Feliza Mirasol is the science editor for 

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

Univercells and University of Pennsylvania Expand Agreement for Gene Therapy Program

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.

GSK’s Application Seeking Blenrep Combinations for Treating Multiple Myeloma Accepted by EMA

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

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FDA Draft Guidance Seeks to Support Drug Developers for Pediatric Inflammatory Bowel Disease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

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.

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