CBO’s Estimates of the Effects of Changes in the Manufacturers’ Discount in the Part D Coverage Gap (CBO)
BIO Applauds Advancement of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 (Press)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
Agios scores its second new drug approval, ivosidenib heads to the AML market (Endpoints)
Scientists explore a new kind of immunotherapy to treat autoimmune diseases (STAT-$)
Dr. Reddy’s Announces the Launch of Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg in the U.S. Market (Press)
FDA Grants Approval of TIBSOVO, the First Oral, Targeted Therapy for Adult Patients with Relapsed/Refractory Acute Myeloid Leukemia and an IDH1 Mutation (Press)
FDA Approves New Indications for ZOMACTON (somatropin) as Ferring Plans Launch of Needle-Free Delivery System (Press)
Genentech to Present New Data Demonstrating the Breadth and Depth of Its Alzheimer’s Program at the Upcoming Alzheimer's Association International Conference (AAIC) (Press)
Medical Devices
Intuitive Surgical Beats Expectations, Driven By da Vinci System (Forbes)
Tendyne investors sue Abbott over $50m milestone (MassDevice)
Medtronic agrees to $43m deal to settle shareholder Infuse lawsuit (MassDevice)
Memory Foam for Vascular Treatment Receives FDA Clearance (NIH)
FDA grants Breakthrough Device Designation for Roche's Elecsys cerebrospinal fluid (CSF) assays to support the improved diagnosis of Alzheimer's disease (Press)
AVITA Medical Announces Expansion of Management Team to Support Planned U.S. Launch of RECELL Device (Press)
US: Assorted & Government
Rite Aid-Albertsons Comeback Hinges On Narrow Pharmacy Networks (Forbes)
We need to improve Medicare’s annual wellness visit to better detect early dementia (STAT)
Warren Questions Trump Administration on Ongoing Failures to Address Opioid Crisis (Sen. Elizabeth Warren)
Guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg) (EMA)
Annex to Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues (EMA)
Thornhill Medical Completes 'Series A' Financing Round Led by Shanghai Based Yonghua Investment Management Co., Ltd. (Press)
General Health & Other Interesting Articles
When medication is essential to mental health (The Outline)
A Health Insurer Tells Patients It Won’t Pay Their E.R. Bills, but Then Pays Them Anyway (NYT)
State Prisons and the Delivery of Hospital Care: How states set up and finance off-site care for incarcerated individuals (Pew)
'Diseases Of Despair' Contribute To Declining U.S. Life Expectancy (Forbes)
The opportunity ‘is huge’: Why tech developers are trying to tackle mental health (STAT)
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