Morning Briefing
Summaries of health policy coverage from major news organizations
FDA Rejects Expanded Use Of Pimavanserin For Alzheimer's Disease
Reuters: U.S. FDA Declines To Approve Expanded Use Of Acadia's Antipsychotic Drug
The U.S. Food and Drug Administration declined to approve expanded use of Acadia Pharmaceuticals Inc's antipsychotic drug for treating psychosis related to Alzheimer's disease, the company said on Thursday. (8/5)
Stat: Everything You Need To Know Before The Next Big Alzheimer’s Readout
With the tumultuous rollout of Aduhelm behind them, partners Biogen and Eisai have the rare opportunity for a do-over, with all-important data on their next Alzheimer’s disease therapy expected next month. (Feuerstein and Garde, 8/10)
In other pharmaceutical developments —
Stat: Side Effects Detour Amgen's Effort To Expand Use Of Lung Cancer Drug
Aclinical trial run by Amgen that combined its KRAS-targeting cancer drug called Lumakras with other immunotherapies caused serious liver side effects — forcing lung cancer patients to abandon treatment and leading to substantially lower tumor response rates. (Feuerstein, 8/7)
Reuters: Amgen Bets On ChemoCentryx's Rare Disease Drug In $3.7 Billion Deal
Amgen Inc on Thursday agreed to buy ChemoCentryx Inc (CCXI.O) for $3.7 billion to gain access to a potential blockbuster treatment for inflammatory disorders and beat quarterly revenue estimates on demand for its bone disease drug. (Mishra, 8/4)
Stat: Karuna Schizophrenia Drug Achieves Study Goals In Late-Stage Trial
Karuna Therapeutics said Monday that a novel combination pill reduced psychosis and related symptoms experienced by patients with schizophrenia, achieving the main goals of a late-stage clinical trial. (Feuerstein, 8/8)
Reuters: AstraZeneca Says Lynparza Gets EU Nod To Treat Early-Stage Breast Cancer
AstraZeneca said on Thursday its drug Lynparza, developed with U.S.-based Merck & Co was approved by the European Union as an adjuvant treatment for patients with a form of a genetically mutated early-stage breast cancer. (8/4)
Stat: Aldosterone Linked To Worsening Kidney Disease, Study Suggests
A drug that has been used to slow progression of kidney and cardiovascular disease in people with type 2 diabetes may also help people with chronic kidney disease who do not have diabetes, according to findings published Monday in the European Heart Journal. (Cueto, 8/8)
Stat: With Pfizer Deal, Global Blood Sees Chance To Reach All Sickle Cell Patients
The $5.4 billion acquisition of Global Blood Therapeutics by Pfizer was sealed with a phone call and a commitment to reach patients with sickle cell disease wherever in the world they live. (Feuerstein, 8/9)
