News

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.

Magnetic separation equipment reduces ferrous metal contamination.

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FDA has issued a draft guidance to assist applicants in the submission of summary-level clinical-site data.

Pfizer has agreed to pay USD 55 million plus interest to settle charges that Wyeth (acquired by Pfizer in October 2009) improperly promoted the drug Protonix (pantoprazole).

Amgen Agrees to Acquire deCODE Genetics; Baxter International Agrees to Acquire Gambro; and More.

Roche and the Innovative Medicines Initiative (IMI) have recently launched an academic-industry partnership, known as STEMBANCC, under which 10 pharmaceutical companies and 23 academic institutions will collaborate on using stem cell technology to accelerate the development of safer and more effective drugs for patients.

The US Supreme Court accepted an appeal by the Federal Trade Commission of a decision that upheld an arrangement of payments by Solvay Pharmaceuticals to generic drug companies to postpone introduction of generic versions of its branded testosterone-replacement drug.

Biogen Idec and Isis Pharmaceuticals announced that they have entered into a global collaboration agreement to discover and develop antisense drugs against three undisclosed targets to treat neurological or neuromuscular disorders.

The Court of Justice of the European Union has dismissed an appeal by AstraZeneca concerning a 2005 decision that found the company guilty of abusing its dominant position in the marketplace.

Biogen Idec Opens New RTP Facility; Tekmira, Marina Biotech Enter into License Agreement for UNA Technology; and More.

MeadWestvaco is recognized at CPhI for its sustainable pharmaceutical packaging.

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

FDA releases guidance documents on PET drugs, labeling of OTC sunscreen, and the use of certain phthalates as excipients.

Myriad Genetics reports that the US Supreme Court has granted certiorari agreeing to hear the company's gene patentability case.

The company issues voluntary recall of certain lots due to possible contamination with small glass particles.

The European Medicines Agency has published a plan to help Europe?s regulatory network prevent, mitigate and manage shortages of important medicines following manufacturing problems.

Eli Lilly released its annual report containing updates on progress and new initiatives in corporate responsibility.

As the battle against counterfeits gains momentum, PharmTech speaks to Mark Davison, CEO of Blue Sphere Health, and Craig Stobie, global life sciences sector manager at Domino Printing Sciences, about the challenges involved.