Dosage Forms

A new technical report guides bio/pharma companies in establishing a risk-based approach for prevention and management of drug shortages.

Assessing risk factors is key to implementing the new ICH Q3D guidelines for elemental impurities.

While the skin offers an alternative route of administration for local and systemic drug delivery, developing semi-solid dosage forms can be a challenge.

A General Chapter on mAbs will be published in USP-NF as biologics increase their role in healthcare.

It is vital that companies involved in the manufacturing and handling of cytotoxic drugs ensure that staff are given the highest possible levels of protection.

FDA announced that it would postpone a meeting that would be critical for the advancement of Celltrion’s Remicade biosimilar in the US.

Remsima will now be available for patients in 12 additional countries in the European Union.

Enclosures contain powders and particulates during hazardous drug manipulation.

Aprecia Pharmaceuticals' new facility in Ohio will create 150 jobs.

Bristol-Myers Squibb announced that it reached an agreement to acquire Flexus Biosciences and has entered into a $309-million partnership with Rigel Pharmaceuticals.

Celltrion announced that its Remicade biosimilar, Rensima, could save France, Italy, and the UK up to €336 million in costs to treat Crohn’s disease.

The Berlin-Buch facility will begin manufacture of the company’s immune cell therapy.

The all-synthetic 3M Emphaze AEX Hybrid Purifier contains both an anion-exchange nonwoven media and a fine-particle, bioburden reduction membrane.

MG America's TEKNA Capsule Filler has advanced controls to reduce powder loss and maintain optimal performance.

Hospira’s Inflectra (infliximab), a biosimilar for Remicade, is approved by the European Commission.

The ongoing battle over drug reimbursement and pricing has raised questions about whether the pharmaceutical industry can continue to rely on high United States revenues to fund biopharmaceutical R&D.

The Center for Drug Evaluation and Research seeks a more flexible system for assessing biotech product quality.

Pfenex announced that it entered into an agreement to partner with Hospira on the development and commercialization of PF582, a biosimilar candidate to Lucentis.

Amgen announced that it met primary and secondary endpoints in its biosimilar evaluation of adalimumab for the treatment of rheumatoid arthritis, when compared to Humira.

Sanofi launched a rapidly absorbed, short-acting inhalable insulin in the US to help control type 1 and type 2 diabetes.

Mylan announced a partnership with Theravance Biopharma to develop and commercialize TD-4208, a novel investigational COPD treatment.

The 2016 White House Budget proposes a change to the data exclusivity period for biologics and the authority to influence drug pricing.

Tooling can be damaged by poor handling or problems in process design or material choice.

Ligand-binding assays are fundamental to characterizing biosimilars.

EMA is under pressure to exert even tighter standards on biosimilars being marketed in Europe.

Market forces may limit the success of CMOs.

Working with biological matrices and understanding the intended use are crucial.

New guidelines focused on the materials of construction in biologic therapy packaging will help vendors prepare comprehensive extractable and leachable testing strategies.

CMO executives share their opinions on where outsourcing is going and what is driving market change.

After launching a new mammalian cell platform, FUJIFILM Diosynth Biotechnologies U.S.A., has acquired fast-track vaccine manufacturing knowhow and a major presence in Texas’ emerging biocorridor with Kalon, its first acquisition.