The man in charge of discovering new drugs at the world's biggest biotech told us how Amgen's 'triple threat' genetics approach can overcome the industry's high failure rates (Business Insider)
After 40 years, the Alzheimer’s Association sees signs of progress against a devastating disease. Is it real? (STAT)
New York Governor Plans Consortium for Alzheimer's Disease Genetic Research (GenomeWeb)
Combating substandard and falsified medical products (WHO)
ICER’s Biopharma Members: Why They Joined And What They Get (Pink Sheet-$)
Animal health vet Juergen Horn makes new antibody play for pets, raking $15M in Series A haul (Endpoints)
Biocon confident of approval for Lantus copy after Malaysia plant inspected by FDA a third time (Fierce)
NGM Bio takes leap forward in crowded NASH field (Endpoints)
Empty AstraZeneca plant sized up by CDMO which may or may not be AGC Biologics (Fierce)
Puma Biotech's Nerlynx remains a dud. Will a breast cancer expansion turn things around? (Fierce)
With strong data on lead drug, Kadmon and CEO Harlan Waksal plot their redemption (STAT) (Fierce)
Opportunities and challenges with microphysiological systems: a pharma end-user perspective (Nature)
Antigen-based metric could better predict which patients benefit from immunotherapy, study says (STAT)
Taro Pharmaceuticals USA Issues Voluntary Nationwide Recall of Phenytoin Oral Suspension USP, 125 mg/5ml Due to Possible Underdosing or Overdosing (FDA)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
FDA grants ‘breakthrough’ status to antibiotic alternative as ContraFect rushes to join fight against superbug (Endpoints)
Novartis gets a boost in blockbuster multiple sclerosis race with Roche (Endpoints) (Scrip-$)
Hormone Blocker Sticker Shock: Kids Drug Costs 8 Times More Than One For Adults (NPR)
FDA approves first adjuvanted quadrivalent flu vaccine in over-65s (Pharmafile) (Press)
Takeda Announces U.S. FDA Grants Priority Review for Supplemental New Drug Application for ALUNBRIG® (brigatinib) as a First-Line Treatment for ALK+ Metastatic Non-Small Cell Lung Cancer (Press)
Teva Announces FDA Approval of ArmonAir® Digihaler™ (fluticasone propionate) Inhalation Powder (Press)
Aura Biosciences Presents Updated Phase 1b/2 Clinical Data for AU-011 at the 43rd Annual Macula Society Meeting (Press)
Magenta Therapeutics Completes Dosing in Phase 1 MGTA-145 Trial, Demonstrating Rapid, Single-Day First Line Stem Cell Mobilization and Collection (Press)
Sojournix Announces Initiation of Phase 2 Clinical Trial of SJX-653, a Novel Selective NK3 Antagonist for Menopausal Hot Flashes (Press)
Concert Pharmaceuticals Selected for Late-Breaking Oral Presentation of CTP-543 Phase 2 Data in Alopecia Areata at the 2020 American Academy of Dermatology Annual Meeting (Press)
Pandion Announces First Subject Dosed in a Phase 1 Clinical Trial of PT101, an IL-2 Mutein Fc Fusion Therapy for Autoimmune Disease (Press)
Tetra Bio-Pharma Provides Additional Information on QIXLEEF Following Letter of Advice & Type B Meeting with USA FDA (Press)
Medical Devices
On FDA's agenda: ortho reclassifications, cancer tests, AI in imaging (MedtechDive)
New Genomic Tests Aim to Diagnose Deadly Infections Faster (NYTimes)
Abbott touts real-world data around FreeStyle Libre system (MassDevice)
FDA Authorizes Marketing of the First Genetic Test to Aid in the Diagnosis of Fragile X Syndrome (FDA) (GenomeWeb)
FDA Grants Premarket Clearance of Asuragen’s AmplideX® Fragile X Dx and Carrier Screen Kit (Press)
Dexcom lands CE Mark for continuous glucose monitor use by pregnant women (MassDevice)
Fist Assist announces CE Mark and European launch (MassDevice)
Abbott Initiates Voluntary Recall of Specific Lots of Two Coronary Catheters (FDA)
US: Assorted & Government
Alkermes sued over death of man who overdosed after taking addiction treatment Vivitrol (STAT)
Attorney general dismisses lawsuit against three opioid distributors, but plans to refile later (The Oklahoman)
Pharma Ruling Broadens Gov't Drug Procurement Options (Law360-$)
Opioid Cos. Must Face Benefit Plans' Suit In MDL (Law360-$)
Feds Want 1st Circ. To Back Convictions Of Ex-NECC Execs (Law360-$)
Teva Floated As Bellwether In Generic Drug Price-Fixing MDL (Law360-$)
Vape Group To Send FDA Deadline Challenge Row To 6th Circ. (Law360-$)
Ad Watchdog Asks FTC To Review Co.'s CBD Health Claims (Law360-$)
AstraZeneca Stuck With FCA Case Over Crestor Marketing (Law360-$)
Ohio Doctor Pleads Guilty to Unlawful Distribution of Opioids (DOJ)
DuPont ramps up safety suit production as coronavirus causes shortages in China (CNBC)
Harvard joins coronavirus fight with $115 million and a high-profile Chinese partner (Endpoints)
MHRA update on novel coronavirus (COVID-19) (MHRA)
South Korea coronavirus cases surge, two more die (Reuters)
Sixth Italian dies from coronavirus in Europe's worst flare-up (Reuters)
Coronavirus kills 12, up to 61 infected in Iran: minister (Reuters)
Three Gulf states, Iraq report first coronavirus cases, linked to Iran (Reuters)
Afghanistan confirms first coronavirus case in province bordering Iran (Reuters)
Israel may quarantine 200 South Korean visitors in army base: report (Reuters)
Samsung Electronics confirms coronavirus case at phone factory complex in South Korea (Reuters)
Third death from Japan cruise ship as health minister vows to set virus strategy (Reuters)
Other International
France pledges US$100 million (€90 million) for WHO Academy (WHO)
General Health & Other Interesting Articles
Physicians, Hospitals Meet Their New Competitor: Insurer-Owned Clinics (WSJ)
Drop in cancer deaths reflect failures of our society. Really (Boston Globe)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
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