Formulation and Drug Delivery

Threshold Pharmaceuticals' anticancer drug TH-302 receives FDA Fast Track designation.

ANSM wants company data on the benefits and risks of using Avastin over Lucentis in the treatment of wet age-related macular degeneration.

Catalent Pharma Solutions announces additional packaging and storage space for highly potent and cytotocix drugs at Kansas City facility.

AstraZeneca announced a partnership with Pharmacyclics and Janssen for combination trials of MEDI4736 (AstraZeneca) with Imbruvica (Pharmacyclics and Janssen) for the treatment of hematologic cancers.

Spectranetics announced that it acquired Covidien's drug-coated balloon platform, Stellarex, for $30 million.

Manufacturers face regulatory overhaul, while brand-generic debates escalate over biosimilars and labeling changes.

The author reviews the challenges in delivering macromolecule biologics.

Measuring syringe plunger force using a texture analyzer instrument.

This review highlights relevant physicochemical drug properties and formulation design considerations critical to quality and performance of the sublingual tablets.

The European Union takes the lead in a global pilot project on the marketing approval of generic medicines, highlighting the challenges of achieving consensus among different nations.

Amgen is suing Sandoz over Sandoz's biosimilar application for filgrastim.

Sigma-Aldrich's custom manufacturing services business unit, SAFC, has launched a new protein quality supplement for biological drug production, including biosimilars.

Bristol-Myers Squibb announced that they have reached an agreement with F-star Alpha, giving BMS the exclusive option to acquire F-star's HER2-targeted breast and gastric cancer treatment.

The divestment will create the number two player in the global influenza vaccine industry.

GSK's investigational Ebola vaccine is in Phase I safety trials.

Johnson& Johnson is collaborating with WHO and others on clinical testing, development, production, and distribution of an Ebola vaccine.

The agency recommends that companies developing drugs to treat Ebola apply for orphan drug designation.

Manufacturers using highly potent APIs must examine cross-contamination routes and determine acceptable limits.

IDT Biologika completes large-scale biologics finishing facility in Dessau, Germany.

The total market for biopharmaceuticals in 2013 was $36.8 billion according to Kalorama Information. Meanwhile, Frost & Sullivan estimates that the biosimilars market, which it pegged at just $1.2 billion in 2013, will grow to $23 billion in 2019, or more than 20-fold increase.

Pharmaceutical Technology Europe spoke with Piero Iamartino, R&D director at Micro-Macinazione, about the role of micronization in pharmaceutical manufacturing.

LABOCHIM SpA completes construction on multipurpose high-potent API plant in Milan.

Demand for new therapies and vaccines spotlights production challenges.

Weighing the pros and cons of hot-melt extrusion and spray drying.

Regulatory agencies in Europe are working to harmonize the marketing approval pathway of generic medicines.