Provention Bio recently announced that it received a complete response letter (CRL) from FDA in response to its biologics license application for its antibody, teplizumab, which aims to delay clinical...
Merck recently announced that FDA approved an expanded label for its anti-PD-1 therapy, Keytruda, as a monotherapy for patients with locally advanced cutaneous squamous cell carcinoma (cSCC).
The...
GSK and Alector recently entered into a strategic global collaboration to develop and commercialize two clinical-stage, potential first-in-class monoclonal antibodies for neurodegenerative...
Pfizer recently paused distribution of its smoking cessation treatment, Chantix, after finding nitrosamines in the pills.
Nitrosamines are cancer-causing agents. Previously, Pfizer had contacted other...
Gilead recently submitted a new drug application to FDA seeking approval for its investigational, long-acting HIV-1 inhibitor, lenacapavir, for HIV treatment.
The submission is supported by data from...
Medicare drug spending reached $560 billion from 2016 through 2018, with pharmaceutical marketing accounting for nearly $324 billion in overall spending, according to a GAO study.
Of the 553...
ViiV Healthcare and biopharmaceutical company Halozyme Therapeutics recently announced a global collaboration and license agreement to develop long-acting HIV treatment.
Under the agreement,...
The Assistant Secretary for Preparedness and Response (ASPR) recently paused all distribution of Eli Lilly and Company’s COVID-19 antibody treatment.
CDC identified that the combined frequencies...
Eli Lilly and Company recently announced that FDA granted breakthrough therapy designation for its investigational antibody therapy, donanemab, intended for Alzheimer’s disease.
This closely...
Genentech’s COVID-19 drug therapy Actemra (tocilizumab) is the latest to receive an emergency use authorization, FDA announced Thursday.
The EUA makes the drug available to treat hospitalized...
Federal health officials recently added new clinical guidance on the potential for myocarditis after COVID-19 vaccination for adolescents and young adults.
The statement, signed by the leaders...
FDA recently approved Boehringer Ingelheim Pharmaceuticals Pradaxa, the first oral blood thinning medication for children three months to less than 12 years old with venous thromboembolism.
Pradaxa...
Denmark-based Orphazyme recently announced that FDA issued a complete response letter regarding its heat shock protein amplifier, arimoclomol, intended for Niemann-Pick disease type C (NPC), a rare...
Consumers have saved nearly $30 billion on their prescription drug costs to date with prices found on the GoodRx platform, the company said in a report.
In 2020, GoodRx users saved an average 79...
Gilead recently announced that its COVID-19 treatment, remdesivir, lowered the risk for mortality compared with matched controls in patients hospitalized with the virus.
The three real-world data...
Bristol Myers Squibb and Japan-based pharmaceutical company, Eisai, recently entered into a global collaboration agreement for the co-development and co-commercialization of an antibody drug conjugate,...
CRISPR Therapeutics and Capsida Biotherapeutics recently entered into a collaboration to develop, manufacture, and commercialize gene therapies.
The companies will leverage adeno-associated...
The Biden Administration recently announced that the US government will procure nearly 1.7 million courses of Merck’s investigational antiviral COVID-19 treatment,...
Drug discovery is a crucial part of the drug development pipeline, beginning with the identification of a disease target to the creation of lead compounds. According to Amanda Garner, PhD, Associate...
FDA has approved Biogen’s drug for Alzheimer’s disease, Aduhelm (aducanumab), despite ongoing debate over the drug’s efficacy.
Aducanumab is a monoclonal antibody selected from...
