZALEX® (daratumumab) Subcutaneous Formulation (Press)
  • Sensorion Receives FDA IND Approval for Arazasetron (SENS-401) (Press)
  • GenSight Biologics completes enrollment of GS010 REFLECT Phase III trial in the treatment of Leber Hereditary Optic Neuropathy ahead of schedule (Press)
Medical Devices
  • A Genetic Test That Reveals Alzheimer's Risk Can Be Cathartic Or Distressing (NPR)
  • Abbott recalls select Ellipse ICDs due to damaged wires (MassDevice)
  • Class 1 Device Recall Alaris" Pump Infusion Sets (FDA)
  • Class 1 Device Recall Giraffe Warmer (FDA)
  • Class 1 Device Recall Panda Infant Radiant Warmer (FDA)
  • Class 1 Device Recall Hamilton G5 Ventilator (FDA)
  • FDA issues another reminder about the risks of connected medical devices to hacking (AHCJ)
  • iCad’s AI-assisted mammography tech wins CE Mark (MassDevice)
  • Nemaura bids for de novo clearance from FDA for SugarBEAT glucose monitor (MassDevice)
  • FDA clears RaySearch’s RayStation 8B (MassDevice)
  • Avoset to develop infusion pump with unnamed pharma giant (MassDevice)
US: Assorted & Government
  • There are fewer opioid prescriptions being written for Medicare Part D beneficiaries (STAT)
  • After Dozens of Fentanyl Killings, Hospital C.E.O. and 23 Employees Are Forced Out (NYTimes)
  • US Democratic hopeful Amy Klobuchar proposes drug cost plan aimed at seniors (Reuters)
  • DOJ Lawyers Try New Tricks To Undo Obamacare. Will It Work? (KHN)
  • Biosimilar Patent Litigation Bill Would Change BPCIA Strategy (Law360-$)
  • Gilead Seeks To Nix Patients' Suit Over HIV Drug Toxicity (Law360-$)
  • Eli Lilly Searches For New GC As Top Atty Plans To Retire (Law360-$)
  • Reed Smith Atty's Widow Fails To Reclaim $3M Win Over GSK (Law360-$)
  • A Money-For-Nothing Pharmaceutical Class Action In California (Drug & Device Law)
  • Telemedicine: Understanding FDA’s Role in Recent Regulatory and Enforcement Actions (FDA Law Blog)
  • The STRONGER Patents Act of 2019: Weakening Post-Grant Proceedings (Patent Docs)
Upcoming Meetings & Events Europe
  • EU Regulatory Roundup: Danish Regulator Bans Staff From Owning Shares in Pharma, Device Companies (Focus)
  • PRAC recommends new measures to avoid dosing errors with methotrexate (EMA)
  • Medicines and Healthcare products Regulatory Agency Privacy Notice (MHRA)
  • Japanese pharma companies closely following 'Boycott Japan' campaign (KoreaBioMed)
  • USFDA issues 5 observations to Dr Reddy's plant in Hyderabad (Economic Times)
  • Pharma sector to post double-digit revenue Q1 growth: Analysts (Economic Times)
  • IPC identifies 17 medical device monitoring centres pan India to analyse SAEs exclusively (Pharmabiz)
  • Audit of Laurus Labs completed by USFDA without objections (Economic Times)
  • Code prohibits doctors from taking gifts from pharmaceutical companies (Economic Times)
  • CannTrust suspends sales of cannabis products during Canada regulatory review (Reuters)
Other International
  • NZ Plans New Medicinal Cannabis Regulatory Scheme & Agency (Pink Sheet-$)
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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A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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