Regulatory Focus™ > News Articles > 6 > Recon: Eli Lilly, AstraZeneca Scrap Two Alzheimer's Drug Trials

Recon: Eli Lilly, AstraZeneca Scrap Two Alzheimer's Drug Trials

Posted 12 June 2018 | By Ana Mulero 

Recon: Eli Lilly, AstraZeneca Scrap Two Alzheimer's Drug Trials

In Focus: US
  • NIH Targets $500 Million At Opioid Crisis (Forbes) (JAMA) (STAT-$)
  • Eli Lilly, AstraZeneca Drop Two Late-Stage Alzheimer’s Drug Trials (WSJ) (Bloomberg) (Financial Times)
  • Leading Salk scientist resigns after allegations of harassment (Science Magazine) (Endpoints)
  • Novartis hands Regenxbio $100M in fast cash for vector tech (Endpoints) (The Pharma Letter)
  • Merck rebuts petition urging SCOTUS to ignore Fosamax appeal (Fierce) (Law360-$)
  • Sage Therapeutics gets ‘go faster’ permission from FDA on oral depression drug (STAT-$) (CNBC)
  • Endo executes master settlement agreement to resolve testosterone lawsuits (Philadelphia Business Journal-$)
  • Trump officials meet with drug companies to push for voluntary price cuts (The Hill)
  • HHS implements changes to NIH-sponsored clinical trials after Public Citizen raises ethical concerns (Public Citizen)
In Focus: International
  • Israeli company Galmed gets positive trial results for liver drug (Reuters) (Endpoints)
  • U.S. Drug Regulator Clears Sun Pharma’s Halol Plant (Bloomberg) (Economic Times)
  • Head of GSK’s vaccines division to leave by year-end (Financial Times) (Fierce) (Endpoints)
  • US margins under stress, Indian drug makers get booster dose in Europe (Business Standard)
  • Paraguay is first country in Americas to eliminate malaria in 45 years (The Guardian) (WHO)
  • River study finds 29 types of drug in the Foss and Ouse (BBC News)
  • European pharma pips North America in remote physician engagement, according to Indegene-TEVA survey (PMLiVE)
  • Opinion: Why pharmaceuticals could be the prescription for trade warfare that truly hurts America (Macleans)
Pharmaceuticals & Biotechnology
  • CRISPR stocks tank after research shows edited cells might cause cancer (CNBC)
  • Pharma R&D Investments Moderating -- But Still High (Forbes)
  • Can Aparito's Wearable Tech Solve Big Pharma's Billion-Dollar Crisis? (Forbes)
  • Ever Heard of Iqvia? Its CEO Made $38 Million (WSJ)
  • The song remains the same in Alzheimer’s (EP Vantage)
  • Roche CEO Severin Schwan isn’t about to tamper with a winning R&D strategy now, but he’s still looking for ways to cut costs (Endpoints)
  • Garabedian has few regrets and is ready to be seen (BioPharma Dive)
  • GlaxoSmithKline to pass $10B in 2024 vaccine sales, with Merck, Sanofi and Pfizer rounding out the top 4: report (Fierce)
  • Drugmaker revives female libido pill Addyi, at half the price (The Gazette)
  • Drug Cos. Unleash Opioid MDL Counterattacks (Law360-$)
  • Aggrenox MDL Nears End As Drug Cos. Reach Final Deal (Law360-$)
  • Bill and Melinda Gates start not-for-profit biotech (pharmaphorum)
  • Aimmune Therapeutics Appoints Dr. Jayson Dallas as CEO (Press)
  • AbCellera Announces Collaboration with Denali Therapeutics to Discover New Antibodies to Treat Neurodegenerative Diseases (Press)
  • Amarin and Mochida Announce Collaboration on Future Development of EPA-based Drug Products and Indications (Press)
  • Medidata Defines the Future of Life Sciences with Acquisition of SHYFT Analytics (Press)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • Idera's dermatomyositis drug flops in phase 2 (Fierce)
  • Nordic Nanovector Announces Betalutin has been Granted Fast Track Designation in the US for Follicular Lymphoma (Press)
  • GenSight Biologics Reports Positive Additional Data from REVERSE Phase III Clinical Trial of GS010 for Treatment of Leber Hereditary Optic Neuropathy (LHON) (Press)
  • Synlogic Presents Preclinical Data from Synthetic Biotic Medicine, SYNB1618, for the Treatment of Phenylketonuria (Press)
  • Sage Announces Pivotal Phase 3 Trial Status for SAGE-217 in Major Depressive Disorder and Postpartum Depression based on FDA Breakthrough Therapy Meeting (Press)
  • Phase 3 data in the online Journal of the American Academy of Dermatology show Aclaris' ESKATA is safe and effective in treating persons with raised seborrheic keratoses (Press)
  • Pluristem Reports Positive Top-Line Results from Its Multinational Phase II Intermittent Claudication Study (Press)
  • Aevi Genomic Medicine Provides Update on Sample Size Re-estimation for Phase 2 ASCEND Trial in ADHD (Press)
Medical Devices
  • Setpoint needs to up its game in Crohn’s (EP Vantage)
  • Humana faces anti-kickback, False Claims Act suit over diabetes testing equipment (Louisville Business First-$)
  • Merck & Co plans software application to help tackle C. diff infections (pharmaphorum)
  • Medical imaging community applauds E&C committee for its attention to device cyber security and hygiene for legacy devices (MITA)
  • Screening for Cardiovascular Disease Risk With Electrocardiography: US Preventive Services Task Force Recommendation Statement (JAMA)
  • FDA Finalizes 510(k) Exemptions for Certain Class II Devices (FDA Law Blog)
  • Biological tissue sensor startup Sensome rakes in $5.4M in funding (MobiHealthNews)
  • A third patent filing shows blood pressure monitoring on Apple's radar (MobiHealthNews)
  • In Digital Device Boom, Tear Film Sees Window for Dry Eye Treatment (Xconomy)
  • Medtech companies need to expand their philosophy: Here’s why (Med Design and Outsourcing)
  • Stealthy Vergent Bioscience raises $9m for tumor-fluorescing tech (MassDevice)
  • FDA issues select recall of Draeger Jaundice Meters (MassDevice)
  • Medical Software Co. Looks To Toss Data Breach MDL (Law360-$)
  • Fed. Circ. Denies Atty Fees In Kidney Device Patent Case (Law360-$)
  • Update: Availability of Deep-Cleaning Service of Certain LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stӧckert 3T Heater-Cooler Systems in the U.S.: FDA Safety Communication (FDA)
  • 2018 Meeting Materials of the Anesthesiology and Respiratory Therapy Devices Panel (FDA)
  • U.S. Food and Drug Administration Clears Wearable Device to Treat Opioid Addiction (Press)
  • MicroVention Announces FDA Clearance For Thrombectomy Device (Press)
  • Fujirebio Diagnostics Announces FDA Clearance of Lumipulse G B•R•A•H•M•S PCT Assay (Press)
  • Dexcom G5 Continuous Glucose Monitoring System Now Available on Mobile, Smart Devices for Medicare Patients with Diabetes (Press)
  • Nexy Robotic Retinal Imaging System Cleared by the FDA for the US Market (Press)
  • RTI Surgical Announces Commercial Launch of Fortilink-TS and -L IBF Systems with TETRAfuse 3D Technology (Press)
  • Innovit Helps Medical Devices Manufacturers Meet Regulatory Compliance, Reduce Counterfeiting with UDI Multi-Connector Product (Press)
US: Assorted & Government
  • Doctors Rip Trump DOJ's Move To Gut Obamacare's Patient Protections (Forbes)
  • Unbeaten At Trial, Bayer and Janssen Say Cycle Of Xarelto Lawsuits 'Needs To Be Stopped' (Forbes)
  • Lawmakers Seek To Hold USPS 'Accountable' In Opioid Bill (Law360-$)
  • Alcohol study failed to seek FDA approval, possibly violating federal rules (STAT)
  • Sexual harassment is rampant in science — and current policies aren’t cutting it, landmark report finds (STAT)
  • The FDA Is Warning Against Sun Protection Pills. Here’s Why. (HuffPost)
  • Fitbit wants to help kids move more—and that's just one way it's changing its business (CNBC)
Upcoming Meetings & Events Europe
  • Targovax refocussing clinical pipeline post-ASCO (European Biotechnology)
  • SMC approves funding for six new therapies on the NHS (PharmaTimes)
  • Cancer Research UK to test Asterias’ lung cancer vaccine (PMLiVE)
  • German manufacturer acquires Precision Medical Products (CPBJ)
  • Court refuses Merck injunction against Clonmel Healthcare pending full hearing (Irish Times)
  • New merger and takeover rules come into force (MHRA)
  • HPRA public consultation on medical devices fees for 2018: Response document (HPRA)
  • ExThera Medical Announces Completion of CE Mark Registration Trial Evaluating the Safety of Seraph 100 Blood Filter (Press)
  • Dexcom G6 CGM System Receives CE Mark (Press)
  • Merck KGaA, Darmstadt, Germany Provides Update on Tepotinib Phase II Results in Advanced Hepatocellular Carcinoma (Press)
Asia India
  • "NPPA has fixed/revised ceiling prices/retail prices of 22 formulations under Drugs (Prices Control) Order, 2013 in related Notification /order dated 12.06.2018." (NPPA)
  • Govt amends D&C Rules to ease regulation to import unapproved life-saving drugs in small quantities for personal use (Pharmabiz)
  • National Health Protection Scheme: 8 states on board, Centre to sign pacts with 12 more on June 14 (Times of India)
Australia
  • As an H.I.V. Prevention Drug Surged in Australia, Condom Use Fell (NYT)
  • NSW Health Department finds not all e-juices are as nicotine free as they claim (ABC News)
Canada
  • Edmonton kratom retailer frustrated by 'aggressive' Health Canada raids (CBC News)
  • Thermi's Temperature-Controlled Radiofrequency Technology Approved In Canada To Treat Dermal Laxity (Press)
General Health & Other Interesting Articles
  • Hypertension costly to patients, society (Reuters)
  • Private equity's thirst for health care providers (Axios)
  • Nurse Practitioner Demand Surges As Insurers Push Retail Care (Forbes)
  • Lobotomies were once used to treat this gut disease, part of a shameful medical history (STAT)
  • Blurred Vision, Burning Eyes: This Is a Lasik Success? (NYT)
  • Amazon's A.I. camera could help people with memory loss recognize old friends and family (CNBC)
  • Hospitals investing big in clinical communications as secure texting gains traction (Healthcare IT News)

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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