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The European Medicines Agency's Committee for Orphan Medicinal Products made recommendations for nine orphan drug designations during its June 2012 meeting. Included in COMP's recommendations were four designation applications for rare forms of lipodystrophy.

The European Federation of Pharmaceutical Industries and Associations has called for the German government to take "urgent action" regarding its pricing system, which is perceived as hindering the market entry of new, innovative medicines in the country.

Eli Lilly announced an increase in its manufacturing network in China through an expanded collaboration with Novast Laboratories, a generic and specialty pharmaceutical company based in Nantong, China.

The National Institutes of Health have gained the participation of Abbott, Bristol-Myers Squibb, GlaxoSmithKline, Janssen Pharmaceutical Research & Development, and Sanofi in their effort to advance new therapeutic research.

European and US associations call for continued vigilance against the threat of counterfeit medicines.

Dr. Reddy's Laboratories and Merck Serono, a division of Merck KGaA, have partnered to codevelop a portfolio of biosimilar compounds in oncology.

Takeda Pharmaceuticals announced that it has completed the acquisition of URL Pharma for an upfront payment of $800 million.

The new guide outlines potential product life-cycle approaches to the change-management system of a pharmaceutical quality system.

The United States Pharmacopeia has stated that references to General Chapter <911> "Viscosity" will be changed to General Chapter <911> "Viscosity-Capillary Viscometer Methods," <912> "Rotational Rheometer Methods," or <913> "Rolling Ball Viscometer Method."

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has welcomed the launch of a EUR 223.7-million ($276.5 million) program to tackle antimicrobial resistance and speed up the development of new antibiotics.

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.

AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Janssen Pharmaceutica NV, Merck Serono, and Pfizer have pledged support of more than £14 million ($23 million) to a translational drug development project being run by the UK's Medical Research Council and the University of Dundee.

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.