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© 2021 MJH Life Sciences and BioPharm International. All rights reserved.
© 2021 MJH Life Sciences™ and BioPharm International. All rights reserved.
FDA sticks with approved vaccine dosing regimen; supply agreements announced
Biopharma looks to deliver on COVID-19 vaccines and other promising therapies.
Annual employment survey reveals more dedication but fewer financial rewards.
January 26, 2021
Clinical material for a Theratechnologies product in development will be produced at PPS’ manufacturing facility in Lexington, KY.
Emergent will use its CDMO services to manufacture drug product batches to support the increased supply of the therapeutic candidate in anticipation of a potential emergency use authorization in the first quarter of 2021.
January 25, 2021
The company is discontinuing the development of its SARS-CoV-2/COVID-19 vaccine candidates, V590 and V591, to focus on advancing its two SARS-CoV-2/COVID-19 therapeutic candidates, MK-4482 and MK-7110.
The companies have entered into an advance purchase agreement with COVAX to provide up to 40 million doses of the Pfizer-BioNTech COVID-19 vaccine, BNT162b2, to lower-middle-income countries.
The site, which is set to be operational in three years, will feature disposable technology and advanced technology filling lines to produce 90 million vials and 50 million pre-filled syringes a year.
The broader national strategy sets seven goals, some fairly general, such as building public trust, safely reopening schools and businesses, advancing racial and ethnic equity, and restoring US global leadership.
Through the acquisition, Lilly will have access to Prevail’s portfolio of clinical-stage and preclinical neuroscience assets.
Woodcock will serve as acting commissioner of FDA, taking over for Stephen Hahn, FDA’s previous acting commissioner.
January 22, 2021
The drug offers immediate post-exposure protection against the virus and will serve as a counterpart to the vaccine during its early phases.
Verquvo is a soluble guanylate cyclase stimulator for the reduction of the risk of cardiovascular death and heart failure hospitalization in adults with symptomatic chronic heart failure.
January 21, 2021
The approval was based on positive results from a single-arm Phase II trial where the treatment demonstrated significant antitumor activities in patients with the disease.
January 20, 2021
The companies will develop up to three CD3-engaging T-cell redirecting bispecific antibody therapies using Merus' proprietary Biclonics platform.