News

Salipro Biotech and Icosagen have entered into a multi-target collaboration to discover and characterize monoclonal antibodies.

The companies will co-promote GSK’s shingles vaccine, Shingrix, to healthcare professionals and points of vaccination in China.

The draft guidance document discusses quality considerations for topical ophthalmic drug products.

The new Digital Health Advisory Committee will advise the agency on issues related to technologies such as AI, virtual reality, and machine learning.

Under this agreement, Acuitas Therapeutics’ LNP technology platform will be transferred to BIOVECTRA for use in manufacturing mRNA-based therapies.

Further, the construction of Gritgen’s GMP facility strictly adheres to the global current GMP (CGMP) standards and complies with the regulatory guidelines of authoritative agencies including the National Medical Products Administration (NMPA), FDA, and the European Medicines Agency (EMA).

Roche will gain exclusive worldwide rights to develop, manufacture, and commercialize Ionis’ investigational RNA-based therapeutic candidates for Alzheimer's and Huntington's disease.

The program will improve access to adeno-associated virus gene therapy vectors.

Janssen has requested an extension to the indication application of its fully-human, bispecific antibody treatment, Rybrevant (amivantamab).

Spinning off Sandoz allows Novartis to focus on the areas of cardiovascular, immunology, renal and metabolic, and oncology.

Orakl Oncology has raised funds to develop its precision oncology platform and accelerate drug development.

Eli Lilly and Company has received a complete response letter from FDA for its anti-dermatitis biologic therapeutic, lebrikizumab.

Sanofi is set to pay $175 million upfront to Janssen, followed by development and commercial milestones.

Laks Pernenkil, principal and practice leader, US Life Sciences Product & Supply Operations, Deloitte, discusses the impact that digitalization is having on data generation and data integrity in bio/pharma manufacturing.

Cambrex has completed the expansion of its North Carolina facility, doubling its manufacturing capacity.

The agreement will enable CTMC to strategically scale the recently completed good manufacturing practice facility to drive high-throughput manufacturing utilizing the automated, closed system capabilities of the Fresenius Kabi Lovo and Cue cell processing systems.

Biosynth has further strengthened its peptide division with the acquisition of Pepceuticals.

The BioIndustry Association reports that with a strong foundation in research and development in mRNA the United Kingdom will be a major player in this rapidly growing industry.

The Japanese biotech company plans to make good use of Orchard’s portfolio, furthering its goal of providing life-changing medical care through cell and gene therapy.

With the acquisition, Sharp plans on offering fully integrated small-to-medium scale sterile injectable services.

Clene was awarded the four-year grant for the National Institute of Neurological Disorders and Stroke to support an Expanded Access Protocol for ALS drug.

POINT is a radiopharmaceutical company with a pipeline of clinical and preclinical-stage radioligand therapies in development for the treatment of cancer.

The program will allow sponsors of certain CBER and/or CDER-regulated products more frequent communication with FDA staff.

The prize was awarded jointly to Katalin Karikó and Drew Weissman for their groundbreaking discovery regarding modification of the bases in mRNA.

EMS is a leader in the cleanroom industry, delivering complete cleanroom monitoring and control solutions, services to customers, and ensuring quality by design from inception to process control.

Pfizer has entered into a collaboration with Ginkgo Bioworks to discover novel RNA molecules across priority research areas.

The new customized system is designed for fully automated and integrated labeling, orientation, and palletization, and it is expected to streamline the current manual processes, according to the press release.

The newly established business under Advent International and Warburg Pincus will be named Simtra BioPharma Solutions.

Government provides a spoonful of sugar, and genuine leadership, for good medicines.

Under the partnership, Sartorius will leverage SPARTA Biodiscovery’s technology to accelerate development of nanoparticles used for drug delivery.