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The Center for Drug Evaluation and Research Ombudsman's office released its annual report detailing the common questions and complaints received by the office in 2011. A total of 461 inquiries was received, an increase of 11% from 2010. The majority of inquiries, 60%, originated from industry, with consumers accounting for 23%, healthcare providers 7%, FDA employees 5%, and other 5%.

GlaxoSmithKline tenders offer of $13.00 per share in an unsolicited bid despite an earlier rejection by Human Genome Sciences.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has formally adopted a memorandum of understanding (MoU) with key partners for a harmonised, European system for medicines verification.

FDA issued a final rule on sterility testing on May 3 which amends the requirements for most licensed biological products and aims to provide manufacturers with the flexibility, as appropriate, to keep pace with technological and scientific advances. Many steps are changed or eliminated.

The company receives FDA and EMA approval for expansion of fill and finish operations for alglucosidase alfa.

The UK's Medicines and Healthcare products Regulatory Agency has launched a new anticounterfeiting strategy with the aim of curbing the occurrence of falsified medicines in the county's supply chain.

GlaxoSmithKline has partnered with Yale University to design a potential new class of medicines that could be beneficial in areas such as oncology, inflammation, and infection.

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.

This month, CDER added a new program in drug safety to its "CDER World" platform for regulatory training and education.

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.