Formulation and Drug Delivery

The US Senate and the US Pharmacopeial Convention debate the necessity of monographs for biologics.

The biosimilar, Kanjinti, is approved for all indications of Herceptin, which includes treating breast, gastric, and gastroesophogeal cancers.

The agency is adding data points to its Paragraph IV Patent Certifications List, which provides brand exclusivity information, in order to help generic-drug applicants determine if their product can be approved and marketed.

Centre for Process Innovation (CPI) is set to host an event in Darlington, UK, on June 26, 2019 to showcase the results of a £11.2-million (US$14.03-million) collaborative project to optimize biotherapeutic development.

Two additional production lines expand Lonza’s HPAPI capacity at Visp, Switzerland facility.

The Michelson Medical Research Foundation and the Human Vaccines Project have awarded three young scientists $150,000 for their novel approaches toward human immune system research.

The acquisition will boost Biogen’s gene-therapy pipeline with the addition of two mid- to late-stage clinical assets and preclinical programs.

EMA has opened a three-month consultation on its draft guidelines on the quality of requirements for drug-device combination products.

European midmarket private equity group, Duke Street, has agreed to acquire Kent Pharmaceuticals and Athlone Laboratories from DCC Vital.

Excipients and new processing techniques can make a real difference in the development of highly potent therapies.

Exploration of various formulation techniques is vital to provide effective delivery of poorly soluble drugs.

Discussing the advantages, limitations, and recent advances of HME with experts from AbbVie.

A connected MDI may encourage compliance and aid proper technique.

Wearable and smart devices allow user-friendly subcutaneous drug delivery.

Prestige BioPharma has announced that the EMA has accepted its marketing authorization application for HD201 (Tuzune) for review.

CDMO, Vibalogics, has revealed that it will be acquired by a private equity firm, Ampersand Capital Partners.

Nanobiotix has launched Curadigm, a spinoff company that will specialize in developing a nanotechnology platform for healthcare applications.

MilliporeSigma awarded its Advance Biotech Grant to three US companies that are focused on traumatic brain injury, vaccine development, and chronic pain.

The company says it will work with payers to create payment options for its recently approved gene therapy, Zolgensma (onasemnogene abeparvovec-xioi), priced at $2.125 million.

By connecting manufacturing processes and logistics technology, GE Healthcare and World Courier look to accelerate the development of advanced therapies.

A new partnership is aiming to advance the use of sublingual delivery technology for challenging drugs.

The agency has approved Zolgensma (onasemnogene abeparvovec-xioi), the first gene therapy to treat pediatric spinal muscular atrophy.

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.

Medherant has announced that it is the recipient of a new £2-million (US$2.5-million) investment from Mercia Technologies.

The agency updated its list of recommended influenza virus strains that manufacturers should include in vaccines for the autumn 2019 season.

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.

Catalent expands gene therapy capabilities with $1.2-billion acquisition of Paragon Bioservices.

WHP has been awarded with the design contract for the United Kingdom’s first dedicated vaccines manufacturing innovation center (VMIC).