News

The reopening of comments addresses the addition of a warning to consumers that acetaminophen may cause skin irritation characterized by reddening, blisters, and rashes.

BioIVT opened new cleanroom manufacturing space, using Germfree’s technology to boost its capabilities for cell and gene therapy development.

The new additions to the company’s equipment at its early phase clinical manufacturing facility in Oregon will allow for cleaning, filling, capping, and sealing, and also detecting defects in drug products.

Enamine’s library of 5400 TPD-related linkers, and 13,000 more linker molecules, is now being integrated into Cresset’s Spark tool for library searching.

Freudenberg Medical has introduced custom single-use assemblies for silicone extrusion and molding for biopharma applications.

Synovial sarcoma is a rare form of cancer impacting about 1000 adults in the United States each year, most of them men in their 30s or younger.

Will Sanofi’s plan to recruit the younger generation through its participation in the upcoming 2024 Olympic and Paralympic Games, being held in Paris, pay off?

Potential conflicts of interest with advisory group members have led to EMA’s impartiality coming into questioned for some marketing authorization decisions.

This acquisition gives AbbVie clinical-stage assets from Cerevel’s pipeline that complement AbbVie's emerging neuroscience pipeline and branded products for treating psychiatric disorders, migraine, and Parkinson's disease.

With the Series A funding, the new biotech company will advance the development of enhanced biologics for treating solid tumors and inflammatory and immunology diseases.

STADA and Alvotech have launched Uzpruvo in Europe, making it the first approved biosimilar to Stelara (ustekinumab) in the European market.

The US Pharmacopeia’s Microbiology Expert Committee approved the inclusion of a chapter into the United States Pharmacopeia–National Formulary that allows the use of non-animal-derived reagents for endotoxin testing.

Scorpius Holdings is set to launch its first CGMP manufacturing campaign at its San Antonio, Texas, facility for mammalian cell culture in the 2024 third quarter.

The HemoTemp II Blood Bag Temperature Indicator, which is an FDA-approved medical device, and the HemoTemp II Activator both were given the “Standards-Compliant” seal.

An additional 11 medicines were recommended for extension of therapeutic indications, while one negative opinion was issued.

BeiGene has opened its new $800 million Hopewell, NJ-based biologics manufacturing facility, which also houses the company's clinical R&D capabilities.

The questions come as FDA is revisiting best practices for advancing the development of new biosimilar products under the terms of its updated Biosimilars Action Plan.

Univercells and the University of Pennsylvania are expanding their collaboration to evaluate certain bioreactors with the aim to scale up gene therapy manufacturing.

GSK's MAA is supported by an interim analyis of Phase III trials, which demonstrated significant progression-free survival benefit and positive overall survival trends from Blenrep combination therapies.

Giroctocogene fitelparvovec is designed to allow patients to produce FVIII on their own for a time after a single infusion, an alternative to routine IV injections.

Combination products may be reviewed in a single application or in separate applications for each constituent part, and in rare cases, FDA may decide which type of application process is appropriate.

While the document does not address treatment or prevention of the long-term complications of ulcerative colitis or Crohn’s disease in children, it aims to help sponsors developing drugs for pediatric patients currently affected.

The addition of BIOVECTRA’s biologics capabilities to accelerate drug development and manufacturing will allow Agilent to expand its end-to-end offerings for biopharma services.

PluriCDMO, Pluri's newly launched CDMO division, has been selected by Kadimastem to manufacture two novel cell therapy product candidates.

With this acquisition, AstraZeneca gets a Phase III therapeutic peptide candidate that adds to the company's rare disease pipeline.

Merck gains a late-phase antibody drug candidate for diabetic macular edema and neovascular age-related macular degeneration through its acquisition of EyeBio.

The company has issued a voluntary recall of one lot of Clonazepam Orally Disintegrating Tablets, USP (C-IV), because of incorrect strength published on product carton.

Johnson & Johnson gains NM26, a Phase II-ready bispecific antibody in development for atopic dermatitis, boosting its immune-mediated and inflammatory disease portfolio.

The acquisition provides Lantheus with worldwide exclusive rights to ß amyloid PET imaging agent, NAV-4694, for its Alzheimer’s disease diagnostic and treatment portfolio.

PRAC is recommending that patients who use glucagon-like peptide-1 receptor agonists (GLP-1 RAs) consider the risk of delayed gastric emptying before undergoing surgery with general anesthesia or deep sedation.