Dosage Forms

Johnson & Johnson’s Janssen partners with Bristol-Myers Squibb to advance next-generation therapies for cardiovascular diseases.

The agency has granted breakthrough therapy designation to Roche’s hemophilia therapy for treating hemophilia A in patients without factor VIII inhibitors.

INTERPHEX presents advances in pharmaceutical container filling, robotic handling, and serialization.

Sartorius Stedim Biotech will supply equipment for Penn State’s new Fermentation Facility in the university’s Center of Excellence in Industrial Biotechnology.

The new facility, to be built in Toronto, Canada, will significantly increase capacity for pediatric and booster vaccines.

New filling and inspection machines and new containers and closures for injectable drugs will be on display at INTERPHEX 2018.

The biopharmaceutical firm has chosen Rhode Island as the site of its next-generation biomanufacturing plant, which will offer flexibility, speed, and efficiency.

The new 300,000-square-foot facility is considered the largest dedicated cell and gene therapy manufacturing facility with fully integrated services.

Roche has acquired a program to develop regenerative therapies for multiple sclerosis.

Under this global collaboration, the companies will develop encapsulated cell therapies for treating Type 1 diabetes.

Celltrion received complete response letters from FDA for its rituximab and trastuzumab biosimilars.

Anthony Qu, PhD, vice president of Scientific Affairs at Halo Pharma, will give a presentation on fixed-dose combination products, drug products containing multiple active ingredients, as an effective approach for simplified dosing at CPhI North America on Wednesday, April 25, 2018 in Philadelphia, PA.

Boehringer Ingelheim and OSE Immunotherapeutics have entered a global immuno-oncology partnership to develop a checkpoint inhibitor for treating advanced solid tumors.

Colorcon Inc. and Applied DNA signed a supply agreement granting Colorcon exclusive right to use Applied DNA’s SigNature molecular tags in film coatings for solid oral dosage forms, and non-exclusive rights to use it in inks and colorants for SOD pharmaceuticals.

The companies have created Syna Therapeutics, a joint venture that will develop biosimilars and new molecules.

The European approval marks the first approval for a biosimilar in that region resulting from the companies’ joint portfolio.

Fujifilm acquires cell culture media companies Irvine Scientific Sales Company and IS Japan.

The active pharmaceutical ingredient and excipient provider has expanded its parenteral ingredient manufacturing capacity and lab services.

A new scientific publication examines analytical processes for the emerging legal cannabis industry.

The agency has accepted AstraZeneca’s biologics license application for an investigational leukemia drug candidate and granted it priority review.

Pfizer transfers CAR-T assets to Allogene Therapeutics under a new alliance to further develop immuno-oncology therapeutics.

Particle engineering using jet milling or spray drying can be used to obtain appropriate particle characteristics for inhalation drug products.

Access to multiple analytical techniques is essential for fully characterizing complex protein formulations.

Accelerated development of new preventives raises challenges for efficient CMC evaluation and production.

The high viscosity of highly concentrated monoclonal antibody formulations not only presents processing and storage difficulties, but also formulation and delivery challenges.

Researchers at MIT have discovered a new set of compounds that do not elicit a foreign body response when implanted. These biomaterials permit the development of a new category of treatment with the ability to deliver therapeutics either at a constant rate or under programmable conditions by using implantable cells as protein factories.

The companies will co-develop and co-promote a CAR T cell therapy in the United States.

Novartis’ Sandoz is seeking approval of its biosimilar referencing Johnson & Johnson’s Remicade (infliximab) for all of Remicade’s indications across gastroenterology, rheumatology, and dermatology.

EMA has recommended approval of the biosimilar for the same indications as Roche’s Herceptin (trastuzumab).

The delivery device and drug form should be considered when choosing a test method for identifying and measuring particulates.