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Pharmaceutical Manufacturing

All articles tagged with #pharmaceutical manufacturing

FDA Names Seven Firms for PreCheck Pilot to Grow Domestic Drug Manufacturing
health18 days ago

FDA Names Seven Firms for PreCheck Pilot to Grow Domestic Drug Manufacturing

The FDA selected seven companies to participate in its new PreCheck Pilot Program aimed at accelerating the development of domestic drug manufacturing, expanding capacity, and strengthening the U.S. drug supply chain. The two-phase program will offer early technical guidance (Phase 1: Facility Readiness) and enhanced pre-submission engagement (Phase 2) to bring drugs to market faster; participants include Amneal (Long Island, NY), Cellares (Bridgewater, NJ), Eli Lilly (Lebanon, IN), FUJIFILM Biotechnologies (Holly Springs, NC), Kriya Therapeutics (Durham, NC), Kyowa Kirin (Sanford, NC), and Regeneron (Saratoga Springs, NY).

via fda.gov|
#biotechnology#domestic-production#fda
FDA Recalls Over 140,000 Bottles of Atorvastatin Cholesterol Medication
health8 months ago

FDA Recalls Over 140,000 Bottles of Atorvastatin Cholesterol Medication

A large recall of atorvastatin, a widely used cholesterol-lowering drug, was issued due to manufacturing defects that affected drug dissolution, potentially reducing its effectiveness and increasing cardiovascular risk. Patients should check if their medication is affected and consult their healthcare provider before stopping or switching drugs. The recall highlights ongoing concerns about overseas manufacturing oversight and the need for vigilant consumer awareness.

via PBS|
#atorvastatin#drug-safety#fda
Kodak expresses doubt over business viability amid debt concerns
business11 months ago

Kodak expresses doubt over business viability amid debt concerns

Kodak, facing upcoming debt obligations and limited liquidity, remains confident it can manage its financial commitments by refinancing and paying down debt, despite raising concerns about its ongoing viability. The company is also transitioning into pharmaceutical manufacturing, with new production facilities nearing completion, but its shares dropped over 25% amid financial uncertainties.

via Yahoo Finance|
#bankruptcy#business#debt
"Varda Space's Orbital Drug Manufacturing Success Drives $90M Funding Boost"
space-technology2 years ago

"Varda Space's Orbital Drug Manufacturing Success Drives $90M Funding Boost"

Varda Space Industries secures $90 million in Series B funding following the successful return of its first drug manufacturing capsule from orbit, marking a significant milestone for the company. The startup, founded by Delian Asparouhov and Will Bruey, aims to commercialize microgravity research for pharmaceutical crystallization, leveraging low-cost rideshare launches and innovations in satellite bus manufacturing. With a focus on pharmaceuticals, Varda plans to scale its missions, drive down mission costs, and improve processing capabilities for on-board pharmaceutical reactors, with a handful of contracts already in place and the next manufacturing mission set to launch later this year.

via TechCrunch|
#funding#microgravity-research#pharmaceutical-manufacturing
"Varda Space's Breakthrough: Manufacturing HIV Medicine in Earth Orbit"
spacescience2 years ago

"Varda Space's Breakthrough: Manufacturing HIV Medicine in Earth Orbit"

Varda Space Industries successfully returned its W-1 capsule from space, carrying the HIV/AIDS medication ritonavir, which was processed in microgravity. The mission aimed to test the feasibility of manufacturing pharmaceuticals in space, with the space-processed ritonavir surviving reentry and providing crucial data on the effects of spaceflight on pharmaceutical production. Varda Space hopes to inspire the viability of space-processed pharmaceuticals and enable cost-effective access to next-generation therapeutics.

via Space.com|
#hivaids-medication#microgravity#pharmaceutical-manufacturing
"Spacecraft Footage: Capsule's Blazing Return to Earth with Space-Grown Antiviral Drug"
space-exploration2 years ago

"Spacecraft Footage: Capsule's Blazing Return to Earth with Space-Grown Antiviral Drug"

Varda Space Industries' W-1 spacecraft successfully landed back on Earth after months in space, capturing unedited footage of its descent through Earth's atmosphere. The capsule, a test for drug production in microgravity, produced crystals of the antiretroviral drug Ritonavir. Its time in space was spent on the Rocket Lab Photon spacecraft, and the successful mission demonstrated in-space manufacturing. The capsule and pharmaceutical sample have been transported back for analysis, with flight data to be shared with NASA and the U.S. Air Force.

via IFLScience|
#pharmaceutical-manufacturing#reentry#space-exploration
Pharmaceutical plant explosion in Newburyport leaves worker missing.
local-news3 years ago

Pharmaceutical plant explosion in Newburyport leaves worker missing.

A worker is missing after a "violent explosion" at Seqens, a pharmaceutical manufacturing company in Newburyport. Four workers were taken to the hospital and treated, while the fifth worker has not been found yet. The explosion caused major structural damage to the building, and firefighters and technical rescue crews haven't been able to go inside. The cause of the explosion is unknown, and authorities said there's no danger to people who live in the area and no concerns about the air quality.

via CBS Boston|
#explosion#local-news#missing-worker
Worker missing after violent explosion at Newburyport chemical/pharmaceutical plant.
us3 years ago

Worker missing after violent explosion at Newburyport chemical/pharmaceutical plant.

A worker is missing after a "violent explosion" at Seqens, a pharmaceutical manufacturing company in Newburyport, Massachusetts. Four workers were taken to the hospital and treated, while the fifth worker has not been found yet. The explosion caused major structural damage to the building, and firefighters and technical rescue crews have not been able to go inside. The cause of the explosion is unknown, and there is no danger to people who live in the area. This is not the first fire at the facility, as there were six explosions three years ago.

via CBS News|
#chemical-facility#explosion#missing-worker