Under a global license and collaboration agreement, AbbVie and OSE Immunotherapeutics will aim to develop OSE-230, a mAb for treating chronic inflammation.

The company is expanding GMP capacities at its Frankfurt site to manufacture early clinical-phase peptide APIs.

Accurately targeted immunotherapies through reliable neoantigen recognition enable personalized medicine development.

The power of collaboration is a critically important for the bio/pharma industry.

Wider life sciences industries in the UK and Europe are receiving favourable financial support from governing bodies.

While Catalent’s acquisition is definitely about making drugs, it’s also very much about making money.

The partnership will allow for both companies to provide end-to-end biopharmaceutical manufacturing solutions.

CordenPharma’s new starter kits are designed to enable effective formulation in the development of mRNA-based therapeutics.

The company is investing more than $250 million into its Bloomington, Ind. Manufacturing site.

Steffen Thirstrup, chief medical officer, EMA, emphasizes the importance of transparency in investigating potential safety issues of CAR-T therapies, while highlighting the need to balance regulatory diligence with maintaining trust within the community and among stakeholders.

CSL will share access to Cytegrity, its proprietary stable production system for lentiviral vector production, with Genezen.

The agency has recommended granting marketing authorization to ALS treatment, Qalsody (tofersen), for adults who have a mutation in the superoxide dismutase 1 (SOD1) gene.

Steffen Thirstrup, chief medical officer of the EMA, discusses manufacturing supply, drug shortages, commercial incentives, politics, and patient wellbeing.

FDA's Drug Safety Priorities FY23 describes the center’s key safety programs and activities involved in promoting and protecting public health.

AstraZeneca has completed its acquisition of Icosavax, gaining the IVX-A12 vaccine candidate that targets RSV and hMPV.

GSK is expanding its respiratory biologics portfolio with its acquisition of Aiolos Bio and its novel therapy, AIO-001.

FDA has approved Iovance Biotherapeutics’ Amtagvi (lifileucel) for treating patients with unresectable or metastatic melanoma.

Two public electronic catalogues will be available for real-world data sources and for real-world data studies.

BioVaxys has acquired the full portfolio of discovery, preclinical, and clinical development-stage assets of the former IMV.

The company’s Itasca, Ill., facility will offer chemistry, manufacturing, and controls analytical testing support.

Under the new partnership, Samsung Biologics will develop and manufacture an antibody for a LegoChem Biosciences ADC candidate.

The agency’s safety committee stressed the risk of potential adverse reactions involved with taking Paxlovid (nirmatrelvir, ritonavir) in combination with certain immunosuppressants.

The three non-commercial developers of ATMPs will benefit from enhanced support from the agency.

Through a €2.7 billion (US$2.9 billion) acquisition of MorphoSys, Novartis will get pelabresib, a late-stage drug candidate in development for cancer treatment.

The guidance discusses how to timely notify the agency of changes in production of APIs and finished products.

Purolite and Repligen have commercially launched a new CH1 affinity resin for the purification of specialized mAbs.

The addition of another amino acid recognizer as well as improvements in surface chemistry, reagents, and software expand the proteome coverage of Quantum-Si’s Platinum sequencing platform.

The CDMOs are joining together to offer end-to-end development and manufacturing services for protein expression systems and viral vectors in Europe.