Drug Development

The new reagents are designed to support clinical-phase and commercialization stages of cell and gene therapy production and to enhance DNA transfection.

Orphan and cancer drugs continue to lead, but treatments for many common diseases were also approved in 2018.

Shortages of life-saving drugs are a regulatory and industry concern. Proper process development may help to ensure drug supply.

While pharma is proving its capabilities to develop novel therapies, the industry still needs to work on manufacturing innovation.

Keeping valuable employees happy-and on the job-may test bio/pharma business decisions.

New approaches seek to address formulation and delivery challenges for these complex molecules.

Intellectual challenge, work/life balance, compensation, and an unclear business outlook create uncertainty among European bio/pharma employees.

Teva Pharmaceuticals and Neos Therapeutics entered into a settlement and licensing agreement to resolve all ongoing litigation involving Neos' patents protecting its Cotempla (methylphenidate) extended-release orally disintegrating tablets.

A report from GlobalData, a data and analytics company, reveals the predicted role of immuno-oncology drug development and personalized medicine in the pharmaceutical industry in 2019.

The companies will develop a digital platform for the development and lifecycle management of antibiotics.

The companies aim to advance research into inflammatory bowel disease.

AbbVie will grant Pfizer license to launch a biosimilar to AbbVie’s Humira worldwide.

Boehringer Ingelheim plans to develop and test new strategies at its Solids Launch facility.

Transdermal patch design, materials, and manufacturing variables, as well as drug formulation and interactions between the API and the adhesive, can affect adhesion and drug delivery.

Virpax’s Patch-in-a-Can technology delivers pain medication using a metered-dose spray film.

Using training devices may ease patient anxiety about using autoinjectors and prefilled syringes, potentially leading to improved patient adherence.

FDA Commissioner Scott Gottlieb has been promoting drug market competition in recent months that includes new guidance documents and targeted advisories to support R&D of complex drugs and combination products.

The acquisition will give Genentech full rights to Jecure’s preclinical portfolio of NLRP3 inhibitors.

Charles River Laboratories has announced a data expansion in its compendium of tumor models for oncology drug R&D.

A new, high-throughput microplate reader cuts down on screening time and works faster than standard ultra-high-performance liquid chromatography processes.

The contract research organization has increased its US-based early phase clinical capacity and doubled its specialty lab space.

The new center will integrate biologics drug discovery, development, clinical manufacturing, and commercial manufacturing.

ADC Biotechnology will invest downstream formulation, fill/finish capabilities, and Lock-Release conjugation technology.

The testing of raw materials is essential as raw material quality determines the outcome of biologic product quality.

Experts believe that the contract development and manufacturing organization market will reach $17.38 billion by 2022, with disruptive business models using Industrial Internet of Things (IIot) and single-use technologies proving more profitable and efficient in the long term.

More-and earlier-interaction between R&D and payers will be essential if innovative therapies are to become more accessible for patients, and more profitable for manufacturers, said panelists at the 2018 Galien Foundation Forum.

Formulation issues cause significant drug project delays and project failures, according to a 2018 survey conducted by Informa Pharma Intelligence, Rentschler Biopharma, and LEUKOCARE.

The decision follows an FDA request for additional information to complement the company’s submission for biosimilar rituximab.

AbbVie will grant Momenta license to launch a biosimilar to AbbVie’s Humira.

The multi-year collaboration will incorporate NextCure's proprietary FIND-IO platform, a technology designed to identify novel cell-surface molecular interactions that drive functional immune responses in the tumor microenvironment and other disease sites.