Articles

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.

Pfizer Gene Therapy for Hemophilia A Patients Shows Promising Results in Study

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.

FDA Issues Combination Product Application User Fee Guidance for Staff and Industry

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.

FDA Draft Guidance Seeks to Support Drug Developers for Pediatric Inflammatory Bowel Disease

Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

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. 

Agilent Expands Biopharma Offerings with BIOVECTRA Acquisition

Feliza Mirasol is the science editor for 

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

Kadimastem and Pluri Enter Cell Therapy Manufacturing Deal

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

AstraZeneca Completes Amolyt Pharma Acquisition and Boosts 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.

Merck Gains Late-Stage Eye Disease Drug Candidate with EyeBio Acquisition

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.

Endo Recalls Clonazepam Because of Mislabeling

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

Johnson & Johnson Gains Bispecific Antibody with Completion of Numab Subsidiary Acquisition

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.

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