Drug Development

Expanded controlled substance capabilities enables Particle Sciences to develop and manufacture Schedule I–V drugs.

The companies will develop a new generation of biotherapeutics from cell-line development through to GMP manufacturing.

The guidance discusses the design and evaluation of comparative analytical studies used to support the biosimilarity of a proposed therapeutic protein product to a reference product licensed under section 351(a) of the Public Health Service Act.

AbbVie grants Boehringer Ingelheim a non-exclusive license to its intellectual property for Humira (adalimumab) in the United States.

Regulatory, cultural, and technical differences between drug and device development can pose challenges to pharmaceutical combination product development.

The company announced plans to construct a 1.3 million-ft2 integrated manufacturing center in Chengdu, China.

Locate Bio has been granted additional investment to the tune of £2 million (US$2.6 million) for the expansion of its cell and gene therapy pipeline.

The acquisition provides Valby, Denmark-based Lundbeck with a discovery platform and a US-based research hub.

Empty and prefilled syringes must pass a range of quality control tests.

Dyadic International has announced its collaboration agreement with Serum Institute of India for the development and manufacture of up to 12 antibodies and vaccines using Dyadic’s C1 gene expression system.

The guidance will assist sponsors in demonstrating a proposed therapeutic protein product is interchangeable with a reference product.

Lonza will provide development and manufacturing services to two of Alector’s neurodegeneration drug candidates.

Samsung BioLogics will provide contract development organization services to drug developer GI Innovation.

The companies have entered into a sub-licensing agreement to develop products based on Dyadic’s C1 expression platform and Alphazymes’ enzyme technology.

Knowing the source and understanding the impact on CQAs is crucial to optimum drug formulation and processing.

The companies will join forces to use artificial intelligence (AI) and machine learning to discover and develop new treatments for two chronic diseases.

Lonza’s SimpliFiH Services addresses bioavailability challenges with drug substance, solid-state characterization, and drug product for first-in-human studies.

University of Southern California scientists have made an advancement in chimeric antigen receptor (CAR) T-cell therapy that seems to eliminate its severe side effects, making the treatment safer and potentially available in outpatient settings.

EDCTP has granted EUR10 million to a collaboration of African and European antimalarial drug researchers to support late-stage clinical trials of a novel antimalarial combination.

Hovione Technology has acquired global rights to a dry powder inhaler for pulmonary drug delivery, the Papillon DPI invented by Dr. Klaus-Dieter Beller.

Catalent’s acquisition of Paragon Bioservices will provide expertise and in expanding gene and cell therapy markets.

Patient-centric drug development is becoming more important in the bio/pharma industry.

Catalent invests $5 million in hot melt extrusion capabilities at Somerset, NJ facility.

The companies form a strategic joint venture for developing and manufacturing live biotherapeutics.

The acquisition is expected to expand CURE Pharmaceutical’s technology platform in oral drug delivery.