Bio/Pharma News

Apellis Pharmaceuticals’ Syfovre is a pegcetacoplan injection intended for the treatment of geographic atrophy secondary to age-related macular degeneration.

LIfT and Minaris will work together to develop a manufacturing process for LIfT’s allogeneic neutrophil progenitor cell therapy.

Takeda’s acquisition of Nimbus Lakshmi will grant them rights to NDI-034858, an oral, selective allosteric TYK2 inhibitor being evaluated for the treatment of multiple autoimmune diseases.

GenScript PrioBio and Bio Immunitas will work together to develop and fast track manufacturing of a novel therapeutic platform.

The kit is meant for use for the detection and quantitation of residual host cell protein.

Growth in outsourcing has been the result of COVID-19 projects taking precedence, which has pushed some contract manufacturing to second-tier CDMOs.

Roche’s Phase III global program, centered around the biologic crovalimab as a treatment for paroxysmal nocturnal haemoglobinuria, showed the drug was non-inferior to current standards of care.

Thermo Fisher and Celltrio are introducing a new automation platform to address critical scale-up challenges in biotherapeutics.

The new plasmid manufacturing facility aims to increase BioNTech’s autonomy and flexibility in manufacturing.

Thermo Fisher’s sponsorship of Momentum Labs is intended to support biotech businesses in the greater Gainesville region.

The COVID-19 pandemic has led to many changes and shifts in the pharmaceutical industry, specifically with how pharmaceutical companies develop vaccines.

FDA granted accelerated approval to Eli Lilly and Company’s pirtobrutinib for treatment of relapsed or refractory mantle cell lymphoma.

FDA approved Stemline Therapeutics’ elacestrant for postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer.

Gerresheimer is presenting its new Clinical Trial Kit to accelerate drug development at Pharmapack in Paris.

AstraZeneca and Thermo Fisher will collaborate to develop a solid tissue and blood-based companion diagnostic test for osimertinib.

Scientific Laboratory Supplies’ acquisition of C&M will bolster the company’s scientific calibration, maintenance, and validation offerings.

deCODE genetics, a subsidiary of Amgen, will whole-genome sequence 35,000 African-American samples provided by Illumina and Nashville Biosciences.

The United States Patent and Trademark Office issued a Notice of Allowance for Zika vaccine patent to GeoVax.

Takeda will pay approximately $400 million upfront for the exclusive worldwide rights to Hutchmed’s fruquintinib, a tyrosine kinase inhibitor, outside of China.

In a response letter, FDA stated that it could not grant Eli Lilly and Company accelerated approval due to concerns surrounding insufficient quantity of clinical trial data.

The efficacy data across multiple clinical endpoints and a favorable safety profile support the potential of AMB-05X as a best-in-class therapy for the treatment of TGCT regardless of surgical resectability.

Snapdragon Chemistry concentrates in API batch and continuous flow process development, utilizing state-of-the-art automation technology and proprietary equipment to solve complex process and analytical development challenges.

Agilent’s $725 million investment is designed to double its capacity to produce APIs.

Pfizer and Gero have partnered to discover potential therapeutic targets for fibrotic diseases using machine learning technology.

The collaboration between AbbVie and Anima Biotech will combine Anima's mRNA Lightning technology platform with AbbVie's extensive expertise in oncology and immunology.

The Vault Quality Suite will help Adare simplify its quality operations across its sites in the United States, France, and Italy.

It is intended to identify the most prevalent and immunogenic targets in solid tumors by uniquely combining high-diversity target libraries with active machine learning.

This self-emulsifying system improves the miscibility and dispersibility of formulations in aqueous environments and may improve API solubility.

The definitive agreement will give AstraZeneca global rights to CinCor’s portfolio of cardiorenal disease treatments.

Chiesi will acquire Amryt Pharma, a commercial-stage biopharmaceutical company, in a deal worth up to $1.47 billion.