Biopharma News

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

Bassem Gayed, PhD, Senior Technical Director of CAR-T Process Engineering, Manufacturing Science & Technology at Bristol Myers Squibb, discusses the connection of process validation and CAR-T processes.

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.

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.

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.

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 contract is part of US Department of Health and Human Services’ ‘Project NextGen’ initiative, aimed at pushing forward new and stronger COVID-19 vaccines and therapies.

The European Commission has granted approval for Tyruko (natalizumab), a biosimilar developed by Polpharma Biologics for treating multiple sclerosis.

Under a new pact, Genentech and PeptiDream will collaborate to discover and develop novel peptide-radioisotope drug conjugates.

BenevolentAI will leverage its suite of AI chemistry design tools in combination with its fully equipped wet lab facility in Cambridge, UK, to deliver small molecule drug development candidates into the Merck pipeline, according to the press release.

The company is currently developing EVX-101 as an adjunctive treatment for MDD due to patients experiencing an inadequate response to first-line antidepressants such as selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors SNRIs.

The AstraZeneca rare disease group hopes to use these new gene therapy programs to bolster its work on genomic medicine.

The EMA’s Committee for Medicinal Products for Human Use has given a positive opinion on Sandoz’ biosimilar trastuzumab for breast and gastric cancer.

Part of the session "Transforming Medicine: Unleashing the Potential of Cell and Gene Therapies," Sadelain discusses CAR-T cells for immunotherapy and the future of cell/gene therapies.

Apollo is a part of a research and development platform for the development of new medicines, with program selection being hesitant to indication and primarily driven by quality of science or the potential to transform the standard of care in major commercial markets, according to the press release.

The companies are collaborating to apply ShapeTX’s AAVid capsid discovery platform and transgene engineering technology in addition to Otsuka’s expertise in genetic payload design and ophthalmology to develop novel treatment options for eye diseases.

Recipharm will provide analytical and process development capabilities to support toxicology studies, in addition to GLP manufacturing of lipid nanoparticles to capture the active pharmaceutical ingredient, an antigen peptide.

Despite the successes that have already been achieved with emerging therapy development and manufacturing, companies are still facing numerous challenges.

Seagen will be responsible for conjugating these degraders to antibodies to make DACs and advancing these DAC drug candidates through preclinical and clinical development and commercialization.

The results showed that PathoQuest’s proprietary NGS approach is an effective, more robust replacement to in vivo adventitious virus testing of cell substrates used in the production of biologics, like monoclonal antibodies, vaccines, cell, and gene therapies.

The agreement states that Orbit will implement its bead-based peptide display engine to discover peptide leads specific to targets related to specific tumors.

Optibrium announced on Aug. 31, 2023 the acquisition of BioPharmics to further expand the 3D drug design and modelling offering and to focus on research and development and application science.

Novo Nordisk receives the full rights to develop and commercialize the lead program.

Both companies have a focus to developing and commercializing treatments for rare diseases with a strong focus on patients and supporting communities with little to no existing therapeutic options.

There are many promising trials in the pipeline that may bring big news for major therapeutic areas.

Twist Bioscience is a synthetic biology and genomics company that has developed a DNA synthesis platform to industrialize the engineering of biology, which is a new method of this process by “writing” DNA on a silicon chip.

This is the first biosimilar to Tysabri, an injection for adults with multiple sclerosis.