News

At the request of FDA, the IOM prepared a report containing recommendations for how FDA might better monitor the safety of drugs after they have been approved.

FDA has issued Warning Letters to 10 companies that manufacture and distribute dietary supplements that contain dimethylamylamine, also known as DMAA. FDA cited the companies for marketing the supplements without submitting evidence that the products are safe.

In a move designed to increase its international presence, Watson Pharmaceuticals has agreed to acquire Actavis for EUR 4.25 billion ($5.62 billion).

Merck KGaA has revealed further details about its previously announced restructuring program, including plans to eliminate approximately 580 jobs.

GlaxoSmithKline has reached an agreement to divest certain over-the-counter brands in selected territories to South Africa's Aspen Pharmacare Holdings for approximately $264.7 million.

The European Commission is offering a EUR 2-million ($2.64 million) inducement prize to encourage innovation in the area of cold-chain logistics and vaccine stability.

FDA Reports Improvement in Drug Oversight.

A new report by FDA details the strategies, programs, and other activities the agency is using to address the rise of imported pharmaceutical products and APIs.

FDA has released a final guidance describing cGMP for preparing media fills for validation of aseptic preparations for positron emission tomography (PET) drugs. Most PET drugs, which are used for imaging, are given parenterally, and produced by aseptic processing. PET drugs came under the auspices of FDA relatively recently, with the passage of the 1997 Food and Drug Administration Modernization Act, and minimum cGMP standards for this class of drugs were established in 2009. A guidance for preparing new drug applications and abbreviated new drug applications for PET drugs was issued in March 2011, and in comments to the March 2011 guidance and in questions raised at the public meeting, stakeholders requested that FDA provide guidance on media fills for validation of aseptic preparation for PET drugs. This most recent guidance is designed to help manufacturers of PET drugs comply with FDA regulations.

Illumina has sent a fourth letter to shareholders urging them to reject Roche?s offer of $51 per share, which Illumina claims is opportunistic and undervaluing the company. In addition, the letter urges shareholders to vote against the candidates that Roche has nominated for election to Illumina?s board of directors. The election will take place at the board?s general meeting on Apr. 18, 2012.

US spending on prescription drugs increased moderately in 2011 reflecting increased generic-drug incursion and lower spending on prescription drugs. Pfizer retained its number one position of the top company of US prescription drug sales, and the generic-drug company Teva Pharmaceutical moved into the top-five companies of US prescription drug sales.

Johnson & Johnson announced this week that Sheri S. McCoy, vice-chairman of the Executive Committee, has resigned from the company. She was considered to be in line for the CEO position, being filled by Alex Gorsky.

Generic-drug incursion and reduced demand contribute to modest gains.

On Mar. 29, 2012, the Generic Pharmaceutical Association (GPhA) reiterated its call for Congress to move forward with user-fee proposals for generic drugs and biosimilar products.

The Management Board of the European Medicines Agency (EMA) has introduced a range of new measures to strengthen and extend its conflicts of interest (COI) policy for scientific-committee members and experts, as well as for members of the management board.

An initiative in the UK will invest £75 million ($120.2 million) into translational science, with the aim of transforming biological understanding into clinical impacts that will benefit patients and the UK economy.

The European Medicines Agency (EMA) has released guidance that outlines a European-wide approach for dealing with transparency and access to information included in marketing authorization applications.

A US court has denied AstraZeneca?s request for a preliminary injunction against FDA.

On Mar. 13, 2012, FDA issued a Warning Letter to Steven Victor, CEO of IntelliCell Biosciences for a violation of the Food, Drug, and Cosmetic Act (FD&C Act), and for violations of cGMP and Good Tissue Practice (GTP) in the manufacture of its adipose tissue-derived stem-cell product.

The National Institute for Bioprocessing Research and Training (NIBRT) in Ireland and Waters are partnering on training and research to increase large-molecule characterization capacity and knowledge, according to an NIBRT press release.

GlaxoSmithKline (GSK) plans to invest more than £500 million ($798 million) in the United Kingdom across its manufacturing sites to increase production of key active ingredients for its pharmaceutical products and vaccines.

GlaxoSmithKline (GSK) is launching a new program that will create apprenticeships in several areas including manufacturing and R&D at the company’s United Kingdom sites.

On Mar. 12, 2012, FDA released a draft guidance document for industry direct-to-consumer (DTC) television advertisements that describes FDA?s plans for implementing predissemination review.

The European Medicines Agency (EMA) has launched a pilot program for submitting centralized marketing authorization applications electronically.

On Mar. 7, 2012, GE Healthcare announced an agreement to acquire Xcellerex, a supplier of manufacturing technologies for the biopharmaceutical industry, for an undisclosed amount.

GlaxoSmithKline (GSK) and Daiichi Sankyo have formed a joint venture that they claim will create the biggest vaccines company in Japan.

Boehringer Ingelheim (BI) has announced in a press release the expansion of its biopharmaceutical manufacturing capabilities at its plants in Biberach, Germany and in Vienna, Austria.

Excellence United, an alliance of six specialty equipment companies, will make its first North American appearance at INTERPHEX 2012, held May 1–3 at the Javits Center in New York.