Formulation and Drug Delivery

Novartis’ Sandoz resubmitted its biologics license application (BLA) for a proposed biosimilar pegfilgrastim to FDA in response to a 2016 complete response letter from the agency.

Pharmaceutical Technology and BioPharm International will present a Keynote Session on Meeting Bioprocessing Manufacturing Capacity Demands on Wednesday, April 3, 2019, during INTERPHEX 2019 at the Javits Center in New York City.

The acquisition is expected to expand CURE Pharmaceutical’s technology platform in oral drug delivery.

Characterizing particles and understanding bulk powder behavior is critical to get the best pharma product.

Intracellular strategies offer an effective alternative approach to deliver a range of therapeutic proteins.

It is important to address manufacturing problems associated with the shorter shelf-life of pegylated L-asparaginase (pegaspargase) upon long-term storage in the form of a solution.

Confidence in the quality systems and scientific competence of the API manufacturing team is essential.

Easier access to information, targeting smaller patient populations, and increased regulatory focus on patient outcomes are driving patient‑centric drug development.

Flexibility and well considered manufacturing approaches could help tablet manufacturers face the increasing pressure resulting from the shifting bio/pharma development landscape.

Market demand and regulatory guidance continues to promote improved medication design.

Laboratory testing found that a novel approach reduced the time required for sample preparation from hours to minutes. This article summarizes test methods and results.

Modified-release oral dosage forms can offer benefits to both formulation scientists and patients.

Researchers at the Georgia Institute of Technology developed a technique for administering contraceptive hormones through ‘pharmaceutical jewelry’.

The organizers of Pharmapack Europe have revealed their prediction that the drug delivery and healthcare packaging industry will experience significant growth during 2019.

Alcami Biologics formed to meet market demands for biological drug development services.

Catalent announces investment for its Zydis ODT technology, offering increased drug load and taste-masking capabilities.

The company received $4.8 million from the Bill & Melinda Gates Foundation to accelerate global health research in the development of vaccines and antibody-based treatments for infectious diseases.

The agency prioritized the review of the generic angiotensin II receptor blocker to help relieve the shortage of valsartan due to recent recalls.

Procarta Biosystems has received investment from Novo Holdings REPAIR Impact Fund to the tune of €1.5 million, which will be used to develop a new class of antibiotics to tackle AMR.

FDA Commissioner Gottlieb released a statement on the agency’s efforts to refine the naming convention for biosimilars to balance competition and to help ensure patient safety.

Janssen’s Spravato (esketamine) gains approval with restricted distribution guidelines.

Hetero Labs recalls losartan potassium tablets due to presence of N-Nitroso-N-methyl-4-aminobutyric acid.

The companies will use GeoVax’s vaccine technology to develop malaria vaccine candidates.

The acquisition will establish a clinical pipeline for Biogen of gene-therapy candidates in ophthalmology.

Do patients get what they pay for when they demand cheaper drugs?

Understanding the API, delivery mechanism, and excipient functionality is essential to solving drug solubility challenges.

Bio/pharma companies facing new challenges in light of the increasing HPAPI market may benefit from outsourcing.

As biologics continue to push boundaries, the industry needs to take a holistic approach to formulation to ensure success.

Harmonization of best practices and regulatory requirements will enable developers to find the best stability testing approach.

Containment valves and smart monitoring can keep employees safe and improve manufacturing efficiency when handling potent APIs, intermediates, and solid-dosage drugs.