Pharmaceutical Technology Editors

Vetter launches new serialization process to support track-and-trace efforts.

Baxter announces plans to split into two independent companies by mid-2015.

Pfizer intends to submit a biologics license application for its investigational Meningococcal B vaccine candidate, Bivalent rlp2086, to FDA by mid-2014.

Adocia has reported positive results for the first clinical trial of its combination insulin formulation of fast- and long-acting insulin in patients with type I diabetes. Results showed that BioChaperone Combo provided both short- and long-term control of blood glucose in type I diabetic patients, with a faster onset and a longer duration of action.

Novartis has launched the prefilled syringe formulation of Lucentis (ranibizumab) in Germany, with other markets to follow throughout 2014. The prefilled syringe formulation has been specifically designed for intraocular injection to enhance patient safety and convenience for the treating clinician.

Aesica has successfully completed the validation of its high capacity manufacturing facility in Queenborough, UK, for commercial production. The

The Pediatric Praziquantel Consortium has been awarded a research grant from the Japanese Global Health Innovative Technology (GHIT) Fund. The grant will be used to fund the Consortium's clinical development program of a newly developed praziquantel pediatric formulation targeted for use in very young children, including infants and toddlers, infected with schistosomiasis.

Looking to improve patient access to new medicines, EMA creates a pilot project to explore an adaptive licensing approach with real medicines in development.

Charles River Laboratories to acquire CROs Argenta and BioFocus.

FDA approves Eliquis (apixaban) for DVT and PE in patients who have undergone hip or knee replacement surgery.

Catalent will recognize 80 years of softgel advancements with presentations at INTERPHEX.

Walker Barrier Systems builds eight mobile clean rooms for the Texas A&M Center for Innovation in Advanced Development and Manufacturing.

FDA clarifies recommendations for injectable drug products packaged in vials and ampules.

HHS plan makes progress in ensuring availability of safe vaccines.

CPhI report shows R&D market diversifying with increased partnerships, mergers, and revenue sharing models.

Pfizer initiates nationwide voluntary recall of two lots Effexor XR and one lot Greenstone's Venlafaxine HCI.

Agencies extend successful pilot program to further harmonization of QbD topics.

FDA approves the extended-release Bydureon Pen for the treatment of type 2 diabetes.

Novartis calls for more research to understand and find treatments for rare disease.

New guidance from FDA asks for documentation of CMC postapproval manufacturing changes.

Lilly Diabetes supports the American Diabetes Association for the seventh year in a row.

MedImmune and AstraZeneca enter a three-year collaboration with the Clinical and Translational Science Institute at the UC San Francisco.

Discovery of split and broken tablets led to drug recalls.

Experts note hepatitis C screening is important for getting care early.

Moody's Investor Service reports AbbVie, Amgen, and Roche are the most exposed to biosimilar competition.

Almac has added new blistering technology at their US packaging facility in Audubon, PA, as a solution to ease the transition between clinical and commercial launch of blister products.

FDA revises interpretation of the five-year NCE exclusivity provisions for certain fixed-combination drug products.

Daiichi Sankyo announced suspension of API shipments from Ranbaxy's Toansa and Dewas plants; issues apology to stakeholders.

FDA and EMA set up regular meetings to harmonize drug safety actions.

The combined company will create blockbuster product franchises in the central nervous system, gastroenterology, women's health, urology, and cardiovascular therapeutic categories.