Pharma News - Chemdiv

Medicare will only cover aduhelm for Alzheimer's patients in clinical trials

Medicare announced Thursday that it will limit its coverage of the pricey new drug Aduhelm to Alzheimer's patients enrolled in clinical trials of the drug.

Novartis Manufacturing Facility Approved for Zolgensma Production

Novartis said the FDA has given the go-ahead for its gene therapy manufacturing facility in Durham, N.C., to manufacture the spinal muscular atrophy drug Zolgensma (onasemnogene abeparvovec) and ot...

FDA Approves Hyftor (sirolimus topical gel) for Facial Angiofibroma Associated with Tuberous Sclerosis

Nobelpharma America, LLC, a pharmaceutical and medical device company headquartered in Bethesda, Maryland, and a subsidiary of Nobelpharma Co., Ltd. in Tokyo, today announced that the U.S. Food an...

BioXcel’s Schizophrenia and Bipolar-Associated Agitation Drug Approved

BioXcel Therapeutics has gained the FDA’s approval for Igalmi, its sublingual film formulation of dexmedetomidine, for the treatment of agitation associated with schizophrenia or bipolar disorder...

AstraZeneca’s AZD8233 Shows Positive Results for Hypercholesterolemia

AZD8233, an investigational antisense oligonucleotide (ASO), met the primary endpoint at 50 mg with 73% reduction in low-density lipoprotein cholesterol (LDL-C) levels from baseline in the ETESIAN...

China Kintor's COVID drug candidate cuts hospital, death risk in trial

China's Kintor Pharmaceutical said on Wednesday its potential COVID-19 treatment proxalutamide effectively reduced the risk of hospitalization and death in a clinical trial involving outpati...

Theravance’s Investigational Drug Ampreloxetine Fails Second Phase 3 Trial

Theravance Biopharma said that its investigational drug ampreloxetine failed its second phase 3 study in patients with symptomatic neurogenic orthostatic hypotension, a condition that frequently i...

African clinical trial denied access to key COVID drug Paxlovid

Supply shortages and limits on research leave low- and middle-income countries struggling to access Pfizer’s COVID-19 antiviral. ...

Alnylam's Onpattro follow-on delayed thanks to manufacturing holdup at FDA

Alnylam must wait a few months longer for a verdict on its potential blockbuster-in-waiting vutrisiran.

How did Merck record an 11% tax rate last year? The Senate finance chairman would like to know

With tax day right around the corner in the U.S., Merck & Co. is the latest Big Pharma to find itself in the crosshairs of a congressional tax probe.

EU Approves Immunocore’s Kimmtrak for Patients With Unresectable/Metastatic Uveal Melanoma

The European Commission has approved Immunocore’s T-cell receptor (TCR) bispecific immunotherapy drug Kimmtrak (tebentafusp) for HLA-A*02:01-positive adult patients with unresectable or metastat...

FDA Puts Emavusertib Clinical Trial for R/R AML and MDS on Partial Hold

The FDA has placed a partial hold on Curis’ phase 1/2a clinical trial of emavusertib in adult patients with relapsed/refractory (R/R) acute myelogenous leukemia (AML) or high-risk myelodysplasti...