News

Federal marshals seized an unapproved topical corticosteroid medication from California-based Crescendo Therapeutics.

Osiris Therapeutics announced that it received marketing authorization from Health Canada to market its stem cell therapy, Prochymal, for the treatment of graft-versus-host disease in children.

The Pharmaceutical Research and Manufacturers of America and Biotechnology Industry Organization released statements last week regarding the Senate's vote to pass the Food and Drug Administration Safety and Innovation Act, which reauthorizes PDUFA.

The US Pharmacopeia has issued a third round of improvements to its blood thinner standard

A recent report from the UK?s All Party Pharmacy Group (APPG) has attributed shortages of prescription medicines in the country to parallel trade and is calling for urgent action.

PDA Revises Technical Report on Sterilized Products

PDA Releases Technical Report on TBA and TCA Odors and Taints

Human Genome Sciences rejects GlaxoSmithKline offer to acquire the company and issues a poison pill to prevent a takeover.

ICH Q11, the anticipated guideline from the International Conference on Harmonization, titled Development and Manufacture of Drug Substances, has achieved international consensus. Q11 has been one of the fastest guidelines to move through the ICH harmonization process.

Senators Max Baucus (D-Mont.) and Chuck Grassley (R-Iowa) send letters to opoid manufacturers and pain groups asking them to disclose financial ties.

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.