Development

Through the acquisition, Merck will gain access to ArQule’s lead investigational candidate, ARQ 531, a novel, oral Bruton’s tyrosine kinase (BTK) inhibitor currently in a Phase II dose expansion study for the treatment of B-cell malignancies.

Newron Pharmaceuticals has received communications from the United States Food and Drug Administration (FDA) suggesting it discusses its proposed statistical plan in a Type A meeting.

Galderma, a Swiss-based dermatology company that the United States Food and Drug Administration (FDA) has granted breakthrough therapy designation to its investigational therapy, nemolizumab.

A drug discovery company based in the United Kingdom, Lunac Therapeutics, has been awarded funding worth £3.14 million (US$4.11 million) under Innovate UK’s Biomedical Catalyst program.

Catalent and Ethicann Pharmaceuticals have announced a partnership aimed at developing a new combination pharmaceutical-grade CBD and THC product to treat MS spasticity using Catalent’s orally disintegrating tablet technology.

BioMed X has announced the successful completion of its first joint research project in the fields of COPD and IPF that it had undertaken with Boehringer Ingelheim.

CPI has partnered with ImmunoBiology (ImmBio) for the development of a heat-stabilized formulation of a mutli-antigen vaccine candidate against Pneumococcal diseases.

Nearly four decades after the first diagnosis, the fight to treat HIV/AIDs continues.

Spray drying is a versatile and rapid technique that can provide companies with a suitable and scalable option to improve the solubility and bioavailability of drug products.

BASF launches digital solutions for the pharma industry during CPhI Worldwide 2019.

The agreement paves the way for GSK’s specialty HIV company, ViiV Healthcare, to develop a broadly neutralizing antibody, N6LS, for HIV treatment and prevention.

The companies have entered into a clinical and commercial agreement to use MaxCyte’s ExPERT platform to enable development of up to five of Vor’s engineered cell therapies.

A simulation-based drug discovery company, Turbine, has announced the closing of an institutional funding round worth EUR 3 million (US $3.3 million), which will be used to redesign the oncology drug discovery process.

GE Healthcare Life Sciences will supply Akeso Pharmaceuticals with the FlexFactory platform to accelerate production of antibody drugs in the Guangzhou region.

Through the agreement, Samsung will provide flexible business terms while offering full regulatory support and improved batch release from small to large scale.

Several factors must be considered when reformulating APIs for pediatric, geriatric, and other specialty patient populations.

Palatability is crucial for adherence and compliance to oral drug regimens.

Takeda Pharmaceutical Company has acquired an exclusive global license from COUR Pharmaceuticals for the development and commercialization of an investigational celiac disease therapy.

CHMP has recommended that Ervebo (rVSVΔG-ZEBOV-GP), a vaccine for active immunization against Ebola, be granted conditional marketing authorization in the EU.

CHMP has recommended that Baqsimi (glucagon), a non-injectable treatment for severe hypoglycemia, be granted marketing authorization in the EU.

A complete understanding of primary packaging physicochemical properties is necessary in the formulation and development of biologics.

Sarah Hardison, head of Regulatory and Pharmacovigilance Solutions, Clarivate Analytics, will regulatory tackle trends in her presentation on the World of Pharma Podium during the second day of CPhI Worldwide.

GammaDelta Therapeutics has unveiled the formation of a new spin-out company, Adaptate Biotherapeutics, aimed at developing antibody-based therapies that modulate gamma delta T-cells.

Lonza, through its Ibex Solutions, will now cover preclinical and clinical development and manufacturing for a significant portion of Genmab’s pipeline.

The agency announced that FDA scientists have developed candidate vaccine viruses that may be used to produce influenza vaccines.

The companies will collaborate to identify and develop in-vivo genome editing therapeutic candidates for genetic diseases, including hemophilia.

CPI, the University of Strathclyde, GSK, and AstraZeneca Collaborate on a continuous direct compression digital twin for pharmaceutical formulation optimization.

Developer of software for drug discovery, Optibrium, has announced in an Oct. 10, 2019 press release the introduction of its Augmented Chemistry services, which incorporate artificial intelligence technologies to help guide drug discovery.

The collaboration focuses on baculovirus/Sf9 expression system for Prevail's pipeline of novel AAV9-based gene therapy programs neurodegenerative diseases.

The new services provide rapid production of antibody drug conjugates (ADCs) for best candidate selection.