The agency’s work with EUnetHTA 21 helped it to prepare the EU for implementation of the regulation.

Anemia, experienced by most myelofibrosis patients, has caused over 30% of patients to discontinue their treatment.

Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses how advanced manufacturing technology can improve things such as cost and efficiency.

Experts discussed how to transform companies into learning organizations at the 2023 PDA/FDA Joint Regulatory Conference.

Iopofosine provides targeted delivery of idodine-131 directly to cancer cells.

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

The draft guidance document discusses the development of labeling for proposed biosimilars and interchangeable biosimilars for submission under section 351(k) of the Public Health Service Act.

The safety profile of erdafitinib observed in THOR was consistent with the previously reported safety profile of erdafitinib in metastatic urothelial carcinoma (mUC).

According to a press release, the implications go to the extent that within the next 10 years, more than 50% of approved drugs will involve AI in their development and/or manufacturing.

Colorcon provides customers with Opadry complete film coating systems, which intends to help reduce complexity with delivering high-quality products and ingredients.

Corning launches a more sustainable glass vial.

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.

Rentschler Biopharma’s ATMP business can now offer its full range of services for the clinical supply of AAV, including bioprocess and analytical development through to cGMP manufacturing at the Stevenage facility in the UK.

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.

Topiramate can cause serious birth defects if exposed to children in the womb.

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

The new policy will require trading partners to supply, accept, and manage all documentation of product and ownership of prescription drugs electronically.

Illumina’s new solutions center in Bengaluru, India, will expand access to genomics in the country.

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.

Further expansions of the pharmaceutical development and manufacturing services of ten23 are happening at the BASE and VIVA facilities to continue to support complex sterile product development, testing, and manufacturing.

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.

Tumour-infiltrating lymphocyte (TIL) therapies offer a new route to target cancer.

European vaccine manufacturing is being boosted with high level investments.

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

Pharma's ability to continually reinvent itself will be critical in growing future business operations.