Pharmaceutical Technology Editors

Merck and Samsung Bioepis have formed an agreement to develop and commercialize multiple prespecified and undisclosed biosimilar candidates.

Biopharmaceuticals – the major source of new medicines and a key knowledge industry for the future – faces another rough year from empowered payers as it makes its slow passage to a renewed product base.

Mylan has entered into a definitive agreement with Biocon Limited for an exclusive collaboration on the development and commercialization of generic versions of three insulin analog products.

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

Biogen Idec has agreed to acquire full Tysabri rights from Elan, and will use its existing cash reserves to make a payment of $3.25 billion to Elan upon the closing of the transaction and make future contingent payments to Elan.

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.

The latest news from the pharmaceutical regulatory community.

The ongoing economic crisis in Europe has accelerated healthcare cost-containment measures targeting the price of pharmaceuticals, but the pharma industry is not giving in without a fight.

Pfizer has reported financial results for fourth-quarter and full-year 2012. Fourth-quarter 2012 revenues were $15.1 billion, a decrease of 7% compared with $16.1 billion in the year-ago quarter, which reflects an operational decline of $802 million, or 5%, and the unfavorable impact of foreign exchange of $271 million, or 2%.

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

EMA announces collaboration with Israel, and USP updates chapter on elemental impurities.

Following its recent acquisition, Actavis (formerly Watson Pharmaceuticals) unveiled its long-term growth strategy during its investor meeting in New York.

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

FDA has approved Protein Sciences's FluBlok, a seasonal influenza vaccine made with novel technology. FluBlok uses recombinant DNA and a modified baculovirus (a virus that infects insects) to produce a safe and effective human flu vaccine. FDA approved Flublok for people 18–49 years old.

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

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.

FDA celebrates 30 years of the Orphan Drug Act.

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

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.

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

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

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

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

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.