News

A roundup of additional company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers.

A roundup of developments in corporate social responsibility (CSR) and sustainability from the bio/pharmaceutical industry, its suppliers, and other public and private organizations.

GlaxoSmithKline partners with the mobile telecommunications company Vodafone to tackle common infectious diseases in Africa.

Shire has signed an agreement to acquire Lotus Tissue Repair, Inc., a biotechnology company developing the first and only protein replacement therapy for the orphan disease, dystrophic epidermolysis bullosa (DEB).

Eli Lilly expects overall revenue growth in the coming year.

FDA celebrates 30 years of the Orphan Drug Act.

The PATH Malaria Vaccine Initiative and Inovio Pharmaceuticals have announced a follow-on collaboration to advance the development of malaria vaccines and new vaccine delivery technologies.

Janssen Pharmaceuticals, Inc. and GlycoVaxyn AG have entered into a three-year agreement to collaborate on the research and development of a multivalent bacterial vaccine utilizing GlycoVaxyn's bio-conjugation technology.

AbbVie, a research-focused, specialty biopharmaceutical company that was spun off from Abbott Pharmaceuticals, was officially launched on Jan. 2, 2013

Mylan, Orion Enter Into Comtan Settlement Agreement; Takeda, Amylin Termination Agreement to Codevelop and Commercialize Compounds for Obesity; and More.

Additional approvals in December have helped to outpace a recent high set in 2011.

The EU fine-tunes legislation for the Falsified Medicines Directive, which is due to take effect this month as part of efforts to better protect patients from counterfeits.

Vaccine manufacturing was predicted in 2008 to be on the cusp of a golden era, but instead the industry has experienced cost pressures, high-profile liability cases and production setbacks.

Chapter 2.9.40 of the European Pharmacopeia is the binding requirement for dosage uniformity. Recently, an additional alternative chapter 2.9.47 has been created titled "Demonstration of Uniformity of Dosage Units using large Sample Sizes".

Tim Freeman of Freeman Technology explains how new analytical technologies have influenced quality criteria and standards for the uniformity of dosage units, and why more accurate systems are leading to greater focus on tablet scoring.

When splitting unscored tablets, the main concerns relate to API dosage control and the potential modification of time-release characteristics. PTE speaks with tableting experts Thierry Menard, Lab Manager, And Bruno Villa, President, both at Medelpharm, about how manufacturers are approaching the challenges.

The US Pharmacopeia (USP) is examining the issue of uniformity of dosage units to address whether scoring yields consistent split doses. Anthony DeStefano, Ph.D., senior vice-president, general chapters and healthcare quality standards, provides an overview of the USP's work in this area.

The management board of the European Medicines Agency (EMA) has endorsed the agency?s work programme and budget for 2013, which includes a budget of EUR231.6 million, a slight increase over 2012.

A University of Connecticut chemical engineering professor received a National Science Foundation grant to study how nanoparticles flow in the bloodstream, which is crucial for their use in drug delivery.

AAIPharma Expands Parenteral Drug Capacity; Novartis Buys Dendreon Plant; and More.

Amgen has agreed to pay $762 million to resolve criminal liability and false claims act allegations.

Mylan issued a voluntary recall of three lots of the painkiller tablets hydrocodone bitartrate and acetaminophen.

Anthrax antitoxin is the first monoclonal antibody approved under FDA's Animal Efficacy Rule, and the first product from BARDA's Project Bioshield to receive FDA approval.

GlaxoSmithKline has formed a partnership with Vodafone to use mobile technology to help vaccinate more children against common infectious diseases in Africa.

The agency recommends to avoid the use of to dibutyl phthalate and di(2-ethylhexyl) phthalate in CDER-regulated drug and biologic products, including prescription and nonprescription products.

Malvern Instruments Opens New Applications Laboratory in Brazil; Roche To Invest in Diagnostics Production in Germany; and More.

BASF extended its offer period to acquire Pronova BioPharma, a producer of omega-3 fatty acids.

Roche's MycoTOOL, which offers rapid detection of mycoplasms based on a polymerase chain reaction (PCR) test, has received FDA acceptance.

Vivalis and Intercell have agreed to the terms of a merger to create a new European biotechnology company called Valneva that will specialize in vaccines and antibodies.

FDA has issued a draft guidance to assist applicants in the submission of summary-level clinical-site data.