News

Biotest Pharmaceuticals Corporation announced that Bivigam [immune globulin intravenous (human), 10% liquid] is now available in the pharmaceutical distribution channel for use by physicians, pharmacists and hospitals throughout the US. Bivigam is a sugar-free, glycine stabilized intravenous immune globulin that has been approved by the FDA in December 2012 for the treatment of patients with primary humoral immunodeficiency (PI).

Heated magnetic nanoparticles consisting of a liposome nanocontainer with superparamagnetic iron oxide nanoparticles are among the recent advances in nano-based drug delivery.

Pharma companies intensify R&D efforts to address treatments for neglected tropical diseases in the developing world.

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 has released a list of more than 50 guidance documents planned for 2013.

Shire announced that it has reached an agreement in principle with the US government to resolve the previously disclosed civil investigation into its sales and marketing practices in the US relating to the company's attention deficit hyperactivity disorder (ADHD) drugs, Adderall XR and Vyvanse as well as the ADHD patch Daytrana.

GlaxoSmithKline has increased its stake in its Indian subsidiary, GlaxoSmithKline Consumer Healthcare Ltd, from 43.2% to 72.5%.

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%.

The European Commission claims that Johnson & Johnson and Novartis may have breached European antitrust rules.

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

Two general chapters on elemental impurities? limits and procedures are to become official Feb. 1, 2013, with implementation proposed for May 1, 2014.

Endo Pharmaceuticals and GVK Biosciences (GVK BIO), a contract research organisation (CRO) based in India, have entered into an agreement to collaborate on the development of small molecules targeting an undisclosed protein. Using its discovery expertise, GVK BIO will deliver a clinical candidate and Endo will be responsible for the development and commercialisation of the product.

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

Ben Venue Laboratories announced that it has voluntarily entered into a consent decree with FDA over violations of cGMP.

GlaxoSmithKline has formed a joint venture with Indian vaccines company Biological E to research and develop a six-in-one combination pediatric vaccine to help protect children in India and other developing countries from certain infectious diseases.

AstraZeneca and Ceram Research, a materials development company based in the UK, have signed an agreement whereby Ceram will develop its inorganic-based controlled release technology in a feasibility study for delivering select AstraZeneca compounds.

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.

Allergan and MAP Pharmaceuticals have entered into a definite merger agreement under which Allergan will purchase all of MAP?s outstanding shares for the price of $25.00 per share.

According to the Federal Trade Commission, the number of potentially anticompetitive patent dispute settlements between branded and generic drug companies increased between 2011 and 2012.

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.

Rutgers engineers constructed a direct compaction line in collaboration with Janssen.

FDA has issued a Warning Letter to Hameln Pharmaceuticals GmbH after observing "significant" cGMP violations for finished pharmaceuticals at the company?s facility in Hameln, Germany.

With so many blockbuster drugs falling off the patent cliff, research-based drug companies are now embracing new development paradigms to increase R&D productivity.

FDA has released Guidance for Industry: Abuse-Deterrent Opioids?Evaluation and Labeling, Draft Guidance

Lonza will invest CHF 14 million ($15.1 million) to double the existing large-scale manufacturing capacity in Visp, Switzerland.

The European Medicines Agency has revised its guideline for the evaluation of anticancer medicinal products.