News

The tools, originally utilized during the COVID-19 pandemic, are now intended to work alongside FDA’s standard procedures.

The companies plan on targeting the production of abundant, low-cost messenger RNA from C1-cells.

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.

VistaPharm is recalling Sucralfate Oral Suspension, 1g/10mL because of Bacillus cereus contamination.

The Novo Nordisk Foundation will invest up to DKK 950 million (€127 million, US$136 million) in a new cell therapy manufacturing facility in Lyngby, Denmark.

FUJIFILM Diosynth Biotechnologies has finished its new viral vector gene therapy manufacturing facility in Darlington, United Kingdom.

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

Pfizer reports ritlecitinib is the first and only treatment for alopecia areata to selectively inhibit Janus kinase 3, and to treat patients as young as 12.

Maik Jornitz, Principal Consultant, BioProcess Resources LLC, discusses how to upgrade facilities in an efficient manner and other highlights from his presentation.

Otsuka Pharmaceutical Europe and Astex Pharmaceuticals have announced the approval of INAQOVI by the European Commission.

As for the topic of subjectivity, Viehmann said how high levels of subjectivity in risk assessments and in QRM are problematic and are not aligned with the 1st QRM principle of Q9.

Under the collaboration, Orionis will receive $47 million upfront to leverage its Allo-Glue platform to discover small-molecule monovalent glues.

Samsung Biologics and Bristol Myers Squibb have further expanded their strategic manufacturing agreement to include the large-scale manufacture of an antibody cancer drug substance.

CN Bio and LifeNet Health LifeSciences have teamed up to provide direct access to a portfolio of highly characterized hepatic cells for the creation of advanced liver-on-a-chip assays.

Leaders at CDER and CBER give update on organizational changes at FDA.

Maik Jornitz, Principal Consultant, BioProcess Resources LLC, discusses the definition of patient safety and how to implement new technologies into upgraded facilities.

The finalists for this year’s CPHI Barcelona Pharma Awards span 12 categories with awards ranging from accelerating innovations through to improved sustainability and best start-up initiative.

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.

It was noted that there was participation by multiple new investors including M&G plc, in addition to two of the largest US public pension plans and the existing investor, Rock Springs Capital. Further, the financing significantly adds to the $195 million previously raised by the company, according to the press release.

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